UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE TO
TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)
OF THE SECURITIES EXCHANGE ACT OF 1934
ZURA BIO LIMITED
(Name of Subject Company and Filing Person (Issuer))
Warrants to Acquire Class A Ordinary Shares | |
G9TY5A119 |
(Title of Class of Securities) | |
(CUSIP Number of Class of Securities) |
Robert Lisicki
1489 W. Warm Springs Rd. #110
Henderson, NV 89014
Tel: (702) 825-9872
(Name, address, and telephone numbers of person
authorized to receive notices and communications on
behalf of filing persons)
Copies of communications to:
Mitchell S. Nussbaum, Esq.
Giovanni Caruso, Esq.
Andrei Sirabionian, Esq.
Loeb & Loeb LLP
345 Park Avenue
New York, New York 10154
Tel: (212) 407-4000
¨ |
|
Check the box if the filing relates solely to preliminary communications before the commencement of a tender offer. |
Check the appropriate boxes below to designate
any transactions to which the statement relates:
¨ |
|
third-party tender offer subject to Rule 14d-1. |
x |
|
issuer tender offer subject to Rule 13e-4. |
¨ |
|
going-private transaction subject to Rule 13e-3. |
¨ |
|
amendment to Schedule 13D under Rule 13d-2. |
Check the following
box if the filing is a final amendment reporting the results of the tender offer: ¨
If applicable, check the appropriate box(es)
below to designate the appropriate rule provision(s) relied upon:
¨ |
|
Rule 13e-4(i) (Cross-Border Issuer Tender Offer) |
¨ |
|
Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) |
This Tender Offer Statement on Schedule TO
(this “Schedule TO”) is filed by Zura Bio Limited, a Cayman Islands exempted company (the “Company,” “us,”
or “we”). This Schedule TO relates to an offer by the Company to all holders of the Company’s outstanding public
and private warrants that were issued in connection with its initial public offering (collectively, the “ IPO warrants”),
including the public warrants and the private placement warrants to purchase the Company’s Class A ordinary shares, par value
$0.0001 per share (“Class A ordinary shares”), to receive 0.30 Class A ordinary shares in exchange for each
outstanding IPO warrant tendered by the holder and exchanged pursuant to the offer (the “Offer”). The Offer is made upon and
subject to the terms and conditions set forth in the prospectus/offer to exchange, dated July 11, 2024 (as it may be amended and
supplemented from time to time, the “Prospectus/Offer to Exchange”), a copy of which is attached hereto as Exhibit (a)(1)(A),
and in the related letter of transmittal and consent (as it may be amended and supplemented from time to time, the “Letter of Transmittal”),
a copy of which is attached hereto as Exhibit (a)(1)(B).
Concurrently with the Offer, we are also soliciting
consents (the “Consent Solicitation”) from holders of the IPO warrants to amend (the “Warrant Amendment”) that
certain warrant agreement, dated as of July 16, 2021, by and between the Company (as successor to JATT Acquisition Corp, our predecessor
and a Cayman Islands exempted company (“JATT”)) and Continental Stock Transfer & Trust Company (“CST”),
as warrant agent (the “Warrant Agreement”), to permit the Company to require that each IPO warrant that is outstanding upon
the closing of the Offer be exchanged for 0.27 Class A ordinary shares, which is a ratio 10% less than the exchange ratio applicable
to the Offer.
Pursuant to the terms of the Warrant Agreement,
the proposed Warrant Amendment requires the vote or written consent of holders of at least a majority of the outstanding public warrants
and at least a majority of the outstanding private placement warrants that were issued in connection with our initial public offering.
For the avoidance of doubt, the IPO warrants do not include the pre-funded warrants the Company issued in 2023 and 2024.
The information in the Prospectus/Offer to Exchange
and in the related Letter of Transmittal, including all schedules and exhibits thereto, is incorporated by reference herein to answer
the items required in this Schedule TO.
Item 1. Summary Term Sheet.
The information set forth in the section of the
Prospectus/Offer to Exchange entitled “Summary” is incorporated herein by reference.
Item 2. Subject Company Information.
| (a) | Name and Address. The
name of the issuer is Zura Bio Limited. The Company’s principal executive offices are located at 1489 W. Warm Springs Rd. #110,
Henderson, Nevada, and our telephone number is (702) 825-9872. |
|
(b) |
Securities. The subject securities were issued in connection with JATT’s initial public offering. Each IPO warrant entitles the holder to purchase one Class A ordinary share at a price of $11.50 per share, subject to adjustment. The public warrants are quoted on the Nasdaq under the symbol “ZURAW.” As of July 10, 2024, a total of 12,809,996 IPO warrants were outstanding. Pursuant to the Offer, we are offering up to an aggregate of 3,842,999 Class A ordinary shares in exchange for all of our outstanding IPO warrants. |
| (c) | Trading Market and Price. The
information set forth in the section of the Prospectus/Offer to Exchange entitled “Market Information, Dividends and Related Shareholder
Matters” is incorporated herein by reference. |
Item 3. Identity and Background of Filing Person.
|
(a) |
Name and Address. The Company is the filing person and the issuer. The information set forth above under Item 2(a) is incorporated herein by reference. The Company’s executive officers and directors as of July 10, 2024 are listed in the table below. |
Name | |
Age | |
Position(s) |
Executive Officers | |
| |
|
Robert Lisicki | |
57 | |
Chief Executive Officer and Director |
Verender Badial | |
51 | |
Chief Financial Officer |
Kim Davis | |
56 | |
Secretary and Chief Legal Officer |
Kiran Nistala | |
52 | |
Chief Medical Officer and Head of Development |
Michael Howell | |
47 | |
Chief Scientific Officer |
Gary Whale | |
51 | |
Chief Technology Officer |
Non-employee Directors | |
| |
|
Amit
Munshi | |
56 | |
Director, Chairman of the Board |
Someit Sidhu | |
34 | |
Director |
Sandeep
Kulkarni | |
42 | |
Director |
Arnout
Ploos van Amstel | |
60 | |
Director |
Steve
Schoch | |
66 | |
Director |
Jennifer
Jarrett | |
54 | |
Director |
Neil
Graham | |
66 | |
Director |
Parvinder
Thiara | |
39 | |
Director |
The information set forth in the section of the
Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Interests of Directors, Executive Officers,
and Others” is incorporated herein by reference.
Item 4. Terms of the Transaction.
| (a) | Material Terms. The
information set forth in the sections of the Prospectus/Offer to Exchange entitled “Summary” and “The Offer and Consent
Solicitation” is incorporated herein by reference. |
| (b) | Purchases. The information
set forth in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Interests
of Directors, Executive Officers, and Others” is incorporated herein by reference. |
Item 5. Past Contracts, Transactions, Negotiations, and Agreements.
| (a) | Agreements Involving the Subject Company’s Securities. The
information set forth in the sections of the Prospectus/Offer to Exchange entitled “Market Information, Dividends, and Related
Shareholder Matters — Transactions and Agreements Concerning Our Securities” and “Description of Securities”
is incorporated herein by reference. The information set forth in the section entitled “Certain Relationships and Related Transactions,
and Director Independence” in Part III, Item 13 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, incorporated by reference into the Prospectus/Offer to Exchange, is incorporated herein by reference. |
Item 6. Purposes of the Transaction and Plans or Proposals.
| (a) | Purposes. The
information set forth in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Background
and Purpose of the Offer and Consent Solicitation” is incorporated herein by reference. |
| (b) | Use of Securities Acquired. The
information set forth in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Background
and Purpose of the Offer and Consent Solicitation” is incorporated herein by reference. |
| (c) | Plans. Except as described
above and in the sections of the Prospectus/Offer to Exchange entitled “Risk Factors” and “The Offer and Consent Solicitation,”
which are incorporated herein by reference, neither the Company, nor any of its directors, executive officers, or controlling persons,
or any executive officers, directors, managers, or partners of its controlling persons, has any plans, proposals, or negotiations that
relate to or would result in: (1) any extraordinary transaction, such as a merger, reorganization, or liquidation, involving the
Company or any of its subsidiaries; (2) any purchase, sale, or transfer of a material amount of assets of the Company or any of
its subsidiaries; (3) any material change in the present dividend rate or policy, or indebtedness
or capitalization of the Company; (4) any change in the present board of directors or management of the Company, including, but not
limited to, any plans or proposals to change the number or the term of directors or to fill any existing vacancies on the board or to
change any material term of the employment contract of any executive officer; (5) any other material change in the Company’s
corporate structure or business; (6) any class of equity securities of the Company to be delisted from The Nasdaq Capital Market;
(7) any class of equity securities of the Company becoming eligible for termination of registration under Section 12(g)(4) of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”); (8) the suspension of the Company’s
obligation to file reports under Section 15(d) of the Exchange Act; (9) the acquisition by any person of additional
securities of the Company, or the disposition of securities of the Company; or (10) any changes in the Company’s Second Amended
and Memorandum and Articles of Association or other governing instruments or other actions that could impede the acquisition of control
of the Company. |
Item 7. Source and Amount of Funds or Other Consideration.
| (a) | Source of Funds. The
information set forth in the section of the Prospectus/Offer to Exchange entitled “Market Information, Dividends, and Related Shareholder
Matters — Source and Amount of Funds” is incorporated herein by reference. |
| (b) | Conditions. Not applicable. |
| (c) | Borrowed Funds. Not
applicable. |
Item 8. Interest in Securities of the Subject Company.
| (a) | Securities Ownership. The
information set forth in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Interests
of Directors, Executive Officers, and Others” is incorporated herein by reference. |
| (b) | Securities Transactions. Except
as set forth in the section of the Prospectus/Offer to Exchange entitled “Market Information, Dividends, and Related Shareholder
Matters — Transactions and Agreements Concerning Our Securities,” which is incorporated herein by reference, neither
the Company, nor any of its directors, executive officers, or controlling persons, or any executive officers, directors, managers, or
partners of any of its controlling persons, has engaged in any transactions in the Company’s IPO warrants in the last 60 days. |
Item 9. Persons/Assets, Retained, Employed, Compensated, or
Used.
| (a) | Solicitations or Recommendations. The
information set forth in the section of the Prospectus/Offer to Exchange entitled “Market Information, Dividends, and Related Shareholder
Matters — Fees and Expenses” is incorporated herein by reference. None of the Company, its management, its board
of directors, or the dealer manager, the information agent, or the exchange agent for the Offer is making any recommendation as to whether
holders of IPO warrants should tender IPO warrants for exchange in the Offer. |
Item 10. Financial Statements.
| (a) | Financial Information. The
financial statements and other financial information of the Company included in the Prospectus/Offer to Exchange are incorporated herein
by reference. The full text of such financial statements and other financial information, as well as the other documents the Company
has filed with the U.S. Securities and Exchange Commission (the “SEC”) prior to, or will file with the SEC subsequent
to, the filing of this Schedule TO relating to the Offer are available for inspection and copying from the SEC’s website at
www.sec.gov. |
| (b) | Pro Forma Information. Not
applicable. |
Item 11. Additional Information.
| (a) | Agreements, Regulatory Requirements, and Legal Proceedings. |
| (1) | The information set forth in the sections of the Prospectus/Offer
to Exchange entitled “The Offer and Consent Solicitation — Agreements, Regulatory Requirements, and Legal Proceedings”
is incorporated herein by reference. The information set forth in the section entitled “Certain Relationships and Related Person
Transactions, and Director Independence” in Part III, Item 13 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, incorporated by reference into the Prospectus/Offer to Exchange, is incorporated herein by reference. |
| (2) | The information set forth in the section of the Prospectus/Offer
to Exchange entitled “The Offer and Consent Solicitation — Agreements, Regulatory Requirements, and Legal Proceedings”
is incorporated herein by reference. |
| (b) | Other Material Information. Not
applicable. |
Item 12. Exhibits.
Exhibit No. |
|
Description |
(a)(l)(A) |
|
Prospectus/Offer to Exchange. |
(a)(1)(B) |
|
Form of Letter of Transmittal and Consent. |
(a)(1)(C) |
|
Form of Notice of Guaranteed Delivery. |
(a)(1)(D) |
|
Form of Letter to Brokers, Dealers, Commercial Banks, Trust Companies, and Other Nominees. |
(a)(1)(E) |
|
Form of Letter to Clients of Brokers, Dealers, Commercial Banks, Trust Companies, and Other Nominees. |
(a)(2) |
|
Not applicable. |
(a)(3) |
|
Not applicable. |
(a)(4) |
|
Prospectus/Offer to Exchange (incorporated by reference to Exhibit (a)(1)(A) herein). |
(a)(5) |
|
Press Release, dated July 12, 2024. |
(b) |
|
Not applicable. |
(c) |
|
Not applicable |
(d)(i) |
|
Business Combination Agreement, dated as of June 16, 2022, by and among JATT, Merger Sub, Merger Sub 2, Holdco and Zura Bio Limited (incorporated by reference to Exhibit 2.1 of JATT’s Current Report on Form 8-K (File No. 001-40598), filed with the SEC on June 17, 2022). |
(d)(ii) |
|
First Amendment dated as of September 20, 2022 to the Business Combination Agreement by and among JATT, Merger Sub, Merger Sub 2 and Holdco and Zura Bio Limited (incorporated by reference to Exhibit 2.2 of JATT’s Form S-4/A (File No. 333-267005), filed with the SEC on October 25, 2022). |
Exhibit No. |
|
Description |
(d)(iii) |
|
Second Amendment dated
as of November 14, 2022 to the Business Combination Agreement by and among JATT, Merger Sub, Merger Sub 2, Holdco and Zura Bio
Limited (incorporated by reference to Exhibit 2.2 of JATT’s Current Report on Form 8-K (File No. 001-40598),
filed with the SEC on November 15, 2022). |
(d)(iv) |
|
Third Amendment dated
as of January 13, 2023 to the Business Combination Agreement by and among JATT, Merger Sub, Merger Sub 2, Holdco and Zura Bio
Limited (incorporated by reference to Exhibit 2.1 of JATT’s Current Report on Form 8-K (File No. 001-40598),
filed with the SEC on January 19, 2023). |
(d)(v) |
|
Second Amended and Restated
Memorandum and Articles of Association of Zura Bio Limited (incorporated by reference to Exhibit 3.1 to Zura’s Form 8-K
(File No. 001-40598), filed with the SEC on March 24, 2023). |
(d)(vi) |
|
Warrant Agreement, dated
as of July 16, 2021, by and between JATT Acquisition Corp and Continental Stock Transfer & Trust Company (incorporated
by reference to Exhibit 4.1 of JATT’s Current Report on Form 8-K (File No. 001-40598), filed with the SEC on
July 19, 2021). |
(d)(vii) |
|
Specimen Class A
Ordinary Share Certificate of Zura (incorporated by reference to Exhibit 4.5 of JATT’s Form S-4 (File No. 333-267005)
filed with the SEC on August 19, 2022). |
(d)(viii) |
|
Specimen Warrant Certificate
of Zura (incorporated by reference to Exhibit 4.6 of JATT’s Form S-4 (File No. 333-267005) filed with the SEC
on August 19, 2022). |
(d)(ix) |
|
Form of 2023 Pre-Funded
Warrant to Purchase Ordinary Shares (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on
Form 8-K, filed with the SEC on May 3, 2023). |
(d)(x) |
|
Form of 2024 Pre-Funded
Warrant to Purchase Ordinary Shares (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by
the Issuer with the SEC on April 22, 2024). |
(d)(xi) |
|
Form of Letter
Agreement, by and among JATT Acquisition Corp and each of JATT Ventures, L.P. and the officers and directors of JATT (incorporated
by reference to Exhibit 10.1 of JATT’s Form S-1 (File No. 333-257120), filed with the SEC on June 15, 2021). |
(d)(xii) |
|
Investment Management
Trust Agreement, dated as of July 16, 2021, by and between JATT Acquisition Corp and Continental Stock Transfer & Trust
Company (incorporated by reference to Exhibit 10.2 of JATT’s Current Report on Form 8-K (File No. 001-40598),
filed with the SEC on July 19, 2021). |
(d)(xiii) |
|
Form of Indemnity
Agreement (incorporated by reference to Exhibit 10.13 of Zura’s Current Report on Form 8-K (File No. 001-40598)
filed with the SEC on March 24, 2023). |
(d)(xiv) |
|
Amended and Restated
Registration Rights Agreement, by and among the Company, the Sponsor and the parties thereto (incorporated by reference to Exhibit 10.2
of the Company’s Form 8-K (File No. 001-40598) filed with the SEC on March 24, 2023). |
(d)(xv) |
|
Administrative Services
Agreement, dated July 16, 2021, between JATT Acquisition Corp and JATT Ventures, L.P. (incorporated by reference to Exhibit 10.6
of JATT’s Current Report on Form 8-K (File No. 001-40598), filed with the SEC on July 19, 2021). |
(d)(xvi) |
|
Sponsor Support Agreement,
dated as of June 16, 2022, by and among JATT Acquisition Corp and certain shareholders (incorporated by reference to Exhibit 10.7
of JATT’s Form S-4 (File No. 333-267005) filed with the SEC on August 19, 2022). |
(d)(xvii) |
|
Company Shareholder
Support Agreement, dated as of June 16, 2022, by and among JATT Acquisition Corp, Zura Holding Company and Zura Bio Ltd (incorporated
by reference to Exhibit 10.8 of JATT’s Form S-4 (File No. 333-267005) filed with the SEC on August 19,
2022). |
(d)(xviii) |
|
Lock-Up Agreement dated
as of June 16, 2022 (incorporated by reference to Exhibit 10.9 of JATT’s Form S-4 (File No. 333-267005)
filed with the SEC on August 19, 2022). |
(d)(xix) |
|
Form of Subscription
Agreement (incorporated by reference to Exhibit 10.10 of JATT’s Form S-4 (File No. 333-267005) filed with the
SEC on August 19, 2022). |
(d)(xx) |
|
Form of 2022 Zura
Bio Equity Incentive Plan (incorporated by reference to Exhibit 10.11 of JATT’s Form S-4/A (File No. 333-267005)
filed with the SEC on October 25, 2022). |
(d)(xxi) |
|
Form of 2022 Zura
Bio Employee Share Purchase Plan (incorporated by reference to Exhibit 10.12 of JATT’s Form S-4/A (File No. 333-267005)
filed with the SEC on December 14, 2022). |
(d)(xxii) |
|
Investment Agreement
between Hana Immunotherapeutics LLC and Zura Bio, Ltd., dated February 20, 2022 (incorporated by reference to Exhibit 10.13
of JATT’s Form S-4 (File No. 333-267005) filed with the SEC on August 19, 2022). |
Exhibit No. |
|
Description |
(d)(xxiii) |
|
Form of
2022 Zura Bio Equity Incentive Plan (incorporated by reference to Exhibit 10.11 of JATT’s Form S-4/A (File No. 333-267005)
filed with the SEC on October 25, 2022). |
(d)(xxiv) |
|
Service
Agreement between Zura Bio Limited and Oliver Jacob Levy, dated June 2, 2022 (incorporated by reference to Exhibit 10.15
of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on January 9, 2023). |
(d)(xxv) |
|
Share
Option Agreement between Zura Bio Limited and Sandeep Kulkarni, dated June 8, 2022 (incorporated by reference to Exhibit 10.16
of JATT’s Form S-4 (File No. 333-267005) filed with the SEC on August 19, 2022). |
(d)(xxvi) |
|
Sponsor
Forfeiture Agreement dated June 16, 2022 (incorporated by reference to Exhibit 10.18 of JATT’s Form S-4 (File
No. 333-267005) filed with the SEC on August 19, 2022). |
(d)(xxvii) |
|
Forward
Purchase Agreement dated August 5, 2021 between JATT Acquisition Corp. and Athanor Master Fund LP (incorporated by reference
to Exhibit 10.1 of JATT’s Quarterly Report on Form 10-Q (File No. 001-40598), filed with the SEC on November 19,
2021). |
(d)(xxviii) |
|
Forward
Purchase Agreement dated August 5, 2021 between JATT Acquisition Corp. and Athanor International Master Fund LP. (incorporated
by reference to Exhibit 10.2 of JATT’s Quarterly Report on Form 10-Q (File No. 001-40598), filed with the SEC
on November 19, 2021). |
(d)(xxix) |
|
Amended
Forward Purchase Agreements dated January 27, 2022 between JATT Acquisition Corp. and Athanor Master Fund LP and Athanor International
Master Fund LP. (incorporated by reference to Exhibit 10.9 of JATT’s Annual Report on Form 10-K (File No. 001-40598),
filed with the SEC on April 11, 2022). |
(d)(xxx) |
|
First
Amendment to the PIPE Subscription Agreement, dated November 25, 2022 (incorporated by reference to Exhibit 10.23 of JATT’s
Form S-4/A (File No. 333-267005) filed with the SEC on December 14, 2022). |
(d)(xxxi) |
|
Equity
Grant Agreement between JATT Acquisition Corp and Eli Lilly and Company dated December 8, 2022 (incorporated by reference to
Exhibit 10.24 of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on December 14, 2022). |
(d)(xxxii) |
|
Form of
Amended and Restated Registration Rights Agreement (incorporated by reference to Exhibit 10.25 of JATT’s Form S-4/A
(File No. 333-267005) filed with the SEC on December 14, 2022). |
(d)(xxxiii) |
|
Form of
Lock-Up Agreement (incorporated by reference to Exhibit 10.26 of JATT’s Form S-4/A (File No. 333-267005) filed
with the SEC on December 14, 2022). |
(d)(xxxiv) |
|
Letter
Agreement, dated as of December 8, 2022, by and among Zura Bio Limited and Stone Peach Properties LLC (incorporated by reference
to Exhibit 10.27 of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on December 14, 2022). |
(d)(xxxvi) |
|
Option
Certificate, dated June 8, 2022, by and between Zura Bio Limited and Oliver Levy (incorporated by reference to Exhibit 10.30
of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on February 2, 2023). |
(d)(xxxvii) |
|
Service
Agreement, dated as of April 7, 2023, by and between the Company and Dr. Someit Sidhu (incorporated by reference to Exhibit 10.1
to the Current Report on Form 8-K filed by the Issuer with the SEC on April 10, 2023). |
(d)(xxxviii) |
|
Service
Agreement, dated as of April 7, 2023, by and between the Company and Verender Badial (incorporated by reference to Exhibit 10.2
to the Current Report on Form 8-K filed by the Issuer with the SEC on April 10, 2023). |
(d)(xxxix) |
|
Severance
and General Release Agreement, dated April 7, 2023, by and between Zura Bio Limited and Preston Klassen (incorporated by reference
to Exhibit 10.1 to the Current Report on Form 8-K filed by the Issuer with the SEC on April 7, 2023). |
(d)(xxxx) |
|
Form of
2022 Zura Bio Employee Share Purchase Plan (incorporated by reference to Exhibit 10.12 of JATT’s Form S-4/A (File
No. 333-267005) filed with the SEC on December 14, 2022). |
(d)(xxxxi) |
|
Zura
Bio Limited 2023 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.12 of the Company’s Current Report
on Form 8-K (File No. 001 40598), filed with the SEC on March 24, 2023). |
(d)(xxxxii) |
|
Zura
Bio Limited 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.29 of JATT’s Form S-4/A (File No. 333-267005)
filed with the SEC on February 2, 2023). |
(d)(xxxxiii) |
|
Share
Option Award Agreement (incorporated by reference to Annex C of the Definitive Proxy Statement on Schedule 14A filed by the Issuer
with the SEC on May 19, 2023). |
(d)(xxxxiv) |
|
License
Agreement between Zura Bio Limited and Pfizer Inc., dated March 22, 2022 (incorporated by reference to Exhibit 10.14 of
JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on February 17, 2023). |
(d)(xxxxvi) |
|
License
Agreement between Zura Bio Limited and Lonza Sales AG, dated July 22, 2022 (incorporated by reference to Exhibit 10.17
of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on February 17, 2023). |
(d)(xxxxvii) |
|
License,
Development and Commercialization Agreement, dated as of December 8, 2022, by and between Eli Lilly and Company and Z33 Bio
Inc (incorporated by reference to Exhibit 10.22 of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC
on February 17,2023). |
(d)(xxxxviii) |
|
Letter
Agreement, dated as of December 8, 2022, by and among Zura Bio Limited and Stone Peach Properties LLC (incorporated by reference
to Exhibit 10.27 of JATT’s Form S-4/A (File No. 333-267005) filed with the SEC on December 14, 2022). |
(d)(xxxxix) |
|
Form of
Subscription Agreement by and among Zura Bio Limited and the other parties signatories thereto (incorporated by reference to Exhibit 10.1
to the Current Report on Form 8-K filed with the SEC on May 3, 2023). |
(d)(xxxxx) |
|
License,
Development and Commercialization Agreement between ZB17 LLC and Eli Lilly and Company, dated April 26, 2023 (incorporated by
reference to Exhibit 10.38to the Annual Report on Form 10-K filed by the Issuer with the SEC on March 28, 2024). |
(d)(xxxxxi) |
|
Offer
Letter, dated March 2, 2023, to Amit Munshi, (incorporated by reference to Exhibit 10.28 of JATT’s Form 10-Q
(File No. 001-40598) filed with the SEC on May 12, 2023). |
(d)(xxxxxii) |
|
Service
Agreement between Zura Bio Limited and Kiran Nistala (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K
filed by the Issuer with the SEC on December 6, 2023). |
(d)(xxxxxiii) |
|
Service
Agreement, dated as of April 7, 2023, by and between the Company and Verender Badial (incorporated by reference to Exhibit 10.2
to the Current Report on Form 8-K filed by the Issuer with the SEC on April 10, 2023). |
(d)(xxxxxiv) |
|
Offer
Letter Agreement with Kim Davis, dated November 22, 2022 (incorporated by reference to Exhibit 10.39 to the Form S-1/A
filed by the Issuer with the SEC on August 11, 2023). |
(d)(xxxxxvi) |
|
Employment
Agreement between Zura Bio Limited and Robert Lisicki (incorporated by reference to Exhibit 10.1 of the Company’s Current
Report on Form 8-K, filed with the SEC on January 8, 2024) |
(d)(xxxxxvii) |
|
Form of
Subscription Agreement by and among Zura Bio Limited and the other parties signatories thereto (incorporated by reference to Exhibit 10.1
to the Current Report on Form 8-K filed with the SEC on May 3, 2023). |
(d)(xxxxxviii) |
|
Form of
Employment Agreement for Someit Sidhu (incorporated by reference to Exhibit 10.31 of JATT’s Form S-4/A (File No. 333-267005)
filed with the SEC on February 8, 2023). |
(d)(xxxxxix) |
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Form of
Subscription Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Issuer
with the SEC on April 22, 2024). |
(d)(xxxxxx) |
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Lock-Up
Agreement, dated as of June 16, 2022, by and among JATT Acquisition Corp and each of the other parties signatories thereto (incorporated
by reference to Exhibit 10.5 to the Current Report on Form 8-K (File No. 001-40598) filed by the Issuer with the SEC
on June 17, 2022). |
(d)(xxxxxxi) |
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Lock-Up
Agreement, dated as of March 20, 2023, by and between JATT Acquisition Corp and Eli Lilly and Company (incorporated by reference
to Exhibit 10.15 to the Current Report on Form 8-K (File No. 001-40598) filed by the Issuer with the SEC on March 24,
2023). |
(d)(xxxxxxii) |
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Dealer Manager Agreement
dated as of July 11, 2024, by and between Zura Bio Limited and Cantor Fitzgerald & Co., as dealer
manager. |
(d)(xxxxxxiii) |
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Tender and Support Agreement
dated July 11, 2024, by and among the Company, and the warrant holder parties thereto. |
(e) |
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Not applicable. |
(f) |
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Not applicable. |
(g) |
|
Not applicable. |
(h) |
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Tax Opinion of Loeb &
Loeb LLP. |
Filing Fee Table.
Item 13. Information Required By Schedule 13E-3.
Not applicable.
SIGNATURE
After due inquiry and to the best of my knowledge
and belief, I certify that the information set forth in this statement is true, complete, and correct.
|
ZURA BIO LIMITED |
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|
|
By: |
/s/
Robert Lisicki |
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Name: |
Robert Lisicki |
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Title: |
Chief Executive Officer |
Dated: July 12, 2024
tm2418824-1_s4 - none - 9.9531613s
The information in this document may change. The registrant may not complete the offer and issue these securities until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This document is not an offer to sell these securities and it is not soliciting an offer to buy these securities, nor shall there be any sale of these securities, in any jurisdiction in which such offer, solicitation, or sale is not permitted or would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
PRELIMINARY — SUBJECT TO COMPLETION, DATED JULY 11, 2024
PROSPECTUS/OFFER TO EXCHANGE
ZURA BIO LIMITED
Offer to Exchange Warrants to Acquire Class A Ordinary Shares
of
ZURA BIO LIMITED
for
Class A Ordinary Shares
of
ZURA BIO LIMITED
and
Consent Solicitation
THE OFFER PERIOD (AS DEFINED BELOW) AND WITHDRAWAL RIGHTS
WILL EXPIRE AT 11:59 P.M., EASTERN TIME, ON AUGUST 8, 2024,
OR SUCH LATER TIME AND DATE TO WHICH WE MAY EXTEND.
Terms of the Offer and Consent Solicitation
Until the Expiration Date (as defined below), we are offering to the holders of our outstanding public warrants and private placement warrants that were issued in connection with our initial public offering (collectively, the “IPO warrants”) to purchase Class A ordinary shares, par value $0.0001 per share (“Class A ordinary shares”), of Zura Bio Limited, a Cayman Islands exempted company (the “Company”), the opportunity to receive 0.30 Class A ordinary shares in exchange for each of our outstanding IPO warrants tendered by the holder and exchanged pursuant to the offer (the “Offer”).
The Offer is being made to all holders of our IPO warrants, including the public warrants and the private placement warrants. The IPO warrants are governed by the warrant agreement, dated as of July 16, 2021, by and between the Company (as successor to JATT Acquisition Corp, our predecessor and a Cayman Islands exempted company (“JATT”)) and Continental Stock Transfer & Trust Company (“CST”), as warrant agent (the “Warrant Agreement”). Our Class A ordinary shares and public warrants are listed on The Nasdaq Capital Market (the “Nasdaq”) under the symbols “ZURA” and “ZURAW,” respectively. As of July 10, 2024, a total of 12,809,996 IPO warrants were outstanding, including our public warrants and private placement warrants. For the avoidance of doubt, the IPO Warrants do not include the 2023 Pre-Funded Warrants nor the 2024 Pre-Funded Warrants (as described herein). Pursuant to the Offer, we are offering up to an aggregate of 3,842,999 Class A ordinary shares in exchange for all of our outstanding IPO warrants.
Each IPO warrant holder whose IPO warrants are exchanged pursuant to the Offer will receive 0.30 of our Class A ordinary shares for each IPO warrant tendered by such holder and exchanged. No fractional Class A ordinary shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid in cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of our Class A ordinary shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes. Our obligation to complete the Offer is not conditioned on the receipt of a minimum number of tendered IPO warrants.
Concurrently with the Offer, we are also soliciting consents (the “Consent Solicitation”) from holders of the IPO warrants to amend the Warrant Agreement (such amendment, the “Warrant Amendment”), which amendment will govern all of the IPO warrants, to permit the Company to require that each IPO warrant that is outstanding upon the closing of the Offer be exchanged for 0.27 Class A ordinary shares, which is a ratio 10% less than the exchange ratio applicable to the Offer. Pursuant to the terms of the Warrant Agreement, subject to certain limited exceptions, all modifications or amendments require the vote or written consent of the holders of at least a majority of the public warrants and, solely with respect to any amendment to the terms of the private placement warrants or any provision of the Warrant Agreement with respect to the private placement warrants, a majority of the number of the then outstanding private placement warrants.
Parties (including certain of our affiliates) representing approximately 40.7% of our outstanding public warrants and approximately 65.3% of our private placement warrants have agreed to tender their respective IPO warrants (as applicable) in the Offer and to consent to the Warrant Amendment in the Consent Solicitation pursuant to a tender and support agreement (the “Tender and Support Agreement”).
Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described herein are satisfied or waived, then the Warrant Amendment will be adopted. For additional detail regarding the Tender and Support Agreement, see “Market Information, Dividends, and Related Shareholder Matters — Transactions and Agreements Concerning Our Securities — Tender and Support Agreement.”
You may not consent to the Warrant Amendment without tendering your IPO warrants in the Offer, and you may not tender such IPO warrants without consenting to the Warrant Amendment. The consent to the Warrant Amendment is a part of the Letter of Transmittal and Consent (as defined below) relating to the IPO warrants, and, therefore, by tendering your IPO warrants for exchange you will be delivering to us your consent. You may revoke your consent at any time prior to the Expiration Date (as defined below) by withdrawing the IPO warrants you have tendered in the Offer.
The Offer and Consent Solicitation is made solely upon the terms and conditions in this prospectus/offer to exchange (this “Prospectus/Offer to Exchange”) and in the related letter of transmittal and consent (as it may be supplemented and amended from time to time, the “Letter of Transmittal and Consent”). The Offer and Consent Solicitation will be open until 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which we may extend the Offer and Consent Solicitation (the period during which the Offer and Consent Solicitation is open, giving effect to any withdrawal or extension, is referred to as the “Offer Period,” and the date and time at which the Offer Period ends is referred to as the “Expiration Date”). The Offer and Consent Solicitation is not made to those holders who reside in states or other jurisdictions where an offer, solicitation, or sale would be unlawful.
We may withdraw the Offer and Consent Solicitation only if the conditions to the Offer and Consent Solicitation are not satisfied or waived prior to the Expiration Date or if we have determined, in our sole discretion, to terminate the Offer and Consent Solicitation. Promptly upon any such withdrawal, we will return the tendered IPO warrants to the holders (and the related consent to the Warrant Amendment will be revoked).
You may tender some or all of your IPO warrants into the Offer. If you elect to tender IPO warrants in response to the Offer and Consent Solicitation, please follow the instructions in this Prospectus/Offer to Exchange and the related documents, including the Letter of Transmittal and Consent. If you tender IPO warrants, you may withdraw your tendered IPO warrants at any time before the Expiration Date and retain them on their current terms, or amended terms if the Warrant Amendment is approved, by following the instructions in this Prospectus/Offer to Exchange. In addition, tendered IPO warrants that are not accepted by us for exchange by August 8, 2024 may thereafter be withdrawn by you until such time as the IPO warrants are accepted by us for exchange. If you withdraw the tender of your IPO warrants, your related consent to the Warrant Amendment will be withdrawn as a result.
IPO warrants not exchanged for our Class A ordinary shares pursuant to the Offer will remain outstanding subject to their current terms, or amended terms if the Warrant Amendment is approved. We reserve the right to redeem any of the IPO warrants, as applicable, pursuant to their current terms at any time, including prior to the completion of the Offer and Consent Solicitation, and, if the Warrant Amendment is approved, we intend to require the conversion of all outstanding IPO warrants to Class A ordinary shares as provided in the Warrant Amendment. Our public warrants are currently listed on the Nasdaq under the symbol “ZURAW”; however, our public warrants may be delisted if, following the completion of the Offer and Consent Solicitation, the extent of public distribution or the aggregate market value of outstanding IPO warrants has become so reduced as to make further listing inadvisable or unavailable.
The Offer and Consent Solicitation is conditioned upon the effectiveness of a registration statement on Form S-4 that we filed with the U.S. Securities and Exchange Commission (the “SEC”) regarding the Class A ordinary shares issuable upon exchange of the IPO warrants pursuant to the Offer. This Prospectus/Offer to Exchange forms a part of the registration statement.
Our board of directors has approved the Offer and Consent Solicitation. However, neither we nor any of our management, our board of directors, or the information agent, the exchange agent, or the dealer manager for the Offer and Consent Solicitation is making any recommendation as to whether holders of IPO warrants should tender IPO warrants for exchange in the Offer and consent to the Warrant Amendment in the Consent Solicitation. Each holder of an IPO warrant must make its own decision as to whether to exchange some or all of its IPO warrants and consent to the Warrant Amendment.
All questions concerning the terms of the Offer and Consent Solicitation should be directed to the dealer manager:
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
Call Toll Free: 212-915-1800
All questions concerning exchange procedures and requests for additional copies of this Prospectus/Offer to Exchange, the Letter of Transmittal and Consent, or the Notice of Guaranteed Delivery should be directed to the information agent:
Alliance Advisors, LLC
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
We will amend our offering materials, including this Prospectus/Offer to Exchange, to the extent required by applicable securities laws to disclose any material changes to information previously published, sent, or given to IPO warrant holders.
The securities offered by this Prospectus/Offer to Exchange involve risks. Before participating in the Offer and consenting to the Warrant Amendment, you are urged to read carefully the section entitled “Risk Factors” beginning on page 13 of this Prospectus/Offer to Exchange and under similar headings in the documents incorporated by reference into this Prospectus/Offer to Exchange.
Neither the SEC nor any state securities commission or any other regulatory body has approved or disapproved of these securities or determined if this Prospectus/Offer to Exchange is truthful or complete. Any representation to the contrary is a criminal offense.
Through the Offer, we are soliciting your consent to the Warrant Amendment. By tendering your IPO warrants, you will be delivering your consent to the proposed Warrant Amendment, which consent will be effective upon our acceptance of such IPO warrants for exchange.
The dealer manager for the Offer and Consent Solicitation is:
Cantor
This Prospectus/Offer to Exchange is dated , 2024.
TABLE OF CONTENTS
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A-1
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ABOUT THIS PROSPECTUS/OFFER TO EXCHANGE
This Prospectus/Offer to Exchange is a part of the registration statement that we filed on Form S-4 with the SEC. You should read this Prospectus/Offer to Exchange, including the detailed information regarding the Company and our Class A ordinary shares and IPO warrants and the financial statements and the notes included herein, as well as the documents incorporated herein by reference and any applicable prospectus supplement.
We have not authorized anyone to provide you with information different from that contained in this Prospectus/Offer to Exchange. We and the dealer manager take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. You should not assume that the information in this Prospectus/Offer to Exchange, any document incorporated herein by reference, or any prospectus supplement is accurate as of any date other than the date on the front of those documents. You should not consider this Prospectus/Offer to Exchange to be an offer or solicitation relating to the securities in any jurisdiction in which such an offer or solicitation relating to the securities is not authorized. Furthermore, you should not consider this Prospectus/Offer to Exchange to be an offer or solicitation relating to the securities offered hereby if the person making the offer or solicitation is not qualified to do so, or if it is unlawful for you to receive such an offer or solicitation.
We are making the Offer to all IPO warrant holders except those holders who reside in states or other jurisdictions where an offer, solicitation, or sale would be unlawful (or would require further action in order to comply with applicable securities laws).
BASIS OF PRESENTATION
We were incorporated as a Cayman Islands exempted company on March 10, 2021. Our wholly owned subsidiary, Zura Bio Limited (“Zura Bio UK”) was formed in the United Kingdom on January 18, 2022. Prior to March 20, 2023, our operations were conducted through Zura Bio UK. On March 20, 2023, Zura Bio Limited, a limited company incorporated under the laws of England and Wales (“Legacy Zura”), JATT Acquisition Corp, a Cayman Islands exempted company (“JATT”), JATT Merger Sub, a Cayman Islands exempted company and wholly owned subsidiary of JATT (“Merger Sub”), JATT Merger Sub 2, a Cayman Islands exempted company and wholly owned subsidiary of JATT (“Merger Sub 2”) and Zura Bio Holdings Ltd, a Cayman Islands exempted company (“Holdco”), consummated the closing of the transactions contemplated by the Business Combination Agreement, dated June 16, 2022, as amended on September 20, 2022, November 14, 2022 and January 13, 2023, by and among Legacy Zura, JATT, Merger Sub, Merger Sub 2 and Holdco (the “Business Combination Agreement”), following the approval at an extraordinary general meeting of JATT’s shareholders held on March 16, 2023 (the “Extraordinary General Meeting” and the consummation of such transactions, the “Closing”).
Pursuant to the Business Combination Agreement, (i) Merger Sub merged with and into Holdco, with Holdco continuing as the surviving company and a wholly owned subsidiary of JATT (the “Merger”); (ii) immediately following the Merger, Holdco merged with and into Merger Sub 2, with Merger Sub 2 continuing as the surviving company and a wholly owned subsidiary of JATT (together with the Merger and the other transactions contemplated by the Business Combination Agreement, the “Business Combination”); and (iii) JATT changed its name to “Zura Bio Limited.”
On November 18, 2022, our Board of Directors approved a change in our fiscal year end from March 31 to December 31. Our 2022 fiscal year began at the Company’s inception on January 18, 2022, and ended on December 31, 2022. The change in fiscal year end also applies retrospectively to all previously issued financial statements for the periods ended March 31, 2022, June 30, 2022, and August 8, 2022. References to a year refer to our fiscal years ended on December 31 of the specified year.
Certain monetary amounts, percentages, and other figures included herein have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables and charts may not be the arithmetic aggregation of the figures that precede them, and figures expressed as percentages in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them.
Unless the context otherwise requires, references in this Prospectus/Offer to Exchange to the “Company,” “Zura,” “we,” “us,” or “our” refer to the business of Zura Bio Limited.
MARKET AND INDUSTRY DATA
This Prospectus/Offer to Exchange includes or incorporates by reference, and any amendment or supplement to this Prospectus/Offer to Exchange may include or incorporate by reference, estimates regarding market and industry data and forecasts, which are based on our own estimates utilizing our management’s knowledge of and experience in, as well as information obtained from trade and business organizations, and other contacts in, the market sectors in which we compete, and from statistical information obtained from publicly available information, industry publications and surveys, reports from government agencies, and reports by market research firms. We confirm that, where such information is reproduced herein, such information has been accurately reproduced and that, so far as we are aware and are able to ascertain from information published by publicly available sources and other publications, no facts have been omitted that would render the reproduced information inaccurate or misleading. Industry publications, reports, and other published data generally state that the information contained therein has been obtained from sources believed to be reliable, but we cannot assure you that the information contained in these reports, and therefore the information contained in this Prospectus/Offer to Exchange or any amendment or supplement to this Prospectus/Offer to Exchange that is derived therefrom, is accurate or complete. Our estimates may prove to be inaccurate because of the method by which we obtain some of the data for our estimates or because this information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process, and other limitations and uncertainties. As a result, although we believe our sources are reliable, we have not independently verified the information and cannot guarantee its accuracy and completeness.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
This Prospectus/Offer to Exchange and the documents incorporated herein by reference contain statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding our financial position and business strategy, and the plans and objectives of management for our future operations. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this Prospectus/Offer to Exchange, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward- looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions. These statements are inherently uncertain and you should not put undue reliance on these statements, including, for example, statements about:
•
our vision and strategy;
•
our market opportunity;
•
our expectations regarding our product candidates and their related benefits;
•
the anticipated timing of key events and initiation of our studies and release of clinical data;
•
our beliefs regarding potential benefits or limitations of competing products both in development and approved; and
•
our expectations regarding the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients.
In addition, statements of belief and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Prospectus/Offer to Exchange, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Many factors could cause actual future events to differ materially from the forward-looking statements in this Prospectus/Offer to Exchange, including, but not limited to:
•
the fact that we have incurred significant losses since inception, and expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future;
•
the fact that we require substantial additional capital to finance our operations, and if we are unable to raise such capital when needed or on acceptable terms, we may be forced to delay, reduce,
•
and/or eliminate one or more of our development programs or future commercialization efforts;
•
our ability to obtain and maintain regulatory approval of any of our product candidates;
•
our ability to research, discover and develop additional product candidates;
•
our ability to obtain and maintain intellectual property protection and not infringe on the rights of others;
•
our ability to renew existing contracts or enter into new ones;
•
our reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials;
•
our ability to respond to general economic conditions;
•
our ability to effectively manage growth;
•
our ability to attract and retain qualified directors, officers, employees and key personnel;
•
our ability to compete with larger pharmaceutical and biotechnology companies that have greater resources, technology, relationships and/or expertise;
•
the impact from future regulatory, judicial, and legislative changes in our industry;
•
our ability to protect and enhance our corporate reputation and brand;
•
our public securities’ potential liquidity and trading;
•
the approval of the Warrant Amendment and our ability to require that all outstanding warrants be exchanged for Class A ordinary shares;
•
the exchange of the IPO warrants for Class A ordinary shares pursuant to the Offer, which will increase the number of shares eligible for future resale in the public market and result in dilution to our shareholders;
•
our ability to maintain the listing of the Public Warrants on Nasdaq; and
•
the lack of a third-party determination that the Offer or the Consent Solicitation is fair to warrant holders.
These and other factors that could cause actual results to differ from those implied by the forward-looking statements in this Prospectus/Offer to Exchange are more fully described under the section titled “Risk Factors” in this Prospectus/Offer to Exchange and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this Prospectus/Offer to Exchange. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements. We undertake no obligations to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
SUMMARY
The Offer and Consent Solicitation
This summary provides a brief overview of the key aspects of the Offer and Consent Solicitation. Because it is only a summary, it does not contain all of the detailed information contained elsewhere in this Prospectus/Offer to Exchange or in the documents incorporated herein by reference or included as exhibits to the registration statement that contains this Prospectus/Offer to Exchange. Accordingly, you are urged to carefully review this Prospectus/Offer to Exchange in its entirety (including all documents incorporated herein by reference or filed as exhibits to the registration statement that contains this Prospectus/Offer to Exchange, which exhibits may be obtained by following the procedures set forth herein in the section entitled “Where You Can Find More Information”).
Summary of the Offer and Consent Solicitation
We are a clinical stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs. Leveraging the extensive experience of our team, we identify relevant diseases and develop our differentiated assets in those diseases. Our strategic focus is to harness the power of dual-pathway biology to provide a broader and deeper level of clinical benefit to patients with autoimmune and inflammatory diseases.
We are currently developing three clinical-stage product candidates to address indications with high unmet needs and significant commercial opportunity.
•
Tibulizumab (ZB-106) is an IgG-scFv bispecific dual-antagonist antibody engineered by the fusion of elements of TALTZ® (ixekizumab) and tabalumab that neutralizes IL-17A and BAFF. These cytokines play pivotal roles in various inflammatory and autoimmune disorders. By targeting IL-17A and BAFF, tibulizumab demonstrates potential in mitigating chronic inflammation while preserving immune system integrity. Three Phase 1/1b clinical studies have been completed with tibulizumab, including in participants with rheumatoid arthritis and Sjögren’s syndrome. We plan to initiate a Phase 2 study in systemic sclerosis (“SSc”) in the fourth quarter of 2024 and a Phase 2 study in hidradenitis suppurativa (HS) in the second quarter of 2025.
•
ZB-168 is a fully human, high affinity monoclonal antibody that binds and neutralizes the IL-7 receptor chain (IL-7R) alpha. IL-7Rα sits at the nexus of two key immune pathways, IL-7 and thymic stromal lymphopoietin (TSLP), thus IL-7Rα has the potential to block activation through either of these pathways. As a result, we believe ZB-168 could be therapeutically relevant in a broad set of indications where the IL-7 or TSLP pathways may be involved. Three Phase 1/1b clinical studies have been conducted to date. There are additional IL-7Rα inhibitors under development for conditions like alopecia areata, atopic dermatitis and ulcerative colitis, with potential data in 2024. We
are actively assessing the competitive landscape and evaluating potential therapeutic indications to guide our future development efforts for ZB-168.
•
Torudokimab (ZB-880) is a fully human, high affinity monoclonal antibody that neutralizes IL-33, preventing ST2-dependent and ST2-independent (e.g., RAGE) inflammation. The IL-33/ST2 axis stands as a validated therapeutic target for conditions such as chronic obstructive pulmonary disease (COPD) and asthma. Three Phase 1/2 clinical studies have been conducted to date. We are actively assessing the competitive landscape and evaluating potential therapeutic indications to guide our future development efforts for torudokimab.
Together, ibulizumab (ZB-106), torudokimab (ZB-880) and ZB-168 are referred to as the “ZB Assets”.
Corporate Contact Information
Our principal executive offices are located at 1489 W. Warm Springs Rd. #110 Henderson, Nevada, and our telephone number is (702) 825-9872. We maintain a website at https://zurabio.com where general information about us is available. The information contained on, or that may be accessed through, our website is not part of, and is not incorporated into, this Prospectus/Offer to Exchange or the registration statement of which it forms a part, and the inclusion of our website address in this Prospectus/Offer to Exchange is an inactive textual reference only.
Warrants that Qualify for the Offer
As of July 10, 2024, a total of 12,809,996 IPO warrants were outstanding, including public warrants and private placement warrants, each exercisable for one share of our Class A ordinary shares at a price of $11.50 per share, subject to adjustments pursuant to the Warrant Agreement. Pursuant to the Offer, we are offering up to an aggregate of 3,842,999 of our Class A ordinary shares in exchange for all of our outstanding IPO warrants. For the avoidance of doubt, the 2023 Pre-Funded Warrants and the 2024 Pre-Funded Warrants (as more fully described herein) are not included in this offering and are not part of the IPO warrants.
Under the Warrant Agreement, we may call the public warrants for redemption at our option:
•
in whole and not in part;
•
upon a minimum of 30 days’ prior written notice of redemption (the “30-day redemption period”) to each public warrant holder; and
•
at a price of $0.01 per public warrant if, and only if, the last reported sales price of our Class A ordinary shares equals or exceeds $18.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations, and the like); provided that there is an effective registration statement covering the Class A ordinary shares issuable upon exercise of the public
warrants, and a current prospectus relating thereto, available throughout the 30-day redemption period.
The private placement warrants will not be redeemable by us so long as they are held by JATT Ventures, L.P., a Cayman Islands exempted limited partnership (the “Sponsor”), members of the Sponsor, or their permitted transferees. The Sponsor or its permitted transferees have the option to exercise the private placement warrants on a cashless basis. If the private placement warrants are held by holders other than the Sponsor or its permitted transferees, the private placement warrants will be redeemable by us in all redemption scenarios and exercisable by the holders on the same basis as the public warrants. If holders of the private placement warrants elect to exercise them on a cashless basis, they would pay the exercise price by surrendering his, her or its private placement warrants for that number of our Class A ordinary shares equal to the quotient obtained by dividing (x) the product of the number of our Class A ordinary shares underlying the private placement warrants, multiplied by the excess of the “sponsor exercise fair market value” (defined below) over the exercise price of the private placement warrants by (y) the sponsor exercise fair market value.
The “sponsor exercise fair market value” will mean the average last reported sale price of our Class A ordinary shares for the ten trading days ending on the third trading day prior to the date on which the notice of private placement warrant exercise is sent to Continental Stock Transfer & Trust Company.
The IPO warrants expire on March 20, 2028, subject to certain terms and conditions.
Market Price of Our Class A Ordinary Shares
Our Class A ordinary shares and public warrants are listed on the Nasdaq under the symbols “ZURA” and “ZURAW,” respectively. See “Market Information, Dividends, and Related Shareholder Matters.”
Each IPO warrant holder who tenders IPO warrants for exchange pursuant to the Offer will receive 0.30 of our Class A ordinary shares for each IPO warrant so exchanged. No fractional Class A ordinary shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of our Class A ordinary shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes. Our obligation to complete the Offer is not conditioned on the receipt of a minimum number of tendered IPO warrants.
Holders of the IPO warrants tendered for exchange will not have to pay any of the exercise price for the tendered IPO warrants in order to receive Class A ordinary shares in the exchange.
The Class A ordinary shares issued in exchange for the tendered IPO warrants will be unrestricted and freely transferable, as long as the holder is not an affiliate of ours and was not an affiliate of ours within the three months prior to the proposed transfer of such shares.
The Offer is being made to all IPO warrant holders except those holders who reside in states or other jurisdictions where an offer, solicitation, or sale would be unlawful (or would require further action in order to comply with applicable securities laws).
In order to tender IPO warrants in the Offer and Consent Solicitation, holders are required to consent (by executing the Letter of Transmittal and Consent or requesting that their broker or nominee consent on their behalf) to an amendment to the Warrant Agreement governing the IPO warrants as set forth in the Warrant Amendment attached hereto as Annex A. If approved, the Warrant Amendment would permit the Company to require that all IPO warrants that are outstanding upon the closing of the Offer be exchanged for Class A ordinary shares at a ratio of 0.27 Class A ordinary shares per IPO warrant (a ratio which is 10% less than the exchange ratio applicable to the Offer). Upon such exchange, no IPO warrants will remain outstanding.
Purpose of the Offer and Consent Solicitation
The purpose of the Offer and Consent Solicitation is to attempt to simplify our capital structure and reduce the potential dilutive impact of the IPO warrants. See “The Offer and Consent Solicitation — Background and Purpose of the Offer and Consent Solicitation.”
The Offer and Consent Solicitation will expire on the Expiration Date, which is 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which we may extend. All IPO warrants tendered for exchange pursuant to the Offer and Consent Solicitation, and all required related paperwork, must be received by the exchange agent by the Expiration Date, as described in this Prospectus/Offer to Exchange.
If the Offer Period is extended, we will make a public announcement of such extension by no later than 9:00 a.m., Eastern Time, on the next business day following the Expiration Date as in effect immediately prior to such extension.
We may withdraw the Offer and Consent Solicitation only if the conditions of the Offer and Consent Solicitation are not satisfied or waived prior to the Expiration Date or if we have determined, in our sole discretion, to terminate the
Offer and Consent Solicitation. Promptly upon any such withdrawal, we will return the tendered IPO warrants (and the related consent to the Warrant Amendment will be revoked). We will announce our decision to withdraw the Offer and Consent Solicitation by disseminating notice by public announcement or otherwise as permitted by applicable law. See “The Offer and Consent Solicitation — General Terms — Offer Period.”
Amendments to the Offer and Consent Solicitation
We reserve the right at any time or from time to time to amend the Offer and Consent Solicitation, including by increasing or (if the conditions to the Offer are not satisfied) decreasing the exchange ratio of Class A ordinary shares issued for every IPO warrant exchanged or by changing the terms of the Warrant Amendment. If we make a material change in the terms of the Offer and Consent Solicitation or the information concerning the Offer and Consent Solicitation, or if we waive a material condition of the Offer and Consent Solicitation, we will extend the Offer and Consent Solicitation to the extent required by Rules 13e-4(d)(2) and 13e-4(e)(3) under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”). See “The Offer and Consent Solicitation — General Terms — Amendments to the Offer and Consent Solicitation.”
Conditions to the Offer and Consent Solicitation
The Offer is subject to customary conditions, including the effectiveness of the registration statement of which this Prospectus/Offer to Exchange forms a part and the absence of any action or proceeding, statute, rule, regulation, or order that would challenge or restrict the making or completion of the Offer. The Offer is not conditioned upon the receipt of a minimum number of tendered IPO warrants. However, the Consent Solicitation is conditioned upon receiving the consent of holders of at least a majority of the outstanding public warrants and a majority of the private placement warrants (which is the minimum threshold required to amend the Warrant Agreement). We may waive some of the conditions to the Offer. See “The Offer and Consent Solicitation — General Terms — Conditions to the Offer and Consent Solicitation.” We reserve the right, notwithstanding the satisfaction of these conditions, to terminate and withdraw the Offer and Consent Solicitation. Promptly upon any such termination and withdrawal, we will return the tendered IPO warrants (and the related consent to the Warrant Amendment will be revoked). We will announce our decision to withdraw the Offer and Consent Solicitation by disseminating notice by public announcement or otherwise as permitted by applicable law. See “The Offer and Consent Solicitation — General Terms — Offer Period.”
We will not complete the Offer and Consent Solicitation unless and until the registration statement described above is effective. If the registration statement is not effective at the
Expiration Date, we may, in our discretion, extend, suspend, or cancel the Offer and Consent Solicitation, and will inform IPO warrant holders of such event.
If you tender your IPO warrants for exchange and change your mind, you may withdraw your tendered IPO warrants (and thereby automatically revoke the related consent to the Warrant Amendment) at any time prior to the Expiration Date, as described in greater detail in the section titled “The Offer and Consent Solicitation — Withdrawal Rights.” If the Offer Period is extended, you may withdraw your tendered IPO warrants (and thereby automatically revoke the related consent to the Warrant Amendment) at any time until the extended Expiration Date. In addition, tendered IPO warrants that are not accepted by us for exchange by August 8, 2024 may thereafter be withdrawn by you until such time as the IPO warrants are accepted by us for exchange.
Participation by Directors, Officers and Affiliates
Certain of our affiliates have agreed to tender their respective IPO warrants in the Offer and to consent to the Warrant Amendment in the Consent Solicitation pursuant to the Tender and Support Agreement. Except as required by the Tender and Support Agreement, none of our directors, officers or affiliates are required to participate in the Offer. See “The Offer and Consent Solicitation — Interests of Directors, Executive Officers and Others” on page 72 of this Prospectus/Offer to Exchange for further information.
Federal and State Regulatory
Approvals
Other than compliance with the applicable federal and state securities laws, no federal or state regulatory requirements must be complied with and no federal or state regulatory approvals must be obtained in connection with the Offer and Consent Solicitation.
Absence of Appraisal or Dissenters’ Rights
Holders of our IPO warrants do not have any appraisal or dissenters’ rights under applicable law in connection with the Offer and Consent Solicitation.
U.S. Federal Income Tax Consequences of the Offer
For a U.S. Holder (as defined below in “Material U.S. Federal Income Tax Consequences”) of our IPO warrants participating in the Offer and for any holders of our IPO warrants subsequently exchanged for Class A ordinary shares pursuant to the terms of the Warrant Amendment, we intend to treat such U.S. Holder’s exchange of IPO warrants for our Class A ordinary shares as a “recapitalization” within the meaning of Section 368(a)(1)(E) of the U.S. Internal Revenue Code of 1986, as amended (the “Code”) pursuant to which, subject to the discussion of the PFIC rules below under “Material U.S. Federal Income Tax Consequences — Passive Foreign Investment Company Rules,” (i) such U.S. Holder should not recognize any gain or loss on the exchange of IPO warrants for
Class A ordinary shares (except to the extent of any cash payment received in lieu of a fractional share in connection with the Offer or such subsequent exchange), (ii) such U.S. Holder’s aggregate tax basis in our Class A ordinary shares received in the exchange should equal the U.S. Holder’s aggregate tax basis in such U.S. Holder’s IPO warrants surrendered in the exchange (except to the extent of any tax basis allocated to a fractional share for which a cash payment is received in connection with the Offer or such subsequent exchange), and (iii) such U.S. Holder’s holding period for our Class A ordinary shares received in the exchange should include the U.S. Holder’s holding period for the surrendered IPO warrants. However, because there is a lack of direct legal authority regarding the U.S. federal income tax consequences of the exchange of our IPO warrants for our Class A ordinary shares, there can be no assurance in this regard and alternative characterizations are possible by the U.S. Internal Revenue Service (the “IRS”) or a court, including ones that would require U.S. Holders to recognize taxable income on the exchange of IPO warrants for our Class A ordinary shares.
Although the issue is not free from doubt, if the Warrant Amendment is approved, we intend to treat all IPO warrants not exchanged for Class A ordinary shares in the Offer as having been exchanged for “new” warrants pursuant to the Warrant Amendment and to treat such deemed exchange as a “recapitalization” within the meaning of Section 368(a)(1)(E) of the Code, pursuant to which, subject to the discussion of the PFIC rules below under “Material U.S. Federal Income Tax Consequences — Passive Foreign Investment Company Rules,”(i) a U.S. Holder of such IPO warrants should not recognize any gain or loss on the deemed exchange of IPO warrants for “new” warrants, (ii) such U.S. Holder’s aggregate tax basis in the “new” warrants deemed to be received in the exchange should equal the U.S. Holder’s aggregate tax basis in such U.S. Holder’s existing IPO warrants deemed surrendered in the exchange, and (iii) such U.S. Holder’s holding period for the “new” warrants deemed to be received in the exchange should include the U.S. Holder’s holding period for the IPO warrants deemed surrendered. Because there is a lack of direct legal authority regarding the U.S. federal income tax consequences of a deemed exchange of IPO warrants for “new” warrants pursuant to the Warrant Amendment, there can be no assurance in this regard and alternative characterizations by the IRS or a court are possible, including ones that would require U.S. Holders to recognize taxable income. See “Market Information, Dividends, and Related Shareholder Matters — Material U.S. Federal Income Tax Consequences.”
Neither we nor any of our board of directors, our management, the dealer manager, the exchange agent, the information agent, or any other person makes any recommendation on whether you should tender or refrain
from tendering all or any portion of your IPO warrants or consent to the Warrant Amendment, and no one has been authorized by any of them to make such a recommendation.
For risks related to the Offer and Consent Solicitation, please read the section titled “Risk Factors” in this Prospectus/Offer to Exchange and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this Prospectus/Offer to Exchange.
The depositary and exchange agent for the Offer and Consent Solicitation is:
Continental Stock Transfer & Trust Company
1 State Street, 30th Floor
New York, New York 10004
The dealer manager for the Offer and Consent Solicitation is:
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
We have other business relationships with the dealer manager, as described in “The Offer and Consent Solicitation — Dealer Manager.”
We recommend that our IPO warrant holders review the registration statement on Form S-4, of which this Prospectus/Offer to Exchange forms a part, including the exhibits that we have filed with the SEC in connection with the Offer and Consent Solicitation and our other materials that we have filed with the SEC, as well as the other documents we have filed with the SEC that are incorporated herein by reference as described under “Where You Can Find More Information; Incorporation by Reference,” before making a decision on whether to tender for exchange in the Offer and consent to the Warrant Amendment. All reports and other documents we have filed with the SEC can be accessed electronically on the SEC’s website at www.sec.gov.
You should direct (1) questions about the terms of the Offer and Consent Solicitation to the dealer manager at its address listed above and (2) questions about the exchange procedures and requests for additional copies of this Prospectus/Offer to Exchange, the Letter of Transmittal and Consent, or Notice of Guaranteed Delivery to the information agent at the below address and phone number:
Alliance Advisors, LLC
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
Emerging Growth Company and Smaller Reporting Company
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, the Company’s consolidated financial statements may not be comparable to companies that comply with public company Financial Accounting Standards Board (“FASB”) standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of an offering or such earlier time that it is no longer an emerging growth company. The Company expects to no longer be an emerging growth company effective December 31, 2026.
For so long as we remain an emerging growth company, we are permitted, and currently intend, to rely on the following provisions of the JOBS Act that contain exceptions from disclosure and other requirements that otherwise are applicable to public companies and file periodic reports with the SEC. These provisions include, but are not limited to:
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being permitted to present only two years of audited financial statements and selected financial data and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our periodic reports and registration statements, subject to certain exceptions;
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not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended;
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reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements, and registration statements, including in this Prospectus/Offer to Exchange;
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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; and
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
We have elected to take advantage of certain of the reduced disclosure obligations in this Prospectus/Offer to Exchange and may elect to take advantage of other reduced reporting requirements in our future filings with the SEC. As a result, the information that we provide to our Class A shareholders may be different than what you might receive from other public reporting companies in which you hold equity interests.
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until December 31, 2024.
Summary Risk Factors
You should carefully consider the risks discussed under the heading “Risk Factors” in this Prospectus/
Offer to Exchange and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this Prospectus/Offer to Exchange, before making a decision to participate in the Offer and Consent Solicitation. If any of these risks actually occurs, our business, financial condition and results of operations would likely be materially adversely affected. Some of these risks are summarized below.
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The Warrant Amendment, if approved, will allow us to require that all outstanding IPO warrants be exchanged for Class A ordinary shares at a ratio 10% lower than the exchange ratio applicable to the Offer.
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The exchange of IPO warrants for Class A ordinary shares will increase the number of shares eligible for future resale and result in dilution to our shareholders.
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We have not obtained a third-party determination that the Offer or the Consent Solicitation is fair to IPO warrant holders.
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There is no guarantee that tendering your IPO warrants in the Offer will put you in a better future economic position.
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The number of Class A ordinary shares offered in the Offer is fixed. The market price of our Class A ordinary shares may fluctuate, and the market price of our Class A ordinary shares when we deliver our Class A ordinary shares in exchange for your IPO warrants could be less than the market price at the time you tender your IPO warrants.
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We have a limited operating history, were not involved in the prior phase 1 clinical studies of our product candidates, and have not as a company initiated, conducted or completed any of our own clinical trials, and have not taken a product through to commercialization.
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We have incurred losses since inception, and we expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have not generated any revenue from the ZB Assets and may never generate revenue or become profitable.
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Our recurring losses from operations and financial condition could raise substantial doubt about our ability to continue as a going concern.
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If we are unable to raise capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts.
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We have never successfully completed the regulatory approval process for any product candidates and we may be unable to do so for any product candidates we develop.
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We are substantially dependent on the success of the ZB Assets, and our anticipated clinical trials of the ZB Assets may not be successful.
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We may find it difficult to enroll patients in our clinical trials. If we experience delays or difficulties in the enrollment of patients in clinical trials, our successful completion of clinical trials and our potential receipt of marketing approvals could be delayed or prevented.
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The results of preclinical testing and early clinical trials may not be predictive of the success of our later clinical trials, and the results of our clinical trials may not satisfy the requirements of the U.S. Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”), or other foreign regulatory authorities.
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Preclinical and clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.
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Preliminary, interim data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures.
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We may develop the ZB Assets in combination with other therapies, which exposes us to additional risks related to clinical trial design, regulatory requirements, other agents or active pharmaceutical or biological ingredients used in combination with our product candidates.
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If the FDA or other regulatory authorities revoke their approval of these other therapies or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the therapies we may choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.
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We depend on license agreements with Pfizer and Lilly to permit us to use certain patents, know-how and technology. Termination of these rights or the failure to comply with obligations under these agreements could materially harm our business and prevent us from developing or commercializing the ZB Assets.
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Our ability to protect our patents and other proprietary rights is uncertain. We enjoy only limited geographical protection with respect to our licensed patents and may not be able to protect our intellectual property rights throughout the world. Patent terms may not protect our competitive position with respect to the ZB Assets for an adequate amount of time. If we do not obtain patent term extension in the United States under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) and in foreign countries under similar legislation, our business may be materially harmed.
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Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
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We may not be able to maintain or enforce trade secret protection for our product candidates.
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Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect the ZB Assets.
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The regulatory approval processes of the FDA, EMA, and other foreign regulatory authorities are complex, time-consuming, and inherently unpredictable. Of the large number of products in development, only a small percentage successfully complete regulatory approval processes and are commercialized.
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We will be subject to extensive ongoing regulatory obligations and continued regulatory review after any potential product approval, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements.
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Our employees, independent contractors, consultants, commercial collaborators, principal investigators, contract research organizations (“CROs”), suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
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Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, governmental and private third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
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Healthcare legislative and regulatory reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business. Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Patient Protection and Affordable Care Act (the “ACA”). It is unclear how other healthcare reform measures of the Biden or future administrations or other efforts, if any, to amend or challenge the ACA, will impact our business.
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We are dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining qualified personnel, including consultants, we may not be able to successfully implement our business strategy.
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In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.
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Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data.
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We may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
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The market price of our securities may be volatile and may decline in the future. Our operating results may fluctuate significantly.
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We have not paid cash dividends in the past and we do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of our Class A ordinary shares.
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Future sales of a substantial number of our Class A ordinary shares may cause the price of our ordinary shares to decline. Sales and issuances of our Class A ordinary shares and future exercise of warrants or registration rights, could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall.
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If certain holders of our Class A ordinary shares sell a significant portion of their securities, it may negatively impact the market price of our Class A ordinary shares and such holders still may receive significant proceeds.
RISK FACTORS
In consultation with your own advisors, you should carefully consider, among other matters, the factors set forth below and under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this Prospectus/Offer to Exchange, before making a decision to participate in the Offer and Consent Solicitation. If any of the risks contained in or incorporated by reference into this Prospectus/Offer to Exchange develop into actual events, our business, financial condition, liquidity, results of operations, and prospects could be materially and adversely affected. Some statements in this Prospectus/Offer to Exchange, including statements in the following risk factors, constitute forward-looking statements. See the “Cautionary Note Regarding Forward Looking Statements” section in this Prospectus/Offer to Exchange.
Risks Related to Our IPO Warrants and the Offer and Consent Solicitation
The Warrant Amendment, if approved, will allow us to require that all outstanding IPO warrants be exchanged for Class A ordinary shares at a ratio 10% lower than the exchange ratio applicable to the Offer.
If we complete the Offer and Consent Solicitation and obtain the requisite approval of the Warrant Amendment by holders of the IPO warrants, the Company will have the right to require holders of all IPO warrants that remain outstanding upon the closing of the Offer to exchange each of their IPO warrants for 0.30 Class A ordinary shares. This represents a ratio of Class A ordinary shares per IPO warrant that is 10% less than the exchange ratio applicable to the Offer. Although we intend to require an exchange of all remaining outstanding IPO warrants as a result of the approval of the Warrant Amendment, we would not be required to effect such an exchange and may defer doing so, if ever, until most economically advantageous to us.
Pursuant to the terms of the Warrant Agreement, subject to certain limited exceptions, all modifications or amendments require the vote or written consent of the holders of at least a majority of the public warrants and, solely with respect to any amendment to the terms of the private placement warrants or any provision of the Warrant Agreement with respect to the private placement warrants, a majority of the number of the then outstanding private placement warrants. Therefore, one of the conditions to the adoption of the Warrant Amendment is the receipt of the consent of holders of at least a majority of the outstanding public warrants and a majority of the private placement warrants. Pursuant to the Tender and Support Agreement, parties (including certain of our affiliates) representing approximately 40.7% of the outstanding public warrants and approximately 65.3% of the private placement warrants have agreed to tender their public warrants and private placement warrants (as applicable) in the Offer and to consent to the Warrant Amendment in the Consent Solicitation. Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described herein are satisfied or waived, then the Warrant Amendment will be adopted.
If adopted, we currently intend to require the exchange of all outstanding IPO warrants for Class A ordinary shares as provided in the Warrant Amendment, which would result in the holders of any remaining outstanding IPO warrants receiving approximately 10% fewer shares than if they had tendered their IPO warrants in the Offer.
The exchange of IPO warrants for Class A ordinary shares will increase the number of shares eligible for future resale and result in dilution to our shareholders.
Our IPO warrants may be exchanged for Class A ordinary shares pursuant to the Offer, which will increase the number of shares eligible for future resale in the public market and result in dilution to our shareholders, although there can be no assurance that such IPO warrant exchange will be completed or that all of the holders of the IPO warrants will elect to participate in the Offer. Any IPO warrants remaining outstanding after the exchange likely will be exercised only if the $11.50 per share exercise price is below the market price of our Class A ordinary shares. We also intend to require an exchange of all remaining outstanding IPO warrants assuming the approval of the Warrant Amendment. To the extent such IPO warrants are exchanged following the approval of the Warrant Amendment or exercised, additional Class A ordinary shares will be issued. These issuances of Class A ordinary shares will result in dilution to our shareholders and increase the number of shares eligible for resale in the public market.
We have not obtained a third-party determination that the Offer or the Consent Solicitation is fair to IPO warrant holders.
None of our board of directors, our officers or employees, our affiliates, the dealer manager, the exchange agent, or the information agent makes any recommendation as to whether you should exchange some or all of your IPO warrants or consent to the Warrant Amendment. We have not retained, and do not intend to retain, any unaffiliated representative to act on behalf of the IPO warrant holders for purposes of negotiating the Offer or Consent Solicitation or preparing a report concerning the fairness of the Offer or the Consent Solicitation. You must make your own independent decision regarding your participation in the Offer and the Consent Solicitation.
There is no guarantee that tendering, or not tendering, your IPO warrants in the Offer will put you in a better future economic position.
We can give no assurance as to the market price of our Class A ordinary shares in the future. If you choose to tender some or all of your IPO warrants in the Offer, future events may cause an increase in the market price of our Class A ordinary shares and IPO warrants, which may result in a lower value realized by participating in the Offer than you might have realized if you did not exchange your IPO warrants. Similarly, if you do not tender your IPO warrants in the Offer, there can be no assurance that you can sell your IPO warrants (or exercise them for Class A ordinary shares) in the future at a higher value than would have been obtained by participating in the Offer. In addition, if the Warrant Amendment is adopted, and you choose not to tender some or all of your IPO warrants in the Offer, you may receive fewer shares than if you had tendered your IPO warrants in the Offer. You should consult your own individual tax and/or financial advisor for assistance on how this may affect your individual situation.
The number of Class A ordinary shares offered in the Offer is fixed. The market price of our Class A ordinary shares may fluctuate, and the market price of our Class A ordinary shares when we deliver our Class A ordinary shares in exchange for your IPO warrants could be less than the market price at the time you tender your IPO warrants.
The number of Class A ordinary shares offered in the Offer for each IPO warrant accepted for exchange is fixed at the number of shares specified on the cover of this Prospectus/Offer to Exchange and will fluctuate in value if there is any increase or decrease in the market price of our Class A ordinary shares or the IPO warrants after the date of this Prospectus/Offer to Exchange. Therefore, the market price of our Class A ordinary shares when we deliver Class A ordinary shares in exchange for your IPO warrants could be less than the market price of the IPO warrants at the time you tender your IPO warrants. The market price of our Class A ordinary shares could continue to fluctuate and be subject to volatility during the period of time between when we accept IPO warrants for exchange in the Offer and when we deliver Class A ordinary shares in exchange for IPO warrants, or during any extension of the Offer Period.
We may amend the terms of the IPO warrants in a manner that may be adverse to holders of the IPO warrants with the approval of the holders of at least a majority of the then-outstanding public warrants and a majority of the then-outstanding private placement warrants, which make up the IPO warrants. As a result, the exercise price of your IPO warrants could be increased, the exercise period could be shortened, and the number of Class A ordinary shares purchasable upon exercise of an IPO warrant could be decreased, all without an IPO warrant holder’s approval.
The IPO warrants are issued in registered form under the Warrant Agreement. The Warrant Agreement provides that the terms of the IPO warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision, but all other modifications or amendments require the vote or written consent of the holders of at least a majority of the public warrants and, solely with respect to any amendment to the terms of the private placement warrants or any provision of the Warrant Agreement with respect to the private placement warrants, a majority of the number of the then outstanding private placement warrants. Accordingly, we may amend the terms of the IPO warrants in a manner adverse to a holder if holders of at least a majority of the then-outstanding public warrants and private placement warrants approve of such amendment. Although our ability to amend the terms of the IPO warrants with the consent of at least a majority of the then-outstanding public warrants and private placement warrants is
unlimited, examples of such amendments could be amendments to, among other things, increase the exercise price of the IPO warrants, exchange the IPO warrants for cash or Class A ordinary shares, shorten the exercise period, or decrease the number of Class A ordinary shares purchasable upon exercise of an IPO warrant.
Registration of our Class A ordinary shares issuable upon exercise of the IPO warrants under the Securities Act may not be in place when an investor desires to exercise IPO warrants.
Under the terms of the Warrant Agreement, we are obligated to file and maintain an effective registration statement under the U.S. Securities Act of 1933, as amended (the “Securities Act”), covering the issuance of our Class A ordinary shares issuable upon exercise of the IPO warrants, and thereafter will use our commercially reasonable efforts to maintain a current prospectus relating to the Class A ordinary shares issuable upon exercise of the IPO warrants, until the expiration of the IPO warrants in accordance with the provisions of the Warrant Agreement. We cannot assure you that we will be able to do so if, for example, any facts or events arise that represent a fundamental change in the information set forth in the registration statement or prospectus, the financial statements contained or incorporated by reference therein are not current or correct, or the SEC issues a stop order. If the shares issuable upon exercise of the IPO warrants are not registered under the Securities Act, we are required to permit holders to exercise their IPO warrants on a cashless basis. However, no IPO warrant will be exercisable for cash or on a cashless basis, and we will not be obligated to issue any shares to holders seeking to exercise their IPO warrants, unless the issuance of the shares upon such exercise is registered or qualified under the securities laws of the state of the exercising holder, or an exemption from registration is available. If and when the IPO warrants become redeemable by us, we may exercise our redemption right even if we are unable to register or qualify the underlying Class A ordinary shares for sale under all applicable state securities laws.
We may redeem your unexpired IPO warrants that are not exchanged prior to their exercise at a time that is disadvantageous to you, thereby making your IPO warrants worthless.
We will have the ability to redeem outstanding IPO warrants (excluding any private placement warrants held by the Sponsor or their permitted transferees) at any time after they become exercisable and prior to their expiration, at $0.01 per IPO warrant, provided that the last reported sales price of our Class A ordinary shares equals or exceeds $18.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations, and the like), we have an effective registration statement under the Securities Act covering our Class A ordinary shares issuable upon exercise of the IPO warrants and a current prospectus relating to them is available. If and when the IPO warrants that are not exchanged become redeemable by us, we may exercise our redemption right even if we are unable to register or qualify the underlying securities for sale under all applicable state securities laws. Redemption of the outstanding IPO warrants could force an IPO warrant holder to (i) exercise your IPO warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so, (ii) sell your IPO warrants at the then-current market price when you might otherwise wish to hold your IPO warrants, or (iii) accept the nominal redemption price which, at the time the outstanding IPO warrants are called for redemption, will be substantially less than the market value of your IPO warrants.
In addition, we may redeem the IPO warrants at any time after they become exercisable and prior to their expiration for a number of our Class A ordinary shares determined based on the fair market value of our Class A ordinary share. The value received upon exercise of the IPO warrants (1) may be less than the value the holders would have received if they had exercised their IPO warrants at a later time where the underlying share price is higher and (2) may not compensate the holders for the value of the IPO warrants.
The liquidity of the IPO warrants that are not exchanged may be reduced.
If the Warrant Amendment is approved, it is unlikely that any IPO warrants will remain outstanding following the completion of the Offer and Consent Solicitation. See “— The Warrant Amendment, if approved, will allow us to require that all outstanding IPO warrants be exchanged for Class A ordinary shares at a ratio 10% lower than the exchange ratio applicable to the Offer.” However, if any unexchanged IPO warrants remain outstanding, then the ability to sell such IPO warrants may become more limited due to the reduction in the number of IPO warrants outstanding upon completion of the Offer and Consent
Solicitation. Additionally, if we fail to satisfy the Nasdaq’s listing requirements as a result of the exchange, then the market for unexchanged IPO warrants will be further impaired. A more limited trading market might adversely affect the liquidity, market price, and price volatility of unexchanged IPO warrants. If there continues to be a market for our unexchanged IPO warrants, these securities may trade at a discount to the price at which the securities would trade if the number outstanding were not reduced, depending on the market for similar securities and other factors.
Nasdaq may delist our public warrants from trading on its exchange, which could limit public warrant holders’ ability to make transactions in our public warrants.
If the Warrant Amendment is approved, it is unlikely that any IPO warrants will remain outstanding following the completion of the Offer and Consent Solicitation. See “— The Warrant Amendment, if approved, will allow us to require that all outstanding IPO warrants be exchanged for Class A ordinary shares at a ratio 10% lower than the exchange ratio applicable to the Offer.” However, if any unexchanged IPO warrants remain outstanding following the completion of the Offer and Consent Solicitation, we cannot assure you that our IPO warrants will continue to be listed on the Nasdaq in the future. In order to continue listing our public warrants on the Nasdaq, there must be a minimum of at least two registered and active market makers for our public warrants.
If a sufficient number of our public warrant holders exchange their public warrants for Class A ordinary shares in the Offer, there may no longer be at least two registered and active market makers for our public warrants as required by the Nasdaq, and the Nasdaq could delist our public warrants.
If the Nasdaq delists our public warrants from trading on its exchange and we are not able to list our securities on another national securities exchange, our public warrants could be quoted on an over-the-counter market. However, even if this were to occur, holders of public warrants could face significant material adverse consequences, including:
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a limited availability of market quotations for the public warrants;
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reduced liquidity for the warrants; and
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the risk that any market makers that do initially make a market in our unexchanged public warrants eventually cease to do so.
Risks Related to Our Limited Operating History, Financial Position, and Capital Requirements
We have a limited operating history, were not involved in the prior phase 1 clinical studies of our product candidates, and have not as a company initiated, conducted or completed any of our own clinical trials, and have not taken a product through to commercialization.
We are a clinical-stage company with limited operating history. To be cash flow positive and viable, we must develop (alone or in partnership(s)) and eventually commercialize (alone or in partnership(s)) a product or products with significant market potential. This will require us to be successful in a range of challenging activities, including establishing our business model and key third-party relationships; completing preclinical studies and clinical trials of our product candidates; obtaining marketing approval for product candidates; obtaining favorable pricing and reimbursement decisions from governmental and private health care payors in the U.S., Europe and other markets we may seek to enter with our products, if approved; manufacturing, marketing and selling those products for which we (either alone or in partnership(s)) may obtain marketing approval; satisfying any post-marketing requirements; and otherwise monetizing products, for example by licensing or selling assets or the Company.
Our products are not approved for commercial sale. Since our inception in January 2022, we have incurred significant operating losses and have utilized substantial resources to in-license and plan for development of the ZB Assets, organize and staff our company, and provide other general and administrative support. We have not conducted or completed clinical trials, including global late-stage clinical trials. As is widespread practice in the life sciences industry, we will engage third-party clinical trial organizations to conduct preclinical and clinical trials. We cannot be certain that our planned preclinical and clinical trials will begin or be completed on time or at all. Furthermore, we cannot be certain whether our planned preclinical
studies and clinical trials will be on budget or have significant cost overruns. We cannot predict whether product candidates will have the desired activity in the clinical trials or whether any side effects will be tolerable. In addition, we have not yet demonstrated an ability to obtain marketing approvals, manufacture a product to commercial scale, or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization.
Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to arrange for third-party contractors to do the following with respect to our product candidates:
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timely file and gain acceptance of investigational new drug applications or clinical trial authorisations to commence planned clinical trials or future clinical trials;
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timely initiate preclinical studies and clinical trials;
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timely enroll patients in clinical trials;
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successfully complete all safety and efficacy studies (preclinical and clinical) required to obtain U.S. and foreign regulatory approval;
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run additional clinical trials or other studies beyond those planned to support the approval and commercialization;
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identify appropriate human doses of our product candidates for use in clinical trials and commercial products;
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successfully manage the prevalence, duration, and severity of potential side effects or other safety issues, if any;
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obtain a positive readout from the clinical trials regarding therapeutic activity;
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successfully demonstrate safety and efficacy to the satisfaction of the FDA, EMA, or similar foreign regulatory authorities;
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obtain the timely receipt of necessary marketing approvals from the FDA, EMA, and similar foreign regulatory authorities;
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manufacture sufficient volume and quality of clinical trial materials to enable the completion of our planned clinical trials;
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establish manufacturing capabilities or make arrangements with third-party manufacturers for future clinical supply and commercial manufacturing;
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launch commercial sales of our products, if and when approved, whether alone or in collaboration with others;
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obtain and maintain acceptance of the products, if and when approved, by patients, the medical community, and third-party payors;
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position our products to effectively compete with other therapies;
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obtain and maintain favorable coverage and reimbursement for our products;
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maintain a continued acceptable safety profile following approval;
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obtain and maintain regulatory exclusivity;
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obtain and maintain patent and trade secret protection;
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enforce and defend our intellectual property rights and claims.
Furthermore, third parties have and may allege that they have intellectual property rights that could block our commercial activities and we may need to seek a license, which may not be available or may not be available at a reasonable price. We may also have a contractual dispute, such as a dispute related to patent inventorship or ownership, which may take significant resources, including the management team’s time, to resolve.
Due to the uncertainties and risks associated with these activities, we are unable to accurately and precisely predict the timing and amount of revenues, if any, the extent of any further losses or if or when we
might achieve profitability. Consequently, any predictions we make about our future success or viability may not be as accurate as they could be if we had a longer operating history or track record of relative success or if our product candidates were in a more advanced stage of research and development. We may never succeed in these activities and, even if we succeed in commercializing the ZB Assets, we may never generate revenue that is significant enough to justify the investment in development, achieve profitability or otherwise successfully monetize product candidates. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis and we may continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Our failure to become and remain profitable or otherwise successfully monetize the products could decrease the value of our shares and impair our ability to raise capital, reduce or eliminate our research and development efforts, or prevent the expansion of our business, or discontinue our operations. Further, we may encounter unexpected expenses, challenges and complications from known and unknown factors such as a global pandemic.
We have incurred losses since inception, and we expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have not generated any revenue from the ZB Assets and may never generate revenue or become profitable.
Investment in biopharmaceutical product development is a highly speculative undertaking and entails substantial upfront costs and capital expenditures over a multi-year timeframe, and ultimately involve a risk that any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval or become commercially viable. We have no products approved for commercial sale, we have not generated any revenue to date, and we continue to incur research and development and other expenses related to our ongoing operations. We do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval from the FDA, EMA and similar foreign regulatory authorities of, and then successfully commercialize, the ZB Assets in one or more indications in one or more territories. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. If we are unable to raise further capital in the near-term, or partner with third parties that fund all or the vast majority of our costs and capital expenditures, then we may be unable to continue operations. We do not expect to generate sufficient revenue through any means to fully fund our operations in the near-term. We cannot assure you that any additional financing that we are able to raise would not have a dilutive impact on your ownership interest in the Company.
We incurred net loss of $7.7 million and an accumulated deficit of $111.2 million for the three months ended March 31, 2024 and net loss of $60.4 million and accumulated deficit of $103.5 million for the year ended December 31, 2023. We expect to continue to incur significant losses for the foreseeable future. Even after finding a means to fund the foreseeable, and unforeseeable, costs to develop our product candidates, thereafter, the progress of our development, and the clinical results achieved, will affect, positively or negatively, the value of our company and accordingly our ability to raise capital. Favorable results may increase the value of the company, increasing our ability to raise capital. Unfavorable results are likely to decrease the value of the company and could impair our ability to raise more capital, which is necessary to maintain our research and development efforts, expand our business and/or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.
Our recurring losses from operations and financial condition could raise substantial doubt about our ability to continue as a going concern.
We expect to fund our operations from existing proceeds as well as through the future sale of equity, debt, borrowing under credit facilities or through potential collaborations with other companies or other strategic transactions.
If we need to raise additional capital and are unable to do so, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. In the future, in our own required quarterly assessments, we may conclude that there is substantial doubt about our
ability to continue as a going concern, and future reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern.
If we are unable to raise capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts.
We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval from the FDA, EMA, and similar foreign regulatory authorities for, the ZB Assets. Even if one or more of the ZB Assets are approved for commercial sale, we anticipate incurring costs associated with sales, marketing, manufacturing and distribution activities to launch the ZB Assets. Our expenses could increase beyond expectations if we are required by the FDA, EMA or other regulatory authorities to perform preclinical studies or clinical trials in addition to those that we currently anticipate. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of funding that will be necessary to successfully complete the development and commercialization of the ZB Assets. Our future capital requirements depend on many factors, including factors that are not within our control.
We do not have any committed external sources of funds and adequate additional financing may not be available to us on acceptable terms, or at all. We may be required to seek additional funds sooner than planned through public or private equity offerings, debt financing, collaborations and licensing arrangements or other sources. Such financing may dilute our shareholders or the failure to obtain such financing may restrict our operating activities. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a shareholder. Debt financing may result in the imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through upfront payments or milestone payments pursuant to future collaborations with third parties, we may have to relinquish valuable rights to the ZB Assets, or grant licenses on terms that are not favorable to us. Our ability to raise additional capital may be adversely impacted by potential worsening global economic and political conditions and volatility in the credit and financial markets in the United States and worldwide. Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research-stage programs, clinical trials or future commercialization efforts.
Our business relies on certain rights licensed from Pfizer and Lilly that can be terminated in certain circumstances. If we breach the agreements, or if we are unable to satisfy our obligations under which we license rights to the ZB Assets, we could lose the ability to develop and commercialize one or more of the ZB Assets.
Our ability to develop and commercialize the ZB Assets is dependent on the use of certain intellectual property and regulatory rights licensed to us from Pfizer (for ZB-168) and Lilly (for torudokimab and tibulizumab). The licenses set forth certain terms and conditions for maintaining the licenses. In the event that the terms and conditions are not met or we become insolvent or bankrupt, the licenses may be terminated and we will no longer be able to develop and commercialize one or more of the ZB Assets. See “Business — License Agreements — 2022 Lilly License” and “Business — License Agreements — 2023 Lilly License”; “Business — License Agreements — Pfizer Agreement” in our Annual Report on Form 10-K. Further, a wholly owned Pfizer subsidiary is the owner of certain intellectual property licensed to us from Pfizer for ZB-168. The confirmatory three-way license agreement provides Pfizer the necessary rights to give effect to the Pfizer License. See “Business — License Agreements — Pfizer Agreement” in our Annual Report on Form 10-K.
If there is any dispute with Pfizer or Lilly regarding our rights under the Pfizer Agreement or the Lilly Licenses, including if we are unable to meet our milestone obligations or become insolvent or bankrupt, our ability to develop and commercialize one or more of the ZB Assets may be adversely affected. Any uncured, material breach by us under the Pfizer Agreement or the Lilly Licenses could result in our loss of exclusive
rights to one or more of the ZB Assets and may lead to a complete termination of our product development efforts for one or more of the ZB Assets.
Due to the significant resources required for the development of the ZB Assets, we must prioritize the pursuit of treatments for certain indications. We may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.
We intend to develop treatments for patients with serious immune system disorders. Due to financial or other constraints, we may be required to limit the scope of our development plans. In the event that we are required to limit our development plans for one or more of the ZB Assets, we may be unable to initiate clinical trials with the same scope that we otherwise intended to pursue, or the geographies in which we initiate such trials.
Our decisions concerning the allocation of research, development, collaboration, management, and financial resources toward particular indications may not lead to the development of any viable commercial product and may divert resources away from other opportunities (including other indications) that later prove to have greater commercial potential or a greater likelihood of success. Even if the endpoint(s) of a clinical trial are met for one or more of the ZB Assets, there is no guarantee that such findings will justify initiation of further trials, including Phase 3 trials that would be required for regulatory approval. Even if the ZB Assets successfully conclude Phase 3 and other necessary clinical trials, and thereafter receive(s) marketing approval, they may not achieve market acceptance or commercial success. If we do not accurately evaluate the commercial potential or target market for the ZB Assets, we may relinquish valuable rights through future collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights. We may make incorrect determinations regarding the viability or market potential of the ZB Assets or misread trends in our industry or in the disease states and therapeutic classes which we are pursuing. Finally, our contractual obligations to make milestone payments to Pfizer and Lilly may impact our ability to fund the development of one or more of the ZB Assets.
We may in the future license additional assets, which may require us to expend additional resources and raise additional capital.
We may execute additional transactions to add to our pipeline. We have not yet entered into any agreements for any such in-licensing transactions. In the event that we do enter into any additional in-license agreements, it is likely that we will need to expend additional resources and raise additional capital. The ability to do so, to some extent, is subject to market, economic, financial, competitive, legislative, and regulatory factors as well as other factors that are beyond our control. There can be no assurance that our business will generate cash flow from operations, or that additional capital will be available to us, in amounts sufficient to enable us to fund our needs.
Risks Related to Anticipated Timing for Initiation, Enrollment, and Completion of Any Planned or Future Clinical Trials
We may not be able to initiate clinical trials if the drug product is not timely available in sufficient quantity at clinical trial sites. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible participants to participate in these trials to conclusion as required by the FDA or foreign regulatory authorities. Additionally, certain clinical trials for our product candidates may be focused on indications with relatively small patient populations, which may further limit enrollment of eligible participants or may result in slower enrollment than we anticipate. The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants.
Participant enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed at which we can recruit participants. Participant enrollment and retention in clinical trials depends on many factors, including the size and nature of the patient population, the severity of the disease under investigation, the nature of the trial protocol, the existing body of safety and efficacy data for the product candidate, the number and nature of competing treatments and ongoing
clinical trials of competing therapies for the same indication, the proximity of participants to clinical sites, the eligibility criteria for the trial, the ability to adequately monitor participants during a clinical trial, clinicians’ and participants’ perceptions as to the potential advantages of the product candidate being studied, and the risk that participants will drop out of a trial before completing all site visits. There are limited patient pools from which to draw in order to complete our clinical trials in a timely and cost-effective manner, particularly for any rare diseases we are pursuing.
Furthermore, a number of factors could delay or prevent potential participants from participating in our clinical trials. For example, our efforts to build relationships with health care providers or patient communities may not succeed, which could result in delays in participant enrollment in our clinical trials. Delays or failures in planned participant enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our product candidates, or could render further development impossible. In addition, natural disasters or public health epidemics may delay or prevent participants from enrolling or from receiving treatment in accordance with the protocol and the required timelines, which could delay our clinical trials, or prevent us or our partners from completing our clinical trials at all, and harm our ability to obtain approval. Further, if participants drop out of our clinical trials, miss scheduled doses or follow-up visits, or otherwise fail to follow clinical trial protocols, the integrity of data from our clinical trials may be compromised or not accepted by the FDA or other regulatory authorities, which would represent a significant setback for the applicable program. In addition, we may rely on CROs and clinical trial sites to ensure proper and timely conduct of our clinical trials and, while we intend to enter into agreements governing their services, we will be limited in our ability to compel their actual performance.
Risks Related to the Clinical Development and Commercialization of Our Product Candidates
Statements included in this Prospectus/Offer to Exchange concerning clinical trials of the ZB Assets have not been reviewed, furnished or endorsed by Pfizer or Lilly, and Pfizer and Lilly have not certified and do not certify any information included herein.
We have never successfully completed the regulatory approval process for any product candidates and we may be unable to do so for any product candidates we develop.
We have not yet demonstrated our ability to obtain regulatory approvals or arrange for a third party to do so on our behalf. If we are required to conduct additional preclinical studies or clinical trials of the ZB Assets beyond those that we currently contemplate, if we are unable to successfully complete preclinical studies or clinical trials of the ZB Assets, or if the corresponding results are not positive or are only modestly positive or if there are safety concerns, we may:
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be delayed in obtaining regulatory approval from the FDA, EMA or other regulatory authorities for our product candidates;
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not obtain regulatory approval at all and lose our right and ability under our license from Pfizer to further develop and commercialize the ZB Assets;
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obtain regulatory approval for indications or patient populations that are not as broad as intended or desired;
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continue to be subject to post-marketing testing requirements from the FDA, EMA or other regulatory authorities; or
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have the product removed from the market after obtaining regulatory approval.
We are substantially dependent on the success of the ZB Assets, and our anticipated clinical trials of the ZB Assets may not be successful.
Our future success is substantially dependent on our ability to successfully develop the ZB Assets for future marketing approval, and then successful commercialization.
In 2015, ZB-168 was placed on clinical hold (an order issued by the United States FDA to the sponsor of an investigational new drug application to delay or to suspend a clinical investigation) due to concern
regarding IL-7Rα expression on certain cell types within the lung and “insufficient information to address the potential risk that RN168 treatment poses to the respiratory system in humans.” The clinical hold was not the result of any adverse events or safety findings emerging from the ongoing clinical studies. Pfizer’s response to the clinical hold included conducting additional non-clinical experiments, a review of IL-7Rα expression in the lung, and proposed pulmonary monitoring plans for future clinical trials, and a detailed assessment of adverse events in the clinical trials conducted to date. The clinical hold was lifted in 2016 with the following conditions/requirements: before enrolling children in studies with ZB-168, data should be submitted supporting that the potential benefits justify the potential risks. We have subsequently received FDA written responses in September 2023, to our pre-IND application, acknowledging that the completed non-clinical studies appear reasonable to support moving forward to a phase 2 study in alopecia areata.
The ZB Assets will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval in multiple jurisdictions, substantial investment, and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote the ZB Assets before we receive marketing approval from the FDA, EMA and comparable foreign regulatory authorities, and we may never receive such marketing approvals.
The success of the ZB Assets will depend on a variety of factors. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, the manufacturing, marketing, distribution and sales efforts of any third parties with whom we choose to collaborate in the future. Accordingly, we cannot assure you that we will ever be able to generate revenue through the sale of the ZB Assets, even if approved. If we are not successful in commercializing the ZB Assets, or are significantly delayed in doing so, our business will be materially harmed.
We may find it difficult to enroll patients in our clinical trials. If we experience delays or difficulties in the enrollment of patients in clinical trials, our successful completion of clinical trials and our receipt of marketing approvals could be delayed or prevented.
We may not be able to initiate or continue clinical trials for the ZB Assets if we are unable to locate and enroll a sufficient number of eligible patients to participate in trials. Patient enrollment may be affected by various factors, including if our competitors have ongoing clinical trials for product candidates that are under development for the same indications as the ZB Assets, and patients instead enroll in such clinical trials. Our inability to enroll a sufficient number of patients would result in significant delays in completing clinical trials or receipt of marketing approvals and increased development costs or may require us to abandon one or more clinical trials altogether.
The results of preclinical studies and early clinical trials of the ZB Assets may not be predictive of the success of our later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, or other foreign regulatory authorities.
We will be required to demonstrate with substantial evidence through well-controlled clinical trials that the ZB Assets are safe and effective before we can seek marketing approval. Demonstrations of efficacy or an acceptable safety profile in prior preclinical studies of the ZB Assets do not mean that future clinical trials will yield the same results, and the translational work that we need to conduct may fail. For instance, we do not know whether the ZB Assets will perform in future preclinical studies or clinical trials as the ZB Assets have performed in preclinical studies and early clinical trials conducted by Pfizer and/or Lilly, as applicable.
The ZB Assets may fail to demonstrate in later-stage clinical trials sufficient safety and efficacy to the satisfaction of the FDA, EMA, and other foreign regulatory authorities despite having progressed through preclinical studies and earlier stage clinical trials. Regulatory authorities may also limit the scope of later-stage trials until we have demonstrated satisfactory safety or efficacy results in preclinical studies or earlier-stage trials, which could prevent us from conducting the clinical trials we currently anticipate. There is no guarantee that the FDA, EMA, and other foreign regulatory authorities will consider the data obtained from prior trials sufficient to allow us to initiate clinical trials within the timelines we anticipate, or at all. Even if we are able to initiate our planned clinical trial on schedule, there is no guarantee that we will be able to complete such trial on the timelines we anticipate or that such trial will produce positive results. Any limitation on our ability to conduct clinical trials could delay or prevent regulatory approval or limit the size of the patient population that can be treated by the ZB Assets, if approved.
Preclinical and clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.
Our clinical trials may not be conducted as planned or completed on schedule, if at all, and a failure of one or more clinical trials can occur at any stage. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials, and the outcome of preclinical studies and early-stage clinical trials for a product candidate for a particular indication may not be predictive of the success of preclinical studies and early-stage clinical trials for the same product candidate for a different indication. Unexpectedly favorable results for the standard of care in any Phase 2 or Phase 3 trial could lead to unfavorable comparisons to the ZB Assets. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates.
We cannot guarantee that any clinical trials will be initiated or conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of an investigational new drug application (“IND”) or similar application will result in the FDA, EMA, or other regulatory authority, as applicable, allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Events that may prevent successful or timely initiation or completion of clinical trials include: inability to generate timely or sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials; delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials; delays or failure in obtaining regulatory authorization to commence a trial; delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; delays in identifying, recruiting and training suitable clinical investigators; delays in obtaining required institutional review board (“IRB”) approval at each clinical trial site; failure to requalify drug substance or drug product for use in clinical trials; failure to demonstrate comparability of drug substance or drug product for regulatory authorization; delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of the ZB Assets for use in clinical trials, or the inability to do any of the foregoing; failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s good clinical practice requirements (“GCPs”) or applicable regulatory guidelines in other countries; changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out of a trial; changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data; transfer of manufacturing processes to larger-scale facilities operated by a contract manufacturing organization (“CMO”) and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process; delays or failure in completing technology transfer for the ZB Assets; delays or failure in obtaining or releasing drug substance or drug product from licensors or third parties; licensors or third parties being unwilling or unable to perform quality control testing of drug substance or drug product; licensors or third parties being unwilling or unable to provide a right of reference to preclinical, manufacturing or clinical data for the ZB Assets; and licensors or third parties being unwilling or unable to satisfy their contractual obligations to us.
We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such clinical trials are being conducted, by the Data Safety Monitoring Board, if any, for such clinical trial or by the FDA or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA, EMA, or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from the ZB Assets, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we are required to conduct additional clinical trials or other testing of the ZB Assets beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of the ZB Assets, if the results of these trials are not positive or are only moderately positive or if there are safety concerns, our business and results of operations may be adversely affected and we may incur significant additional costs.
Preliminary, interim data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures.
From time to time, we may publicly disclose preliminary data from our preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data. We might also make assumptions, estimations, calculations and conclusions as part of our analyses of these data without the opportunity to fully and carefully evaluate complete data. As a result, the preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures.
From time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the ZB Assets and our company in general. In addition, the information we choose to publicly disclose regarding a particular preclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the preliminary or interim data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, the ZB Assets may be harmed, which could harm our business, operating results, prospects or financial condition.
We may develop the ZB Assets in combination with other therapies, which exposes us to additional risks related to clinical trial design, regulatory requirements, other agents or active pharmaceutical or biological ingredients used in combination with our product candidates.
In the future, we may develop the ZB Assets to be used in combination with one or more approved or investigational therapies. The necessary clinical trials and regulatory approval requirements for such combination therapies can be more complex, time consuming, expensive, and uncertain than for single-drug therapies. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing approved therapies, we would continue to be subject to the risks that the FDA or other regulatory authorities could revoke approval of the therapy used in combination with our product candidates or that safety, efficacy, intellectual property, manufacturing or supply issues could arise with these existing therapies. This could result in our own products being removed from the market or being less successful commercially.
If the FDA or other regulatory authorities revoke their approval of these other therapies or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the therapies we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.
We may also evaluate our future product candidates in combination with one or more other therapies that have not yet been approved for marketing by the FDA or other regulatory authorities. We will not be able to market any product candidate we develop in combination with any such unapproved therapies that do not ultimately obtain marketing approval. In addition, unapproved therapies face the same risks described with respect to our product candidates, including the potential for serious adverse effects, delays in clinical trials and lack of FDA approval.
The ZB Assets may have a safety profile that could prevent regulatory approval of clinical trials, marketing approval or market acceptance, or limit commercial potential.
Patients in previous trials for the ZB Assets experienced adverse events. If the ZB Assets are associated with unacceptable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or INDs, we may need to interrupt, delay or abandon development or limit development to more narrow uses or subpopulations in which such potential
side effects or other characteristics may be less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trials or result in potential product liability claims. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the ZB Assets and may adversely affect our business, financial condition and prospects significantly.
Additionally, if the ZB Assets receive marketing approval, we or others may later identify unexpected or unexpectedly severe side effects or adverse events caused by the ZB Assets. In such cases, regulatory authorities may suspend, limit or withdraw approvals of or seek an injunction against their manufacture or distribution, require additional warnings on the label, including “boxed” warnings, or issue safety alerts, require press releases or other communications containing warnings or other safety information, require us to change the way the ZB Assets is administered or conduct additional clinical trials or post-approval studies, require us to create a risk evaluation and mitigation strategy (“REMS”) which could include a medication guide outlining the risks of such side effects for distribution to patients or impose fines, injunctions or criminal penalties. We could also be sued and held liable for harm caused to patients, and our reputation may suffer. Any of these events could prevent us from achieving or maintaining market acceptance of the ZB Assets, if approved, and could seriously harm our business.
The ZB Assets are protein therapeutics and thus carry the risk of provoking immune responses.
The ZB Assets are protein therapeutics, which can provoke adverse immune responses when administered to patients. For example, the formation of anti-drug antibodies (“ADA”) were observed in the majority of patients who were dosed with ZB-168 in a phase 1b trial in T1D mellitus, including 54.5% of patients who developed neutralizing ADA. Although these ADAs did not appear to affect drug concentrations based on visual inspection, there can be no assurance that ADAs will not develop in future studies that may reduce exposure or lead to adverse safety events. The development of ADA could also trigger hypersensitivity reactions that manifest as serious adverse events for the ZB Assets, including but not limited to anaphylaxis. If patients experience adverse events, including anaphylaxis, our trials could be delayed or stopped and our development programs may be halted entirely if this is observed during clinical development. Even if ADAs are not detected in early clinical trials, they may be detected after product launch and may significantly reduce the commercial potential or even result in the product being pulled from the market.
Risks Related to our Dependence on Third Parties or Their Actions
We intend to rely on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
We do not currently have the ability to independently conduct preclinical studies or clinical trials required to develop our product candidates. We intend to rely on CROs, clinical trial sites, and other third parties to ensure the proper and timely conduct of our preclinical studies and clinical trials, and we expect to have limited influence over their actual performance. We intend to rely upon CROs and others to monitor, manage, and report data for our clinical trials, which includes biostatistical analysis and programming. Our reliance on the CROs and others will not relieve us of our regulatory responsibilities.
We, our CROs, and other third parties we might engage will be required to comply with good laboratory practices (“GLPs”) and GCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for any of our product candidates that are in preclinical and clinical development. The regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators, and clinical trial sites. Although we will rely on CROs and others to conduct GCP-compliant clinical trials, we remain responsible for ensuring that each of our GLP preclinical studies and clinical trials is conducted in accordance with our investigational plan and protocol and applicable laws and regulations, and our reliance on the CROs and others does not relieve us of our regulatory responsibilities. If we, CROs and other third parties we engage fail to comply with GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials for
approval. Accordingly, if our CROs or others fail to comply with these regulations or fail to recruit a sufficient number of participants, we may be required to repeat clinical trials, which would delay the regulatory approval process.
While we will have agreements governing their activities, CROs and other third parties we engage will not be our employees, and we will not directly control whether or not they devote sufficient time and resources to our programs. These CROs and others may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other product development activities which could harm our business. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs and others, which may reduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology. In addition, certain of our agreements with CROs or other third parties provide for monetary and other limitations on their liability. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize our product candidates.
If our relationships with any CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can negatively impact our ability to meet our desired clinical development timelines. Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a negative impact on our business, financial condition, and prospects.
In addition, investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA. The FDA may conclude that a financial relationship between us and an investigator has created a conflict of interest or otherwise affected interpretation of the trial. The FDA may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of product approval.
We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of our product candidates. Reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost.
We have no or limited experience in drug formulation or manufacturing as a company, and we do not own or operate, and we do not expect to own or operate, facilities for drug manufacturing, storage and distribution, or testing. We are dependent on third parties, including some located in China, such as WuXi AppTec, to manufacture the clinical supplies of our product candidates. For any activities conducted in China, we are exposed to the increased possibility of supply disruptions and higher costs in the event of changes in the policies of the U.S. or Chinese governments, political unrest or unstable economic conditions including sanctions on China or any of our China-based suppliers. Our manufacturing costs could also increase as a result of potential future appreciation of the local currency in China or increased labor costs if the demand for skilled laborers increases and/or the availability of skilled labor declines in China. In addition, certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements, or proposed legislation by the U.S. government, which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting the supply of material to us. For example, the recently proposed BIOSECURE Act introduced in the U.S. House of Representatives, and a substantially similar bill in the U.S. Senate, target U.S. government contracts, grants, and loans for entities that use equipment and services from certain specified Chinese biotechnologies service provides, including WuXi AppTec, and authorizes the U.S. government to include additional Chinese biotechnologies companies of concern. If these bills become law, or similar laws are passed, they would have the potential to severely restrict the ability of companies to work with certain Chinese biotechnology companies of concern without losing
the ability to contract with, or otherwise receive funding from, the U.S. government. Such disruption could have adverse effects on the development of our product candidates and our business operations.
Further, we also will rely on third-party manufacturers to supply us with sufficient quantities of our product candidates, to be used, if approved, for commercialization. We do not have long-term supply agreements or commitments with a manufacturer to produce raw materials, active pharmaceutical ingredients or the finished products of our product candidates or the associated packaging. Furthermore, the raw materials for our product candidates are sourced, in some cases, from a single-source supplier. If we were to experience an unexpected loss of supply of any of our product candidates or any of our future product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials. For example, adverse macroeconomic or geopolitical developments such as a health epidemic or pandemic, or the ongoing conflicts in Ukraine and the Middle East, could impact our ability to procure sufficient supplies for the development of our products and product candidates. Any significant delay in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay completion of our clinical trials, product testing and potential regulatory approval of our product candidates.
Our reliance on third-party manufacturers entails various risks, some of which we would not be subject to if we manufactured product candidates ourselves, including:
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inability to meet our drug specifications and quality requirements consistently;
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delay or inability to procure or expand sufficient manufacturing capacity;
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issues related to scale-up of manufacturing;
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costs and validation of new equipment and facilities required for scale-up;
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failure to comply with current good manufacturing practices (“cGMP”) or similar foreign standards;
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inability to negotiate manufacturing agreements with third parties under commercially reasonable terms, if at all;
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termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
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reliance on single sources for drug components or finished drug product;
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lack of qualified backup suppliers for components or finished drug product purchased from a sole or single source supplier;
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misappropriation of proprietary information, including our trade secrets and know-how;
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the mislabeling of clinical supplies, potentially resulting, e.g., in the wrong dose amounts being supplied or study drug or placebo not being properly identified;
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clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions;
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operations of our third-party manufacturers or suppliers being disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; and
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carrier disruptions or increased costs that are beyond our control.
We do not have complete control over all aspects of the manufacturing process of, and are dependent on, our contract manufacturing partners for compliance with cGMP regulations for manufacturing both active drug substances and finished drug products. Third-party manufacturers may not be able to or may fail to comply with cGMP regulations or similar regulatory requirements outside of the United States. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain marketing approval for their manufacturing facilities. In addition, we do not have control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative
manufacturing facilities, which would significantly impact our ability to develop, obtain marketing approval for or market our product candidates, if approved. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates or drugs and harm our business and results of operations.
Our current and anticipated future dependence upon others for the manufacture of our product candidates or drugs may adversely affect our potential future profit margins and our ability to commercialize any product candidates that may receive marketing approval on a timely and competitive basis.
Risks Related to Our Intellectual Property
Our business relies on certain licensing rights from Pfizer for ZB-168 that can be terminated in certain circumstances. If we breach the agreement, or if we are unable to satisfy our obligations under which we license rights to torudokimab from Pfizer, we could lose the ability to develop and commercialize ZB-168.
We are party to a license agreement with Pfizer under which we were granted rights to certain patents, know-how and technology that are important and necessary to our business, including for ZB-168. Our rights to use these patents and employ the inventions claimed therein, as well as the exploitation of licensed technology and know-how, are subject to the continuation of, and our compliance with, the terms of our license agreement.
Our license agreement with Pfizer imposes upon us various diligence, payment and other obligations, including as described in the section titled “Business — License Agreements — Pfizer Agreement.”
If we fail to comply with any of our obligations under the Pfizer Agreement, or we are subject to a bankruptcy or dissolution, Pfizer may have the right to terminate the license agreement, in which event we would not be able to market any ZB-168 product.
We are heavily reliant upon the license from Pfizer to certain patent rights that are important or necessary to the development of ZB-168. Pfizer retains all rights not expressly granted by the license as well as retaining rights to make, have made, use and import ZB-168 or any products containing ZB-168 for all internal research, development and regulatory purposes, except that Pfizer does not have the right to conduct clinical trials to develop ZB-168 or any products containing ZB-168.
We are responsible for filing, prosecuting (including in connection with any reexaminations, oppositions and the like) and maintaining the licensed patent rights and to provide Pfizer a reasonable opportunity to review and comment on proposed submissions to any patent office and reasonably consider any comments provided by Pfizer. We must notify Pfizer prior to permitting any patent right to go abandoned. Pfizer may then choose at its option to continue prosecution or maintenance of said patent right and the license granted to us will become nonexclusive as to that right. The patents and patent applications licensed by Pfizer were not drafted by us or our attorneys, and we have not controlled or had any input into the prosecution of these patents and patent applications. We cannot be certain that drafting or prosecution of those patents and patent applications were conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents.
Pursuant to the Pfizer Agreement, we are required to prepare a development plan and use Commercially Reasonable Efforts (as that term is defined in the Pfizer Agreement) to develop and seek regulatory approval for ZB-168 in several countries and then to commercialize each product where regulatory approval is obtained. If we fail to comply with the obligations under our license agreement, or if we use the licensed intellectual property in an unauthorized manner, we may be required to pay damages and Pfizer may have the right to terminate the license. If our license agreement is terminated, we may not be able to develop, manufacture, market or sell the product candidate covered by our agreement and those being tested or approved in combination with such product. Such an occurrence could materially adversely affect the value of the product candidate being developed under any such agreement.
Pursuant to the Pfizer Agreement, we have the first right, but not the obligation, to enforce the licensed patents at our expense. Without Pfizer’s consent, we may not settle any such initiated litigation that would (i) adversely affect the validity, enforceability or scope of any of the licensed patent rights, (ii) give rise to liability of Pfizer or its Affiliates (as defined in the Pfizer Agreement), (iii) admit non-infringement of any licensed patent rights, or (iv) otherwise impair Pfizer’s rights in any licensed technology or the license agreement. If we decide not to enforce the licensed patents, our licensor has the option to enforce them and may determine not to pursue litigation against other companies that are infringing these patents, or may pursue such litigation less aggressively than is desirable. Without protection for the intellectual property we license, other companies might be able to offer substantially identical products for sale, which could adversely affect our competitive business position and harm our business prospects.
Our business relies on certain licensing rights from Lilly for torudokimab that can be terminated in certain circumstances. If we breach the agreement, or if we are unable to satisfy our obligations under which we license rights to torudokimab from Lilly, we could lose the ability to develop and commercialize torudokimab.
Our ability to continue to develop and commercialize torudokimab is dependent on the use of certain intellectual property that is licensed to us from Lilly. The license sets forth certain terms and condition for maintaining the license. In the event that the terms and conditions are not met or we become insolvent or bankrupt, the license may be terminated and we will no longer be able to develop and commercialize torudokimab.
The Lilly-Z33 License imposes upon us various diligence, payment and other obligations, as described in the section titled “Business — License Agreements — 2022 Lilly License.”
If we fail to comply with any of our obligations under the Lilly-Z33 License, Lilly may have the right to terminate the license agreement, in which event we would not be able to market any torudokimab product.
If there is any dispute with Lilly regarding our rights under the Lilly-Z33 License, including if we are unable to meet our milestone obligations or become insolvent or bankrupt, our ability to develop and commercialize torudokimab may be adversely affected. Any uncured, material breach by us under the Lilly‑Z33 License could result in our loss of exclusive rights to torudokimab and may lead to a complete termination of our product development efforts for torudokimab.
Our business relies on certain licensing rights from Lilly for tibulizumab that can be terminated in certain circumstances. If we breach the agreement, or if we are unable to satisfy our obligations under which we license rights to tibulizumab from Lilly, we could lose the ability to develop and commercialize tibulizumab.
Our ability to continue to develop and commercialize tibulizumab is dependent on the use of certain intellectual property that is licensed to us from Lilly. The license sets forth certain terms and conditions for maintaining the license. In the event that the terms and conditions are not met or we become insolvent or bankrupt, the license may be terminated and we will no longer be able to develop and commercialize tibulizumab.
Our license agreement with Lilly for tibulizumab imposes upon us various diligence, payment and other obligations, as described in the section titled “Business — License Agreements — 2023 Lilly License.”
If we fail to comply with any of our obligations under the Lilly-ZB17 License, Lilly may have the right to terminate the license agreement, in which event we would not be able to market any tibulizumab product.
If there is any dispute with Lilly regarding our rights under the Lilly-ZB17 License, including if we are unable to meet our milestone obligations or become insolvent or bankrupt, our ability to develop and commercialize tibulizumab may be adversely affected. Any uncured, material breach by us under the Lilly-ZB17 License could result in our loss of exclusive rights to tibulizumab and may lead to a complete termination of our product development efforts for tibulizumab.
Intellectual property disputes may impact our business and/or our ability to develop and commercialize the ZB Assets
Disputes may arise regarding intellectual property subject to, and any of our rights and obligations under, any license or other strategic agreement, including:
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the scope of rights granted under the license agreement and other interpretation-related issues;
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the extent to which our technology and processes infringe, misappropriate or violate the intellectual property of the licensor that is not subject to the license agreement;
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our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
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the sublicensing of patent and other rights to third parties under any such agreement or collaborative relationships;
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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and
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the priority of invention of patented technology.
In addition, the agreements under which we license intellectual property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidate.
Our business also would suffer if any current or future licensors fail to abide by the terms of the license, if the licensors fail to enforce licensed patents against infringing third parties, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor’s rights.
In addition, if we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have to seek alternative options, such as developing new product candidates with design-around technologies, which may require more time and investment, or abandon development of the relevant research programs or product candidates and our business, financial condition, results of operations and prospects could suffer.
Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
Our success depends in large part on our ability to obtain and maintain patent protection for the ZB Assets and their uses, components, formulations, methods of manufacturing and methods of treatment, as well as our ability to operate without infringing on or violating the proprietary rights of others. We have licensed rights, including composition of matter patent families, related to the ZB Assets. Licensing assets from third parties involves technical and scientific due diligence to assess the opportunity, the strength of the intellectual property protection for the asset and the ability to commercialize the asset. This due diligence is usually conducted over a relatively short period of time. It can be difficult to identify all the issues relevant to the assessment. Failure to identify all the relevant issues can impact negatively on the value of the asset.
Our intellectual property strategy is, where appropriate, to file new patent applications on inventions, including improvements to existing products/candidates and processes to improve our competitive edge or to improve business opportunities. We continually assess and refine our intellectual property strategy to ensure appropriate protection and rights are secured. Thus, we may be able to file patent applications in the United States and abroad related to our novel discoveries and technologies, for example new uses/methods of treatment, new formulations and improvements to manufacturing methods, that are important to our business, as opportunities arise.
Identifying and seeking patent protection is expensive and time consuming and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost, in a timely manner or
in all jurisdictions where protection may be commercially advantageous, or we may financially not be able to protect our proprietary rights at all. Despite our efforts to protect our proprietary rights, unauthorized parties may be able to obtain and use information we regard as proprietary. Where possible, we seek to file for patent protection in commercial jurisdictions relevant to the product or technology; however, this is assessed on a case-by-case basis.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our future patent applications may not result in patents being issued which protect our technology or product candidates or which do not effectively prevent others from commercializing competitive technologies and product candidates. The patent examination process may require us or our licensors to narrow the scope of the claims of our or our licensors’ pending and future patent applications, which may limit the scope of patent protection that may be obtained. We cannot assure you that all of the potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it can invalidate a patent or prevent a patent application or certain patent claims from being issued.
The issuance of a patent does not ensure that it is valid or enforceable. Therefore, even if we are issued a patent, it may not be valid or enforceable against third parties. Issued patents may be challenged, narrowed, invalidated or circumvented. In addition, court decisions may introduce uncertainty in the enforceability or scope of patents owned by pharmaceutical and biotechnology companies. Thus, any of our patents, including patents that we may rely on to protect our market for approved products, may be held invalid or unenforceable by a court.
Because patent applications in the United States, Europe and many other jurisdictions are typically not published until 18 months after filing, and because publications of discoveries in scientific literature lag behind actual discoveries, we cannot be certain that we or our licensors were the first to make the inventions claimed in our issued patents or future patent applications, or that we or our licensors were the first to file for protection of the corresponding inventions. As a result, we may not be able to obtain or maintain protection for certain inventions. Such patent protection may be of insufficient scope to achieve our business objectives.
In addition, the issuance of a patent does not necessarily give us the right to practice the patented invention. Third parties may have blocking patents that prevent marketing of our products or working our own technology. We endeavor to identify early third-party patents and patent applications which may be block a product or technology, to minimize this risk. However, relevant patents or patent applications may be overlooked or missed, which may in turn impact our ability to commercialize the ZB Assets.
The term of a patent depends upon the laws of the country in which it is issued. In most jurisdictions, including the United States, Europe, China and Japan, the basic patent term is 20 years from the earliest filing date of a non-provisional patent application, subject to the payment of renewal fees. Some jurisdictions, including the United States, Europe and Japan, provide for up to an additional five years as a patent term extension for therapeutic products that require marketing approval. The requirements for this supplementary protection are set by the relevant authorities in the given jurisdiction. Products approved before the expiry of the basic patent term may benefit from such a patent term extension. It is our strategy to apply for such supplementary protection, where possible.
In addition to patent protection, statutory provisions in the United States, Europe and other jurisdictions may provide a period of clinical data exclusivity which may be followed by an additional period of market exclusivity to compensate for the time required for regulatory approval of our product candidates. Once the relevant criteria are satisfied, the protection applies. The length of protection depends on the jurisdiction and may also depend on the type of therapy.
Third parties may seek to market “similar” versions of our approved products, if any. Alternatively, third parties may seek approval to market their own products, similar or otherwise, that compete with our products. We may not be able to block the commercialization of these products, which may erode our commercial position in the marketplace.
If disputes over intellectual property and other rights that we have licensed, own in the future or co-own in the future prevent or impair our ability to maintain our licensing or exclusivity arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidate.
We enjoy only limited geographical protection with respect to our licensed patents and may not be able to protect our intellectual property rights throughout the world.
We may not be able to protect our intellectual property rights throughout the world and the legal systems in certain countries may not favor enforcement or protection of patents, trade secrets and other intellectual property. Filing, prosecuting and defending patents worldwide can be prohibitively expensive and our intellectual property rights in some foreign jurisdictions may be less extensive than those in the United States.
The life of a patent and the protection it affords is limited. For example, in the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest US non-provisional filing date. In Europe, the expiration of an invention patent is 20 years from its filing date. Certain US patents have a longer patent term pursuant to patent term adjustment (35 U.S.C. §154(b)).
Our competitors may operate in countries where we do not have patent protection and can freely use our technologies and discoveries. For example, we may lack patent protection or pending patent applications in manufacturing countries such as China, India, and Singapore.
Even if patents are granted, they may be difficult to enforce in certain countries, for example, in China. Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business and financial condition may be adversely affected. Many countries also limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
Periodic maintenance and annuity fees on any issued patent are due to be paid to the United States Patent and Trademark Office (“USPTO”) and foreign patent agencies over the lifetime of a patent. In addition, the USPTO and other foreign patent agencies require compliance with a number of procedural, documentary, and other similar provisions during the patent application process. While an inadvertent failure to make payment of fees or to comply with such provisions can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which such non-payment or non-compliance will result in the abandonment or lapse of the patent or patent application, and the partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, and non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits. If we or our licensors fail to maintain the patents and patent applications covering our product candidates or if we or our licensors otherwise allow our patents or patent applications to be abandoned or lapse, our competitors might be able to enter the market, which would hurt our competitive position and could impair our ability to successfully commercialize our product candidates.
Issued patents covering one or more of our product candidates could be found invalid or unenforceable.
Any issued patents that we may license or own covering the ZB Assets could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO. We may be subject to claims challenging the inventorship, validity, or enforceability of our patents and/or other intellectual property. Finally, changes in US patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect the ZB Assets. Further, if we encounter delays in our clinical trials or delays in obtaining regulatory approval, the period of time during which we could market the ZB Assets under patent protection would be reduced. Thus, the patents that we own and license may not afford us any meaningful competitive advantage.
Moreover, we or our licensors may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in opposition, derivation, revocation, reexamination, inter partes review, post-grant review or interference proceedings. An adverse determination in any such submission, proceeding or
litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or the ZB Assets and compete directly with us, or result in our inability to manufacture or commercialize drugs without infringing third-party patent rights. If the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize the ZB Assets.
We may not be able to maintain or enforce trade secret protection for our product candidates.
In addition to seeking patents, we may also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. Any disclosure, either intentional or unintentional, by our employees, the employees of third parties with whom we share our facilities or third-party consultants and vendors that we engage to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive position. In order to protect our proprietary technology and processes, we rely in part on confidentiality agreements with our collaborators, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure. We may need to share our proprietary information, including trade secrets, with future business partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors and those affiliated with or controlled by state actors. In addition, while we undertake efforts to protect trade secrets and other confidential information from disclosure, others may independently discover trade secrets and proprietary information, and in such cases, we may not be able to assert any trade secret rights against such party. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
As is common in the biotechnology and pharmaceutical industries, we employ individuals and engage the services of consultants who previously worked for other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers, or that our consultants have used or disclosed trade secrets or other proprietary information of their former or current clients. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Class A ordinary shares. This type of litigation or proceeding could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can. Uncertainties resulting from the initiation and continuation of patent litigation or other intellectual property related proceedings could adversely affect our ability to compete in the marketplace.
Patent terms may not protect our competitive position with respect to the ZB Assets for an adequate amount of time.
The life of a patent, and the protection it affords, is limited. Once patents covering the ZB Assets have expired, we may be open to competition from competitive products, including generics or biosimilars. Given
the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our licensed and owned patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, our business may be materially harmed.
In the United States, the patent term of a patent that covers an FDA-approved drug may be eligible for limited patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review. However, a patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug may be extended and only those claims covering the approved drug or its use it may be extended. Similar provisions are available in Europe and certain other non-United States jurisdictions to extend the term of a patent that covers an approved drug.
If and when the ZB Assets receive FDA approval, we expect to apply for patent term extension on patents covering those ZB Assets, there is no guarantee that the applicable authorities will agree with our assessment of whether such extension should be granted, and even if granted, the length of such extension. We may not be granted patent term extension either in the United States or in any foreign country because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than we request. If we are unable to obtain any patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing products following the expiration of our patent rights, and our business, financial condition, results of operations and prospects could be materially harmed.
It is possible that we will not obtain patent term extension under the Hatch-Waxman Act for a U.S. patent covering one or more of the ZB Assets even where that patent is eligible for patent term extension, or if we obtain such an extension, it may be for a shorter period than we had sought.
There are detailed rules and requirements regarding the patents that may be submitted to the FDA for listing in the Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (also known as the “Purple Book”), a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act. We may be unable to obtain patents covering those ZB Assets that contain one or more claims that satisfy the requirements for listing in the Purple Book. Even if we submit a patent for listing in the Purple Book, the FDA may decline to list the patent, or a manufacturer of biosimilar or interchangeable drugs may challenge the listing. If the ZB Assets are approved and patents covering the ZB Assets are not listed in the Purple Book, a manufacturer of biosimilar or interchangeable drugs would not have to provide advance notice to us of any abbreviated new drug application filed with the FDA to obtain permission to sell a biosimilar or interchangeable version of either of the ZB Assets.
Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect the ZB Assets.
Changes in either the patent laws or interpretation of patent laws in the United States, including patent reform legislation such as the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) could increase the uncertainties and costs surrounding the prosecution of our future owned and in-licensed patent applications and the maintenance, enforcement or defense of our owned and in-licensed patents. The Leahy-Smith Act includes a number of significant changes to United States patent law. These changes include provisions that affect the way patent applications are prosecuted, redefine prior art, provide more efficient and cost-effective avenues for competitors to challenge the validity of patents, and enable third-party submission
of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent at USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith Act, the United States transitioned to a first-to-file system in which, assuming that the other statutory requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. As such, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.
In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. Recent US Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and altered the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents once obtained. Depending on future legislation by the US Congress, decisions by the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and our ability to protect, defend and enforce our patent rights in the future. For example, in the case Amgen v. Sanofi, the Supreme Court held broad functional antibody claims invalid for lack of enablement. Similarly, in the case Juno v. Kite, the Federal Circuit held genus claims directed to CAR-T cells invalid for lack of written description for failing to provide disclosure commensurate with the scope of the claims. While we do not believe that any of the patents licensed or owned by us will be found wholly invalid based on these decisions, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents. Similarly, changes in the patent laws of other jurisdictions could adversely affect our ability to obtain and effectively enforce our patent rights, which would have a material adverse effect on our business and financial condition.
We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market the ZB Assets.
We cannot guarantee that any of our patent searches or analyses, including the identification of relevant third-party patents, the scope of said patent claims or the expiration of relevant patents, are complete, accurate or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of the ZB Assets. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect. Our determination of the expiration date of any patent that we consider relevant may be incorrect. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market the ZB Assets.
In addition, because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our patents or our pending applications, or that we were the first to invent the technology. Our competitors may have filed, and may in the future file, patent applications covering the ZB Assets or technology similar to ours. Any such patent application may have priority over our patent applications or patents, which could require us to obtain rights to patents covering such technologies.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We generally enter into confidentiality and intellectual property assignment agreements with our employees, consultants, and contractors. These agreements generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property. However, those agreements
may not be honored and may not effectively assign intellectual property rights to us. Moreover, there may be some circumstances where we are unable to negotiate such ownership rights.
We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing the ZB Assets or as a result of questions regarding co-ownership of potential joint inventions. Arbitration or litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, arbitration or litigation could result in substantial costs and be a distraction to management and other employees.
We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing the ZB Assets.
Because the intellectual property landscape in the biotechnology industry is rapidly evolving and is interdisciplinary, it is difficult to conclusively assess our freedom to operate without infringing on or violating third-party rights. If a third party successfully brings a claim against us, we may be required to pay substantial damages, be forced to abandon the ZB Assets and/or seek a license from the patent holder. In addition, any intellectual property claims (e.g., patent infringement or trade secret theft) brought against us, whether or not successful, may cause us to incur significant legal expenses and divert the attention of our management and key personnel from other business concerns. We cannot be certain that patents owned or licensed by us will not be challenged by others in the course of litigation. Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise funds at a particular market price.
Competitors may infringe or otherwise violate our patents, trademarks, copyrights or other intellectual property. To counter infringement or other violations, we may be required to file claims, which can be expensive and time-consuming. Any such claims could provoke these parties to assert counterclaims against us, including claims alleging that we infringe their patents or other intellectual property rights. In addition, in a patent infringement proceeding, a court or administrative body may decide that one or more of the patents we assert is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to prevent the other party from using the technology at issue on the grounds that our patents do not cover the technology. Similarly, if we assert trademark infringement claims, a court or administrative body may determine that the marks we have asserted are invalid or unenforceable or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In such a case, we could ultimately be forced to cease use of such marks. In any intellectual property litigation, even if we are successful, any award of monetary damages or other remedy we receive may not be sufficient.
Further, we may be required to protect our patents through procedures created to challenge the validity of a patent at the USPTO. An adverse determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.
In addition, if any of the ZB Assets is found to infringe the intellectual property rights of third parties, these third parties may assert infringement claims against our future licensees and other parties with whom we have business relationships and we may be required to indemnify those parties for any damages they suffer as a result of these claims, which may require us to initiate or defend protracted and costly litigation
on behalf of licensees and other parties regardless of the merits of such claims. If any of these claims succeed, we may be forced to pay damages on behalf of those parties or may be required to obtain a license.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.
Our license from Pfizer is subject to retained rights.
Pfizer retains certain rights under its license agreement with us, including (a) the right to make, have made, use and import the underlying technology for all internal research, development and regulatory purposes; provided, that Pfizer shall not have the right to conduct clinical trials to develop the underlying technology in the treatment, diagnosis or prevention of diseases in humans, (b) the right to use the licensed patent rights and know-how for purposes other than those exclusively license to us under the Pfizer Agreement and (c) the rights that have been provided by Pfizer to (i) a reagent supplier to make or sell the underlying technology or (ii) a non-commercial entity to use the underlying technology, in each case in the form of non- cGMP samples of the underlying technology in milligram quantities solely as a research reagent.
Pfizer may also use for any purpose information in non-tangible form which may be retained by persons who have had access to ZB-168 and the licensed know-how, including ideas, concepts or techniques contained therein.
It is difficult to monitor whether Pfizer limits its use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.
Our licenses from Lilly are subject to retained rights.
Lilly retains certain rights under its license agreement with us, including the right to use the underlying technology for internal research, development and regulatory purposes. It is difficult to monitor whether Lilly limits its use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.
We may not be able to effectively secure first-tier technologies when competing against other companies or investors.
Our future success may require that we acquire patent rights and know-how to new or complementary technologies. However, we compete with a substantial number of other companies that may also compete for technologies we desire. In addition, many venture capital firms and other institutional investors, as well as other biotechnology companies, invest in companies seeking to commercialize various types of emerging technologies. Many of these companies have greater financial, scientific and commercial resources than us. Therefore, we may not be able to secure the technologies we desire. Furthermore, should any commercial undertaking by us prove to be successful, there can be no assurance competitors with greater financial resources will not offer competitive products and/or technologies.
Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
The degree of future protection afforded by our intellectual property rights, whether licensed or owned, is uncertain because intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors, or permit us to maintain our competitive advantage. Moreover, if a third party has intellectual property rights that cover the practice of our technology, we may not be able to fully exercise or extract value from our intellectual property rights. The factors that may limit any potential competitive advantage provided by our intellectual property rights include:
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pending patent applications that we may file or license may not lead to issued patents;
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patents, should they issue, that we own or license, may not provide us with any competitive advantages, or may be challenged and held invalid or unenforceable;
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others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology but that is not covered by the claims of any of our owned or in-licensed patents, should any such patents issue;
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third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection;
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we (or our licensor) might not have been the first to make the inventions covered by a pending patent application that we own or license;
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we (or our licensor) might not have been the first to file patent applications covering a particular invention;
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others may independently develop similar or alternative technologies without infringing our intellectual property rights;
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we may not be able to obtain and/or maintain necessary licenses on reasonable terms or at all;
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third parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property;
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we may not be able to maintain the confidentiality of our trade secrets or other proprietary information;
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we may not develop or in-license additional proprietary technologies that are patentable; and
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the patents of others may have an adverse effect on our business.
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Should any of these events occur, they could significantly harm our business and results of operation.
If approved, our product candidates that are regulated as biologics may face competition from biosimilars or interchangeable biosimilars approved through an abbreviated regulatory pathway.
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), was enacted as part of the ACA to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic. Under the BPCIA, a reference biological product may be granted 12 years of data exclusivity from the time of first licensure of the product, and the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference product. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still develop and receive approval of a competing biologic, so long as their biologics license application (“BLA”) does not rely on the reference product, sponsor’s data or submit the application as a biosimilar application. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty, and any new policies or processes adopted by the FDA could have a material adverse effect on the future commercial prospects for our biological products.
We believe that if any of the ZB Assets is approved in the United States as a biological product under a BLA it would qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider the subject product candidate to be a reference product for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for non-biological drug products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. The approval of a biosimilar or interchangeable biosimilar of our product candidates could have a material adverse impact on our business due to increased competition and pricing pressure.
Risks Related to Regulatory and Legal Compliance
The regulatory approval processes of the FDA, EMA, and other foreign regulatory authorities are complex, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for the ZB Assets, we may not be able to commercialize, or may be delayed in commercializing, the ZB Assets, and our ability to generate revenue will be materially impaired.
The process of obtaining regulatory approvals in the United States, European Union (“EU”), and other jurisdictions is complex, expensive and typically takes many years following commencement of clinical trials, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. We cannot commercialize the ZB Assets without first obtaining regulatory approval from the FDA in the United States and comparable foreign regulatory authorities outside of the United States. Before obtaining regulatory approvals for the commercial sale of the ZB Assets, we must demonstrate through complex and expensive preclinical studies and clinical trials that the ZB Assets are both safe and effective for each targeted indication. Securing regulatory approval also requires the submission of information about the drug manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authorities. Further, the ZB Assets may not be effective, may be only moderately effective or may prove to have unacceptable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval. The FDA, EMA, and comparable foreign regulatory authorities have discretion in the approval process and may refuse to accept any application or may decide that the data we submit are insufficient for product approval and require additional preclinical, clinical studies or other data. Any of the ZB Assets could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including: the FDA, EMA, or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; we may be unable to demonstrate to the satisfaction of the FDA, EMA, or comparable foreign regulatory authorities that is the ZB Assets are safe and effective for their proposed indications; the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA, or comparable foreign regulatory authorities for approval; serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using products similar to the ZB Assets; we may be unable to demonstrate that the clinical and other benefits of the ZB Assets outweigh their safety risks; the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; the data collected from clinical trials of the ZB Assets may not be acceptable or sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials; the FDA, EMA, or the applicable foreign regulatory authority may disagree regarding the formulation, labeling and/or the specifications of the ZB Assets; the FDA, EMA, or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical or commercial supplies; and the approval policies or regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. Further, the approval requirements for the ZB Assets are likely to vary by jurisdiction such that success in one jurisdiction is not necessarily predicative of success elsewhere.
Of the large number of products in development, only a small percentage successfully complete the FDA, EMA, or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market the ZB Assets, which would significantly harm our business, results of operations and prospects.
If we were to obtain approval, regulatory authorities may approve the ZB Assets for fewer or more limited indications than we request, including failing to approve the most commercially promising indications, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve the ZB Assets with a label that does not include the labeling claims necessary or desirable for the successful commercialization of the ZB Assets. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for the ZB Assets, we may not be able to commercialize, or may be delayed in commercializing, the ZB Assets and our ability to generate revenue could be materially impaired.
We will be subject to extensive ongoing regulatory obligations and continued regulatory review after any potential product approval, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with the ZB Assets.
Any regulatory approvals that we may receive for the ZB Assets will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of the ZB Assets, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. In addition, if the FDA, EMA, or comparable foreign regulatory authorities approve the ZB Assets, the ZB Assets and the activities associated with their respective development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export will be subject to comprehensive regulation by the FDA, EMA, and comparable foreign regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs, and compliance with GCPs for any clinical trials that we conduct following approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA, EMA, and other regulatory authorities for compliance with applicable regulations including cGMPs.
If we or a regulatory authority discover previously unknown problems with the ZB Assets, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the ZB Assets are manufactured, a regulatory authority may impose restrictions on the ZB Assets, the manufacturing facility or us, including requiring recall or withdrawal of the ZB Assets from the market or suspension of manufacturing, restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials, restrictions on the manufacturing process, warning or untitled letters, civil and criminal penalties, injunctions, product seizures, detentions or import bans, voluntary or mandatory publicity requirements and imposition of restrictions on operations, including costly new manufacturing requirements. The occurrence of any event or penalty described herein may inhibit our ability to commercialize the ZB Assets and generate revenue and could require us to expend significant time and resources to respond and could generate negative publicity.
The FDA’s, EMA’s and other comparable regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit, delay, increase the cost or risks of obtaining regulatory approval of our product candidates, including if as a result new or more costly or difficult to achieve clinical trial or manufacturing quality requirements are imposed. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any regulatory approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
Due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer the ZB Assets at competitive prices which would seriously harm our business.
Our ability to successfully commercialize the ZB Assets also will depend in part on the extent to which reimbursement will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels.
The FDA, EMA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of unapproved (off-label) uses.
If one or more of the ZB Assets is approved and we are found to have improperly promoted off-label uses, we may become subject to significant liability. If we cannot successfully manage the promotion of the ZB Assets, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.
Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors acting for or on our behalf may engage in misconduct or other improper activities. We have adopted a Code of Conduct applicable to all employees of the Company, and we have contractual compliance obligations in our agreements with our third-party collaborators, but it is not always possible to identify and deter misconduct by these parties and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, governmental and private third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute the ZB Assets, if approved. See the section titled “Business — Health Care Laws and Regulations” for a more detailed description of the laws that may affect our ability to operate.
Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we obtain regulatory approval. Our future arrangements with third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any product candidates for which we obtain regulatory approval.
The size of the potential market for the ZB Assets is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
Our current and future target patient populations are based on our beliefs and estimates regarding the incidence or prevalence of certain types of the indications that may be addressable by the ZB Assets, which is derived from a variety of sources, including scientific literature and surveys of clinics. Our estimations may prove to be incorrect and the number of potential patients may turn out to be lower than expected. The total addressable market opportunity for our product candidates will ultimately depend upon a number of factors including the diagnosis and treatment criteria included in the final label, if approved for sale in specified indications, acceptance by the medical community, patient access, the success of competing therapies and product pricing and reimbursement. Even if we obtain significant market share for our product candidates, because the potential target populations could be small, we may never achieve profitability without obtaining regulatory approval for additional indications.
Healthcare legislative and regulatory reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business.
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding healthcare systems that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we may obtain marketing approval.
Payors, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted
for new technologies. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes that could impact our ability to sell our products profitably. In particular, in 2010, the ACA was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives to programs that increase the federal government’s comparative effectiveness research.
There has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which have resulted in several U.S. presidential executive orders, Congressional inquiries, proposed and enacted federal and state legislation, and other regulatory actions designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, reform government program reimbursement methodologies for drug products, and otherwise reduce drug prices. For example, the Inflation Reduction Act of 2022 (“IRA”), among other things, (1) extends enhanced subsidies for individuals purchasing health insurance coverage through plan year 2025 in the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, marketplaces, (2) eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program, (3) directs U.S. Department of Health and Human Services (“HHS”) to negotiate the price of certain single-source drugs and biologics covered under Medicare and (4) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA and related federal actions are likely to have a significant impact on the pharmaceutical industry. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
We cannot predict what healthcare reform initiatives may be adopted in the future. We expect that these and other healthcare reform measures that may be adopted may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Reform measures that result in decreased physician reimbursement may adversely affect our business. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates.
Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA. It is unclear how other healthcare reform measures of the Biden or future administrations or other efforts, if any, to amend or challenge the ACA, will impact our business.
Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
At a federal level, President Biden signed an Executive Order on July 9, 2021 affirming the administration’s policy to (i) support legislative reforms that would lower the prices of prescription drug and biologics, including by allowing Medicare to negotiate drug prices, by imposing inflation caps, and, by
supporting the development and market entry of lower-cost generic drugs and biosimilars; and (ii) support the enactment of a public health insurance option. Among other things, the Executive Order also directs the HHS to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic drug supply chain, reduce the price that the Federal government pays for drugs, and address price gouging in the industry; and directs the FDA to work with states and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and the FDA’s implementing regulations. The FDA released such implementing regulations on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. On September 25, 2020, the HHS’s Centers for Medicare & Medicaid Services (“CMS”) stated that drugs imported by states under this rule will not be eligible for federal rebates under Section 1927 of the Social Security Act and manufacturers would not report these drugs for “best price” or Average Manufacturer Price purposes. Since these drugs are not considered covered outpatient drugs, CMS further stated it will not publish a National Average Drug Acquisition Cost for these drugs. If implemented, importation of drugs from Canada may materially and adversely affect the price we receive for any of our product candidates. Further, on November 20, 2020, CMS issued an Interim Final Rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B reimbursement rates would have been calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita. However, the MFN rule was immediately challenged in federal courts and on August 6, 2021 CMS announced a proposed rule to rescind it. Additionally, on December 2, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. On November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. In response to litigation, the Biden administration agreed to delay the effective date of the rule until January 1, 2023. Further, implementation of these changes and new safe harbors for point-of-sale reductions in price for prescription pharmaceutical products and pharmacy benefit manager service fees are currently under review by the Biden administration and may be amended or repealed. Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that it will continue to seek new legislative measures to control drug costs. The effect of these legislative and executive activities on our business model and operations is currently unclear.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
We and our external partners are subject to complex environmental, health and safety laws and regulations, including those governing laboratory procedures, the handling, use, storage, treatment and disposal of hazardous materials and wastes, and the rehabilitation of contaminated sites. Our operations, including those performed by our external partners, may involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. In addition, we and/or our external partners may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
We are subject to laws and regulations related to privacy, data protection, information security and consumer protection across different markets where we conduct our business. Our actual or perceived failure to comply with such obligations could harm our business.
We are subject to laws and regulations related to, among other things, privacy, data protection, information security and consumer protection across different markets where we conduct our business. Such laws and regulations are constantly evolving and changing and are likely to remain uncertain for the foreseeable future. Our actual or perceived failure to comply with such obligations could have an adverse effect on our business, operating results and financial operations. Complying with these numerous, complex, and often changing regulations is expensive and difficult, and failure to comply with any privacy laws or data security laws or any security incident or breach involving the potential or actual misappropriation, loss or other unauthorized processing, use or disclosure of sensitive or confidential patient, consumer or other personal information, whether by us, one of our collaborators or another third party, could adversely affect our business, financial condition, and results of operations, including but not limited to investigation costs, material fines and penalties, compensatory, special, punitive, and statutory damages, litigation, consent orders regarding our privacy and security practices, requirements that we provide notices, credit monitoring services, and/or credit restoration services or other relevant services to impacted individuals, adverse actions against our licenses to do business, reputational damage and injunctive relief.
European data collection is also governed by restrictive regulations governing the use, processing and cross-border transfer of personal information. The collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in Europe, including personal health data, is subject to the EU General Data Protection Regulation (“GDPR”), which imposes strict requirements for processing the personal data of individuals within the European Economic Area (the “EEA”), such as Norway, Iceland and Liechtenstein. The GDPR is directly applicable in each EU member state and is extended to the EEA. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. The GDPR implements more stringent operational requirements than its predecessor legislation. Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities. For example, the GDPR applies extraterritorially, requires us to make more detailed disclosures to data subjects, requires disclosure of the legal basis on which we can process personal data, makes it harder for us to obtain valid consent for collecting and processing personal data (including data from clinical trials), requires the appointment of data protection officers, such as when sensitive personal data, such as health data, is processed on a large scale, provides more robust rights for data subjects, including far reaching information rights and the right to erasure, introduces mandatory data breach notification through the EU, imposes additional obligations on us when contracting with service providers and requires us to adopt appropriate privacy governance, including policies, procedures, training, and data audit. The GDPR provides that EU member states and EEA countries may establish their own laws and regulations that go beyond the GDPR in certain areas, such as regarding the mandatory appointment of data protection officers or further limiting the processing of personal data, including genetic, biometric, or health data, which could limit our ability to use and share personal data or could cause our costs to increase. Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, and the efficacy and longevity of current transfer mechanisms between the EU and the United States remains uncertain. For example, in 2016, the EU and the United States agreed to a transfer framework for data transferred from the EU to the United States (the “Privacy Shield”), but the Privacy Shield was invalidated in July 2020 by the Court of Justice of the European Union (“CJEU”). While the CJEU upheld the adequacy of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism, and potential alternative to the Privacy Shield), it made clear that reliance on them alone may not necessarily be sufficient in all circumstances. Use of the standard contractual clauses must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals and additional
measures and/or contractual provisions may need to be put in place, however, the nature of these additional measures is currently uncertain. After Brexit the United Kingdom is also a third country from an EU perspective, but the EU Commission adopted adequacy decisions for the United Kingdom on June 28, 2021 largely permitting the free flow of data from the EU to the United Kingdom. However, for the first time, the adequacy decisions include a so-called “sunset clause” and, therefore, will automatically expire four years after their entry into force.
We cannot assure you that our third-party service providers with access to our or our customers’, suppliers’, trial patients’ and employees’ personally identifiable and other sensitive or confidential information will not breach contractual obligations imposed by us, or that they will not experience data security breaches or attempts thereof, which could have a corresponding effect on our business, including putting us in breach of our obligations under privacy laws and regulations and/or which could in turn adversely affect our business, results of operations, and financial condition. We cannot assure you that our contractual measures and our own privacy and security-related safeguards will protect us from the risks associated with the third-party processing, use, storage, and transmission of such information. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects.
We do not have a compliance program in place consistent with Federal agencies’ guidances on corporate compliance programs.
We have not established a formal compliance function with the independence and resources that Federal regulators would expect of established corporate compliance programs. We are in the process of developing policies and procedures for compliance training, auditing, and monitoring activities. We have not established a dedicated Chief Compliance Officer. Accordingly, risks associated with regulatory schemes described herein may arise undetected and unmitigated by corporate leadership. Furthermore, any potential enforcement action for regulatory violations might result in compliance obligations in addition to fines, penalties, or administrative actions (e.g., U.S. Department of Justice monitorships or U.S. Department of Health and Human Services, Office of Inspector General Corporate Integrity Agreements).
Risks Related to Our Business Operations, Employee Matters, and Managing Growth
We are dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining qualified personnel, including consultants, we may not be able to successfully implement our business strategy.
Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain qualified managerial, scientific and medical personnel. We are dependent on our managerial, scientific and medical personnel, including our Chief Executive Officer, Chief Operating Officer, Chief Medical Officer, Chief Financial Officer and Chief Scientific Officer. If we do not succeed in attracting and retaining qualified personnel, it could materially adversely affect our business, financial condition and results of operations. We could in the future have difficulty attracting and retaining experienced personnel and may be required to expend significant financial resources in our employee recruitment and retention efforts. We have relied upon and plan to continue to rely upon third parties, including consultants, to act in management roles for the Company. While we have agreements with such third parties, we do not have the same ability to influence their time commitment to the Company as we would if they were employees. Furthermore, we are dependent on our ability to attract, hire, relocate and retain qualified managerial, scientific and medical personnel from various jurisdictions. Therefore, immigration requirements may have a significant influence on our human resources planning. Immigration applications can take several months or more to be finalized. If we are unable to complete the requisite visa applications, either as a result of changing requirements or otherwise, our ability to successfully implement our business strategy could suffer, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
We rely on third parties, including consultants, independent clinical investigators and CROs to conduct and sponsor some of the clinical trials of our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidates may delay or impair our ability to obtain regulatory approval for our product candidates.
We have relied upon and plan to continue to rely upon third parties, including independent clinical investigators, academic partners, medical institutions, regulatory affairs consultants and third-party CROs,
to conduct our preclinical studies and clinical trials, including in some instances sponsoring such clinical trials, and to engage with regulatory authorities and monitor and manage data for our ongoing preclinical and clinical programs. While we have, or will have, agreements governing the activities of such third parties, we will control only certain aspects of their activities and have limited influence over their actual performance.
Any of these third parties may terminate their engagements with us under certain circumstances. We may not be able to enter into alternative arrangements or do so on commercially reasonable terms. In addition, there is a natural transition period when a new contract research organization begins work. As a result, delays would likely occur, which could negatively impact our ability to meet our expected clinical development timelines and harm our business, financial condition and prospects.
We remain responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the EEA and other regulatory authorities for all of our products in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators and trial sites. If we fail to exercise adequate oversight over any of our academic partners or CROs or if we or any of our academic partners or CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements, or for any other reasons, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, the EMA or other regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon a regulatory inspection of us, our academic partners or our CROs or other third parties performing services in connection with our clinical trials, such regulatory authority will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with product produced under applicable cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
Furthermore, the third parties conducting clinical trials on our behalf are not our employees, and except for remedies available to us under our agreements with such contractors, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing development programs. These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could impede their ability to devote appropriate time to our clinical programs. If these third parties, including clinical investigators, do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates. If that occurs, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
In addition, with respect to investigator-sponsored trials that may be conducted, we do not control the design or conduct of these trials, and it is possible that the FDA or EMA will not view these investigator- sponsored trials as providing adequate support for future clinical trials or market approval, whether controlled by us or third parties, for any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results. We expect that such arrangements may provide us certain information rights with respect to the investigator-sponsored trials, including the ability to obtain a license to obtain access to use and reference the data, including for our own regulatory submissions, resulting from the investigator-sponsored trials. However, we do not have control over the timing and reporting of the data from investigator-sponsored trials, nor do we own the data from the investigator-sponsored trials. If we are unable to confirm or replicate the results from the investigator-sponsored trials or if negative results are obtained, we would likely be further delayed or prevented from advancing further clinical development. Further, if investigators or institutions breach their obligations with respect to the clinical development of our product candidates, or if the data proves to be inadequate compared to the firsthand knowledge we might have gained had the investigator-sponsored trials been sponsored and conducted by us, then our ability to design and conduct any future clinical trials ourselves may be adversely affected. Additionally, the FDA or
EMA may disagree with the sufficiency of our right of reference to the preclinical, manufacturing or clinical data generated by these investigator-sponsored trials, or our interpretation of preclinical, manufacturing or clinical data from these investigator-sponsored trials. If so, the FDA or EMA may require us to obtain and submit additional preclinical, manufacturing, or clinical data.
In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.
We expect to experience significant growth in the number of our employees and/or number of consultants as well as the scope of our operations, particularly in the areas of drug development, clinical operations, regulatory affairs and, potentially, others. To manage our anticipated future growth, we must continue to implement and develop our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.
Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
Despite the implementation of security measures in an effort to protect systems that store our information, given their size and complexity and the increasing amounts of information maintained on our internal information technology systems and those of our third-party CROs, other contractors (including sites performing our clinical trials) and consultants, these systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners and/or other third parties, or from cyber-attacks by malicious third parties, which may compromise our system infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, our data. To the extent that any disruption or security breach were to result in a loss, destruction, unavailability, alteration or dissemination of, or damage to, our data or applications, or for it to be believed or reported that any of these occurred, we could incur liability and reputational damage and the development and commercialization of the ZB Assets could be delayed. Further, our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption in, or failure or security breach of, our systems or third-party systems where information important to our business operations or commercial development is stored.
We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize the ZB Assets.
We plan to utilize and depend upon independent investigators and collaborators, such as medical institutions, CROs, contract development and manufacturing organization (“CDMOs”) and strategic partners, to conduct and support our preclinical studies and clinical trials under agreements with us. We will rely heavily on these third parties over the course of our preclinical studies and clinical trials, and we control only certain aspects of their activities. As a result, we will have less direct control over the conduct, timing and completion of these preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required to comply with GCP regulations, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA, or comparable foreign regulatory authorities
may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations, even if responsibilities have been outlined in agreements with external partners, such as CROs. In addition, our clinical trials must be conducted with product produced under cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.
Any third parties conducting our clinical trials will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether they devote sufficient time and resources to the ZB Assets. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize the ZB Assets.
We intend to rely on third parties to manufacture the ZB Assets. There can be no assurance that we will successfully negotiate future agreements with third-party manufacturers for the ZB Assets on acceptable terms or at all. Our business could be adversely affected if the third-party manufacturers are unable to produce the ZB Assets, fail to provide us with sufficient quantities of the ZB Assets or fail to do so at acceptable quality levels or prices.
We do not currently own or operate any facility that may be used to manufacture the ZB Assets (including any drug substance or finished drug product) and must rely on CDMOs to produce them for us. We have not yet validated the commercial scale and may not be able to do so for the ZB Assets for approval. For tibulizumab, we do not currently own any cGMP compliant drug product and will not be able to conduct any clinical trials until we do. There can be no assurance that we will successfully negotiate agreements with CDMOs to manufacture future ZB Assets on acceptable terms or at all.
We have not participated in the manufacturing process of, and are completely dependent on, our contract manufacturing partners for manufacture of the ZB Assets and for compliance with cGMP requirements and any other regulatory requirements of the FDA or other regulatory authorities for the manufacture of the ZB Assets. If our partners do not successfully carry out their contractual duties, meet expected deadlines, or manufacture the ZB Assets in accordance with regulatory requirements, or if there are disagreements between us and our CDMO, we will not be able to complete, or may be delayed in completing, the clinical trials required to support approval of the ZB Assets or the FDA, EMA or other regulatory agencies may refuse to accept our clinical or preclinical data. If the FDA, EMA, or a comparable foreign regulatory authority does not approve these facilities for the manufacture of the ZB Assets or if it withdraws any approval in the future, we may need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs and materially and adversely affect our ability to develop, obtain regulatory approval for or market the ZB Assets, if approved. Similarly, our failure, or the failure of our CDMOs, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of the ZB Assets, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of the ZB Assets and harm our business and results of operations.
Moreover, if any CDMO on which we will rely are unable to produce the ZB Assets at all, or fail to manufacture quantities of the ZB Assets at quality levels necessary to meet our clinical requirements, or regulatory requirements at a scale sufficient to meet anticipated demand, and at a cost that allows us to continue development and to achieve profitability, our business, financial condition and prospects could be materially and adversely affected. Our business could be similarly affected by business disruptions to our third-party providers with potential impacts on our future revenue and financial condition and our costs and expenses. If any CDMOs we contract with are unable to meet our timelines or cost and quantity demands,
we may need to find additional CDMOs and negotiate new manufacturing agreements. We may also incur substantial fees if we contract with a CDMO to access a cell-line and may incur substantial fees if we ultimately decide not to use that cell-line or that CDMO for the manufacturing of the ZB Assets and need to obtain resources elsewhere. Each of these risks could delay or prevent the commencement as well as the completion of our clinical trials or the approval of the ZB Assets by the FDA, including by causing us to have to rerun clinical studies, which would result in higher costs and could adversely impact the commercialization of the ZB Assets.
In addition, some third party CDMOs have intellectual property, such as patents and/or know-how for which they require an annual fee, milestones and/or royalties. These financial obligations increase the overall cost of goods and can reduce profitability or reduce the valuation of the product. We have such agreements in place, and may need additional agreements in the future.
We may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
We may, in the future, form or seek strategic alliances, create joint ventures or collaborations, or enter into licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to the ZB Assets and/or the Company more broadly. Any of these relationships may require us to increase our near and long-term expenditures, issue securities that dilute our existing shareholders or disrupt our management and business.
In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy and obtain marketing approval. Further, collaborations involving our product candidates are subject to numerous risks, which may include the following:
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collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;
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collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization of our product candidates based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
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collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates;
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a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;
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collaborators may not properly protect our intellectual property or proprietary information or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
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disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;
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collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidate; and
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collaborators may own or co-own intellectual property covering our product candidates that results from our collaborating with them, and in such cases, we would not have the exclusive right to such intellectual property or may require a license from the collaborator for such intellectual property in order to commercialize the product candidate and/or discourage generic competition.
As a result, if we enter into future collaboration agreements and strategic partnerships or license our product candidates, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Furthermore, if conflicts arise between our future corporate or academic collaborators or strategic partners and us, the other party may act in a manner adverse to us and could limit our ability to implement our strategies. Any delays in entering into future collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.
The increasing use of social media platforms presents new risks and challenges.
Social media is increasingly being used to communicate about our clinical development programs and the diseases our therapeutics are being developed to treat, and we intend to utilize appropriate social media in connection with our commercialization efforts following approval of our product candidates, if any. Social media practices in the biotechnology and biopharmaceutical industry continue to evolve and regulations and regulatory guidance relating to such use are evolving and not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business, resulting in potential regulatory actions against us, along with the potential for litigation related to off-label marketing or other prohibited activities and heightened scrutiny by the FDA, the SEC and other regulators. For example, patients may use social media channels to comment on their experience in an ongoing blinded clinical trial or to report an alleged adverse event. If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our product candidates. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. In addition, we may encounter attacks on social media regarding our company, management, product candidate or products. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
As a public company, we are subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, we could fail to recognize actual or potential conflicts arising from the relationship or arrangement that our directors or executive officers have with another company. Our directors or executive officers could inadvertently fail to disclose a new relationship or arrangement causing us to fail to make a required related party transaction disclosure. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.
We may identify material weaknesses in our internal control over financial reporting in the future or fail to maintain an effective system of internal control over financial reporting, which may result in material misstatements of our consolidated financial statements or cause us to fail to meet periodic reporting obligations.
As a public company, Zura is required to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act and make an ongoing, formal assessment of the effectiveness of our internal controls over financial reporting.
We cannot assure you that the measures we have taken to date, and actions we may take in the future, will prevent or avoid control deficiencies that could lead to material weaknesses in our internal control over financial reporting in the future. Our current controls, and any new controls that we develop, may become inadequate because of changes in conditions in our business. Further, deficiencies in our disclosure controls and internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective controls or any difficulties encountered in their implementation or improvement could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods.
We have performed a formal evaluation of our internal control over financial reporting under the supervision and with the participation of management, including our principal executive officer and principal financial officer, as required by Section 404 of the Sarbanes-Oxley Act. We have not engaged an independent registered public accounting firm to perform an audit of our internal control over financial reporting as of any balance sheet date or for any period reported in our financial statements. We are required to evaluate and disclose changes made in our internal controls and procedures on a quarterly basis. Failure to comply with the Sarbanes-Oxley Act could potentially subject us to sanctions or investigations by the SEC, the applicable stock exchange or other regulatory authorities, which would require additional financial and management resources.
If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor confidence in Zura and, as a result, the market price of our ordinary shares.
As a public company, we are required to comply with the requirements of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, including, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. We continue to develop and refine our disclosure controls and other procedures that are designed to ensure that information we are required to disclose in the reports that we will file with the SEC are recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and that information required to be disclosed in reports under the Exchange Act, is accumulated and communicated to our management, including our principal executive and financial officers.
We must continue to improve our internal control over financial reporting. We are currently required to make a formal assessment of the effectiveness of our internal control over financial reporting. To achieve compliance with these requirements within the prescribed time period, we will be engaging in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. There is a risk that we will not be able to conclude, within the prescribed time period or at all, that our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act. Moreover, our testing, or the subsequent testing by our independent registered public accounting firm, may reveal additional deficiencies in our internal control over financial reporting that are deemed to be material weaknesses.
Any failure to implement and maintain effective disclosure controls and procedures and internal control over financial reporting, including the identification of one or more material weaknesses, could cause investors to lose confidence in the accuracy and completeness of our financial statements and reports, which would likely adversely affect the market price of our ordinary shares. In addition, we could be
subject to sanctions or investigations by the stock exchange on which our ordinary shares are listed, the SEC and other regulatory authorities.
Increasing regulatory focus on privacy and security issues and expanding laws and regulatory requirements could impact our business models and expose us to increased liability.
We are subject to global data protection, privacy and security laws, regulations and codes of conduct that relate to our business activities, which may include sensitive, confidential, and personal information. These laws, regulations and codes are inconsistent across jurisdictions and are subject to evolving and differing (sometimes conflicting) interpretations. Government officials and regulators, privacy advocates and class action attorneys are increasingly scrutinizing how companies collect, process, use, store, share and transmit personal data. This scrutiny can result in new and shifting interpretations of existing laws, thereby further impacting our business. For example, GDPR in the European Economic Area, and the United Kingdom continues to be interpreted by European and UK courts in novel ways leading to shifting requirements, country specific differences in application and uncertain enforcement priorities. More recently enacted laws, such as the Personal Information Protection Law in China, and new and emerging state laws in the United States on privacy, data and related technologies, such as the California Consumer Privacy Act, the California Privacy Rights Act, the Colorado Privacy Act and the Virginia Consumer Data Protection Act, as well as industry self-regulatory codes and regulatory requirements, create new privacy and security compliance obligations and expand the scope of potential liability, either jointly or severally with our customers and suppliers. As a security example, pursuant to the U.S. Securities and Exchange Commission’s Rules on Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure, we are required to make certain disclosures related to material cybersecurity incidents and the reasonably likely impact of such an incident on a Current Report on Form 8-K and will be required to make certain other cybersecurity disclosures in our Annual Report on Form 10-K. Determining whether a cybersecurity incident is notifiable or reportable may not be straightforward and any such mandatory disclosures could be costly and lead to negative publicity, loss of customer confidence in the effectiveness of our security measures, diversion of management’s attention and governmental investigations.
While we have invested in readiness to comply with applicable requirements, the dynamic and evolving nature of these laws, regulations and codes, as well as their interpretation by regulators and courts, may affect our ability to implement our business models effectively and to adequately address disclosure requirements. These laws, regulations and codes may also impact our innovation and business drivers and may force us to bear the burden of more obligations. Perception of our practices, products, services or solutions, even if unfounded, as a violation of individual privacy, data protection rights or cybersecurity requirements, subjects us to public criticism, lawsuits, investigations, claims and other proceedings by regulators, industry groups or other third parties, all of which could disrupt or adversely impact our business and reputation and expose us to increased liability, fines and other punitive measures including prohibition on sales of our products, services or solutions, restrictive judicial orders and disgorgement of data.
We face substantial competition, which may result in others discovering, developing, licensing or commercializing products before or more successfully than we do.
We face substantial competition from major pharmaceutical companies and biotechnology companies worldwide. Many of our competitors have significantly greater financial, technical and human resources. Smaller and early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. As a result, our competitors may discover, develop, license or commercialize products before or more successfully than we do.
Furthermore, pharmaceutical companies that develop and/or market products for the indications we are pursuing are likely to represent substantial competition. These include companies actively developing and/or marketing IL-7R inhibitors (such as Q32 Bio Inc. and OSE Immunotherapeutics SA); as well as TSLPR inhibitors (such as Upstream Bio, Inc.), IL-33 inhibitors (such as Regeneron/Sanofi and AstraZeneca), ST2 inhibitors (such as Roche/Genentech), IL-17A inhibitors (such as MoonLake, Novartis, and Acelryin), and BAFF inhibitors (such as GSK). The above mechanisms may be of potential therapeutic use in one or more of the indications we plan to pursue in the Phase 2 program. If the ZB Assets do not offer sustainable
advantages over competing products, we may otherwise not be able to successfully compete against current and future competitors.
Our competitors may obtain regulatory approval of their products more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize the ZB Assets. Our competitors may also develop drugs that are more effective, more convenient, more widely used or less costly or have a better safety profile than the ZB Assets and these competitors may also be more successful than us in manufacturing and marketing their products.
Furthermore, we also face competition more broadly across the market for existing cost-effective and reimbursable treatments for T-cell and B-cell mediated diseases, autoimmune diseases, and inflammatory diseases. The ZB Assets, if approved, may compete with these existing drug and other therapies but may not be competitive with them in price. We expect that if the ZB Assets are approved, they will be priced at a significant premium over generic, including branded generic, products. As a result, obtaining market acceptance of, and gaining significant share of the market for the ZB Assets will pose challenges.
Public health crises such as pandemics or similar outbreaks have affected and could continue to seriously and adversely affect our preclinical studies and anticipated clinical trials, business, financial condition and results of operations.
As a result of pandemics, related “shelter in place” orders and other public health guidance measures, we may experience disruptions that could seriously harm our business. Potential disruptions include but are not limited to: delays or difficulties in enrolling patients in, initiating or expanding our clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff; increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19 or other health conditions or being forced to quarantine; interruption of key clinical trial activities, such as clinical trial site data monitoring and efficacy, safety and translational data collection, processing and analyses, due to limitations on travel imposed; recommendations by federal, state or local governments, employers and others or interruptions of clinical trial subject visits, which may impact the collection and integrity of subject data and clinical trial endpoints; diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; delays or disruptions in preclinical experiments and IND-enabling studies due to restrictions of on-site staff and unforeseen circumstances at CROs and vendors; interruption or delays in the operations of the FDA, EMA, and comparable foreign regulatory authorities including delays in receiving approval from local regulatory authorities to initiate our planned clinical trials; interruption of, or delays in receiving, supplies of the ZB Assets due to staffing shortages, raw materials shortages, production slowdowns or stoppages and disruptions in delivery systems; and limitations on employee or other resources that would otherwise be focused on the conduct of our clinical trials and preclinical work, including because of sickness of employees or their families, the desire of employees to avoid travel or contact with large groups of people, an increased reliance on working from home, school closures or mass transit disruptions.
Pandemics and other public health guided measures may also affect the ability of the FDA, EMA, and other regulatory authorities to perform routine functions. If global health concerns prevent the FDA, EMA, or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA, EMA, or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
The extent to which pandemics evolve may affect our clinical trials, business, financial condition and results of operations will depend on future developments, which are highly uncertain and cannot be predicted, such as the duration of the pandemic, new or continued travel restrictions and actions to contain the outbreak or treat its impact, such as social distancing and quarantines or lock-downs, business closures or business disruptions. Future developments in these and other areas present material uncertainty and risk with respect to our clinical trials, business, financial condition and results of operations.
Pandemics and other similar disruptions may also have the effect of heightening many of the other risks described in this “Risk Factors” section.
Our business, operations, financial position, and clinical development plans and timelines could be materially adversely affected by international conflict.
Our financial position and operations may be materially and adversely affected by international conflicts, including military action (e.g., in Ukraine and Israel) and economic sanctions imposed by certain governments. These conflicts may impact our ability to carry out clinical development activities in certain countries or regions. As our ability to continue to operate will be dependent on raising debt and equity finance, any adverse impact to those markets as a result of international conflict, including due to increased market volatility, decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all), could negatively impact our business, operations or financial position. The extent of any potential impact is not yet determinable, however.
Third-party manufacturers in other countries may be subject to U.S. legislation or investigations, including the proposed BIOSECURE Act, sanctions, trade restrictions, and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials, and could adversely affect our financial condition and business prospects.
We currently rely on WuXi Biologics (Shanghai) and its affiliates (“WuXi Biologics”) as the sole supplier of torudokimab. Accordingly, there is a risk that supplies of torudokimab may be significantly delayed by, or may become unavailable as a result of, manufacturing, equipment, process, regulatory, or business-related issues affecting that company. We may also face additional manufacturing and supply-chain risks due to the regulatory and political structure of The People’s Republic of China (“PRC”), or as a result of the international relationship with the PRC, including but not limited to potential sanctions imposed by the U.S. government on WuXi. Although we are developing plans to move certain activities outside of WuXi Biologics’ Chinese facilities, there can be no assurance that our plans will be successful or that our operations would not be impacted in the future by a negative impact on the supply of, or use of, torudokimab. See “Risks Related to our Dependence on Third Parties or Their Actions — We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of our product candidates. Reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost.”
Risks Related to Ownership of Our Class A Ordinary Shares
Since the consummation of the Business Combination, the market value of our securities has fluctuated. Future fluctuations in the price of our securities could contribute to the loss of all or part of a shareholder’s investment. The market prices for securities of biotechnology and pharmaceutical companies have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. If an active market for our securities continues, the market price of our ordinary shares may fluctuate significantly in response to numerous factors, some of which are beyond our control, such as:
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our ability to commercialize the ZB Assets, if approved;
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the status and cost of our marketing commitments for the ZB Assets;
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announcements regarding results of any clinical trials relating to our product candidates;
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unanticipated serious safety concerns related to the use of the ZB Assets;
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adverse regulatory decisions;
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changes in laws or regulations applicable to the ZB Assets, including but not limited to clinical trial requirements for approvals;
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legal disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for the ZB Assets, government investigations and the results of any proceedings or lawsuits, including, but not limited to, patent or shareholder litigation;
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our decision to initiate a clinical trial, not initiate a clinical trial or to terminate an existing clinical trial;
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our dependence on third parties;
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announcements of the introduction of new products by our competitors;
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market conditions and trends in the pharmaceutical and biotechnology sectors;
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announcements concerning product development results or intellectual property rights of others;
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future issuances of ordinary shares or other securities;
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the recruitment or departure of key personnel;
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failure to meet or exceed any financial guidance or expectations regarding product development milestones that we may provide to the public;
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actual or anticipated variations in quarterly operating results;
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our failure to meet or exceed the estimates and projections of the investment community;
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overall performance of the equity markets and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies;
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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
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changes in financial estimates by us or by any securities analysts who might cover our shares;
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fluctuation of the market values of any of our potential strategic investments;
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issuances of debt or equity securities;
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compliance with our contractual obligations
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sales of our Class A ordinary shares by us or our shareholders in the future;
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trading volume of our Class A ordinary shares;
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ineffectiveness of our internal controls;
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publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;
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general political and economic conditions;
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effects of natural or man-made catastrophic events;
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effects of public health crises, pandemics and epidemics; and
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other events or factors, many of which are beyond our control.
Further, the equity markets in general have recently experienced extreme price and volume fluctuations. Continued market fluctuations could result in extreme volatility in the price of our Class A ordinary shares, which could cause a decline in the value of our Class A ordinary shares. Price volatility of our Class A ordinary shares might worsen if the trading volume of our Class A ordinary shares is low. In the past, shareholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ share. Such litigation, if instituted against Zura, could cause it to incur substantial costs and divert management’s attention and resources from our business. The realization of any of the above risks or any of a broad range of other risks, including those described in these “Risk Factors,” could have a dramatic and material adverse impact on the market price of our Class A ordinary shares.
We have not paid cash dividends in the past and we do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of our Class A ordinary shares.
We have not paid cash dividends on our ordinary shares and we do not anticipate paying cash dividends on our ordinary shares in the foreseeable future. The payment of dividends on our shares will depend on our
ability to comply with relevant legal requirements as well as our earnings, financial condition and other business and economic factors affecting us at such time as the Zura Board may consider relevant. Since we do not intend to pay dividends, a shareholder’s ability to receive a return on such shareholder’s investment will depend on any future appreciation in the market value of our ordinary shares. There is no guarantee that a Class A ordinary share will appreciate or even maintain the price at which our shareholders have purchased it.
Future sales of a substantial number of our Class A ordinary shares may cause the price of our securities to decline.
If our existing shareholders sell, or indicate an intention to sell, substantial amounts of our Class A ordinary shares, the trading price of our securities could decline and it could impair our ability to raise capital through the sale of additional securities. Certain Zura shareholders and directors entered into lock-up agreements in connection with the Business Combination and are subject to lock-up provisions that restrict their ability to transfer our Class A ordinary shares or any security convertible into or exercisable or exchanged for our Class A ordinary shares until 6 months, 12 months and 24 months, as applicable, from the Effective Time, subject to certain exceptions. Additionally, our directors and executive officers entered into lock-up agreements in connection with the April 2024 Private Placement, which restrict their ability to transfer our Class A ordinary shares or any security convertible into or exercisable or exchanged for our Class A ordinary shares until 90 days after the closing of the April 2024 Private Placement.
Sales and issuances of our Class A ordinary shares and future exercise of warrants or registration rights, could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall.
If we sell our Class A ordinary shares, convertible securities or other equity securities, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing shareholders, and new investors could gain rights, preferences, and privileges senior to existing holders of our Class A ordinary shares. Sales of a substantial number of our Class A ordinary shares in the public market, including the resale of the Class A ordinary shares held by our shareholders, could occur at any time. These sales, or the perception in the market that the holders of a large number of Class A ordinary shares intend to sell shares, could reduce the market price of our Class A ordinary shares. Of the 63,746,453 Class A ordinary shares outstanding as of July 10, 2024, an aggregate of 4,162,968 shares are currently subject to restrictions on transfer pursuant to the lock-up agreements. These shares will become eligible for public sale on March 21, 2025. Pursuant to our Amended and Restated Registration Rights Agreement, dated March 20, 2023, by and among us and the shareholders party thereto (the “Registration Rights Agreement”), certain shareholders are entitled to have a registration statement kept effective for a prolonged period of time such that registered resales of their Class A ordinary shares can be made.
The resale, or expected or potential resale, of a substantial number of our Class A ordinary shares in the public market could adversely affect the market price for our Class A ordinary shares and make it more difficult for you to sell your holdings at times and prices that you determine are appropriate. In addition, our Class A ordinary shares are also subject to potential dilution from the exercise of warrants and stock options, the issuance of Class A ordinary shares pursuant to the vesting of restricted stock units, and issuance of Class A ordinary shares in connection with future equity and or convertible debt financings. Sales of substantial numbers of such shares in the public market, including the resale of the Class A ordinary shares held by our shareholders, could adversely affect the market price of our Class A ordinary shares, the impact of which is increased as the value of our stock price increases.
Our operating results may fluctuate significantly.
We expect our operating results to be subject to quarterly, and possibly annual, fluctuations. Our net loss and other operating results will be affected by numerous factors, including:
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variations in the level of expenses related to our development programs;
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the addition or termination of clinical trials;
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any intellectual property infringement lawsuit in which we may become involved;
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regulatory developments affecting the ZB Assets, regulatory approvals, and the level of underlying demand for such products and purchasing patterns; and
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our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements.
If our quarterly or annual operating results fall below the expectations of investors or securities analysts, the price of our ordinary shares could decline substantially. Furthermore, any quarterly or annual fluctuations in our operating results may, in turn, cause the price of our ordinary shares to fluctuate substantially.
If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our share, our share price and trading volume could decline.
The trading market for our Class A ordinary shares will be influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. Since we became public through a merger, securities analysts of major brokerage firms may not provide coverage of us since there is no incentive to brokerage firms to recommend the purchase of our ordinary shares. If no or few securities or industry analysts commence coverage of us, the trading price for our shares would be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover it issues an adverse opinion regarding us, our business model, our intellectual property or our share performance, or if our clinical trials and operating results fail to meet the expectations of analysts, our share price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline.
Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require it to relinquish rights to the ZB Assets.
We may issue additional equity securities to fund future expansion and pursuant to equity incentive or employee benefit plans. It may also issue additional equity for other purposes. These securities may have the same rights as our Class A ordinary shares or, alternatively, may have dividend, liquidation or other preferences to our Class A ordinary shares. The issuance of additional equity securities will dilute the holdings of existing shareholders and may reduce the share price of our Class A ordinary shares.
Pursuant to the Equity Incentive Plan, which became effective the day prior to the Closing, we are authorized to grant equity awards to our employees, directors and consultants. In addition, pursuant to the Employee Share Purchase Plan (the “ESPP”), which became effective the day prior to the Closing, we are authorized to sell shares to our employees. A total of 9,594,213 and 4,029,898 our Class A ordinary shares have been reserved for future issuance under the Equity Incentive Plan and the ESPP, respectively. In addition, the Equity Incentive Plan provides for annual automatic increases in the number of shares reserved thereunder, beginning on January 1, 2024. As a result of such annual increases, our shareholders may experience additional dilution, which could cause the price of our Class A ordinary shares to fall.
If we raise additional funds through collaboration, licensing or other similar arrangements, we may have to relinquish valuable rights to the ZB Assets, or grant licenses on terms unfavorable to us. If adequate funds are not available, our ability to achieve profitability or to respond to competitive pressures would be significantly limited and we may be required to delay, significantly curtail or eliminate the development of the product candidates.
Our principal shareholders, directors and executive officers own a significant percentage of our capital shares, and have significant influence over our management.
Our directors, executive officers, holders of 5% or more of our capital shares and their respective affiliates beneficially own, in the aggregate, approximately 88.7% of our issued and outstanding voting shares as of July 10, 2024. This concentration of voting power may make it less likely that any other holder of our Class A ordinary shares will be able to affect the way we are managed and could delay or prevent an acquisition on terms that other shareholders may desire. This could prevent transactions in which
shareholders might otherwise recover a premium for their shares over current market prices. See above for additional information regarding our influence and control. See “Principal Shareholders” for information regarding the ownership of our outstanding shares by our directors, executive officers, and current beneficial owners of 5% or more of our voting securities and their respective affiliates.
If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our ordinary shares.
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources. If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our Class A ordinary shares.
Anti-takeover provisions in the Company’s Second Amended and Memorandum and Articles of Association (the “MAA”) and under Cayman Islands law could make an acquisition, which may be beneficial to our shareholders, more difficult and may prevent attempts by our shareholders to replace or remove our current management.
The MAA and the Cayman Islands Companies Act contain provisions that could make it more difficult for a third party to acquire us, even if doing so might be beneficial to our shareholders. Among other things, these provisions:
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allow the Zura Board to authorize the issuance of up to 1,000,000 undesignated preference shares, the terms of which may be established and which may be issued without shareholder approval, and which may include supermajority voting, special approval, dividend, or other rights or preferences superior to the rights of other shareholders;
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provide that directors may only be removed (a) for cause by the vote of a majority of the other directors then in office or (b) by the affirmative vote of holders of at least 662∕3% in voting power of all the then-outstanding Zura shares entitled to vote thereon, voting together as a single class;
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prohibit shareholder action by written resolution;
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provide that extraordinary general meetings may only be called by or at the direction of (a) the Chairman of the Zura Board, the Zura Board or the Chief Executive Officer or (b) members holding not less than 10% in par value of the issued shares which as at the date of the requisition for a meeting carry the right to vote at general meetings;
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provide that any alteration, amendment or repeal, in whole or in part, of any provision of the MAA by our shareholders will require the affirmative vote of the holders of at least 662∕3% in voting power of all the then-outstanding Zura shares entitled to vote thereon, voting together as a single class; and
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establish advance notice requirements for nominations for elections to the Zura Board and for proposing matters that can be acted upon by shareholders at shareholder meetings.
These anti-takeover provisions and other provisions in the MAA and Cayman Islands law could make it more difficult for shareholders or potential acquirors to obtain control of the Zura Board or initiate actions that are opposed by our then-current Zura Board and could also delay or impede a merger, tender offer or proxy contest involving us. The existence of these provisions could negatively affect the price of our Class A ordinary shares and limit opportunities for a shareholder to realize value in a corporate transaction. For information regarding these and other provisions, see the section titled “Description of Securities.” In addition,
if prospective takeovers are not consummated for any reason, we may experience negative reactions from the financial markets, including negative impacts on the price of our Class A ordinary shares.
The MAA designates the Cayman Islands as the exclusive forum for certain litigation that may be initiated by our shareholders and the federal district courts of the United States as the exclusive forum for litigation arising under the Securities Act, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
Pursuant to the MAA, unless we contest in writing to the selection of an alternative forum, the Courts of the Cayman Islands and any appellate court therefrom, will, to the fullest extent permitted by law, be the sole and exclusive forum for any claim or dispute arising out of or in connection with the MAA or otherwise relating to each shareholder’s shareholding in Zura, including but not limited to (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our shareholders; (iii) any action asserting a claim arising pursuant to any provision of the Cayman Islands Companies Act, or the MAA; (iv) any action asserting a claim against us governed by the “internal affairs doctrine,” (as such concept is recognized under the laws of the United States of America); provided that, for the avoidance of doubt, the foregoing forum selection provision will not apply to claims arising under the Securities Act, the Exchange Act or any other claim for which the federal district courts are, as a matter of the laws of the United States, the sole and exclusive forum for determination of such a claim.
The forum selection provisions in the MAA may have the effect of discouraging lawsuits against our directors and officers. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings and there is uncertainty as to whether a court would enforce such provisions. In addition, investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If the enforceability of our forum selection provisions were to be challenged, it may incur additional costs associated with resolving such challenge. While we currently has no basis to expect any such challenge would be successful, if a court were to find its forum selection provisions to be inapplicable or unenforceable with respect to one or more of these specified types of actions or proceedings, we may incur additional costs associated with having to litigate in other jurisdictions, which could result in a diversion of the time and resources of our employees, management and Zura Board, and could have an adverse effect on our business, financial condition and results of operations.
We are an emerging growth company, and it cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our securities less attractive to investors.
We are an emerging growth company, as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory shareholder votes on executive compensation and shareholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our ordinary shares less attractive because we may rely on these exemptions. If some investors find our Class A ordinary shares less attractive as a result, there may be a less active trading market for our Class A ordinary shares and our share price may be more volatile.
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the closing of the IPO, (b) in which it has total annual gross revenue of at least $1.235 billion, or (c) in which it is deemed to be a large accelerated filer, which requires the market value of our ordinary shares that is held by non-affiliates to exceed $700 million as of the last business day of the second fiscal quarter of such year, and (2) the date on which we have issued more than $1 billion in non-convertible debt during the prior three-year period.
Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail itself of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth
companies. As a result, changes in rules of U.S. generally accepted accounting principles or their interpretation, the adoption of new guidance or the application of existing guidance to changes in our business could significantly affect our business, financial condition and results of operations.
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
We have and will continue to incur increased costs as a result of operating as a public company, and our management will devote substantial time to related compliance initiatives.
As a public company, we have and will continue to incur significant legal, accounting and other expenses that Legacy Zura did not incur as a private company, and these expenses may increase even more after it is no longer an “emerging growth company.” we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, as well as rules and regulations adopted, and to be adopted, by the SEC and Nasdaq. Our management and other personnel will need to continue to devote a substantial amount of time to these compliance initiatives. Moreover, we expect these rules and regulations to substantially increase legal and financial compliance costs and to make some activities more time-consuming and costly, which will increase operating expenses. For example, we expect these rules and regulations to make it more difficult and more expensive to obtain directors’ and officers’ liability insurance and we may be required to incur substantial costs to maintain sufficient coverage. We cannot predict or estimate the amount or timing of additional costs it may incur to respond to these requirements. The impact of these requirements could also make it more difficult to attract and retain qualified persons to serve on the Zura Board, committees of the Zura Board or as executive officers. Advocacy efforts by shareholders and third parties may also prompt additional changes in governance and reporting requirements, which could further increase costs.
In addition, we are implementing an enterprise resource planning (“ERP”) system. The ERP system is intended to combine and streamline the management of our financial, accounting, human resources, sales and marketing and other functions, enabling it to manage operations and track performance more effectively. Any disruptions or difficulties in implementing or using the ERP system could adversely affect our controls and harm our business, financial condition and results of operations, including our ability to forecast and collect receivables. Moreover, such disruption or difficulties could result in unanticipated costs and diversion of management attention.
As a public company, we are required to incur additional costs and obligations in order to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act. Under these rules, we are required to make a formal assessment of the effectiveness of our internal control over financial reporting. To achieve compliance with Section 404 within the prescribed period, we are engaging in a process to document and evaluate internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reporting.
The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation to meet the detailed standards under the rules. During the course of testing, our management may identify material weaknesses or deficiencies which may not be remedied in time to meet the deadline imposed by the Sarbanes-Oxley Act. See above for additional information regarding a previously identified material weakness. These reporting and other obligations place significant demands on our management and administrative and operational resources, including accounting resources.
In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may
evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of our management’s time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and there could be a material adverse effect on our business, financial condition and results of operations.
A failure to meet Nasdaq’s continued listing requirements could result in a delisting of ordinary shares.
In order to continue to maintain the listing of our securities on Nasdaq, we will be required to demonstrate ongoing compliance with Nasdaq’s continued listing requirements. If we fail to satisfy Nasdaq’s continued listing requirements, such as the minimum number of round-lot shareholders, the minimum dollar value of the public float, the total minimum capital, the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist our Class A ordinary shares. We cannot assure you that we will be able to meet all continued listing requirements.
In the event of a delisting, we can provide no assurance that any action taken to restore compliance with listing requirements would allow our ordinary shares to become listed again, stabilize the market price or improve the liquidity of our ordinary shares, prevent our ordinary shares from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
The IPO warrants may never be in the money, they may expire worthless and therefore we may not receive cash proceeds from the exercise of warrants. The terms of the IPO warrants may be amended in a manner adverse to a holder if holders of a majority of the then-outstanding IPO warrants approve of such amendment.
The IPO warrants were issued in registered form under the Warrant Agreement between Continental, as warrant agent, and JATT. The Warrant Agreement provides that the terms of the IPO warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision or correct any mistake, but requires the approval by the holders of a majority of the then-outstanding IPO warrants to make any change that adversely affects the interests of the registered holders of the IPO warrants. Accordingly, we may amend the terms of the IPO warrants in a manner adverse to a holder if holders of a majority of the then- outstanding IPO warrants approve of such amendment. Although our ability to amend the terms of the IPO Warrants with the consent of majority of the then-outstanding IPO warrants is unlimited, examples of such amendments could be amendments to, among other things, increase the exercise price of the IPO warrants, convert the IPO warrants into cash, shorten the exercise period, or decrease the number of our Class A ordinary shares purchasable upon exercise of an IPO warrant.
The exercise of the IPO warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Class A ordinary shares and the spread between the exercise price of the IPO warrant and the price of our Class A ordinary shares at the time of exercise. For example, to the extent that the price of our Class A ordinary shares exceeds $11.50 per share, it is more likely that holders of our Public Warrants and Private Placement Warrants will exercise their warrants. If the price of our Class A ordinary shares is less than $11.50 per share, it is unlikely that such holders will exercise their warrants. As of July 10, 2024, the closing price of our Class A ordinary shares was $3.65 per share. There can be no assurance that all of our IPO warrants will be in the money prior to their expiration. Our Public Warrants under certain conditions, as described in the Warrant Agreement, are redeemable by the Company at a price of $0.01 per warrant or on a cashless basis. Our Private Placement Warrants are not redeemable so long as they are held by the initial shareholders or permitted transferees and are exercisable on a cashless basis. Our 2023 Pre-Funded Warrants and 2024 Pre-Funded Warrants are not redeemable and are exercisable on a cashless basis. As such, it is possible that we may never generate any cash proceeds from the exercise of our warrants. Accordingly, as of the date of this Prospectus/Offer to Exchange, we have neither included nor intend to include any potential cash proceeds from the exercise of our warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability of warrant exercise over the life of our warrants and the merit of including potential cash proceeds from the exercise thereof in our
liquidity projections. Nevertheless, we believe our existing cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the date of this Prospectus/Offer to Exchange. However, our liquidity assumptions may prove to be incorrect, and we could utilize our available financial resources sooner than we currently expect. Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth under “Risk Factors” elsewhere in this Prospectus/Offer to Exchange.
If the Company were a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes, U.S. Holders of Class A ordinary shares or IPO warrants could be subject to adverse U.S. federal income tax consequences.
If the Company is treated as a PFIC, within the meaning of Section 1297 of the Code for any taxable year (or portion thereof) during which a U.S. Holder (as defined in “Material U.S. Federal Income Tax Consequences”) holds Class A ordinary shares or IPO warrants (regardless of whether the Company remains a PFIC for subsequent taxable years), certain adverse U.S. federal income tax consequences, such as taxation at the highest marginal ordinary income tax rates on capital gains and on certain actual or deemed distributions, and interest charges on certain taxes treated as deferred, may apply to such U.S. Holder and such U.S. Holder might be subject to additional reporting requirements. Under certain circumstances, certain elections may be available to U.S. Holders of Class A ordinary shares to mitigate some of the adverse tax consequences resulting from PFIC treatment, but U.S. Holders will not be able to make similar elections with respect to the IPO warrants.
The Company’s PFIC status for the current taxable year or any subsequent taxable year will not be determinable until after the end of each such taxable year, and the Company cannot assure you that it will not be a PFIC in the current taxable year or in any subsequent taxable year. If the Company were later determined to be a PFIC, you may be unable to make certain advantageous elections with respect to your ownership of the Class A ordinary shares that would mitigate the adverse consequences of the Company’s PFIC status, or making such elections retroactively could have adverse tax consequences to you. The Company is not representing to you, and there can be no assurance, that the Company will not be treated as a PFIC for this taxable year or in any subsequent taxable year. The Company has not sought and will not seek any rulings from the IRS or any opinion from any tax advisor as to such tax treatment. U.S. Holders should consult with, and rely solely upon, their tax advisors to determine the application of the PFIC rules to them and any resultant tax consequences.
Please see the section titled “Material U.S. Federal Income Tax Consequences — Passive Foreign Investment Company Rules” for a more detailed discussion with respect to our potential PFIC status. U.S. Holders (as defined in “Material U.S. Federal Income Tax Consequences”) are urged to consult their tax advisors regarding the possible application of the PFIC rules to holders of our Class A ordinary shares or IPO warrants.
THE OFFER AND CONSENT SOLICITATION
Participation in the Offer and Consent Solicitation involves a number of risks, including, but not limited to, the risks identified in the section above entitled “Risk Factors” and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this Prospectus/Offer to Exchange. IPO warrant holders should carefully consider these risks and are urged to speak with their personal legal, financial, investment, and/or tax advisor as necessary before deciding whether or not to participate in the Offer and Consent Solicitation. In addition, we strongly encourage you to read this Prospectus/Offer to Exchange in its entirety, and the information and documents that have been included herein or are incorporated herein by reference, before making a decision regarding the Offer and Consent Solicitation.
General Terms
Until the Expiration Date, we are offering to holders of our IPO warrants the opportunity to receive 0.30 Class A ordinary shares in exchange for each IPO warrant they hold. Holders of the IPO warrants tendered for exchange will not have to pay the exercise price for the tendered IPO warrants in order to receive Class A ordinary shares pursuant to the Offer. Our obligation to complete the Offer is not conditioned on the receipt of a minimum number of tendered IPO warrants.
No fractional shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of our Class A ordinary shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes.
As part of the Offer, we are also soliciting from the holders of the IPO warrants their consent to the Warrant Amendment, which, if approved, will permit the Company to require that all IPO warrants outstanding upon completion of the Offer be exchanged for Class A ordinary shares at a ratio of 0.27 Class A ordinary shares per IPO warrant, which is a ratio 10% less than the exchange ratio applicable to the Offer. The Warrant Amendment will permit us to eliminate all of the IPO warrants that remain outstanding after the Offer is consummated. A copy of the Warrant Amendment is attached hereto as Annex A. We urge that you carefully read the Warrant Amendment in its entirety. Pursuant to the terms of the Warrant Agreement, the consent of holders of at least a majority of the then-outstanding public warrants and a majority of the private placement warrants is required to approve the Warrant Amendment.
Holders who tender IPO warrants for exchange in the Offer will automatically be deemed, without any further action, to have given their consent to approval of the Warrant Amendment (effective upon our acceptance of the tendered IPO warrants). The consent to the Warrant Amendment is a part of the Letter of Transmittal and Consent relating to the IPO warrants.
You cannot tender any IPO warrants for exchange in the Offer without giving your consent to the Warrant Amendment. Thus, before deciding whether to tender any IPO warrants, you should be aware that a tender of public warrants may result in the approval of the Warrant Amendment.
The Offer and Consent Solicitation is subject to the terms and conditions contained in this Prospectus/Offer to Exchange and the Letter of Transmittal and Consent.
You may tender some or all of your IPO warrants into the Offer.
If you elect to tender IPO warrants in the Offer and Consent Solicitation, please follow the instructions in this Prospectus/Offer to Exchange and the related documents, including the Letter of Transmittal and Consent.
If you tender IPO warrants, you may withdraw your tendered IPO warrants at any time before the Expiration Date and retain them on their current terms, or amended terms if the Warrant Amendment is approved, by following the instructions herein. In addition, IPO warrants that are not accepted by us for exchange by August 8, 2024 may thereafter be withdrawn by you until such time as the IPO warrants are accepted by us for exchange.
Corporate Information
Our principal executive offices are located at 1489 W. Warm Springs Rd. #11 Henderson, NV 89014, and our telephone number is (702) 825-9872. We maintain a website at www.zurabio.com where general information about us is available. The information contained on, or that may be accessed through, our website is not part of, and is not incorporated into, this Prospectus/Offer to Exchange or the registration statement of which it forms a part, and the inclusion of our website address in this Prospectus/Offer to Exchange is an inactive textual reference only.
Our Class A ordinary shares and public warrants are listed on the Nasdaq under the symbols “ZURA” and “ZURAW,” respectively.
Warrants Subject to the Offer
The warrants subject to the Offer were issued in connection with our initial public offering, which include the public warrants included in the units sold and the private placement warrants . Each IPO warrant entitles the holder to purchase one Class A ordinary share at a price of $11.50 per share, subject to adjustment. The public warrants are quoted on the Nasdaq under the symbol “ZURAW.” As of July 10, 2024, a total of 12,809,996 IPO warrants were outstanding, including our public warrants and private placement warrants. Pursuant to the Offer, we are offering up to an aggregate of 3,842,999 of our Class A ordinary shares in exchange for all of our outstanding IPO warrants. For the avoidance of doubt, the 2023 Pre-Funded Warrants and the 2024 Pre-Funded Warrants (as further discussed and described below) are not included in this offering and are not part of the IPO warrants.
Offer Period
The Offer and Consent Solicitation will expire on the Expiration Date, which is 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which we may extend. We expressly reserve the right, in our sole discretion, at any time or from time to time, to extend the period of time during which the Offer and Consent Solicitation is open. There can be no assurance that we will exercise our right to extend the Offer Period. During any extension, all IPO warrant holders who previously tendered IPO warrants will have a right to withdraw such previously tendered IPO warrants until the Expiration Date, as extended. If we extend the Offer Period, we will make a public announcement of such extension by no later than 9:00 a.m., Eastern Time, on the next business day following the Expiration Date as in effect immediately prior to such extension.
We may withdraw the Offer and Consent Solicitation only if the conditions to the Offer and Consent Solicitation are not satisfied or waived prior to the Expiration Date or if we have determined, in our sole discretion, to terminate the Offer and Consent Solicitation. Upon any such withdrawal, we are required by Rule 13e-4(f)(5) under the Exchange Act to promptly return the tendered IPO warrants. We will announce our decision to withdraw the Offer and Consent Solicitation by disseminating notice by public announcement or otherwise as permitted by applicable law.
At the expiration of the Offer Period, the current terms of the IPO warrants, or the amended terms if the Warrant Amendment is approved, will continue to apply to any unexchanged IPO warrants until the IPO warrants expire on March 20, 2028, subject to certain terms and conditions.
Amendments to the Offer and Consent Solicitation
We reserve the right, at any time or from time to time, to amend the Offer and Consent Solicitation, including by increasing or (if the conditions to the Offer are not satisfied) decreasing the exchange ratio of Class A ordinary shares issued for every IPO warrant exchanged or by changing the terms of the Warrant Amendment.
If we make a material change in the terms of the Offer and Consent Solicitation or the information concerning the Offer and Consent Solicitation, or if we waive a material condition of the Offer and Consent Solicitation, we will extend the Offer and Consent Solicitation to the extent required by Rules 13e-4(d)(2) and 13e-4(e)(3) under the Exchange Act. These rules require that the minimum period during which an offer must remain open after material changes in the terms of the offer or information concerning the offer,
other than a change in price or a change in percentage of securities sought, will depend upon the facts and circumstances, including the relative materiality of the changed terms or information.
If we increase or decrease the exchange ratio of our Class A ordinary shares issuable in exchange for an IPO warrant, the amount of IPO warrants sought for tender, or the dealer manager’s soliciting fee, and the Offer and Consent Solicitation is scheduled to expire at any time earlier than the end of the tenth business day from the date that we first publish, send, or give notice of such an increase or decrease, then we will extend the Offer and Consent Solicitation until the expiration of that ten-business-day period.
Other material amendments to the Offer and Consent Solicitation may require us to extend the Offer and Consent Solicitation for a minimum of five business days.
Partial Exchange Permitted
Our obligation to complete the Offer is not conditioned on the receipt of a minimum number of tendered IPO warrants. If you choose to participate in the Offer, you may tender less than all of your IPO warrants pursuant to the terms of the Offer. No fractional shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of our Class A ordinary shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes.
Conditions to the Offer and Consent Solicitation
The Offer and Consent Solicitation are conditioned upon the following:
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the registration statement, of which this Prospectus/Offer to Exchange forms a part, shall have become effective under the Securities Act, and shall not be the subject of any stop order or proceeding seeking a stop order;
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no action or proceeding by any government or governmental, regulatory, or administrative agency, authority, or tribunal or any other person, domestic or foreign, shall have been threatened, instituted, or pending before any court, authority, agency, or tribunal that directly or indirectly challenges the making of the Offer or the tender of some or all of the IPO warrants pursuant to the Offer or otherwise relates in any manner to the Offer;
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there shall not have been any action threatened, instituted, pending, or taken, or approval withheld, or any statute, rule, regulation, judgment, order, or injunction threatened, proposed, sought, promulgated, enacted, entered, amended, enforced, or deemed to be applicable to the Offer or Consent Solicitation or us, by any court or any authority, agency, or tribunal that, in our reasonable judgment, would or might, directly or indirectly, (i) make the acceptance for exchange of, or exchange for, some or all of the IPO warrants illegal or otherwise restrict or prohibit completion of the Offer or Consent Solicitation or (ii) delay or restrict our ability, or render us unable, to accept for exchange or exchange some or all of the IPO warrants; and
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there shall not have occurred: (i) any general suspension of trading in securities in U.S. securities or financial markets; (ii) a declaration of a banking moratorium or any suspension of payments in respect to banks in the United States; (iii) any limitation (whether or not mandatory) by any government or governmental, regulatory, or administrative authority, agency, or instrumentality, domestic or foreign, or other event that, in our reasonable judgment, would or would be reasonably likely to affect the extension of credit by banks or other lending institutions; or (iv) a natural disaster, a significant worsening of the ongoing COVID-19 pandemic, an outbreak of a pandemic or contagious disease other than COVID-19, or a commencement or significant worsening of a war or armed hostilities or other national or international calamity, including, but not limited to, catastrophic terrorist attacks against the United States or its citizens, which, in our reasonable judgment, is or may be materially adverse to us or otherwise makes it inadvisable for us to proceed with the Offer and Consent Solicitation.
The Consent Solicitation is conditioned on our receiving the consent of holders of at least a majority of the then-outstanding public warrants and a majority of the then-outstanding private placement warrants to approve the Warrant Amendment (which is the minimum threshold required to amend the Warrant Agreement).
We will not complete the Offer and Consent Solicitation unless and until the registration statement described above is effective. If the registration statement is not effective at the Expiration Date, we may, in our discretion, extend, suspend, or cancel the Offer and Consent Solicitation, and will inform IPO warrant holders of such event. If we extend the Offer Period, we will make a public announcement of such extension and the new Expiration Date by no later than 9:00 a.m., Eastern Time, on the next business day following the Expiration Date as in effect immediately prior to such extension.
In addition, as to any IPO warrant holder, the Offer and Consent Solicitation is conditioned upon such IPO warrant holder desiring to tender IPO warrants in the Offer delivering to the exchange agent in a timely manner the holder’s IPO warrants to be tendered and any other required paperwork, all in accordance with the applicable procedures described in this Prospectus/Offer to Exchange and set forth in the Letter of Transmittal and Consent.
The foregoing conditions are solely for our benefit, and we may assert one or more of the conditions, in whole or in part, prior to the Expiration Date. We may also, in our sole and absolute discretion, waive these conditions in whole or in part, subject to the potential requirement to disseminate additional information and extend the Offer Period. The determination by us as to whether any condition has been satisfied shall be conclusive and binding on all parties. The failure by us at any time to exercise any of the foregoing rights shall not be deemed a waiver of any such right, and each such right shall be deemed a continuing right which may be asserted at any time and from time to time prior to the Expiration Date. If any of the conditions described above are not satisfied prior to the Expiration Date, we will promptly disclose our decision whether or not to waive such condition and, if the condition is material, we may be required to extend the Offer Period.
We may withdraw the Offer and Consent Solicitation only if the conditions of the Offer and Consent Solicitation are not satisfied or waived prior to the Expiration Date or if we have determined, in our sole discretion, to terminate the Offer and Consent Solicitation. Promptly upon any such withdrawal, we will return the tendered IPO warrants (and the related consent to the Warrant Amendment will be revoked). We will announce our decision to withdraw the Offer and Consent Solicitation by disseminating notice by public announcement or otherwise as permitted by applicable law.
No Recommendation; IPO Warrant Holder’s Own Decision
None of our board of directors, our officers or employees, our affiliates, the dealer manager, the exchange agent, or the information agent is making any recommendations to any IPO warrant holder as to whether to exchange their IPO warrants and deliver their consent to the Warrant Amendment. Each IPO warrant holder must make its own decision as to whether to tender IPO warrants for exchange pursuant to the Offer and consent to the amendment of the Warrant Agreement pursuant to the Consent Solicitation.
Procedure for Tendering IPO Warrants for Exchange and Consenting to the Warrant Amendment
Issuance of Class A ordinary shares upon exchange of IPO warrants pursuant to the Offer and acceptance by us of IPO warrants for exchange pursuant to the Offer and providing your consent to the Warrant Amendment will be made only if IPO warrants are properly tendered pursuant to the procedures described below and set forth in the Letter of Transmittal and Consent. A tender of IPO warrants pursuant to such procedures, if and when accepted by us, will constitute a binding agreement between the tendering holder of IPO warrants and us upon the terms and subject to the conditions of the Offer and Consent Solicitation. The proper tender of your IPO warrants will constitute a consent to the Warrant Amendment with respect to each IPO warrant tendered.
A tender of IPO warrants made pursuant to any method of delivery set forth herein will also constitute an agreement and acknowledgement by the tendering IPO warrant holder that, among other things: (i) the IPO warrant holder agrees to exchange the tendered IPO warrants on the terms and conditions set forth in
this Prospectus/Offer to Exchange and Letter of Transmittal and Consent, in each case, as may be amended or supplemented prior to the Expiration Date; (ii) the IPO warrant holder consents to the Warrant Amendment; (iii) the Offer is discretionary and may be extended, modified, suspended, or terminated by us as provided herein; (iv) such IPO warrant holder is voluntarily participating in the Offer; (v) the future value of our IPO warrants and Class A ordinary shares is unknown and cannot be predicted with certainty; (vi) such IPO warrant holder has read this Prospectus/Offer to Exchange, the Letter of Transmittal and Consent, and the Warrant Amendment; and (viii) regardless of any action that the Company takes with respect to any or all income/capital gains tax, social security or insurance, transfer tax, or other tax-related items (“Tax Items”) related to the Offer and the disposition of IPO warrants, the ultimate liability for all Tax Items is and remains the responsibility solely of the holder, and in that regard, such holder will authorize the Company to withhold all applicable Tax Items legally payable by or on behalf of such holder.
Registered Holders of IPO Warrants; Beneficial Owners of IPO Warrants
For purposes of the tender procedures set forth below, the term “registered holder” means any person in whose name IPO warrants are registered on our books or who is listed as a participant in a clearing agency’s security position listing with respect to the IPO warrants.
Persons whose IPO warrants are held through a direct or indirect participant of The Depository Trust Company (“DTC”), such as a broker, dealer, commercial bank, trust company, or other financial intermediary, are not considered registered holders of those IPO warrants but are “beneficial owners.” Beneficial owners cannot directly tender IPO warrants for exchange pursuant to the Offer. Instead, a beneficial owner must instruct its broker, dealer, commercial bank, trust company, or other financial intermediary to tender IPO warrants for exchange on behalf of the beneficial owner. See “— Required Communications by Beneficial Owners.”
Tendering IPO Warrants Using Letter of Transmittal and Consent
A registered holder of IPO warrants may tender their IPO warrants for exchange using a Letter of Transmittal and Consent in the form provided by us with this Prospectus/Offer to Exchange. A Letter of Transmittal and Consent is to be used only if delivery of IPO warrants is to be made by book-entry transfer to the exchange agent’s account at DTC pursuant to the procedures set forth in “— Tendering Warrants Using Book-Entry Transfer”; provided, however, that it is not necessary to execute and deliver a Letter of Transmittal and Consent if instructions with respect to the tender of such IPO warrants are transmitted through DTC’s Automated Tender Offer Program (“ATOP”). If you are a registered holder of IPO warrants, unless you intend to tender those IPO warrants through ATOP, you should complete, execute, and deliver a Letter of Transmittal and Consent to indicate the action you desire to take with respect to the Offer and Consent Solicitation.
In order for IPO warrants to be properly tendered for exchange pursuant to the Offer using a Letter of Transmittal and Consent, the registered holder of the IPO warrants being tendered must ensure that the exchange agent receives the following: (i) a properly completed and duly executed Letter of Transmittal and Consent, in accordance with the instructions of the Letter of Transmittal and Consent (including any required signature guarantees); (ii) delivery of the IPO warrants by book-entry transfer to the exchange agent’s account at DTC; and (iii) any other documents required by the Letter of Transmittal and Consent.
In the Letter of Transmittal and Consent, the tendering registered IPO warrant holder must set forth: (i) its name and address; (ii) the number of IPO warrants being tendered by the holder for exchange; and (iii) certain other information specified in the form of Letter of Transmittal and Consent.
In certain cases, all signatures on the Letter of Transmittal and Consent must be guaranteed by an Eligible Institution (as defined below). See “— Signature Guarantees.”
If the Letter of Transmittal and Consent is signed by someone other than the registered holder of the tendered IPO warrants (for example, if the registered holder has assigned the IPO warrants to a third-party), or if our Class A ordinary shares to be issued upon exchange of the tendered IPO warrants are to be issued in a name other than that of the registered holder of the tendered IPO warrants, the tendered IPO warrants must be properly accompanied by appropriate assignment documents, in either case, signed exactly
as the name(s) of the registered holder(s) appear on the IPO warrants, with the signature(s) on the IPO warrants or assignment documents guaranteed by an Eligible Institution (as defined below).
Any IPO warrants duly tendered and delivered as described above shall be automatically cancelled upon the issuance of Class A ordinary shares in exchange for such IPO warrants as part of the completion of the Offer.
Signature Guarantees
In certain cases, all signatures on the Letter of Transmittal and Consent must be guaranteed by an “Eligible Institution.” An “Eligible Institution” is a bank, broker dealer, credit union, savings association, or other entity that is a member in good standing of the Securities Transfer Agents Medallion Program or a bank, broker, dealer, credit union, savings association, or other entity that is an “eligible guarantor institution,” as that term is defined in Rule 17Ad-15 promulgated under the Exchange Act.
Signatures on the Letter of Transmittal and Consent need not be guaranteed by an Eligible Institution if (i) the Letter of Transmittal and Consent is signed by the registered holder of the IPO warrants tendered therewith exactly as the name of the registered holder appears on such IPO warrants and such holder has not completed the box entitled “Special Issuance Instructions” or the box entitled “Special Delivery Instructions” in the Letter of Transmittal and Consent, or (ii) such IPO warrants are tendered for the account of an Eligible Institution. In all other cases, an Eligible Institution must guarantee all signatures on the Letter of Transmittal and Consent by completing and signing the table in the Letter of Transmittal and Consent entitled “Guarantee of Signature(s).”
Required Communications by Beneficial Owners
Persons whose IPO warrants are held through a direct or indirect DTC participant, such as a broker, dealer, commercial bank, trust company, or other financial intermediary, are not considered registered holders of those IPO warrants, but are “beneficial owners,” and must instruct the broker, dealer, commercial bank, trust company, or other financial intermediary to tender IPO warrants on their behalf. Your broker, dealer, commercial bank, trust company, or other financial intermediary should have provided you with an “Instructions Form” with this Prospectus/Offer to Exchange. The Instructions Form is also filed as an exhibit to the registration statement of which this Prospectus/Offer to Exchange forms a part. The Instructions Form may be used by you to instruct your broker or other custodian to tender and deliver IPO warrants on your behalf.
Tendering IPO Warrants Using Book-Entry Transfer
The exchange agent has established an account for the IPO warrants at DTC for purposes of the Offer and Consent Solicitation. Any financial institution that is a participant in DTC’s system may make book-entry delivery of IPO warrants by causing DTC to transfer such IPO warrants into the exchange agent’s account in accordance with ATOP. However, even though delivery of IPO warrants may be effected through book-entry transfer into the exchange agent’s account at DTC, a properly completed and duly executed Letter of Transmittal and Consent (with any required signature guarantees), or an “Agent’s Message” as described in the next paragraph, and any other required documentation, must in any case also be transmitted to and received by the exchange agent at its address set forth in this Prospectus/Offer to Exchange prior to the Expiration Date, or the guaranteed delivery procedures described under “— Guaranteed Delivery Procedures” must be followed.
DTC participants desiring to tender IPO warrants for exchange pursuant to the Offer may do so through ATOP and, in that case, the participant need not complete, execute, and deliver a Letter of Transmittal and Consent. DTC will verify the acceptance and execute a book-entry delivery of the tendered IPO warrants to the exchange agent’s account at DTC. DTC will then send an “Agent’s Message” to the exchange agent for acceptance. Delivery of the Agent’s Message by DTC will satisfy the terms of the Offer and Consent Solicitation as to execution and delivery of a Letter of Transmittal and Consent by the DTC participant identified in the Agent’s Message. The term “Agent’s Message” means a message, transmitted by DTC to, and received by, the exchange agent and forming a part of a Book-Entry Confirmation, which states that DTC has received an express acknowledgment from the participant in DTC tendering the IPO
warrants for exchange that such participant has received and agrees to be bound by the terms of the Letter of Transmittal and Consent and that we may enforce such agreement against the participant. Any DTC participant tendering by book-entry transfer must expressly acknowledge that it has received and agrees to be bound by the Letter of Transmittal and Consent and that the Letter of Transmittal and Consent may be enforced against it.
Any IPO warrants duly tendered and delivered as described above shall be automatically cancelled upon the issuance of Class A ordinary shares in exchange for such IPO warrants as part of the completion of the Offer.
Delivery of a Letter of Transmittal and Consent or any other required documentation to DTC does not constitute delivery to the exchange agent. See “— Timing and Manner of Deliveries.”
Guaranteed Delivery Procedures
If a registered holder of IPO warrants desires to tender its IPO warrants for exchange pursuant to the Offer, but (i) the procedure for book-entry transfer cannot be completed on a timely basis or (ii) time will not permit all required documents to reach the exchange agent prior to the Expiration Date, the holder can still tender its IPO warrants if all the following conditions are met:
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the tender is made by or through an Eligible Institution;
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the exchange agent receives by hand, mail, overnight courier, facsimile, or electronic mail transmission, prior to the Expiration Date, a properly completed and duly executed Notice of Guaranteed Delivery in the form we have provided with this Prospectus/Offer to Exchange, with signatures guaranteed by an Eligible Institution; and
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a confirmation of a book-entry transfer into the exchange agent’s account at DTC of all IPO warrants delivered electronically, together with a properly completed and duly executed Letter of Transmittal and Consent with any required signature guarantees (or, in the case of a book-entry transfer, an Agent’s Message in accordance with ATOP), and any other documents required by the Letter of Transmittal and Consent, must be received by the exchange agent within one day that the Nasdaq is open for trading after the date the exchange agent receives such Notice of Guaranteed Delivery.
In any case where the guaranteed delivery procedure is utilized for the tender of IPO warrants pursuant to the Offer, the issuance of Class A ordinary shares for those IPO warrants tendered for exchange pursuant to the Offer and accepted pursuant to the Offer will be made only if the exchange agent has timely received the applicable foregoing items.
Timing and Manner of Deliveries
UNLESS THE GUARANTEED DELIVERY PROCEDURES DESCRIBED ABOVE ARE FOLLOWED, IPO WARRANTS WILL BE PROPERLY TENDERED ONLY IF, BY THE EXPIRATION DATE, THE EXCHANGE AGENT RECEIVES SUCH IPO WARRANTS BY BOOK-ENTRY TRANSFER, TOGETHER WITH A PROPERLY COMPLETED AND DULY EXECUTED LETTER OF TRANSMITTAL AND CONSENT OR AN AGENT’S MESSAGE.
ALL DELIVERIES IN CONNECTION WITH THE OFFER AND CONSENT SOLICITATION, INCLUDING ANY LETTER OF TRANSMITTAL AND CONSENT AND THE TENDERED IPO WARRANTS, MUST BE MADE TO THE EXCHANGE AGENT. NO DELIVERIES SHOULD BE MADE TO US. ANY DOCUMENTS DELIVERED TO US WILL NOT BE FORWARDED TO THE EXCHANGE AGENT AND THEREFORE WILL NOT BE DEEMED TO BE PROPERLY TENDERED. THE METHOD OF DELIVERY OF ALL REQUIRED DOCUMENTS IS AT THE OPTION AND RISK OF THE TENDERING IPO WARRANT HOLDERS. IF DELIVERY IS BY MAIL, WE RECOMMEND REGISTERED MAIL WITH RETURN RECEIPT REQUESTED (PROPERLY INSURED). IN ALL CASES, SUFFICIENT TIME SHOULD BE ALLOWED TO ENSURE TIMELY DELIVERY.
Determination of Validity
All questions as to the form of documents and the validity, eligibility (including time of receipt), and acceptance for exchange of any tender of IPO warrants will be determined by us, in our sole discretion, and our determination will be final and binding. We reserve the absolute right to reject any or all tenders of IPO warrants that we determine are not in proper form or reject tenders of IPO warrants that may, in the opinion of our counsel, be unlawful. We also reserve the absolute right to waive any defect or irregularity in any tender of any particular IPO warrant, whether or not similar defects or irregularities are waived in the case of other tendered IPO warrants. Neither we nor any other person will be under any duty to give notice of any defect or irregularity in tenders, nor shall any of us or them incur any liability for failure to give any such notice.
Fees and Commissions
Tendering IPO warrant holders who tender IPO warrants directly to the exchange agent will not be obligated to pay any charges or expenses of the exchange agent, the dealer manager, or any brokerage commissions. Beneficial owners who hold IPO warrants through a broker or bank should consult that institution as to whether or not such institution will charge the owner any service fees in connection with tendering IPO warrants on behalf of the owner pursuant to the Offer and Consent Solicitation.
Transfer Taxes
We will pay all transfer taxes, if any, applicable to the transfer of IPO warrants to us in the Offer. If transfer taxes are imposed for any other reason, the amount of those transfer taxes, whether imposed on the registered holder or any other persons, will be payable by the tendering holder. Other reasons transfer taxes could be imposed include (i) if our Class A ordinary shares are to be registered or issued in the name of any person other than the person signing the Letter of Transmittal and Consent or (ii) if tendered IPO warrants are registered in the name of any person other than the person signing the Letter of Transmittal and Consent. If satisfactory evidence of payment of or exemption from those transfer taxes is not submitted with the Letter of Transmittal and Consent, the amount of those transfer taxes will be billed directly to the tendering holder and/or withheld from any payment due with respect to the IPO warrants tendered by such holder.
Withdrawal Rights
By tendering IPO warrants for exchange, a holder will be deemed to have validly delivered its consent to the Warrant Amendment. Tenders of IPO warrants made pursuant to the Offer may be withdrawn at any time prior to the Expiration Date. Consents to the Warrant Amendment in connection with the Consent Solicitation may be revoked at any time before the Expiration Date by withdrawing the tender of your IPO warrants. A valid withdrawal of tendered IPO warrants before the Expiration Date will be deemed to be a concurrent revocation of the related consent to the Warrant Amendment. Tenders of IPO warrants and consent to the Warrant Amendment may not be withdrawn after the Expiration Date. If the Offer Period is extended, you may withdraw your tendered IPO warrants at any time until the expiration of such extended Offer Period. After the Offer Period expires, such tenders are irrevocable; provided, however, that IPO warrants that are not accepted by us for exchange by August 8, 2024 may thereafter be withdrawn by you until such time as the IPO warrants are accepted by us for exchange.
To be effective, a written notice of withdrawal must be timely received by the exchange agent at its address identified in this Prospectus/Offer to Exchange. Any notice of withdrawal must specify the name of the person who tendered the IPO warrants for which tenders are to be withdrawn and the number of IPO warrants to be withdrawn. If the IPO warrants to be withdrawn have been delivered to the exchange agent, a signed notice of withdrawal must be submitted prior to release of such IPO warrants. In addition, such notice must specify the name of the registered holder (if different from that of the tendering IPO warrant holder). A withdrawal may not be cancelled, and IPO warrants for which tenders are withdrawn will thereafter be deemed not validly tendered for purposes of the Offer and Consent Solicitation. However, IPO warrants for which tenders are withdrawn may be tendered again by following one of the procedures described above in this section entitled “— Procedure for Tendering Warrants for Exchange” at any time prior to the Expiration Date.
A beneficial owner of IPO warrants desiring to withdraw tendered IPO warrants previously delivered through DTC should contact the DTC participant through which such owner holds its IPO warrants. In order to withdraw IPO warrants previously tendered, a DTC participant may, prior to the Expiration Date, withdraw its instruction by (i) withdrawing its acceptance through DTC’s Participant Tender Offer Program (“PTOP”) function or (ii) delivering to the exchange agent, by mail, hand delivery, or facsimile transmission, notice of withdrawal of such instruction. The notice of withdrawal must contain the name and number of the DTC participant. A withdrawal of an instruction must be executed by a DTC participant as such DTC participant’s name appears on its transmission through the PTOP function to which such withdrawal relates. If the tender being withdrawn was made through ATOP, it may only be withdrawn through PTOP, and not by hard copy delivery of withdrawal instructions. A DTC participant may withdraw a tendered IPO warrant only if such withdrawal complies with the provisions described in this paragraph.
A holder who tendered its IPO warrants other than through DTC should send written notice of withdrawal to the exchange agent specifying the name of the IPO warrant holder who tendered the IPO warrants being withdrawn. All signatures on a notice of withdrawal must be guaranteed by an Eligible Institution, as described above in the section entitled “— Procedure for Tendering Warrants for Exchange — Signature Guarantees”; provided, however, that signatures on the notice of withdrawal need not be guaranteed if the IPO warrants being withdrawn are held for the account of an Eligible Institution. Withdrawal of a prior IPO warrant tender will be effective upon receipt of the notice of withdrawal by the exchange agent. Selection of the method of notification is at the risk of the IPO warrant holder, and notice of withdrawal must be timely received by the exchange agent.
All questions as to the form and validity (including time of receipt) of any notice of withdrawal will be determined by us, in our sole discretion, which determination shall be final and binding. Neither we nor any other person will be under any duty to give notification of any defect or irregularity in any notice of withdrawal or incur any liability for failure to give any such notification.
Acceptance for Issuance of Shares
Upon the terms and subject to the conditions of the Offer and Consent Solicitation, we will accept for exchange IPO warrants validly tendered until the Expiration Date, which is 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which we may extend. Our Class A ordinary shares to be issued upon exchange of IPO warrants pursuant to the Offer, along with written notice from Exchange Agent confirming the balance of any IPO warrants not exchanged, will be delivered promptly following the Expiration Date. In all cases, IPO warrants will only be accepted for exchange pursuant to the Offer after timely receipt by the exchange agent of (i) book-entry delivery of the tendered IPO warrants, (ii) a properly completed and duly executed Letter of Transmittal and Consent, or compliance with ATOP where applicable, (iii) any other documentation required by the Letter of Transmittal and Consent, and (iv) any required signature guarantees.
For purposes of the Offer and Consent Solicitation, we will be deemed to have accepted for exchange IPO warrants that are validly tendered and for which tenders are not withdrawn, unless we give written notice to the IPO warrant holder of our non-acceptance.
Announcement of Results of the Offer and Consent Solicitation
We will announce the final results of the Offer and Consent Solicitation, including whether all of the conditions to the Offer and Consent Solicitation have been satisfied or waived and whether we will accept the tendered IPO warrants for exchange, as promptly as practicable following the end of the Offer Period. The announcement will be made by a press release and by amendment to the Schedule TO we will file with the SEC in connection with the Offer and Consent Solicitation.
Background and Purpose of the Offer and Consent Solicitation
Our board of directors approved the Offer and Consent Solicitation on July 11, 2024. The purpose of the Offer and Consent Solicitation is to attempt to simplify our capital structure and reduce the potential dilutive impact of the IPO warrants. The IPO warrants that are tendered for exchange pursuant to the Offer
will be retired and cancelled automatically upon the issuance of Class A ordinary shares in exchange for such IPO warrants pursuant to the Offer.
Agreements, Regulatory Requirements and Legal Proceedings
Except for the Warrant Agreement and the Tender and Support Agreement, there are no present or proposed agreements, arrangements, understandings, or relationships between us, and any of our directors, executive officers, affiliates, or any other person relating, directly or indirectly, to the Offer and Consent Solicitation or to our securities that are the subject of the Offer and Consent Solicitation.
Pursuant to the Tender and Support Agreement, parties (including certain of our affiliates) representing approximately 40.7% of the outstanding public warrants and approximately 65.3% of the outstanding private placement warrants have agreed to tender their public warrants and private placement warrants (as applicable) in the Offer and to consent to the Warrant Amendment in the Consent Solicitation. Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described herein are satisfied or waived, then the Warrant Amendment will be adopted.
Except for the requirements of applicable federal and state securities laws, we know of no federal or state regulatory requirements to be complied with or federal or state regulatory approvals to be obtained by us in connection with the Offer and Consent Solicitation. There are no antitrust laws applicable to the Offer and Consent Solicitation. The margin requirements under Section 7 of the Exchange Act, and the related regulations thereunder, are inapplicable to the Offer and Consent Solicitation.
There are no pending legal proceedings relating to the Offer and Consent Solicitation.
Interests of Directors, Executive Officers and Others
The Sponsor holds 2,783,701 private placement warrants. Dr. Someit Sidhu, a director of the Company, is the sole director of JATT Ventures, Ltd., which is the sole general partner of the Sponsor, and has voting and dispositive power over the securities held by the Sponsor. Dr. Sidhu separately and beneficially owns an additional 1,750,000 public warrants and 656,572 private placement warrants. Verender Badial, Chief Financial Officer of the Company, beneficially owns 420,519 private placement warrants. Ewon Comfortech Co., Ltd. beneficially owns 1,653,466 private placement warrants. Certain of our directors, officers, and affiliates, including Someit Sidhu and Verender Badial, have agreed to tender their respective IPO warrants in the Offer and to consent to the Warrant Amendment in the Consent Solicitation pursuant to the Tender and Support Agreement. Except as required by the Tender and Support Agreement, none of our directors, officers or affiliates are required to participate in the Offer.
MARKET INFORMATION, DIVIDENDS, AND RELATED SHAREHOLDER MATTERS
Market Information of Class A Ordinary Shares and IPO Warrants
Our Class A ordinary shares and public warrants are listed on the Nasdaq under the symbols “ZURA” and “ZURAW,” respectively. As of July 10, 2024 a total of 12,809,996 warrants were outstanding, including our public warrants and private placement warrants and are referred to collectively as the IPO warrants. The closing price of our Class A ordinary shares and public warrants on July 10, 2024 was $3.65 and $0.65, respectively.
As of July 10, 2024, there were approximately 25 holders of record of our Class A ordinary shares and 18 holders of record of our public warrants and private placement warrants. Such numbers do not include DTCC participants or beneficial owners holding securities through nominee names.
Dividends
We have never declared or paid any dividends on our Class A ordinary shares. We currently intend to retain all available funds and any future earnings for the operation and expansion of our business. Accordingly, we do not currently pay dividends, and may not pay dividends, for the foreseeable future. The payment of any future dividends will be at the discretion of our board of directors and will depend on our results of operations, capital requirements, financial condition, prospects, contractual arrangements, any limitations on payment of dividends present in any financing agreements, and other factors that our board of directors may deem relevant.
Source and Amount of Funds
Because this transaction is an offer to holders to exchange their existing IPO warrants for our Class A ordinary shares, there is no source of funds or other cash consideration being paid by us to, or to us from, those tendering IPO warrant holders pursuant to the Offer, other than the amount of cash paid in lieu of a fractional share in the Offer. We estimate that the total amount of cash required to complete the transactions contemplated by the Offer and Consent Solicitation, including the payment of any fees, expenses and other related amounts incurred in connection with the Offer and Consent Solicitation and the payment of cash in lieu of fractional shares, will be approximately $1.75 million. We expect to have sufficient funds to complete the transactions contemplated by the Offer and Consent Solicitation and to pay fees, expenses, and other related amounts from our cash on hand.
Exchange Agent
Continental Stock Transfer & Trust Company has been appointed as the exchange agent for the Offer and Consent Solicitation. The Letter of Transmittal and Consent and all correspondence in connection with the Offer should be sent or delivered by each holder of the IPO warrants, or a beneficial owner’s custodian bank, depositary, broker, trust company, or other nominee, to the exchange agent at the address and telephone numbers set forth on the back cover page of this Prospectus/Offer to Exchange. We will pay the exchange agent reasonable and customary fees for its services and will reimburse it for its reasonable, out-of-pocket expenses in connection therewith.
Information Agent
Alliance Advisors LLC has been appointed as the information agent for the Offer and Consent Solicitation, and will receive customary compensation for its services. Questions concerning tender procedures and requests for additional copies of this Prospectus/Offer to Exchange or the Letter of Transmittal and Consent should be directed to the information agent at the address and telephone numbers set forth on the back cover page of this Prospectus/Offer to Exchange.
Dealer Manager
We have retained Cantor Fitzgerald & Co.. to act as dealer manager in connection with the Offer and Consent Solicitation and will pay the dealer manager a customary fee as compensation for its services. We will also reimburse the dealer manager for certain expenses. The obligations of the dealer manager to perform
this function are subject to certain conditions. We have agreed to indemnify the dealer manager against certain liabilities, including liabilities under the federal securities laws.
The dealer manager and its affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage, and other financial and non-financial activities and services. The dealer manager and its affiliates have provided, and may in the future provide, a variety of these services to us and to persons and entities with relationships with us, for which they have received or will receive customary fees and expenses.
In the ordinary course of their various business activities, the dealer manager and its affiliates, officers, directors, and employees may purchase, sell, or hold a broad array of investments and actively traded securities, derivatives, loans, commodities, currencies, credit default swaps, and other financial instruments for their own account and for the accounts of their customers, and such investment and trading activities may involve or relate to assets, securities, and/or instruments of us (directly, as collateral securing other obligations, or otherwise) and/or persons and entities with relationships with us. The dealer manager and its affiliates may also communicate independent investment recommendations, market color, or trading ideas and/or publish or express independent research views in respect of such assets, securities, or instruments and may at any time hold, or recommend to clients that they should acquire, long and/or short positions in such assets, securities, and instruments. In the ordinary course of its business, the dealer manager or its affiliates may at any time hold long or short positions, and may trade for their own accounts or the accounts of customers, in securities of the Company, including IPO warrants, and, to the extent that the dealer manager or its affiliates own IPO warrants during the Offer and Consent Solicitation, they may tender such IPO warrants under the terms of the Offer and Consent Solicitation.
Fees and Expenses
The expenses of soliciting tenders of the IPO warrants and the Consent Solicitation will be borne by us. The principal solicitations are being made by mail; however, additional solicitations may be made by facsimile transmission, telephone, or in person by the dealer manager and the information agent, as well as by our officers and other employees and affiliates.
You will not be required to pay any fees or commissions to us, the dealer manager, the exchange agent, or the information agent in connection with the Offer and Consent Solicitation. If your IPO warrants are held through a broker, dealer, commercial bank, trust company, or other nominee that tenders your IPO warrants on your behalf, your broker or other nominee may charge you a commission or service fee for doing so. You should consult your broker, dealer, commercial bank, trust company, or other nominee to determine whether any charges will apply.
Transactions and Agreements Concerning Our Securities
Other than as set forth below and (i) in the section of this Prospectus/Offer to Exchange entitled “Description of Securities” and (ii) as set forth in our MAA, there are no agreements, arrangements, or understandings between the Company, or any of our directors or executive officers, and any other person with respect to our securities that are the subject of the Offer and Consent Solicitation.
Neither we, nor any of our directors, executive officers, or controlling persons, or any executive officers, directors, managers, or partners of any of our controlling persons, has engaged in any transactions in our IPO warrants in the last 60 days.
Tender and Support Agreement
Parties (including certain of our affiliates) representing approximately 40.7% of the outstanding public warrants and 65.3% of the outstanding private placement warrants have agreed to tender their public warrants and private placement warrants (as applicable) in the Offer and consent to the Warrant Amendment in the Consent Solicitation pursuant to the Tender and Support Agreement.
Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described herein are satisfied or waived, then the Warrant Amendment will be adopted.
Registration Under the Exchange Act
The IPO warrants currently are registered under the Exchange Act. This registration may be terminated upon application by us to the SEC if there are fewer than 300 record holders of the IPO warrants. We currently do not intend to terminate the registration of the IPO warrants, if any, that remain outstanding after completion of the Offer and Consent Solicitation. Notwithstanding any termination of the registration of our IPO warrants, we will continue to be subject to the reporting requirements under the Exchange Act as a result of the continuing registration of our Class A ordinary shares.
Accounting Treatment
The Company is currently evaluating the accounting treatment, however we expect we will account for the exchange of the public warrants as a Class A ordinary share issuance for no additional value. The par value of each Class A ordinary share issued in the Offer will be recorded as an increase in Class A ordinary shares and a decrease in additional paid-in capital. Any cash paid in lieu of fractional shares will be recorded as a decrease in cash and a decrease in additional paid-in capital. We expect we will account for the exchange of the private placement warrants as a decrease to the warrant liability, increase in the par value of each Class A ordinary share, increase in additional paid-in capital, and a gain or loss on the warrant exchange. The Offer will not modify the current accounting treatment for the unexchanged IPO warrants.
Absence of Appraisal or Dissenters’ Rights
Holders of the IPO warrants do not have any appraisal or dissenters’ rights under applicable law in connection with the Offer and Consent Solicitation.
Material U.S. Federal Income Tax Consequences
The following discussion is a summary of material U.S. federal income tax considerations for U.S. Holders (as defined below) of the receipt of Class A ordinary shares in exchange for IPO warrants pursuant to the Offer, of the Warrant Amendment of IPO warrants not exchanged for Class A ordinary shares in the Offer and of the ownership and disposition of our Class A ordinary shares received in exchange for IPO warrants pursuant to the Offer. This section applies only to U.S. Holders that hold their IPO warrants and, upon the exchange of the IPO warrants pursuant to the Offer, Class A ordinary shares as “capital assets” for U.S. federal income tax purposes (generally, property held for investment).
This discussion is included for general informational purposes only, does not purport to consider all aspects of U.S. federal income taxation that might be relevant to a Holder, and does not constitute, and is not, a tax opinion for or tax advice to any particular U.S. Holder. This discussion is limited to U.S. federal income tax considerations and does not address estate or any gift tax considerations or considerations arising under the tax laws of any state, local or non-U.S. jurisdiction. This discussion does not describe all of the U.S. federal income tax consequences that may be relevant to you in light of your particular circumstances, including the alternative minimum tax, the Medicare tax on certain investment income and the different consequences that may apply to U.S. Holders that are subject to special rules under U.S. federal income tax law that apply to certain types of investors, such as:
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financial institutions or financial services entities;
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broker-dealers;
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taxpayers that are subject to the mark-to-market accounting rules with respect to our Class A ordinary shares or IPO warrants;
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persons required to accelerate the recognition of any item of gross income with respect to our Class A ordinary shares or IPO warrants as a result of such income being recognized on an applicable financial statement;
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tax-exempt entities;
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governments or agencies or instrumentalities thereof;
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insurance companies;
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mutual funds;
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pension plans;
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individual retirement accounts or other tax-deferred accounts;
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regulated investment companies or real estate investment trusts;
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partnerships (including entities or arrangements treated as partnerships for U.S. federal income tax purposes);
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U.S. expatriates or former long-term residents of the United States;
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persons that directly, indirectly or constructively own ten percent or more (by vote or value) of our capital stock;
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S corporations;
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trusts and estates;
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persons that acquired their IPO warrants pursuant to an exercise of employee share options, in connection with employee share incentive plans or otherwise as compensation;
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persons that hold Class A ordinary shares or IPO warrants as part of a straddle, constructive sale, constructive ownership transaction, hedging, wash sale, synthetic security, conversion or other integrated or similar transaction;
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U.S. Holders whose functional currency is not the U.S. dollar; or
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“controlled foreign corporations,” “passive foreign investment companies” or corporations that accumulate earnings to avoid U.S. federal income tax.
If a partnership (or any entity or arrangement treated as a partnership for U.S. federal income tax purposes) holds our IPO warrants or Class A ordinary shares received in exchange for the IPO warrants in the Offer, the tax treatment of such partnership and a person treated as a partner of such partnership will generally depend on the status of the partner and the activities of the partnership. Partnerships holding our IPO warrants or Class A ordinary shares received in exchange for the IPO warrants in the Offer and persons that are treated as partners of such partnerships should consult their tax advisors as to the particular U.S. federal income tax consequences to them.
This discussion is based on the Code, proposed, temporary and final Treasury Regulations promulgated thereunder, and judicial and administrative interpretations thereof, all as of the date hereof. All of the foregoing is subject to change, which change could apply retroactively and could affect the tax considerations described herein.
We have not sought, and do not intend to seek, any rulings from the IRS as to any U.S. federal income tax considerations described herein. There can be no assurance that the IRS will not take positions inconsistent with the considerations discussed below or that any such positions would not be sustained by a court.
THIS DISCUSSION IS ONLY A SUMMARY OF CERTAIN U.S. FEDERAL INCOME TAX CONSIDERATIONS APPLICABLE TO U.S. HOLDERS OF OUR WARRANTS AND OF CLASS A ORDINARY SHARES RECEIVED IN EXCHANGE FOR THE WARRANTS IN THE OFFER. EACH HOLDER SHOULD CONSULT ITS OWN TAX ADVISOR WITH RESPECT TO THE PARTICULAR TAX CONSEQUENCES TO SUCH HOLDER OF THE FOREGOING, INCLUDING THE APPLICABILITY AND EFFECTS OF U.S. FEDERAL NON-INCOME, STATE AND LOCAL AND NON-U.S. TAX LAWS.
As used herein, a “U.S. Holder” is a beneficial owner of a IPO warrant or an Ordinary Share who or that is, for U.S. federal income tax purposes:
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an individual who is a citizen or resident of the United States;
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a corporation (or other entity that is treated as a corporation for U.S. federal income tax purposes) that is created or organized (or treated as created or organized) in or under the laws of the United States or any state thereof or the District of Columbia;
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an estate whose income is subject to U.S. federal income tax regardless of its source; or
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a trust if (1) a U.S. court can exercise primary supervision over the administration of such trust and one or more United States persons have the authority to control all substantial decisions of the trust or (2) it has a valid election in place to be treated as a United States person.
Exchange of IPO Warrants for our Class A Ordinary Shares
For a U.S. Holder of IPO warrants who participates in the Offer, we intend to treat such U.S. Holder’s exchange of IPO warrants for Class A ordinary shares in the Offer as a “recapitalization” within the meaning of Section 368(a)(1)(E) of the Code pursuant to which, subject to the PFIC rules below, (i) such U.S. Holder should not recognize any gain or loss on the exchange of IPO warrants for Class A ordinary shares, (ii) such U.S. Holder’s aggregate tax basis in the Class A ordinary shares received in the exchange should equal the U.S. Holder’s aggregate tax basis in the IPO warrants surrendered in the exchange and (iii) such U.S. Holder’s holding period for the Class A ordinary shares received in the exchange should include the U.S. Holder’s holding period for the surrendered IPO warrants. Special tax basis and holding period rules apply to U.S. Holders that acquired different blocks of IPO warrants at different prices or at different times. U.S. Holders should consult their tax advisors as to the applicability of these special rules to their particular circumstances. Because there is a lack of direct legal authority regarding the U.S. federal income tax consequences of the exchange of IPO warrants for Class A ordinary shares, there can be no assurance in this regard. Alternative characterizations by the IRS or a court are possible, including ones that would require U.S. Holders to recognize taxable income. If our treatment of the exchange of IPO warrants for Class A ordinary shares were successfully challenged by the IRS and such exchange were not treated as a recapitalization for United States federal income tax purposes, exchanging U.S. Holders may be subject to taxation in a manner analogous to the rules applicable to dispositions of Class A ordinary shares described below under “— Gain or Loss on Sale, Taxable Exchange or Other Taxable Disposition of our Class A Ordinary Shares.”
Although we believe the exchange of IPO warrants for Class A ordinary shares pursuant to the Offer is a value-for-value transaction, because of the uncertainty inherent in any valuation, there can be no assurance that the IRS or a court would agree. If the IRS or a court were to view the exchange pursuant to the Offer as the issuance of Class A ordinary shares to an exchanging Holder having a value in excess of the IPO warrants surrendered by such Holder, such excess value could be viewed as a constructive dividend or a fee received in consideration for consenting to the Warrant Amendment (which fee may be taxable as ordinary income to the U.S. Holder).
If we are or have been treated as a PFIC, as discussed below under “— Passive Foreign Investment Company Rules,” under certain proposed Treasury regulations, any gain realized on the exchange of IPO warrants for Class A ordinary shares pursuant to the Offer might be subject to certain special and adverse rules requiring recognition even though the exchange pursuant to the Offer may otherwise qualify as a nonrecognition transaction for U.S. federal income tax purposes. Losses would not be recognized. U.S. Holders are urged to consult with their tax advisors regarding the treatment of the Offer if we are or have been treated as a PFIC.
If a U.S. Holder exchanges IPO warrants for Class A ordinary shares pursuant to the Offer, and if the U.S. Holder holds five percent or more of Class A ordinary shares prior to the exchange, or if the U.S. Holder holds IPO warrants and other securities of ours prior to the exchange with a tax basis of $1 million or more, such U.S. Holder will be required to file with its U.S. federal income tax return for the year in which the exchange occurs a statement setting forth certain information relating to the exchange (including the fair market value, prior to the exchange, of the IPO warrants transferred in the exchange and the U.S. Holder’s tax basis, prior to the exchange, in Class A ordinary shares or other securities), and to maintain permanent records containing such information.
IPO Warrants not exchanged for our Class A Ordinary Shares if the Warrant Amendment is approved
Although not free from doubt, if the Warrant Amendment is approved, we intend to treat all IPO warrants not exchanged for Class A ordinary shares in the Offer as having been exchanged for “new” warrants pursuant to the Warrant Amendment and to treat such deemed exchange as a “recapitalization” within the
meaning of Section 368(a)(1)(E) of the Code, pursuant to which (i) a U.S. Holder of such IPO warrants should not recognize any gain or loss on the deemed exchange of IPO warrants for “new” warrants, (ii) such U.S. Holder’s aggregate tax basis in the “new” warrants deemed to be received in the exchange should equal the U.S. Holder’s aggregate tax basis in its existing IPO warrants deemed surrendered in the exchange, and (iii) such U.S. Holder’s holding period for the “new” warrants deemed to be received in the exchange should include the U.S. Holder’s holding period for the IPO warrants deemed surrendered. Special tax basis and holding period rules apply to holders that acquired different blocks of IPO warrants at different prices or at different times. U.S. Holders should consult their tax advisor as to the applicability of these special rules to their particular circumstances.
Because there is a lack of direct legal authority regarding the U.S. federal income tax consequences of the deemed exchange of IPO warrants for “new” warrants pursuant to the Warrant Amendment, there can be no assurance in this regard and alternative characterizations by the IRS or a court are possible, including ones that would require U.S. Holders to recognize taxable income. If our treatment of the deemed exchange of IPO warrants for “new” warrants pursuant to the Warrant Amendment were successfully challenged by the IRS and such exchange were not treated as a recapitalization for United States federal income tax purposes, exchanging U.S. Holders may be subject to taxation in a manner analogous to the rules applicable to dispositions of Class A ordinary shares described below under “— Gain or Loss on Sale, Taxable Exchange or Other Taxable Disposition of our Class A Ordinary Shares.”
If we are or have been treated as a PFIC as discussed below under “Passive Foreign Investment Company Rules,” under certain proposed Treasury regulations, any gain realized on the deemed exchange of IPO warrants for “new” warrants pursuant to the Warrant Amendment might be subject to certain special and adverse rules requiring recognition even though the deemed exchange pursuant to the Warrant Amendment may otherwise qualify as a nonrecognition transaction for U.S. federal income tax purposes. Losses would not be recognized. U.S. Holders are urged to consult with their tax advisors regarding the treatment of the Warrant Amendment if we were characterized as a PFIC.
IPO Warrants not exchanged for our Class A Ordinary Shares if the Warrant Amendment is not approved
If the Warrant Amendment is not approved, a U.S. Holder should not have any U.S. federal income tax consequences from the Offer with respect to IPO warrants that are not exchanged for our Class A ordinary shares pursuant to the Offer.
Dividends and Other Distributions on our Class A Ordinary Shares
As described in “Market Information, Dividends and Related Shareholder Matters — Dividends,” we do not anticipate making distributions to U.S. Holders of Class A ordinary shares at this time. Subject to the PFIC rules discussed below under the heading “— Passive Foreign Investment Company Rules,” distributions on our Class A ordinary shares will generally be taxable as a dividend for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Distributions in excess of our current and accumulated earnings and profits will constitute a return of capital that will be applied against and reduce (but not below zero) the U.S. Holder’s adjusted tax basis in its Class A ordinary shares. Any remaining excess will be treated as gain realized on the sale or other disposition of the Class A ordinary shares and will be treated as described below under the heading “— Gain or Loss on Sale, Taxable Exchange or Other Taxable Disposition of our Class A Ordinary Shares.” Because we do not calculate our earnings and profits under U.S. federal income tax principles, a U.S. Holder should expect all cash distributions to be reported as dividends for U.S. federal income tax purposes. The amount of any such distribution will include any amounts withheld by us (or another applicable withholding agent). Amounts treated as dividends that we pay to a U.S. Holder that is a taxable corporation generally will be taxed at regular tax rates and will not qualify for the dividends received deduction generally allowed to domestic corporations in respect of dividends received from other domestic corporations. With respect to non-corporate U.S. Holders, under tax laws currently in effect and subject to certain exceptions (including, but not limited to, dividends treated as investment income for purposes of investment interest deduction limitations), dividends generally will be taxed at the lower applicable long-term capital gains rate only if our Class A ordinary shares are readily tradable on an established securities market in the United States or we are eligible for benefits under an applicable tax treaty with the United States, and, in each case,
we are not treated as a PFIC with respect to such U.S. Holder at the time the dividend was paid or in the preceding year and provided certain holding period requirements are met. U.S. Holders should consult their tax advisors regarding the availability of the lower rate for dividends paid with respect to our Class A ordinary shares.
The amount of any dividend distribution, if any, paid in foreign currency will be the U.S. dollar amount calculated by reference to the applicable exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into U.S. dollars at that time. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt.
Amounts taxable as dividends will generally be treated as income from sources outside the U.S. and will, depending on the circumstances of the U.S. Holder, generally be “passive” category income which is treated separately from other types of income for purposes of computing the foreign tax credit allowable to such U.S. Holder. Additionally, the rules governing the treatment of foreign taxes imposed on a U.S. Holder and foreign tax credits are complex and the United States Treasury recently issued additional regulations imposing further restrictions on the use of foreign tax credits. Accordingly, U.S. Holders should consult their tax advisors about the impact of these rules in their particular situations.
Gain or Loss on Sale, Taxable Exchange or Other Taxable Disposition of our Class A Ordinary Shares
Subject to the PFIC rules discussed below under the heading “— Passive Foreign Investment Company Rules,” upon any sale, exchange or other taxable disposition of our Class A ordinary shares, a U.S. Holder generally will recognize gain or loss in an amount equal to the difference between (i) the sum of (x) the amount of cash and (y) the fair market value of any other property received in such sale, exchange or other taxable disposition and (ii) the U.S. Holder’s adjusted tax basis in such Class A ordinary shares, in each case as calculated in U.S. dollars. Any such gain or loss generally will be capital gain or loss and will be long-term capital gain or loss if the U.S. Holder’s holding period for such Class A ordinary shares exceeds one year. Long-term capital gain realized by a non-corporate U.S. Holder generally will be taxable at a reduced rate. The deduction of capital losses is subject to limitations. The gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes.
Passive Foreign Investment Company Rules
The treatment of U.S. Holders of our Class A ordinary shares received in exchange for IPO warrants pursuant to the Offer could be materially different from that described above if we are treated as a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes. U.S. Holders are urged to consult with their tax advisors regarding the treatment of the Offer and our Class A ordinary shares received in exchange for IPO warrants pursuant to the Offer if we were characterized as a PFIC.
A non-U.S. corporation generally will be a PFIC for any taxable year if either (i) at least 75% of its gross income is passive income or (ii) at least 50% of its assets (determined based on a quarterly average) are held for the production of, or produce, passive income (such test described in clause (ii), “Asset Test”). Passive income generally includes, among other things, dividends, interest, rents and royalties (other than rents or royalties derived from the active conduct of a trade or business) and gains from the disposition of passive assets. In making this determination, the non-U.S. corporation is treated as earning its proportionate share of any income and owning its proportionate share of any assets of any corporation in which it holds, directly or indirectly, a 25% or greater interest by value of the stock. While the Asset Test is generally performed based on the fair market value of the assets, special rules apply with respect to the Asset Test in the case of the assets held by controlled foreign corporations. There can be no assurance regarding our PFIC status for the current taxable year or any subsequent taxable year, because PFIC status is determined annually and requires a factual determination that depends on, among other things, the composition of a company’s income, assets and activities in each taxable year, and can only be made annually after the close of each taxable year, and is thus subject to significant uncertainty. Furthermore, the value of our gross assets is likely to be determined in part by reference to our market capitalization, which may fluctuate significantly. Accordingly, there can be no assurance that we will not be a PFIC for any taxable year.
Although our PFIC status is determined annually, we will generally continue to be treated as a PFIC in subsequent years in the case of a U.S. Holder who held our Class A ordinary shares while we were a PFIC,
whether or not we meet the test for PFIC status in those subsequent years. If we are determined to be a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. Holder of our Class A ordinary shares and, in the case of our Class A ordinary shares, the U.S. Holder did not make an applicable PFIC election (or elections), as further described below, for our first taxable year in which we were treated as a PFIC and in which the U.S. Holder held (or was deemed to hold) such Class A ordinary shares or otherwise, such U.S. Holder generally will be subject to special and adverse rules with respect to (i) any gain recognized by the U.S. Holder on the sale or other disposition of its Class A ordinary shares (which may include gain realized by reason of transfers of our Class A ordinary shares that would otherwise qualify as nonrecognition transactions for U.S. federal income tax purposes) and (ii) any “excess distribution” made to the U.S. Holder (generally, any distributions to such U.S. Holder during a taxable year of the U.S. Holder that are greater than 125% of the average annual distributions received by such U.S. Holder in respect of the Class A ordinary shares during the three preceding taxable years of such U.S. Holder or, if shorter, such U.S. Holder’s holding period for the Class A ordinary shares). Under proposed regulations, these rules could apply to any portion of the holding period of the Class A ordinary shares received in exchange for IPO warrants pursuant to the Offer, or pursuant to the terms of the Warrant Amendment, if approved, that is attributable to the holding period for the IPO warrant prior to such exchange.
Under these rules:
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the U.S. Holder’s gain or excess distribution will be allocated ratably over the U.S. Holder’s holding period for our Class A ordinary shares;
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the amount allocated to the U.S. Holder’s taxable year in which the U.S. Holder recognized the gain or received the excess distribution, or to the period in the U.S. Holder’s holding period before the first day of our first taxable year in which we are a PFIC, will be taxed as ordinary income;
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the amount allocated to other taxable years (or portions thereof) of the U.S. Holder and included in its holding period will be taxed at the highest tax rate in effect for that year and applicable to the U.S. Holder without regard to the U.S. Holder’s other items of income and loss for such year; and
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an additional tax equal to the interest charge generally applicable to underpayments of tax will be imposed on the U.S. Holder with respect to the tax attributable to each such other taxable year of the U.S. Holder.
Under proposed Treasury regulations, for purposes of the above rules (i) the exercise of a warrant to acquire stock in a PFIC is not treated as a disposition of PFIC stock and (ii) gain is not recognized on a disposition of PFIC stock that results from a nonrecognition transfer if PFIC stock is exchanged for stock in the same or another corporation that is also a PFIC. However, (i) the exchange of IPO warrants for Class A ordinary shares pursuant to the Offer or (ii) the deemed exchange of IPO warrants not exchanged for Class A ordinary shares in the Offer for “new” warrants pursuant to the terms of the Warrant Amendment may not be eligible for those rules. U.S. Holders of IPO warrants should consult their tax advisors with respect to the application of these rules to the exercise, exchange or amendment of their IPO warrants if the Company were characterized as a PFIC for any taxable year (or portion thereof) that is included in the holding period of the U.S. Holder of our IPO warrants or Class A ordinary shares.
If the Company is a PFIC and, at any time, owns equity in a non-U.S. corporation that is classified as a PFIC, a U.S. Holder generally would be deemed to own a proportionate amount of the shares of such lower-tier PFIC, and generally could incur liability for the deferred tax and interest charge described above if the Company receives a distribution from, or disposes of all or part of its interest in, the lower-tier PFIC, or the U.S. Holder otherwise was deemed to have disposed of an interest in the lower-tier PFIC. There can be no assurance that we will have timely knowledge of the status of any such lower-tier PFIC. U.S. Holders are urged to consult their tax advisors regarding the tax issues raised by lower-tier PFICs.
If we are a PFIC and our Class A ordinary shares constitute “marketable stock,” a U.S. Holder may avoid the adverse PFIC tax consequences discussed above if such U.S. Holder makes a mark-to-market election with respect to such shares for the first taxable year in which it holds (or is deemed to hold) our Class A ordinary shares and each subsequent taxable year. Such U.S. Holder generally will include for each of its taxable years as ordinary income the excess, if any, of the fair market value of its Class A ordinary shares at the end of such year over its adjusted basis in its Class A ordinary shares. These amounts of ordinary
income would not be eligible for the favorable tax rates applicable to qualified dividend income or long-term capital gains. The U.S. Holder also will recognize an ordinary loss in respect of the excess, if any, of its adjusted basis of its Class A ordinary shares over the fair market value of its Class A ordinary shares at the end of its taxable year (but only to the extent of the net amount of previously included income as a result of the mark-to-market election). The U.S. Holder’s basis in its Class A ordinary shares will be adjusted to reflect any such income or loss amounts, and any further gain recognized on a sale or other taxable disposition of its Class A ordinary shares will be treated as ordinary income.
The mark-to-market election is available only for “marketable stock,” generally, stock that is regularly traded on a national securities exchange that is registered with the SEC, or on a foreign exchange or market that the IRS determines has rules sufficient to ensure that the market price represents a legitimate and sound fair market value. For this purpose, Class A ordinary shares generally will be considered regularly traded (i) during the calendar year of initial public offering if they are traded, other than in de minimis quantities, on 1/6 of the days remaining in the quarter in which the initial public offering occurs and on at least 15 days during each remaining quarter of that calendar year (or, if the initial public offering occurs in the fourth quarter, on the greater of 1/6 of the days remaining in such quarter or 5 days) and (ii) during any other calendar year during which they are traded, other than in de minimis quantities, on at least 15 days during each quarter. Any trades that have as their principal purpose meeting this requirement will be disregarded. If made, a mark-to-market election would be effective for the taxable year for which the election was made and for all subsequent taxable years unless our Class A ordinary shares cease to qualify as “marketable stock” for purposes of the PFIC rules or the IRS consents to the revocation of the election. Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. Holder will generally continue to be subject to the PFIC rules discussed above with respect to such Holder’s indirect interest in any investments the Company holds that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. As a result, it is possible that any mark-to-market election will be of limited benefit. A U.S. Holder that is eligible to make a mark-to-market with respect to such Holder’s Class A ordinary shares may do so by providing the appropriate information on IRS Form 8621 and timely filing that form with the U.S. Holder’s tax return for the year in which the election becomes effective. U.S. Holders are urged to consult their tax advisors regarding the availability and tax consequences of a mark-to-market election with respect to our Class A ordinary shares under their particular circumstances. Under current law, a mark-to-market election may not be made with respect to IPO warrants that are not exchanged for Class A ordinary shares.
Alternatively, a U.S. Holder of a PFIC may generally be able to avoid the adverse PFIC tax consequences described above in respect of stock of the PFIC by making and maintaining a timely and valid qualified electing fund (“QEF”) election (if eligible to do so) to include in income its pro rata share of the PFIC’s net capital gains (as long-term capital gain) and other earnings and profits (as ordinary income), on a current basis, in each case whether or not distributed, in the first taxable year of the U.S. Holder in which or with which the PFIC’s taxable year ends and each subsequent taxable year. The U.S. Holder’s adjusted basis in Class A ordinary shares will be increased by the amounts so included in gross income. Any subsequent distribution by the Company that is paid out of the earnings and profits that were previously so included in gross income of the U.S. Holder generally will not be taxable as a dividend to the U.S. Holder, and the U.S.
Holder’s adjusted basis in the Class A ordinary shares will decrease by the amount of the distribution not treated as a taxable dividend. If a U.S. Holder has timely made a QEF election with respect to the Class A ordinary shares, any gain such U.S. Holder recognizes upon the sale or other disposition of the Class A ordinary shares generally will be treated as capital gain, and no interest charge will be imposed. In order to comply with the requirements of a QEF election, a U.S. Holder must receive a PFIC Annual Information Statement from the PFIC. We do not presently intend to provide a PFIC Annual Information Statement in order for U.S. Holders to make or maintain a QEF election.
It is not entirely clear how various aspects of the PFIC rules apply to the IPO warrants. However, QEF elections are not available with respect to IPO warrants, and U.S. Holders of IPO warrants who exchange IPO warrants for Class A ordinary shares generally may not benefit from a QEF election if the Company were a PFIC during any period in which such Holder held IPO warrants. U.S. Holders are urged to consult their tax advisors as to the application of the PFIC rules to the IPO warrants.
PFIC Reporting Requirements
A U.S. Holder that owns (or is deemed to own) shares in a PFIC during any taxable year of the U.S. Holder, may have to file an IRS Form 8621 (whether or not a mark-to-market or any other election is made) and to provide such other information as may be required by the U.S. Treasury Department. Failure to do so, if required, will extend the statute of limitations applicable to such U.S. Holder until after such required information is furnished to the IRS.
The rules governing PFICs and mark-to-market and other elections are very complex and are affected by various factors in addition to those described above. Accordingly, U.S. Holders of our Class A ordinary shares are urged to consult their own tax advisors concerning the application of the PFIC rules to our securities under their particular circumstances.
Additional Reporting Requirements
Certain U.S. Holders holding specified foreign financial assets with an aggregate value in excess of the applicable dollar thresholds are required to report information to the IRS relating to our Class A ordinary shares, subject to certain exceptions (including an exception for our Class A ordinary shares held in accounts maintained by U.S. financial institutions), by attaching a complete IRS Form 8938 (Statement of Specified Foreign Financial Assets) with their tax return for each year in which they hold our Class A ordinary shares. Substantial penalties apply to any failure to file IRS Form 8938 and the period of limitations on assessment and collection of U.S. federal income taxes will be extended in the event of a failure to comply. U.S. Holders are urged to consult their tax advisors regarding the effect, if any, of these rules on the ownership and disposition of our Class A ordinary shares.
Information Reporting and Backup Withholding
Payments of dividends and sales proceeds that are made within the United States or through certain U.S.-related financial intermediaries are subject to information reporting and may be subject to backup withholding.
Backup withholding generally will not apply, however, to a U.S. Holder if (i) the U.S. Holder is a corporation (other than an S corporation) or other exempt recipient or (ii) the U.S. Holder provides a correct taxpayer identification number and certifies that it is not subject to backup withholding.
Backup withholding is not an additional tax. The amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against such U.S. Holder’s U.S. federal income tax liability and may entitle it to a refund, provided that the required information is timely furnished to the IRS.
THE U.S. FEDERAL INCOME TAX DISCUSSION SET FORTH ABOVE IS INCLUDED FOR GENERAL INFORMATION ONLY AND MAY NOT BE APPLICABLE TO YOU DEPENDING UPON YOUR PARTICULAR SITUATION. YOU ARE URGED TO CONSULT YOUR OWN TAX ADVISOR WITH RESPECT TO THE TAX CONSEQUENCES TO YOU OF THE RECEIPT, OWNERSHIP AND DISPOSITION OF CLASS A ORDINARY SHARES OR OF THE WARRANT AMENDMENT OR WARRANTS NOT EXCHANGED FOR CLASS A ORDINARY SHARES IN THE OFFER, INCLUDING THE TAX CONSEQUENCES UNDER STATE, LOCAL, ESTATE, NON-U.S. AND OTHER TAX LAWS AND TAX TREATIES AND THE POSSIBLE EFFECTS OF CHANGES IN U.S. OR OTHER TAX LAWS.
Exchange Agent
The depositary and exchange agent for the Offer and Consent Solicitation is:
Continental Stock Transfer & Trust Company
1 State Street, 30th Floor
New York, New York 10004
Additional Information; Amendments
We have filed with the SEC a Tender Offer Statement on Schedule TO, of which this Prospectus/Offer to Exchange is a part. We recommend that IPO warrant holders review the Schedule TO, including the
exhibits thereto, and our other materials that have been filed with the SEC before making a decision on whether to accept the Offer and Consent Solicitation.
We will assess whether we are permitted to make the Offer and Consent Solicitation in all jurisdictions. If we determine that we are not legally able to make the Offer and Consent Solicitation in a particular jurisdiction, we will inform IPO warrant holders of this decision. The Offer and Consent Solicitation is not made to those holders who reside in any jurisdiction where the offer or solicitation would be unlawful.
Our board of directors recognizes that the decision to accept or reject the Offer and Consent Solicitation is an individual one that should be based on a variety of factors and IPO warrant holders should consult with personal advisors if they have questions about their financial or tax situation.
We are subject to the information requirements of the Exchange Act and, in accordance therewith, file and furnish reports and other information with the SEC. All reports and other documents we have filed or furnished with the SEC, including the registration statement on Form S-4 relating to the Offer and Consent Solicitation, or will file or furnish with the SEC in the future, can be accessed electronically on the SEC’s website at www.sec.gov. If you have any questions regarding the Offer and Consent Solicitation or need assistance, you should contact the information agent for the Offer and Consent Solicitation. You may request additional copies of this document, the Letter of Transmittal and Consent, or the Notice of Guaranteed Delivery from the information agent. All such questions or requests should be directed to:
Alliance Advisors, LLC
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
We will amend our offering materials, including this Prospectus/Offer to Exchange, to the extent required by applicable securities laws to disclose any material changes to information previously published, sent, or given by us to IPO warrant holders in connection with the Offer and Consent Solicitation.
DESCRIPTION OF SECURITIES
The following summary of the material terms of our securities is not intended to be a complete summary of the rights and preferences of such securities. You are encouraged to read the applicable provisions of Cayman Islands law and our MAA in their entirety for a complete description of the rights and preferences of our securities.
General
Unless the context otherwise requires, for purposes of this section, the terms “we,” “us,” “our,” “the Company” or “Zura” refer to Zura Bio Limited following the consummation of the Business Combination.
We are a company incorporated in the Cayman Islands as an exempted company and our affairs are governed by the MAA, the Cayman Islands Companies Act and the common law of the Cayman Islands. Pursuant to the MAA, our authorized share capital is $30,100 divided into 300,000,000 Class A ordinary shares of a par value of $0.0001 each, no Class B Ordinary Shares of a par value of $0.001 each, and 1,000,000 preference shares of a par value of $0.0001 each. The following description summarizes certain terms of our shares as set out more particularly in the MAA. Because it is only a summary, it may not contain all the information that is important to you.
Ordinary shares
As of July 10, 2024, we have 63,746,453 Class A ordinary shares outstanding. Our shareholders of record are entitled to one vote for each share held on all matters to be voted on by shareholders.
The members of our board of directors serve until the next annual general meeting. There is no cumulative voting with respect to the appointment of directors, with the result that the holders of more than 50% of the shares eligible to vote for the appointment of directors and voting at the applicable meeting can appoint all of the directors. Subject to the rights of any holders of preference shares to appoint directors, the number of directors that shall constitute the Zura board shall be as determined from time to time exclusively by the Zura board.
Directors may only be removed for cause by a majority of the other directors then in office or by the affirmative vote of at least two-thirds (662∕3%) of the voting power of all then-outstanding shares of Zura entitled to vote thereon, voting together as a single class.
Our shareholders have no conversion, preemptive or other subscription rights and there are no sinking fund or redemption provisions applicable to the ordinary shares.
Register of Members
Under Cayman Islands law, we must keep a register of members and there will be entered therein:
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the names and addresses of the members, a statement of the shares held by each member, and of the amount paid or agreed to be considered as paid, on the shares of each member and the voting rights of the shares of each member;
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whether voting rights are attached to the shares in issue;
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the date on which the name of any person was entered on the register as a member; and
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the date on which any person ceased to be a member.
Under Cayman Islands law, the register of members of our company is prima facie evidence of the matters set out therein (i.e. the register of members will raise a presumption of fact on the matters referred to above unless rebutted) and a member registered in the register of members will be deemed as a matter of Cayman Islands law to have legal title to the shares as set against its name in the register of members. However, there are certain limited circumstances where an application may be made to a Cayman Islands court for a determination on whether the register of members reflects the correct legal position. Further, the Cayman Islands court has the power to order that the register of members maintained by a company should be rectified where it considers that the register of members does not reflect the correct legal position.
if an application for an order for rectification of the register of members were made in respect of our shares, then the validity of such shares may be subject to re-examination by a Cayman Islands court.
Founder Shares
Founder Shares were outstanding JATT Class B Ordinary Shares that automatically converted into our Class A ordinary shares at the closing of the Business Combination on a one-for-one basis, subject to adjustment. The Founder Shares are henceforth identical to the other Class A ordinary shares, and holders of Founder Shares have the same shareholder rights as public shareholders, except that (i) the Founder Shares are subject to certain transfer restrictions, as described in more detail below and (ii) the founder shares are entitled to registration rights.
With certain limited exceptions, the Founder Shares are subject to a lock-up agreement (the “Lock-Up Agreement”), which took effect at the closing of the business combination (the “Closing”), containing restrictions on transfer with respect to Class A Ordinary Shares held by each such holder (subject to certain exceptions, the “Lock-Up Shares”) for a period as follows: one-third (1/3) of the Lock-Up Shares will be restricted until 6 months after the Closing, one-third (1/3) of the Lock-Up Shares will be restricted until 12 months after the Closing, and one-third (1/3) of the Lock-Up Shares shall be restricted until 24 months after the Closing; provided, that each portion of the Lock-Up Shares will be freely tradable on the earlier of (i) the date on which the closing price of the Class A ordinary shares equals or exceeds $12.00 per share (as adjusted for share splits, share dividends, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period on a VWAP (as defined below) basis during the relevant lock-up period; and (ii) the date on which the Company consummates a liquidation, merger, capital share exchange, reorganization, or other similar transaction that results in all our shareholders having the right to exchange their Class A ordinary shares for cash, securities or other property. For purposes of the Lock-Up Agreement, “VWAP” means, for any date, the daily volume weighted average price of the Class A ordinary shares for such date (or the nearest preceding date) on the trading market on which the Class A ordinary shares are then listed or quoted as reported by Bloomberg L.P. (based on a trading day from 9:30 a.m. (New York City time) to 4:00 p.m. (New York City time)).
Preference shares
Our MAA provides that preference shares may be issued from time to time in one or more series. Our board of directors are authorized to fix the voting rights, if any, designations, powers, preferences, the relative, participating, optional or other special rights and any qualifications, limitations and restrictions thereof, applicable to the shares of each series. Our board of directors are able to, without shareholder approval, issue preference shares with voting and other rights that could adversely affect the voting power and other rights of the holders of the ordinary shares and could have anti-takeover effects. The ability of our board of directors to issue preference shares without shareholder approval could have the effect of delaying, deferring or preventing a change of control of us or the removal of existing management. We have no preference shares outstanding at the date hereof. Although we do not currently intend to issue any preference shares, we cannot assure you that we will not do so in the future. No preference shares were issued or registered in connection with the Business Combination.
Redeemable Warrants
Public Shareholders’ Warrants
Each whole public warrant entitles the registered holder to purchase one Class A ordinary share at a price of $11.50 per share, subject to adjustment as discussed below. Pursuant to the Warrant Agreement, a public warrant holder may exercise its public warrants only for a whole number of Class A ordinary shares. This means only a whole public warrant may be exercised at a given time by a public warrant holder. No fractional warrants will be issued upon separation of the units and only whole warrants will trade. The public warrants will expire five years after the completion of the Business Combination, at 5:00 p.m., New York City time, or earlier upon redemption or liquidation.
We are not obligated to deliver any Class A ordinary shares pursuant to the exercise of a public warrant and will have no obligation to settle such public warrant exercise unless a registration statement
under the Securities Act with respect to the Class A ordinary shares underlying the public warrants is then effective and a current prospectus relating thereto is current, subject to our satisfying our obligations described below with respect to registration. No public warrant will be exercisable, and we will not be obligated to issue Class A ordinary shares upon exercise of a warrant unless Class A ordinary shares issuable upon such warrant exercise has been registered, qualified or deemed to be exempt under the securities laws of the state of residence of the registered holder of the public warrants. In the event that the conditions in the two immediately preceding sentences are not satisfied with respect to a public warrant, the holder of such warrant will not be entitled to exercise such public warrant and such warrant may have no value and expire worthless. In no event will we be required to net cash settle any public warrant. In the event that a registration statement is not effective for the exercised public warrants, the purchaser of a unit containing such warrant, if not cash settled, will have paid the full purchase price for the unit solely for the Class A ordinary shares underlying such unit.
We have filed a registration statement with the SEC registering the issuance of the Class A ordinary shares issuable upon exercise of the IPO warrants which was declared effective by the SEC on June 4, 2024. Once the IPO warrants become exercisable, we may call the IPO warrants for redemption:
•
in whole and not in part;
•
at a price of $0.01 per IPO warrant;
•
upon not less than 30 days’ prior written notice of redemption (the “30-day redemption period”) to each warrant holder; and
•
if, and only if, the reported closing price of the Class A ordinary shares equals or exceeds $18.00 per share (as adjusted for share sub-divisions, share dividends, reorganizations, recapitalizations and the like).
If and when the public warrants become redeemable by us, we may not exercise our redemption right if the issuance of ordinary shares upon exercise of the public warrants is not exempt from registration or qualification under applicable state blue sky laws or we are unable to effect such registration or qualification. We will use our best efforts to register or qualify such ordinary shares under the blue sky laws of the state of residence in those states in which the IPO warrants were initially offered by us in the IPO.
We have established the last of the redemption criteria discussed above to prevent a redemption call unless there is at the time of the call a significant premium to the public warrant exercise price. If the foregoing conditions are satisfied and we issue a notice of redemption of the public warrants, each warrant holder will be entitled to exercise its public warrant prior to the scheduled redemption date. However, the price of the Class A ordinary shares may fall below the $18.00 redemption trigger price (as adjusted for share sub-divisions, share dividends, reorganizations, recapitalizations and the like), as well as the $11.50 public warrant exercise price after the redemption notice is issued.
If we call the public warrants for redemption as described above, our management will have the option to require any holder that wishes to exercise its public warrant to do so on a cashless basis. In determining whether to require all holders to exercise their public warrants on a cashless basis, our management will consider, among other factors, our cash position, the number of public warrants that are outstanding and the dilutive effect on our shareholders of issuing the maximum number of Class A ordinary shares issuable upon the exercise of our public warrants. If our management takes advantage of this option, all holders of public warrants would pay the exercise price by surrendering their public warrants for that number of Class A ordinary shares equal to the quotient obtained by dividing (x) the product of the number of Class A ordinary shares underlying the public warrants multiplied by and the excess of the “fair market value” (defined below) over the exercise price of the public warrants by (y) the fair market value. The “fair market value” shall mean the average reported closing price of the Class A ordinary shares for the 10 trading days ending on the third trading day prior to the date on which the notice of redemption is sent to the holders of public warrants. If our management takes advantage of this option, the notice of redemption will contain the information necessary to calculate the number of Class A ordinary shares to be received upon exercise of the public warrants, including the “fair market value” in such case. Requiring a cashless exercise in this manner will reduce the number of shares to be issued and thereby lessen the dilutive effect of a public warrant redemption. We believe this feature is an attractive option to us if we do not need the cash from the
exercise of the public warrants after our Business Combination. If we call our public warrants for redemption and our management does not take advantage of this option, our sponsor and its permitted transferees would still be entitled to exercise their private placement warrants for cash or on a cashless basis using the same formula described above that other warrant holders would have been required to use had all warrant holders been required to exercise their public warrants on a cashless basis, as described in more detail below.
A holder of a public warrant may notify us in writing in the event it elects to be subject to a requirement that such holder will not have the right to exercise such public warrant, to the extent that after giving effect to such exercise, such person (together with such person’s affiliates), to the public warrant agent’s actual knowledge, would beneficially own in excess of 4.9% or 9.8% (or such other amount as a holder may specify) of the Class A ordinary shares outstanding immediately after giving effect to such exercise.
If the number of outstanding Class A ordinary shares is increased by a share dividend payable in Class A ordinary shares, or by a sub-division-up of Class A ordinary shares or other similar event, then, on the effective date of such share dividend, sub-division-up or similar event, the number of Class A ordinary shares issuable on exercise of each public warrant will be increased in proportion to such increase in the outstanding Class A ordinary shares. A rights offering to holders of Class A ordinary shares entitling holders to purchase Class A ordinary shares at a price less than the fair market value will be deemed a share dividend of a number of Class A ordinary shares equal to the product of (i) the number of Class A ordinary shares actually sold in such rights offering (or issuable under any other equity securities sold in such rights offering that are convertible into or exercisable for Class A ordinary shares) and (ii) one minus the quotient of (x) the price per Class A ordinary share paid in such rights offering divided by (y) the fair market value. For these purposes (i) if the rights offering is for securities convertible into or exercisable for Class A ordinary shares, in determining the price payable for Class A ordinary shares, there will be taken into account any consideration received for such rights, as well as any additional amount payable upon exercise or conversion and (ii) fair market value means the volume weighted average price of Class A ordinary shares as reported during the 10 trading day period ending on the trading day prior to the first date on which the Class A ordinary shares trade on the applicable exchange or in the applicable market, regular way, without the right to receive such rights.
In addition, if we, at any time while the public warrants are outstanding and unexpired, pay a dividend or make a distribution in cash, securities or other assets to the holders of Class A ordinary shares on account of such Class A ordinary shares (or other of our shares into which the public warrants are convertible), other than (a) as described above or (b) certain ordinary cash dividends, then the public warrant exercise price will be decreased, effective immediately after the effective date of such event, by the amount of cash and/or the fair market value of any securities or other assets paid on each Class A ordinary share in respect of such event.
If the number of outstanding Class A ordinary shares is decreased by a consolidation, combination, reverse share sub-division or reclassification of Class A ordinary shares or other similar event, then, on the effective date of such consolidation, combination, reverse share sub-division, reclassification or similar event, the number of Class A ordinary shares issuable on exercise of each public warrant will be decreased in proportion to such decrease in outstanding Class A ordinary shares.
Whenever the number of Class A ordinary shares purchasable upon the exercise of the public warrants is adjusted, as described above, the public warrant exercise price will be adjusted by multiplying the public warrant exercise price immediately prior to such adjustment by a fraction (x) the numerator of which will be the number of Class A ordinary shares purchasable upon the exercise of the public warrants immediately prior to such adjustment, and (y) the denominator of which will be the number of Class A ordinary shares so purchasable immediately thereafter.
In case of any reclassification or reorganization of the outstanding Class A ordinary shares (other than those described above or that solely affects the par value of such Class A ordinary shares), or in the case of any merger or consolidation of us with or into another corporation (other than a consolidation or merger in which we are the continuing corporation and that does not result in any reclassification or reorganization of our outstanding Class A ordinary shares), or in the case of any sale or conveyance to another corporation or entity of the assets or other property of us as an entirety or substantially as an entirety in connection with which we are dissolved, the holders of the public warrants will thereafter have the right to purchase and
receive, upon the basis and upon the terms and conditions specified in the public warrants and in lieu of our Class A ordinary shares immediately theretofore purchasable and receivable upon the exercise of the rights represented thereby, the kind and amount of shares or other securities or property (including cash) receivable upon such reclassification, reorganization, merger or consolidation, or upon a dissolution following any such sale or transfer, that the holder of the public warrants would have received if such holder had exercised their public warrants immediately prior to such event. If less than 70% of the consideration receivable by the holders of Class A ordinary shares in such a transaction is payable in the form of Class A ordinary shares in the successor entity that is listed for trading on a national securities exchange or is quoted in an established over-the-counter market, or is to be so listed for trading or quoted immediately following such event, and if the registered holder of the public warrant properly exercises the public warrant within 30 days following public disclosure of such transaction, the public warrant exercise price will be reduced as specified in the public warrant agreement based on the Black-Scholes value (as defined in the public warrant agreement) of the public warrant. The purpose of such exercise price reduction is to provide additional value to holders of the public warrants when an extraordinary transaction occurs during the exercise period of the public warrants pursuant to which the holders of the public warrants otherwise do not receive the full potential value of the public warrants. This formula is to compensate the warrant holder for the loss of the option value portion of the public warrant due to the requirement that the warrant holder exercise the public warrant within 30 days of the event. The Black-Scholes model is an accepted pricing model for estimating fair market value where no quoted market price for an instrument is available.
The public warrant agreement provides that the terms of the public warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision, and that all other modifications or amendments will require the vote or written resolution of the holders of at least a majority of the then outstanding public warrants and, solely with respect to any amendment to the terms of the private placement warrants, a majority of the then outstanding private placement warrants.
The public warrants may be exercised upon surrender of the warrant certificate on or prior to the expiration date at the offices of the warrant agent, with the exercise form on the reverse side of the warrant certificate completed and executed as indicated, accompanied by full payment of the exercise price (or on a cashless basis, if applicable), by certified or official bank check payable to us, for the number of public warrants being exercised. The warrant holders do not have the rights or privileges of holders of Class A ordinary shares or any voting rights until they exercise their public warrants and receive Class A ordinary shares. After the issuance of Class A ordinary shares upon exercise of the public warrants, each holder will be entitled to one vote for each share held of record on all matters to be voted on by shareholders.
No fractional shares will be issued upon exercise of the public warrants. If, upon exercise of the public warrants, a holder would be entitled to receive a fractional interest in a share, we will, upon exercise, round down to the nearest whole number of Class A ordinary shares to be issued to the warrant holder. As a result, warrant holders not purchasing an even number of public warrants must sell any odd number of public warrants in order to obtain full value from the fractional interests that will not be issued.
We have agreed that, subject to applicable law, any action, proceeding or claim against us arising out of or relating in any way to the Warrant Agreement will be brought and enforced in the courts of the State of New York or the United States District Court for the Southern District of New York, and we irrevocably submit to such jurisdiction, which jurisdiction will be the exclusive forum for any such action, proceeding or claim. This provision applies to claims under the Securities Act but does not apply to claims under the Exchange Act or any claim for which the federal district courts of the United States of America are the sole and exclusive forum.
Private Placement Warrants
Pursuant to the Sponsor Forfeiture Agreement, the Sponsor forfeited 4,137,000 of its private placement warrants acquired in the IPO. The forfeited private placement warrants were transferred from the Sponsor to the FPA Investors and Ewon on a pro rata basis in accordance with such FPA Investors’ and Ewon’s total invested capital.
The private placement warrants (including the Class A ordinary shares issuable upon exercise of the private placement warrants) will not be redeemable by us so long as they are held by our sponsor or its
permitted transferees. Except as described below, the private placement warrants have terms and provisions that are identical to those of the public warrants sold as part of the units in the IPO, including as to exercise price, exercisability and exercise period. If the private placement warrants are held by holders other than the sponsor or its permitted transferees, the private placement warrants will be redeemable by us and exercisable by the holders on the same basis as the public warrants included in the units sold in the IPO.
If holders of the private placement warrants elect to exercise them on a cashless basis, they would pay the exercise price by surrendering their private placement warrants for that number of Class A ordinary shares equal to the quotient obtained by dividing (x) the product of the number of Class A ordinary shares underlying the private placement warrants multiplied by the excess of the “fair market value” (defined below) over the exercise price of the private placement warrants by (y) the fair market value. The “fair market value” means the average reported closing price of the Class A ordinary shares for the 10 trading days ending on the third trading day prior to the date on which the notice of warrant exercise is sent to the warrant agent. The reason that we agreed that these warrants will be exercisable on a cashless basis so long as they are held by the sponsor or its permitted transferees is because it was not known at the time whether they will be affiliated with us following a business combination. If they remain affiliated with us, their ability to sell our securities in the open market will be significantly limited. We expect to have policies in place that prohibit insiders from selling our securities except during specific periods of time. Even during such periods of time when insiders will be permitted to sell our securities, an insider cannot trade in our securities if he or she is in possession of material non-public information. Accordingly, unlike public shareholders who could exercise their private placement warrants and sell the Class A ordinary shares issuable upon exercise of the warrants freely in the open market, the insiders could be significantly restricted from doing so. As a result, we believe that allowing the holders to exercise such warrants on a cashless basis is appropriate.
Pre-Funded Warrants
2023 Pre-Funded Warrants
On April 26, 2023, the Company entered into certain subscription agreements (the “2023 PIPE Subscription Agreements”) with certain individual and institutional accredited investors in connection with the sale by the Company of Class A ordinary shares and pre-funded warrants (the “2023 Pre-Funded Warrant”). Pursuant to the terms of the subscription agreements, each 2023 Pre-Funded Warrant was sold at a price of $4.249 per 2023 Pre-Funded Warrant. Each 2023 Pre-Funded Warrant has an exercise price of $0.001 per Class A ordinary share and is exercisable for one Class A ordinary share at any time or times on or after April 26, 2023 until exercised in full. The 2023 Pre-Funded Warrants and the Class A ordinary shares issuable upon exercise of the 2023 Pre-Funded Warrants rely on the exemptions from registration provided by Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder, for transactions not involving a public offering.
2024 Pre-Funded Warrants
On April 18, 2024, the Company entered into certain subscription agreements with certain individual and institutional accredited investors (the “2024 PIPE Subscription Agreements”) in connection with the sale by the Company of Class A ordinary shares and pre-funded warrants (the “2024 Pre-Funded Warrants”). Pursuant to the terms of the subscription agreements, each 2024 Pre-Funded Warrant was sold at a price of $3.107 per 2024 Pre-Funded Warrant. Each 2024 Pre-Funded Warrant has an exercise price of $0.001 per Class A ordinary share and is exercisable for one Class A ordinary share at any time or times on or after April 22, 2024 until exercised in full. The 2024 Pre-Funded Warrants and the Class A ordinary shares issuable upon exercise of the 2024 Pre-Funded Warrants rely on the exemptions from registration provided by Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder, for transactions not involving a public offering.
For the avoidance of doubt, the 2023 Pre-Funded Warrants and the 2024 Pre-Funded Warrants are not included in this Offer and are not part of the IPO warrants.
Registration Rights
March 2023 A&R Registration Rights Agreement
On March 20, 2023, in connection with and effective upon the consummation of the Business Combination, Zura, the sponsor and certain other parties entered into the A&R Registration Rights Agreement at the Closing, pursuant to which they agreed to register for resale certain Class A ordinary shares and other equity securities that are held by parties thereto from time to time. The A&R Registration Rights Agreement includes customary demand and piggyback registration rights.
With certain limited exceptions, certain of our Class A ordinary shares held by parties to the A&R Registration Rights Agreement are subject to restrictions on transfer with respect to Class A Ordinary Shares for a period as follows: one-third (1/3) of the Lock-Up Shares will be restricted until 6 months after the Closing, one-third (1/3) of the Lock-Up Shares will be restricted until 12 months after the Closing, and one-third (1/3) of the Lock-Up Shares shall be restricted until 24 months after the Closing; provided, that each portion of the Lock-Up Shares will be freely tradable on the earlier of (i) the date on which the closing price of the Class A ordinary shares equals or exceeds $12.00 per share (as adjusted for share splits, share dividends, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period on a VWAP basis during the relevant lock-up period; and (ii) the date on which the Company consummates a liquidation, merger, capital share exchange, reorganization, or other similar transaction that results in all our shareholders having the right to exchange their Class A ordinary shares for cash, securities or other property.
April 2023 Private Placement
Under the terms of the 2023 PIPE Subscription Agreements, the Company agreed to prepare and file, within 45 days after the closing of the April 2023 Private Placement (the “2023 Filing Deadline”), one or more registration statements (each a “2023 PIPE Registration Statement”) with the SEC to register for resale the Class A ordinary shares (the “2023 PIPE Shares”) issued under the 2023 PIPE Subscription Agreements and the Class A ordinary shares issuable upon exercise of the 2023 Pre-Funded Warrants (the “2023 Warrant Shares”) issued pursuant to the 2023 PIPE Subscription Agreements, and to cause the applicable 2023 PIPE Registration Statement(s) to become effective within a specified period after the 2023 Filing Deadline. The Company also agreed to use its best efforts to keep such 2023 PIPE Registration Statement effective until the earlier of (i) the date all 2023 PIPE Shares and 2023 Warrant Shares held by or issuable to a subscriber may be sold under Rule 144 (“Rule 144”) promulgated under the Securities Act without being subject to any volume or manner of sale requirements, (ii) the date on which all 2023 PIPE Shares and 2023 Warrant Shares have actually been sold pursuant to Rule 144 or pursuant to the 2023 PIPE Registration Statement and (iii) the date which is two years from the date that the initial 2023 PIPE Registration Statement is declared effective (or any Additional Effectiveness Date (as defined in the 2023 PIPE Subscription Agreements), if applicable). The Company filed the 2023 PIPE Registration Statement and it was declared effective by the SEC on September 14, 2023.
April 2024 Private Placement
Under the terms of the 2024 PIPE Subscription Agreements, the Company agreed to prepare and file, within 35 days after the closing of the April 2024 Private Placement (the “2024 Filing Deadline”), one or more registration statements (each a “2024 PIPE Registration Statement”) with the SEC to register for resale the Class A ordinary shares (the “2024 PIPE Shares”) issued under the 2024 PIPE Subscription Agreements and the Class A ordinary shares issuable upon exercise of the 2024 Pre-Funded Warrants (the “2024 Warrant Shares”) issued pursuant to the 2024 PIPE Subscription Agreements, and to cause the applicable 2024 PIPE Registration Statement(s) to become effective within a specified period after the 2024 Filing Deadline. The Company also agreed to use its best efforts to keep such 2024 PIPE Registration Statement effective until the earlier of (i) the date all 2024 PIPE Shares and 2024 Warrant Shares held by or issuable to a subscriber may be sold under Rule 144 (“Rule 144”) promulgated under the Securities Act without being subject to any volume or manner of sale requirements, (ii) the date on which all 2024 PIPE Shares and 2024 Warrant Shares have actually been sold pursuant to Rule 144 or pursuant to the 2024 PIPE Registration Statement and (iii) the date which is two years from the date that the initial 2024 PIPE Registration
Statement is declared effective (or any Additional Effectiveness Date (as defined in the 2024 PIPE Subscription Agreements), if applicable). The Company filed the 2024 PIPE Registration Statement and it was declared effective by the SEC on June 3, 2024.
Dividends
We have not paid any cash dividends on our shares to date and do not expect to pay cash dividends in the foreseeable future. The payment of cash dividends in the future will be dependent upon our ability to comply with relevant legal requirements as well as our revenues and earnings, if any, capital requirements and general financial condition. The payment of any dividends will be within the discretion of the Zura board. It is the present intention of our board of directors to retain all earnings, if any, for use in our business operations and, accordingly, our board does not anticipate declaring any dividends in the foreseeable future.
Our Transfer Agent and Warrant Agent
The transfer agent for our ordinary shares and the warrant agent for our warrants is Continental Stock Transfer & Trust Company, 1 State Street, 30th floor, New York, New York 10004. We have agreed to indemnify Continental Stock Transfer & Trust Company in its roles as transfer agent and warrant agent, its agents and each of its shareholders, directors, officers and employees against all claims and losses that may arise out of acts performed or omitted for its activities in that capacity, except for any liability due to any gross negligence, willful misconduct or bad faith of the indemnified person or entity.
Listing of Our Securities
Our Class A ordinary shares and public warrants are listed on Nasdaq under the symbols “ZURA” and “ZURAW,” respectively.
Extraordinary General Meetings of Shareholders
Our MAA provides that the directors, the chief executive officer or the chairman of the board of directors may call general meetings, and they shall on a shareholders’ requisition forthwith proceed to convene an extraordinary general meeting of the Company. A shareholders’ requisition is a requisition of shareholders holding at the date of deposit of the requisition not less than 10% in par value of the issued shares which as at that date carry the right to vote at general meetings of the Company.
Advance Notice Requirements for Shareholder Proposals and Director Nominations
Our MAA provides that shareholders seeking to bring business before our annual general meeting, or to nominate candidates for election as directors at our annual general meeting, must provide timely notice of their intent in writing. To be timely, a shareholder’s notice will need to be delivered to our principal executive offices not less than 120 calendar days before the date of the proxy statement released to shareholders in connection with the previous year’s annual general meeting or, if we did not hold an annual general meeting in the previous year, or if the date of the current year’s annual general meeting has been changed by more than 30 days from the date of the previous year’s annual general meeting, then the deadline shall be set by our Board of Directors with such deadline being a reasonable time before we begin to print and send the related proxy materials. Our MAA also specifies certain requirements as to the form and content of a shareholders’ meeting. These provisions may preclude our shareholders from bringing matters before our annual general meeting or from making nominations for directors at our annual general meeting.
Authorized but Unissued Shares
Our authorized but unissued Class A ordinary shares and preference shares are available for future issuances without shareholder approval and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, acquisitions and employee benefit plans. The existence of authorized but unissued and unreserved Class A ordinary shares and preference shares could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.
BENEFICIAL OWNERSHIP OF SECURITIES
PRINCIPAL SHAREHOLDERS
The following table sets forth certain information known to us regarding the beneficial ownership of our Class A ordinary shares as of July 10, 2024 regarding (i) the actual beneficial ownership of our Class A ordinary shares prior to the completion of the Offer and Consent Solicitation and (ii) the expected beneficial ownership of our Class A ordinary shares following the completion of the Offer and Consent Solicitation and the approval of the Warrant Amendment, on both a “full value exchange” scenario, as described below:
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each of our executive officers and directors;
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all of our executive officers and directors as a group; and
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each person or entity, or group of affiliated persons or entities, known by us to beneficially own more than 5% of our outstanding ordinary shares.
Information with respect to beneficial ownership is based on information furnished to us by each director and executive officer and information furnished by shareholders holding more than 5% of our outstanding Class A ordinary shares to us and/or on Schedules 13G or 13D filed with the SEC, as the case may be. Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he or she possesses sole or shared voting or investment power of that security, and includes options, restricted share units and warrants that are currently exercisable or that vest, as applicable, within 60 days of July 10, 2024. Options and warrants to purchase Class A ordinary shares that are exercisable or restricted share units that vest within 60 days of July 10, 2024 are deemed to be beneficially owned by the persons holding these options, restricted share units and warrants for the purpose of computing percentage ownership of that person, but are not treated as outstanding for the purpose of computing any other person’s ownership percentage. Except as indicated in the footnotes below, each of the beneficial owners named in the table below has, to our knowledge, sole voting and investment power with respect to all Class A ordinary shares listed as beneficially owned by him or her, except for Class A ordinary shares owned jointly with that person’s spouse.
The expected beneficial ownership of our ordinary shares reflects the following:
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the completion of the Offer and Consent Solicitation;
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the tendering of a sufficient number of IPO warrants such that the Warrant Amendment is approved; and
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a “full value exchange” scenario whereby all IPO warrant holders exchange 100% of outstanding IPO warrants for 0.30 Class A ordinary shares per IPO warrant.
We have based our calculation of beneficial ownership on 63,746,453 of our Class A ordinary shares outstanding prior to the completion of the Offer and Consent Solicitation. Based on the foregoing assumptions, there would be 67,589,452 Class A ordinary shares outstanding immediately following the “full value exchange” scenario. If the actual facts are different from the foregoing assumptions, ownership figures reflected in the table that follows on a post-exchange basis will be different.
Unless otherwise indicated, we believe that all persons named in the table below have sole voting and investment power with respect ordinary shares beneficially owned by them. Unless otherwise indicated, the address for each of the shareholders in the table below is c/o Zura Bio Limited, 1489 W. Warm Springs Rd., #110, Henderson, Nevada 89014.
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Zura Bio Limited
Securities Beneficially
Owned Before
Exchange of IPO warrants
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Zura Bio Limited
Securities Beneficially
Owned Following
Exchange of IPO warrants(1)
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Name of Beneficial Owner
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Number of
Class A
Ordinary
Shares
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Percentage
of Voting
Power
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Number of
Class A
Ordinary
Shares
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Percentage
of Voting
Power
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5% and Greater Shareholders:
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Entities affiliated with Venrock Healthcare Capital Partners
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6,335,666(2) |
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9.9% |
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6,753,166 |
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9.9% |
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AI Biotechnology LLC
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6,582,725(3) |
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9.9% |
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6,752,725 |
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9.9% |
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Entities affiliated with Deep Track Capital, L.P.
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6,216,327(4) |
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9.3% |
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6,216,327 |
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9.2% |
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Hana Immunotherapeutics LLC
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5,404,274(5) |
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8.5% |
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5,404,274 |
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|
|
8.0% |
|
|
Suvretta Capital Management, LLC
|
|
|
|
|
4,860,939(6) |
|
|
|
|
|
7.6% |
|
|
|
|
|
4,860,939 |
|
|
|
|
|
7.2% |
|
|
Entities affiliated with Athanor Capital, L.P.
|
|
|
|
|
4,801,633(7) |
|
|
|
|
|
7.5% |
|
|
|
|
|
4,801,633 |
|
|
|
|
|
7.1% |
|
|
Great Point Partners, LLC
|
|
|
|
|
4,766,529(8) |
|
|
|
|
|
7.5% |
|
|
|
|
|
4,766,529 |
|
|
|
|
|
7.1% |
|
|
Ewon Comfortech Co., Ltd.
|
|
|
|
|
3,653,466(9) |
|
|
|
|
|
5.6% |
|
|
|
|
|
2,496,040 |
|
|
|
|
|
3.7% |
|
|
Entities affiliated with RA Capital Management, L.P
|
|
|
|
|
3,217,503(10) |
|
|
|
|
|
5.0% |
|
|
|
|
|
3,217,503 |
|
|
|
|
|
4.8% |
|
|
Executive Officers and Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert Lisicki
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
Kim Davis
|
|
|
|
|
200,549(11) |
|
|
|
|
|
*
|
|
|
|
|
|
200,549 |
|
|
|
|
|
*
|
|
|
Michael Howell
|
|
|
|
|
98,221(12) |
|
|
|
|
|
*
|
|
|
|
|
|
98,221 |
|
|
|
|
|
*
|
|
|
Verender Badial
|
|
|
|
|
1,003,549(13) |
|
|
|
|
|
1.6% |
|
|
|
|
|
709,186 |
|
|
|
|
|
1.0% |
|
|
Someit Sidhu
|
|
|
|
|
9,515,320(14) |
|
|
|
|
|
13.8% |
|
|
|
|
|
5,882,128 |
|
|
|
|
|
8.7% |
|
|
Amit Munshi
|
|
|
|
|
1,532,389(15) |
|
|
|
|
|
2.4% |
|
|
|
|
|
1,532,389 |
|
|
|
|
|
2.3% |
|
|
Sandeep Kulkarni
|
|
|
|
|
348,927(16) |
|
|
|
|
|
*
|
|
|
|
|
|
348,927 |
|
|
|
|
|
*
|
|
|
Arnout Ploos van Amstel
|
|
|
|
|
20,000(17) |
|
|
|
|
|
*
|
|
|
|
|
|
20,000 |
|
|
|
|
|
*
|
|
|
Steve Schoch
|
|
|
|
|
12,433(18) |
|
|
|
|
|
*
|
|
|
|
|
|
12,433 |
|
|
|
|
|
*
|
|
|
Jennifer Jarrett
|
|
|
|
|
12,433(19) |
|
|
|
|
|
*
|
|
|
|
|
|
12,433 |
|
|
|
|
|
*
|
|
|
Neil Graham
|
|
|
|
|
12,433(20) |
|
|
|
|
|
*
|
|
|
|
|
|
12,433 |
|
|
|
|
|
*
|
|
|
Parvinder Thiara
|
|
|
|
|
4,817,683(21) |
|
|
|
|
|
7.6% |
|
|
|
|
|
4,817,683 |
|
|
|
|
|
7.1% |
|
|
All current named executive officers and directors as a group (12 individuals)
|
|
|
|
|
17,592,675 |
|
|
|
|
|
25.3% |
|
|
|
|
|
13,665,120 |
|
|
|
|
|
20.1% |
|
|
(1)
The percentage of beneficial ownership upon completion of the exchange pursuant to the Offer and Consent Solicitation is calculated based on 67,589,452 Class A ordinary shares deemed outstanding, which assumes that all IPO warrants are surrendered for exchange pursuant to the Offer and Consent Solicitation.
(2)
The indicated ownership is based in part on a Schedule 13G filed with the SEC on May 2, 2024 by Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh (collectively, the “Venrock Holders”). Consists of (i) 1,312,448 Class A ordinary shares and 440,429 Class A ordinary shares underlying pre-funded warrants (“PFWs”), of which, 68,094 are currently exercisable, held by Venrock Healthcare Capital Partners III, L.P.; (ii) 131,305 Class A ordinary shares and 44,063 Class A ordinary shares underlying PFWs, of which, 6,812 are currently exercisable, held by VHCP Co-Investment Holdings III, LLC; and (iii) 4,579,413 Class A ordinary shares and 1,536,750 Class A ordinary shares underlying PFWs, of which, 237,594 are currently exercisable, held by Venrock Healthcare Capital Partners EG, L.P. Under the terms of the PFWs, the Company may not effect the exercise of any such PFWs, and a holder will not be entitled to
exercise any portion of such PFWs, if, upon giving effect to such exercise, the aggregate number of Class A ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of Class A ordinary shares outstanding immediately after giving effect to the exercise. The principal business addresses of each of the Venrock Holders is 7 Bryant Park, 23rd Floor, New York, NY 10018.
(3)
The indicated ownership is based in part on a Schedule 13G/A filed with the SEC on February 14, 2024 by AI Biotechnology LLC (“AI Biotechnology”), Access Industries Holdings LLC (“AIH”), Access Industries Management, LLC (“AIM”) and Len Blavatnik (collectively with AI Biotechnology, AIH and AIM, the “AI Reporting Persons”). Consists of (i) 4,052,725 Class A ordinary shares held directly by AI Biotechnology and (ii) 2,530,000 Class A ordinary shares issuable upon the conversion of PFWs held directly by AI Biotechnology, which are exercisable at any time or times on or after the date of issuance (the “AI PFWs”). The AI PFWs may not be exercised if the aggregate number of Class A ordinary shares beneficially owned by the holder thereof immediately following such exercise would exceed 9.99% of the outstanding Class A ordinary shares, as calculated under Rule 13d-3 of the Securities Exchange Act of 1934, as amended; provided, however, that AI Biotechnology may increase or decrease the foregoing beneficial ownership limitation by giving notice to the Company (such notice not to be effective until the sixty-first day after the notice is delivered to the Company), but not to exceed any percentage in excess of 19.99% (the “Beneficial Ownership Blocker”). 4,052,725 Class A ordinary shares and AI PFWs exercisable into 2,530,000 Class A ordinary shares, all of which may be deemed to be beneficially owned as of the date of this filing pursuant to the Beneficial Ownership Blocker, are held directly by AI Biotechnology and may be deemed to be beneficially owned by AIM, AIH and Mr. Blavatnik because (i) Mr. Blavatnik controls AIM and AIH, (ii) AIM controls AIH, and (iii) AIH owns all of the voting units of AI Biotechnology. Each of AIH, AIM and Mr. Blavatnik, and each of their affiliated entities and the officers, partners, members and managers thereof, disclaims beneficial ownership of these securities. The principal business address of each of the AI Reporting Persons is c/o Access Industries, Inc., 40 West 57th Street, 28th Floor, New York, NY 10019.
(4)
The indicated ownership is based in part on a Schedule 13G/A filed with the SEC on April 22, 2024 by Deep Track Capital, L.P., Deep Track Biotechnology Master Fund, Ltd. and David Kroin. Consists of 3,327,375 Class A ordinary shares and 2,888,952 underlying PFWs, subject to a 9.99% maximum percentage exercise limitation. . The Company shall not effect the exercise of any portion of the PFWs, and the holder shall not have the right to exercise any portion of the PFWs, pursuant to the terms and conditions of the PFWs, to the extent that after giving effect to such exercise, the holder collectively would beneficially own in excess of 9.99% of the number of Class A ordinary shares outstanding immediately after giving effect to such exercise. The principal business addresses of Deep Track Capital, L.P., Deep Track Biotechnology Master Fund, Ltd. and David Kroin are 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830, c/o Walkers Corporate Limited, 190 Elgin Ave, George Town, KY1-9001, Cayman Islands and c/o Deep Track Capital, LP, 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830, respectively.
(5)
The indicated ownership is based in part on a Schedule 13G filed with the SEC on April 5, 2023 by Hana Immunotherapeutics LLC (“Hana”) and Chris Kim (together, the “Hana Reporting Persons”). Consists of 5,404,274 Class A ordinary shares, which are held of record by Hana Immunotherapeutics LLC (“Hana”). Mr. Kim is the controlling shareholder of Hana. Mr. Kim has voting and dispositive power over, and may be deemed to be the beneficial owner of, the shares held by Hana. The business address of each of the Hana Reporting Persons is 2064 Christie St., Fullerton, CA 92833.
(6)
Includes 4,860,939 Class A ordinary shares held by Averill Master Fund, Ltd (“Averill”). Suvretta Capital Management, LLC (“Suvretta Capital”) is the investment manager of Averill. Aaron Cowen is a control person of Suvretta Capital and as such may be deemed to beneficially own these shares. The address of the principal business office of Averill, Suvretta Capital and Aaron Cowen is 540 Madison Avenue, 7th Floor, New York, NY 10022.
(7)
The indicated ownership is based in part on a Schedule 13G filed with the SEC on December 14, 2023 by Athanor Capital, LP (“Athanor Capital”), Athanor Capital GP, LLC (“Athanor Capital GP”), Athanor Master Fund, LP the “Master Fund”), Athanor Capital Partners, LP (“Master GP”), Athanor International Master Fund, LP (the “International Master Fund,” and together with the Master Fund, the “Funds”), Athanor International Fund GP, LP (“international Master GP”) and Parvinder
Thiara (collectively, the “Athanor Reporting Persons”). Consists of (i) 3,357,742 Class A ordinary shares that are held of record by Athanor Master Fund, LP, a Cayman Islands limited partnership (“Athanor MF”) and (ii) 1,443,891 Class A ordinary shares that are held of record by Athanor International Master Fund, LP, a Cayman Islands limited partnership (“Athanor IMF”). Athanor Capital Partners, LP, a Delaware limited partnership (“Master GP”), is the general partner of Athanor MF. Athanor International Fund GP, LP, a Delaware limited partnership (“International Master GP”), is the general partner of Athanor IMF. Athanor Capital, LP, a Delaware limited partnership (“Athanor Capital”) is the investment adviser to Athanor MF and Athanor IMF. Athanor Capital GP, LLC, a Delaware limited liability company (“Athanor Capital GP”), is the general partner of Athanor Capital. Parvinder Thiara is the managing member of (i) Athanor Capital GP, (ii) Athanor Capital Partners GP, LLC (“ACPGP”), the general partner of Master GP, and (iii) Athanor International Fund Ultimate GP, LLC (“AIFUGP”), the general partner of International Master GP and has voting and dispositive power over the shares held by Athanor MF and Athanor IMF. The table also excludes options held by Mr. Thiara to purchase 16,050 Class A Ordinary shares that are exercisable within 60 days of July 10, 2024. The principal business address of each Athanor Reporting Person is c/o Athanor Capital, LP, 142 W 57th St. Suite 09-126 (11th Floor for Mail), New York, NY 10019. Athanor Master Fund, LP (“AMF”) is the record owner of 3,357,742 shares (the “AMF Shares”) and Athanor Capital, LP by virtue of the beneficial ownership detailed in Item 4 may be deemed to be the beneficial owner of the AMF Shares.
(8)
Consists of (i) 2,631,123 Class A ordinary shares held by Biomedical Value Fund, L.P. (“BVF”), (ii) 1,811,283 Class A ordinary shares held by Biomedical Offshore Value Fund, Ltd. (“BOVF”) and (iii) 324,123 Class A ordinary shares held by Cheyne Select Master Fund ICAV - Cheyne Global Equity Fund (“CGEF” and together with BVF and BOVF, the “GPP Entities”). Great Point Partners LLC (“GPP LLC”) is the investment manager of BVF and BOVF, and the Sub-Advisor to CGEF, and by virtue of such status may be deemed to be the beneficial owner of the shares held by these entities. Each of Dr. Jay, as Senior Managing Member of Great Point, and Mr. Yehudai, as Managing Director of Great Point, has voting and investment power with respect to the shares held by the GPP Entities, and therefore may be deemed to be the beneficial owner of the shares held by the GPP Entities. Notwithstanding the above, Great Point, Dr. Jay and Mr. Yehudai disclaim beneficial ownership of the shares held by the GPP Entities, except to the extent of their respective pecuniary interests. The GPP Entities’ address is 165 Mason Street, 3rd Floor, Greenwich, CT 06830.
(9)
The indicated ownership is based in part on a Schedule 13G filed with the SEC on April 13, 2023 by Ewon Comfortech Co., Ltd (“Ewon”). Consists of 3,653,466 Class A ordinary shares, including 1,653,466 Class A ordinary shares underlying private placement warrants, which are held of record by Ewon. The business address of Ewon is 8 Cheomdan 1-ro Jeongeup, Jeonbuk, 56212 Republic of South Korea.
(10)
The indicated ownership is based in part on a Schedule 13G filed with the SEC on May 2, 2024 by RA Capital Management, L.P. (“RA Capital”), Peter Kolchinsky, Rajeev Shah, and RA Capital Healthcare Fund, L.P. (the “Fund” and collectively with RA Capital, Dr. Kolchinsky and Dr. Shah, the “RA Holders”)). Represents 3,217,503 Class A ordinary shares held by the Fund. RA Capital Healthcare Fund GP, LLC is the general partner of the Fund. The general partner of RA Capital is RA Capital Management GP, LLC, of which Dr. Kolchinsky and Mr. Shah are the controlling persons. RA Capital serves as investment adviser for the Fund and may be deemed a beneficial owner, for purposes of Section 13(d) of the Act, of any securities of the Issuer held by the Fund. The Fund has delegated to RA Capital the sole power to vote and the sole power to dispose of all securities held in the Fund’s portfolio, including Class A ordinary shares. Because the Fund has divested voting and investment power over the reported securities it holds and may not revoke that delegation on less than 61 days’ notice, the Fund disclaims beneficial ownership of the securities it holds for purposes of Section 13(d) of the Securities Act. As managers of RA Capital, Dr. Kolchinsky and Mr. Shah may be deemed beneficial owners, for purposes of Section 13(d) of the Securities Act, of any securities of the Issuer beneficially owned by RA Capital. RA Capital, Dr. Kolchinsky, and Mr. Shah disclaim beneficial ownership of the securities reported in this Schedule 13G other than for the purpose of determining their obligations under Section 13(d) of the Securities Act, and the filing of this Schedule 13G shall not be deemed an admission that either RA Capital, Dr. Kolchinsky, or Mr. Shah is the beneficial owner of such securities for any other purpose. The principal business addresses of each of the RA Holders is c/o RA Capital Management, L.P., 200 Berkeley Street, 18th Floor, Boston, MA 02116.
(11)
Consists of (i) 68,848 Class A ordinary shares underlying options exercisable that have vested as of July 10, 2024 and (ii) 131,701 Class A ordinary shares issuable pursuant to options exercisable and RSUs that vest within 60 days of July 10, 2024.
(12)
(Consists of (i) 7,987 Class A ordinary shares held of record by Mountaineer Biosciences, Inc. (“Mountaineer”), (ii) 18,738 Class A ordinary shares held of record by Mr. Howell, (iii) 63,552 underlying options exercisable and RSUs that have vested as of July 10, 2024 held by Mr. Howell and (iv) 7,944 Class A ordinary shares issuable pursuant to options exercisable and RSUs that vest within 60 days of July 10, 2024 held by Mr. Howell. Mr. Howell is the President and Co-Founder of Mountaineer and, as such, has the power to vote and dispose of the Class A ordinary shares held by Mountaineer.
(13)
Consists of (i) 391,964 Class A ordinary shares held of record by Mr. Badial, (ii) 420,519 Class A ordinary shares which can be issued upon the exercise of 420,519 Private Placement Warrants, (iii) 167,708 Class A ordinary shares issuable pursuant to options exercisable within 60 days of July 10, 2024.
(14)
Consists of (i) 2,137,146 Class A ordinary shares held of record by Dr. Sidhu, (ii) 568,749 Class A ordinary shares issuable pursuant to options exercisable as of July 10, 2024 held of record by Dr. Sidhu, (iii) 81,250 Class A ordinary shares issuable pursuant to options exercisable within 60 days of July 10, 2024 held of record by Dr. Sidhu, (iv) 1,750,000 Class A ordinary shares which can be issued upon the exercise of 1,750,000 public warrants held by Dr. Sidhu, (v) 656,573 Class A ordinary shares which can be issued upon exercise of 656,573 Private Placement Warrants held by Dr. Sidhu, (vi) 1,186,901 Class A ordinary shares held of record by Pegasus LLC (“Pegasus”), (vii) 351,000 Class A ordinary shares held of record by JATT Ventures, L.P. a Cayman Islands exempted limited partnership (the “Sponsor”) and (viii) 2,783,701 Class A ordinary shares which can be issued upon exercise of 2,783,701 Private Placement Warrants. Dr. Sidhu is the sole director of JATT Ventures, Ltd., which is the sole general partner of the Sponsor, and has voting and dispositive power over the Class A ordinary shares held by the Sponsor.
(15)
Consists of (i) 402,389 Class A ordinary shares held of record by Mr. Munshi and (ii) 1,130,000 Class A ordinary shares issuable pursuant to options exercisable within 60 days of as of July 10, 2024.
(16)
Consists of (i) 327,860 Class A ordinary shares underlying options exercisable as of July 10, 2024 and (ii) 21,067 Class A ordinary shares underlying options exercisable within 60 days of July 10, 2024.
(17)
Consists of 20,000 Class A ordinary shares.
(18)
Consists of (i) 11,902 Class A ordinary shares underlying options exercisable as of July 10, 2024 and (ii) 531 Class A ordinary shares underlying options exercisable within 60 days of July 10, 2024.
(19)
Consists of (i) 11,902 Class A ordinary shares underlying options exercisable as of July 10, 2024 and (ii) 531 Class A ordinary shares underlying options exercisable within 60 days of July 10, 2024.
(20)
Consists of (i) 11,902 Class A ordinary shares underlying options exercisable as of July 10, 2024 and (ii) 531 Class A ordinary shares underlying options exercisable within 60 days of July 10, 2024.
(21)
Consists of (i) 4,801,633 Class A ordinary shares held of record by entities affiliated with Athanor Capital and (ii) 16,050 Class A ordinary shares underlying options exercisable as of July 10, 2024 held of record by Mr. Thiara. Mr. Thiara is the managing member of (i) Athanor Capital GP, (ii) ACPGP, the general partner of Master GP, and (iii) AIFUGP, the general partner of International Master GP and has voting and dispositive power over the shares held by Athanor MF and Athanor IMF.
LEGAL MATTERS
The validity of the Class A ordinary shares offered in this Prospectus/Offer to Exchange is being passed upon for us by Ogier (Cayman) LLP, Cayman Islands. Loeb & Loeb LLP, New York, New York has provided an opinion regarding certain federal income tax matters relating to the Offer and the Class A ordinary shares covered by this Prospectus/Offer to Exchange. Certain legal matters relating to the securities offered hereby will be passed upon for the dealer manager by DLA Piper LLP (US).
EXPERTS
The consolidated financial statements of Zura Bio Limited and subsidiaries as of December 31, 2023 and for the year then ended and as of December 31, 2022 and for the period January 18, 2022 (date of inception) through December 31, 2022, have been incorporated by reference herein in reliance upon the report of WithumSmith+Brown, PC, independent registered public accounting firm, incorporated by reference herein, and upon the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
Available Information
We file reports, proxy statements, and other information with the SEC. The SEC maintains a website that contains reports, proxy, and information statements, and other information about issuers, such as us, who file electronically with the SEC. The address of that website is http://www.sec.gov.
Our website address is www.zurabio.com. Information contained on our website is not a part of this Prospectus/Offer to Exchange, and the inclusion of our website address in this Prospectus/Offer to Exchange is an inactive textual reference only.
This Prospectus/Offer to Exchange and any prospectus supplement are part of a registration statement that we filed with the SEC and do not contain all of the information in the registration statement or the exhibits. The full registration statement may be obtained from the SEC or us, as provided below. The documents establishing the terms of any offered securities are or may be filed as exhibits to the registration statement or documents incorporated by reference in the registration statement. Statements in this Prospectus/Offer to Exchange or any prospectus supplement about these documents are summaries and each statement is qualified in all respects by reference to the document to which it refers. You should refer to the actual documents for a more complete description of the relevant matters. You may inspect a copy of the registration statement through the SEC’s website, as provided above.
Incorporation of Certain Information By Reference
The SEC’s rules allow us to “incorporate by reference” information into this Prospectus/Offer to Exchange, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this Prospectus/Offer to Exchange, and subsequent information that we file with the SEC will automatically update and supersede that information. Any statement contained in this Prospectus/Offer to Exchange or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this Prospectus/Offer to Exchange to the extent that a statement contained in this Prospectus/Offer to Exchange or a subsequently filed document incorporated by reference modifies or replaces that statement.
This Prospectus/Offer to Exchange and any accompanying prospectus supplement incorporate by reference the documents set forth below that have previously been filed with the SEC (other than those documents or the portions of those documents that are “furnished” unless otherwise specified below):
•
•
our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024, filed with the SEC on May 9, 2024 (as amended on May 15, 2024);
•
•
All reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14, or 15(d) of the Exchange Act in this Prospectus/Offer to Exchange, prior to the termination of this offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated by reference into this Prospectus/Offer to Exchange and deemed to be part of this Prospectus/Offer to Exchange from the date of the filing of such reports and documents.
You may request a free copy of any of the documents incorporated by reference in this Prospectus/Offer to Exchange by writing or telephoning us at the following address:
Zura Bio Limited
1489 W. Warm Springs Rd. #110
Henderson, NV 89014
Tel: (702) 825-9872
Exhibits to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this Prospectus/Offer to Exchange or any accompanying prospectus supplement.
Annex A
FORM OF WARRANT AMENDMENT
AMENDMENT NO. 1 TO WARRANT AGREEMENT
This amendment (this “Amendment”) is made as of [ ], 2024, by and between Zura Bio Limited, a Cayman Islands exempted company (the “Company”), and Continental Stock Transfer & Trust Company, a New York corporation, as warrant agent (the “Warrant Agent”), and constitutes an amendment to that certain Warrant Agreement, dated as of July 16, 2021 by and between the Company (as successor to JATT Acquisition Corp, our predecessor and a Cayman Islands exempted company (“JATT”)) and Continental Stock Transfer & Trust Company (“CST”), as warrant agent (the “Existing Warrant Agreement”). Capitalized terms used but not otherwise defined in this Amendment shall have the meanings given to such terms in the Existing Warrant Agreement.
WHEREAS, on March 20, 2023, the Company and JATT completed a business combination (the “Business Combination”);
WHEREAS, in accordance with Section 4.5 of the Existing Warrant Agreement, upon effectiveness of the Business Combination, the holders of the Warrants thereafter had the right to purchase and receive, upon the basis and upon the terms and conditions specified in the Warrants and in lieu of Ordinary Shares of JATT immediately theretofore purchasable and receivable upon the exercise of the rights represented thereby, an Alternative Issuance (as defined in the Existing Warrant Agreement) of Class A ordinary shares, par value $0.0001 per share, of the Company (the “Class A ordinary shares”);
WHEREAS, Section 9.8 of the Existing Warrant Agreement provides that the Company and the Warrant Agent may amend, subject to certain conditions provided therein, the Existing Warrant Agreement with the vote or written consent of the Registered Holders of at least a majority of the Public Warrants and, solely with respect to any amendment to the terms of the Private Placement Warrants or any provision of the Existing Warrant Agreement with respect to the Private Placement Warrants, a majority of the number of the then outstanding Private Placement Warrants (the Public Warrants together with the Private Placement Warrants, the “Warrants”);
WHEREAS, the Company desires to amend the Existing Warrant Agreement to provide the Company with the right to require the holders of the Warrants to exchange all of the outstanding Warrants for Class A ordinary shares, on the terms and subject to the conditions set forth herein; and
WHEREAS, in the exchange offer and consent solicitation undertaken by the Company pursuant to the Registration Statement on Form S-4 filed with the U.S. Securities and Exchange Commission, the Registered Holders of more than a majority of the then-outstanding Public Warrants and a majority of the then-outstanding Private Placement Warrants consented to and approved this Amendment.
NOW, THEREFORE, in consideration of the mutual agreements contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the parties hereto agree to amend the Existing Warrant Agreement as set forth herein.
1. Amendment of Existing Warrant Agreement. The Existing Warrant Agreement is hereby amended by adding:
(a) the new Section 6A thereto:
“6A Mandatory Exchange.
6A.1 The Business Combination. On March 20, 2023, the Company and JATT completed the Business Combination. In accordance with Section 4.5 of this Agreement, upon effectiveness of the Business Combination, the holders of the Warrants thereafter had the right to purchase and receive, upon the basis and upon the terms and conditions specified in the Warrants and in lieu of Ordinary Shares of the Company immediately theretofore purchasable and receivable upon the
exercise of the rights represented thereby, an Alternative Issuance of Class A ordinary shares, par value $0.0001 per share, of Zura Bio Limited (the “Class A ordinary shares”).
6A.2 Company Election to Exchange. Notwithstanding any other provision in this Agreement to the contrary, all (and not less than all) of the outstanding Warrants may be exchanged, at the option of the Company, at any time while they are exercisable and prior to their expiration, at the office of the Warrant Agent, upon notice to the Registered Holders of the then-outstanding Warrants, as described in Section 6A.3 below, for Class A ordinary shares (or any Alternative Issuance pursuant to Section 4.5), at the exchange rate of 0.30 Class A ordinary shares (or any Alternative Issuance pursuant to Section 4.5) for each Warrant held by the holder thereof (the “Consideration”) (subject to equitable adjustment by the Company in the event of any stock splits, stock dividends, recapitalizations, or similar transaction with respect to the Class A ordinary shares). In lieu of issuing fractional shares, any holder of Warrants who would otherwise have been entitled to receive fractional shares as Consideration will, after aggregating all such fractional shares of such holder, be paid in cash (without interest) in an amount equal to such fractional part of a share multiplied by [ ]1.
6A.3 Date Fixed for, and Notice of, Exchange. In the event that the Company elects to exchange all of the Warrants, the Company shall fix a date for the exchange (the “Exchange Date”). Notice of exchange shall be mailed by first class mail, postage prepaid, by the Company not less than 15 days prior to the Exchange Date to the Registered Holders at their last addresses as they shall appear on the registration books. Any notice mailed in the manner herein provided shall be conclusively presumed to have been duly given whether or not the Registered Holder received such notice. The Company will make a public announcement of its election following the mailing of such notice.
6A.4 Exercise After Notice of Exchange. The Warrants may be exercised, for cash (or on a “cashless basis” in accordance with subsections 3.3.1(b) or (c) of this Agreement) at any time after notice of exchange shall have been given by the Company pursuant to Section 6A.3 hereof and prior to the Exchange Date. On and after the Exchange Date, the Registered Holder of the Warrants shall have no further rights except to receive, upon surrender of the Warrants, the Consideration.
2. Miscellaneous Provisions.
2.1 Severability. This Amendment shall be deemed severable, and the invalidity or unenforceability of any term or provision hereof shall not affect the validity or enforceability of this Amendment or of any other term or provision hereof. Furthermore, in lieu of any such invalid or unenforceable term or provision, the parties hereto intend that there shall be added as a part of this Amendment a provision as similar in terms to such invalid or unenforceable provision as may be possible and be valid and enforceable.
2.2 Applicable Law. The validity, interpretation, and performance of this Amendment and of the Warrants shall be governed in all respects by the laws of the State of New York, without giving effect to conflicts of law principles that would result in the application of the substantive laws of another jurisdiction. The Company hereby agrees that any action, proceeding, or claim against it arising out of or relating in any way to this Amendment shall be brought and enforced in the courts of the State of New York or the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum.
2.3 Counterparts. This Amendment may be executed in any number of counterparts (which may include counterparts delivered by any standard form of telecommunication) and each of such counterparts shall for all purposes be deemed to be an original, and all such counterparts shall together
1
This will be the last sale price of the Class A ordinary shares on The Nasdaq Capital Market on the last trading day of the Offer Period (as defined in the Registration Statement on Form S-4 filed with the U.S. Securities and Exchange Commission on , 2024).
constitute but one and the same instrument. The words “execution,” “signed,” “signature,” and words of like import in this Amendment or in any other certificate, agreement, or document related to this Amendment, if any, shall include images of manually executed signatures transmitted by facsimile or other electronic format (including, without limitation, “pdf,” “tif,” or “jpg”) and other electronic signatures (including, without limitation, DocuSign and AdobeSign). The use of electronic signatures and electronic records (including, without limitation, any contract or other record created, generated, sent, communicated, received, or stored by electronic means) shall be of the same legal effect, validity, and enforceability as a manually executed signature or use of a paper-based record-keeping system to the fullest extent permitted by applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, and any other applicable law, including, without limitation, any state law based on the Uniform Electronic Transactions Act or the Uniform Commercial Code.
2.4 Effect of Headings. The section headings herein are for convenience only and are not part of this Amendment and shall not affect the interpretation thereof.
2.5 Entire Agreement. The Existing Warrant Agreement, as modified by this Amendment, constitutes the entire understanding of the parties and supersedes all prior agreements, understandings, arrangements, promises, and commitments, whether written or oral, express, or implied, relating to the subject matter hereof, and all such prior agreements, understandings, arrangements, promises, and commitments are hereby canceled and terminated.
[Signature Pages Follow]
IN WITNESS WHEREOF, each of the parties has caused this Amendment to be duly executed as of the date first above written.
ZURA BIO LIMITED
Name:
Title:
CONTINENTAL STOCK TRANSFER & TRUST COMPANY, as Warrant Agent
Name:
Title:
ZURA BIO LIMITED
Offer to Exchange Warrants to Acquire Class A Ordinary Shares
of
Zura Bio Limited
for
Class A Ordinary Shares
of
Zura Bio Limited
and
Consent Solicitation
PROSPECTUS
The Exchange Agent for the Offer and the Consent Solicitation is:
Continental Stock Transfer & Trust Company
Attn: Voluntary Corporate Actions
1 State Street, 30th Floor
New York, New York 10004
Any questions or requests for assistance may be directed to the dealer manager at the address and telephone number set forth below. Requests for additional copies of this Prospectus/Offer to Exchange and the Letter of Transmittal and Consent may be directed to the information agent. Beneficial owners may also contact their custodian for assistance concerning the Offer and Consent Solicitation.
The Information Agent for the Offer and Consent Solicitation is:
Alliance Advisors, LLC
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
The Dealer Manager for the Offer and the Consent Solicitation is:
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
Call Toll Free: 212-915-1800
tm2418824-1_s4_DIV_13-exh99x1 - none - 2.2031465s
Exhibit (a)(1)(B)
LETTER OF TRANSMITTAL AND CONSENT
Offer to Exchange Warrants to Acquire Class A Ordinary Shares
of
Zura Bio Limited
for
Class A Ordinary Shares
of
Zura Bio Limited
and
Consent Solicitation
THE OFFER AND CONSENT SOLICITATION (AS DEFINED BELOW) AND WITHDRAWAL RIGHTS WILL EXPIRE AT 11:59 P.M., EASTERN TIME, ON AUGUST 8, 2024, OR SUCH LATER TIME AND DATE TO WHICH WE MAY EXTEND THE OFFER. IPO WARRANTS (AS DEFINED BELOW) TENDERED PURSUANT TO THE OFFER AND CONSENT SOLICITATION (EACH AS DEFINED BELOW) MAY BE WITHDRAWN PRIOR TO THE EXPIRATION DATE (AS DEFINED BELOW). CONSENTS MAY BE REVOKED ONLY BY WITHDRAWING THE TENDER OF THE RELATED IPO WARRANTS, AND THE WITHDRAWAL OF ANY IPO WARRANTS WILL AUTOMATICALLY CONSTITUTE A REVOCATION OF THE RELATED CONSENTS.
The Exchange Agent for the Offer and Consent Solicitation is:
CONTINENTAL STOCK TRANSFER & TRUST COMPANY
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By First Class Mail:
One State Street, 30th Floor
New York, NY 10004
Attn: Corporate Actions Department
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By Overnight or Hand Delivery:
One State Street, 30th Floor
New York, NY 10004
Attn: Corporate Actions Department
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THE METHOD OF DELIVERY OF THIS LETTER OF TRANSMITTAL AND CONSENT (AS IT MAY BE AMENDED AND SUPPLEMENTED FROM TIME TO TIME, THIS “LETTER OF TRANSMITTAL AND CONSENT”), THE IPO WARRANTS AND ALL OTHER REQUIRED DOCUMENTS, INCLUDING DELIVERY THROUGH BOOK-ENTRY TRANSFER, IS AT THE OPTION AND RISK OF THE TENDERING IPO WARRANT HOLDER AND, EXCEPT AS OTHERWISE PROVIDED IN THE INSTRUCTIONS BELOW, THE DELIVERY WILL BE DEEMED MADE ONLY WHEN ACTUALLY RECEIVED BY THE EXCHANGE AGENT. IF DELIVERY IS BY MAIL, REGISTERED MAIL WITH RETURN RECEIPT REQUESTED — PROPERLY INSURED — IS RECOMMENDED. THE IPO WARRANT HOLDER HAS THE RESPONSIBILITY TO CAUSE THIS LETTER OF TRANSMITTAL AND CONSENT, THE TENDERED IPO WARRANTS, AND ANY OTHER DOCUMENTS TO BE TIMELY DELIVERED. IN ALL CASES, SUFFICIENT TIME SHOULD BE ALLOWED TO ENSURE TIMELY DELIVERY. PLEASE READ THIS ENTIRE LETTER OF TRANSMITTAL AND CONSENT, INCLUDING THE INSTRUCTIONS, CAREFULLY BEFORE COMPLETING THIS LETTER OF TRANSMITTAL AND CONSENT.
Zura Bio Limited, a Cayman Islands exempted company (the “Company,” “we,” “our,” and “us”), has delivered to the undersigned a copy of the prospectus/offer to exchange, dated July 11, 2024 (as it may be amended and supplemented from time to time, the “Prospectus/Offer to Exchange”) of the Company and this Letter of Transmittal and Consent, which together set forth the offer of the Company to each holder of the Company’s warrants that were issued in connection with its initial public offering to purchase the Company’s Class A ordinary shares, par value $0.0001 per share (the “Class A ordinary shares”), to receive 0.3 Class A ordinary shares in exchange for each warrant tendered by the holder and exchanged pursuant to the offer (the “Offer”).
The Offer is being made to all holders of:
•
the warrants that were (i) sold as part of the units in connection with the initial public offering of JATT Acquisition Corp (“JATT”) (the “IPO”) (whether they were purchased in the IPO or thereafter in the open market) or (ii) initially issued as private placement warrants to certain parties in connection with the IPO that have been transferred to any person other than permitted transferees (collectively, the “public warrants”) and
•
the warrants that were issued to certain parties in a private placement in connection with the closing of the IPO that have not become public warrants as a result of being transferred to any person other than permitted transferees or issued in connection with the closing of the Company’s business combination with JATT (the “private placement warrants” and, together with the public warrants, the “IPO warrants”). For the avoidance of doubt, the IPO warrants do not include the pre-funded warrants issued by the Company in 2023 and 2024.
Each IPO warrant entitles the holder to purchase one Class A Ordinary Share at a price of $11.50 per share, subject to adjustment. The public warrants are quoted on The Nasdaq Capital Market (the “Nasdaq”) under the symbol “ZURAW.” As of July 10, 2024 a total of 12,809,996 IPO warrants were outstanding, including our public warrants and private placement warrants. Pursuant to the Offer, the Company is offering up to an aggregate of 3,842,999 Class A ordinary shares in exchange for the IPO warrants.
Concurrently with the Offer, the Company is also soliciting consents (the “Consent Solicitation”) from holders of the IPO warrants to amend (the “Warrant Amendment”) that certain Warrant Agreement, dated as of July 16, 2021, by and between the Company (as successor to JATT), and Continental Stock Transfer & Trust Company (“CST”), as warrant agent (the “Warrant Agreement”), to permit the Company to require that each IPO warrant that is outstanding upon the closing of the Offer be exchanged for 0.27 Class A ordinary shares, which is a ratio 10% less than the exchange ratio applicable to the Offer.
Pursuant to the terms of the Warrant Agreement, the proposed Warrant Amendment requires the vote or written consent of holders of at least a majority of the outstanding public warrants and a majority of the outstanding private placement warrants.
Parties representing approximately 40.7% of the outstanding public warrants and 65.3% of the outstanding private placement warrants have agreed to tender their public warrants and private placement warrants (as applicable) in the Offer and consent to the Warrant Amendment in the Consent Solicitation pursuant to a tender and support agreement. Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants agree to consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described on the Offer and Consent Solicitation are satisfied or waived, then the Warrant Amendment will be adopted.
Holders of IPO warrants may not consent to the Warrant Amendment without tendering IPO warrants in the Offer and holders may not tender such IPO warrants without consenting to the Warrant Amendment. The consent to the Warrant Amendment is a part of this Letter of Transmittal and Consent relating to the IPO warrants and, therefore, by tendering IPO warrants for exchange, holders will be delivering to us their consent to the Warrant Amendment. Warrant holders may revoke consent at any time prior to the Expiration Date by withdrawing the IPO warrants holders have tendered in the Offer.
IPO warrants not exchanged for our Class A ordinary shares pursuant to the Offer will remain outstanding subject to their current terms, or amended terms if the Warrant Amendment is approved. If the Warrant Amendment is approved, the Company intends to require the exchange of all outstanding IPO warrants to Class A ordinary shares as provided in the Warrant Amendment.
The Offer and Consent Solicitation is made solely upon the terms and conditions in the Prospectus/Offer to Exchange and this Letter of Transmittal and Consent. The Offer and Consent Solicitation will be open until 11:59 p.m., Eastern Time, on August 8, 2024 or such later time and date to which the Company may extend (the period during which the Offer and Consent Solicitation is open, giving effect to any withdrawal or extension, is referred to as the “Offer Period,” and the date and time at which the Offer Period ends is referred to as the “Expiration Date”).
Each holder whose IPO warrants are exchanged pursuant to the Offer and Consent Solicitation will receive 0.30 Class A ordinary shares for each IPO warrant tendered by such holder and exchanged. Any IPO warrant holder that participates in the Offer and Consent Solicitation may tender less than all of its IPO warrants for exchange.
No fractional Class A ordinary shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid in cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of our Class A ordinary shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes. Our obligation to complete the Offer is not conditioned on the receipt of a minimum number of tendered IPO warrants.
The Company may withdraw the Offer and Consent Solicitation only if the conditions to the Offer and Consent Solicitation are not satisfied or waived prior to the Expiration Date or if the Company has determined, in its sole discretion, to terminate the Offer and Consent Solicitation. Promptly upon any such withdrawal, the Company will return the tendered IPO warrants to the holders (and the related consent to the Warrant Amendment will be revoked).
This Letter of Transmittal and Consent is to be used to accept the Offer and Consent Solicitation if the applicable IPO warrants are to be tendered by effecting a book-entry transfer into the Exchange Agent’s account at the Depository Trust Company (“DTC”) and instructions are not being transmitted through DTC’s Automated Tender Offer Program (“ATOP”). Except in instances where a holder intends to tender IPO warrants through ATOP, the holder should complete, execute and deliver this Letter of Transmittal and Consent to indicate the action it desires to take with respect to the Offer and Consent Solicitation.
Holders of IPO warrants tendering IPO warrants by book-entry transfer to the Exchange Agent’s account at DTC may execute the tender through ATOP, and in that case need not complete, execute, and deliver this Letter of Transmittal and Consent. DTC participants accepting the Offer and Consent Solicitation may transmit their acceptance to DTC, which will verify the acceptance and execute a book-entry delivery to the Exchange Agent’s account at DTC. DTC will then send an “Agent’s Message” to the Exchange Agent for its acceptance. Delivery of the Agent’s Message by DTC will satisfy the terms of the Offer and Consent Solicitation as to execution and delivery of a Letter of Transmittal and Consent by the DTC participant identified in the Agent’s Message.
As used in this Letter of Transmittal and Consent with respect to the tender procedures set forth herein, the term “registered holder” means any person in whose name IPO warrants are registered on the books of the Company or who is listed as a participant in a clearing agency’s security position listing with respect to the IPO warrants.
THE OFFER AND CONSENT SOLICITATION IS NOT MADE TO THOSE HOLDERS WHO RESIDE IN STATES OR OTHER JURISDICTIONS WHERE AN OFFER, SOLICITATION, OR SALE WOULD BE UNLAWFUL.
PLEASE SEE THE INSTRUCTIONS TO THIS LETTER OF TRANSMITTAL AND CONSENT BEGINNING ON PAGE 10 FOR THE PROPER USE AND DELIVERY OF THIS LETTER OF TRANSMITTAL AND CONSENT.
DESCRIPTION OF IPO WARRANTS TENDERED
List below the IPO warrants to which this Letter of Transmittal and Consent relates. If the space below is inadequate, list the registered IPO warrant certificate numbers on a separate signed schedule and affix the list to this Letter of Transmittal and Consent.
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Name(s) and Address(es) of Registered Holder(s) of IPO Warrants
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Number of IPO Warrants Tendered
Total:
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☐ CHECK HERE IF THE IPO WARRANTS LISTED ABOVE ARE BEING DELIVERED BY BOOK-ENTRY TRANSFER MADE TO THE ACCOUNT MAINTAINED BY THE EXCHANGE AGENT WITH DTC AND COMPLETE THE FOLLOWING (FOR USE BY ELIGIBLE INSTITUTIONS ONLY):
Name of Tendering Institution:
Account Number:
Transaction Code Number:
By crediting the IPO warrants to the Exchange Agent’s account at DTC using ATOP and by complying with applicable ATOP procedures with respect to the Offer and Consent Solicitation, including, if applicable, transmitting to the Exchange Agent an Agent’s Message in which the holder of the IPO warrants acknowledges and agrees to be bound by the terms of, and makes the representations and warranties contained in, this Letter of Transmittal and Consent, the participant in DTC confirms on behalf of itself and the beneficial owner(s) of such IPO warrants all provisions of this Letter of Transmittal and Consent (including consent to the Warrant Amendment, if applicable, and all representations and warranties) applicable to it and such beneficial owner(s) as fully as if it had completed the required information and executed and transmitted this Letter of Transmittal and Consent to the Exchange Agent.
NOTE: SIGNATURES MUST BE PROVIDED BELOW.
PLEASE READ THE ACCOMPANYING INSTRUCTIONS CAREFULLY.
Zura Bio Limited
c/o Continental Stock Transfer & Trust Company, as Exchange Agent
1 State Street, 30th Floor
New York, New York 10004
Attn: Corporate Actions Department
Upon and subject to the terms and conditions set forth in the Prospectus/Offer to Exchange and in this Letter of Transmittal and Consent, receipt of which is hereby acknowledged, the undersigned hereby:
(i) tenders to the Company for exchange pursuant to the Offer and Consent Solicitation the number of IPO warrants indicated above under “Description of IPO warrants Tendered — Number of IPO warrants Tendered”;
(ii) subscribes for the Class A ordinary shares issuable upon the exchange of such tendered IPO warrants pursuant to the Offer and Consent Solicitation, being 0.30 Class A ordinary shares for each IPO warrant so tendered for exchange; and
(iii) consents to the Warrant Amendment.
Except as stated in the Prospectus/Offer to Exchange, the tender made hereby is irrevocable. The undersigned understands that this tender will remain in full force and effect unless and until such tender is withdrawn and revoked in accordance with the procedures set forth in the Prospectus/Offer to Exchange and this Letter of Transmittal and Consent. The undersigned understands that this tender may not be withdrawn after the Expiration Date, and that a notice of withdrawal will be effective only if delivered to the Exchange Agent in accordance with the specific withdrawal procedures set forth in the Prospectus/Offer to Exchange.
If the undersigned holds IPO warrants for beneficial owners, the undersigned represents that it has received from each beneficial owner thereof a duly completed and executed form of “Instructions Form” in the form attached to the “Letter to Clients of Brokers, Dealers, Commercial Banks, Trust Companies, and Other Nominees” which was sent to the undersigned by the Company with this Letter of Transmittal and Consent, instructing the undersigned to take the action described in this Letter of Transmittal and Consent.
If the undersigned is not the registered holder of the IPO warrants indicated under “Description of IPO Warrants Tendered” above or such holder’s legal representative or attorney-in-fact (or, in the case of IPO warrants held through DTC, the DTC participant for whose account such IPO warrants are held), then the undersigned has obtained a properly completed irrevocable proxy that authorizes the undersigned (or the undersigned’s legal representative or attorney-in fact) to deliver a consent in respect of such IPO warrants on behalf of the holder thereof, and such proxy is being delivered to the Exchange Agent with this Letter of Transmittal and Consent.
The undersigned understands that, upon and subject to the terms and conditions set forth in the Prospectus/Offer to Exchange and this Letter of Transmittal and Consent, any IPO warrants properly tendered and not withdrawn that are accepted for exchange will be exchanged for Class A ordinary shares. The undersigned understands that, under certain circumstances, the Company may not be required to accept any of the IPO warrants tendered (including any IPO warrants tendered after the Expiration Date). If any IPO warrants are not accepted for exchange for any reason, or if tendered IPO warrants are withdrawn, such unexchanged or withdrawn IPO warrants will be returned without expense to the tendering holder, if applicable, and the related consent to the Warrant Amendment will be revoked.
The undersigned understands that, upon and subject to the terms and conditions set forth in the Prospectus/Offer to Exchange and this Letter of Transmittal and Consent, any IPO warrants properly tendered and not validly withdrawn that are accepted for exchange constitute the holder’s validly delivered consent to the Warrant Amendment. A holder of IPO warrants may not consent to the Warrant Amendment without tendering his or her IPO warrants in the Offer, and a holder of IPO warrants may not tender his or her IPO warrants without consenting to the Warrant Amendment. A holder may revoke his or her consent to the Warrant Amendment at any time prior to the Expiration Date by withdrawing the IPO warrants he
or she has tendered. Subject to, and effective upon, the Company’s acceptance of the undersigned’s tender of IPO warrants for exchange pursuant to the Offer and Consent Solicitation as indicated under “Description of IPO Warrants Tendered — Number of IPO Warrants Tendered” above, the undersigned hereby:
(i) assigns and transfers to, or upon the order of, the Company, all right, title, and interest in and to, and any and all claims in respect of or arising or having arisen as a result of the undersigned’s status as a holder of, such IPO warrants;
(ii) waives any and all rights with respect to such IPO warrants;
(iii) releases and discharges the Company from any and all claims the undersigned may have now, or may have in the future, arising out of or related to such IPO warrants;
(iv) acknowledges that the Offer may be extended, modified, suspended, or terminated by the Company as provided in the Prospectus/Offer to Exchange; and
(v) acknowledges the future value of the IPO warrants is unknown and cannot be predicted with certainty.
The undersigned understands that tenders of IPO warrants pursuant to any of the procedures described in the Prospectus/Offer to Exchange and in the instructions in this Letter of Transmittal and Consent, if and when accepted by the Company, will constitute a binding agreement between the undersigned and the Company upon the terms and subject to the conditions of the Offer and Consent Solicitation.
Effective upon acceptance for exchange, the undersigned hereby irrevocably constitutes and appoints the Exchange Agent, acting as agent for the Company, as the true and lawful agent and attorney-in-fact of the undersigned with respect to the IPO warrants tendered hereby, with full power of substitution (such power of attorney being deemed to be an irrevocable power coupled with an interest) to:
(i) transfer ownership of such IPO warrants on the account books maintained by DTC together with all accompanying evidences of transfer and authenticity to or upon the order of the Company;
(ii) present such IPO warrants for transfer of ownership on the books of the Company;
(iii) cause ownership of such IPO warrants to be transferred to, or upon the order of, the Company on the books of the Company or its agent and deliver all accompanying evidences of transfer and authenticity to, or upon the order of, the Company; and
(iv) receive all benefits and otherwise exercise all rights of beneficial ownership of such IPO warrants;
all in accordance with the terms of the Offer and Consent Solicitation, as described in the Prospectus/Offer to Exchange and this Letter of Transmittal and Consent.
The undersigned hereby represents, warrants, and agrees that:
(i) the undersigned has full power and authority to tender the IPO warrants tendered hereby and to sell, exchange, assign, and transfer all right, title, and interest in and to such IPO warrants;
(ii) the undersigned has full power and authority to subscribe for all of the Class A ordinary shares issuable pursuant to the Offer and Consent Solicitation in exchange for the IPO warrants tendered hereby;
(iii) the undersigned has good, marketable, and unencumbered title to the IPO warrants tendered hereby, and upon acceptance of such IPO warrants by the Company for exchange pursuant to the Offer and Consent Solicitation, the Company will acquire good, marketable, and unencumbered title to such IPO warrants, in each case, free and clear of any security interests, liens, restrictions, charges, encumbrances, conditional sales agreements, or other obligations of any kind, and not subject to any adverse claim;
(iv) the undersigned has full power and authority to consent to the Warrant Amendment;
(v) the undersigned will, upon request, execute and deliver any additional documents deemed by the Company or the Exchange Agent to be necessary or desirable to complete and give effect to the transactions contemplated hereby;
(vi) the undersigned has received and reviewed the Prospectus/Offer to Exchange, this Letter of Transmittal and Consent, and the Warrant Amendment;
(vii) the undersigned acknowledges that none of the Company, the information agent, the Exchange Agent, the dealer manager, or any person acting on behalf of any of the foregoing has made any statement, representation, or warranty, express or implied, to the undersigned with respect to the Company, the Offer and Consent Solicitation, the IPO warrants, or the Class A ordinary shares, other than the information included in the Prospectus/Offer to Exchange (as amended or supplemented prior to the Expiration Date);
(viii) the terms and conditions of the Prospectus/Offer to Exchange shall be deemed to be incorporated in, and form a part of, this Letter of Transmittal and Consent, which shall be read and construed accordingly;
(ix) the undersigned understands that tenders of IPO warrants pursuant to the Offer and Consent Solicitation and in the instructions hereto constitute the undersigned’s acceptance of the terms and conditions of the Offer and Consent Solicitation;
(x) the undersigned is voluntarily participating in the Offer; and
(xi) the undersigned agrees to all of the terms of the Offer and Consent Solicitation.
Unless otherwise indicated under “Special Issuance Instructions” below, the Company will issue, in the name(s) of the undersigned as indicated under “Description of IPO warrants Tendered” above, the Class A ordinary shares to which the undersigned is entitled pursuant to the terms of the Offer and Consent Solicitation in respect of the IPO warrants tendered and exchanged pursuant to this Letter of Transmittal and Consent. If the “Special Issuance Instructions” below are completed, the Company will issue such Class A ordinary shares in the name of (and pay cash in lieu of any fractional shares to) the person or account indicated under “Special Issuance Instructions.”
The undersigned agrees that the Company has no obligation under the “Special Issuance Instructions” provision of this Letter of Transmittal and Consent to effect the transfer of any IPO warrants from the holder(s) thereof if the Company does not accept for exchange any of the IPO warrants tendered pursuant to this Letter of Transmittal and Consent.
The acknowledgments, representations, warranties, and agreements of the undersigned in this Letter of Transmittal and Consent will be deemed to be automatically repeated and reconfirmed on and as of each of the Expiration Date and completion of the Offer and Consent Solicitation. The authority conferred or agreed to be conferred in this Letter of Transmittal and Consent shall not be affected by, and shall survive, the death or incapacity of the undersigned, and every obligation of the undersigned under this Letter of Transmittal and Consent shall be binding upon the heirs, executors, administrators, trustees in bankruptcy, personal and legal representatives, successors, and assigns of the undersigned.
The undersigned acknowledges that the undersigned has been advised to consult with its own legal counsel and other advisors (including tax advisors) as to the consequences of participating or not participating in the Offer and Consent Solicitation.
SPECIAL ISSUANCE INSTRUCTIONS (SEE INSTRUCTIONS, INCLUDING INSTRUCTIONS 3, 4, AND 5)
To be completed ONLY if the Class A ordinary shares issued pursuant to the Offer and Consent Solicitation in exchange for IPO warrants tendered hereby and any IPO warrants delivered to the Exchange Agent herewith but not tendered and exchanged pursuant to the Offer and Consent Solicitation are to be issued in the name of someone other than the undersigned. Issue all such Class A ordinary shares and untendered IPO warrants to:
Name:
Address:
(PLEASE PRINT OR TYPE)
(INCLUDE ZIP CODE)
(TAX IDENTIFICATION OR SOCIAL SECURITY NUMBER)
IMPORTANT: PLEASE SIGN HERE
(SEE INSTRUCTIONS AND ALSO COMPLETE ACCOMPANYING IRS FORM W-9 OR
APPROPRIATE IRS FORM W-8)
By completing, executing, and delivering this Letter of Transmittal and Consent, the undersigned hereby tenders the IPO warrants indicated in the table above entitled “Description of IPO Warrants Tendered.”
SIGNATURES REQUIRED
Signature(s) of Registered Holder(s) of IPO Warrants
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Name:
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Address:
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Date:
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(The above lines must be signed by the registered holder(s) of IPO warrants as the name(s) appear(s) on the IPO warrants or on a security position listing, or by person(s) authorized to become registered holder(s) by a properly completed assignment from the registered holder(s), a copy of which must be transmitted with this Letter of Transmittal and Consent. If IPO warrants to which this Letter of Transmittal and Consent relates are held of record by two or more joint holders, then all such holders must sign this Letter of Transmittal and Consent. If signature is by a trustee, executor, administrator, guardian, attorney-in-fact, officer of a corporation, or other person acting in a fiduciary or representative capacity, then such person must set forth his or her full title below and, unless waived by the Company, submit evidence satisfactory to the Company of such person’s authority so to act. See Instruction 3 regarding the completion and execution of this Letter of Transmittal and Consent.)
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Name:
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Capacity:
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Address:
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Area Code and Telephone Number:
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(PLEASE PRINT OR TYPE)
(INCLUDE ZIP CODE)
GUARANTEE OF SIGNATURE(S) (IF REQUIRED) (SEE INSTRUCTIONS, INCLUDING INSTRUCTION 4)
Certain signatures must be guaranteed by Eligible Institution.
Signature(s) guaranteed by an Eligible Institution:
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Authorized Signature
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Title
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Name of Firm
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Address, Including Zip Code
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Area Code and Telephone Number
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Date:
INSTRUCTIONS
FORMING PART OF THE TERMS AND CONDITIONS OF THE OFFER AND
CONSENT SOLICITATION
1. Delivery of Letter of Transmittal and Consent and IPO warrants. This Letter of Transmittal and Consent is to be used only if tenders of IPO warrants are to be made by book-entry transfer to the Exchange Agent’s account at DTC and instructions are not being transmitted through ATOP with respect to such tenders.
IPO warrants may be validly tendered pursuant to the procedures for book-entry transfer as described in the Prospectus/Offer to Exchange. In order for IPO warrants to be validly tendered by book-entry transfer, the Exchange Agent must receive the following prior to the Expiration Date, except as otherwise permitted by use of the procedures for guaranteed delivery as described below:
(i) timely confirmation of the transfer of such IPO warrants to the Exchange Agent’s account at DTC (a “Book-Entry Confirmation”);
(ii) either a properly completed and duly executed Letter of Transmittal and Consent, or a properly transmitted “Agent’s Message” if the tendering IPO warrant holder has not delivered a Letter of Transmittal and Consent; and
(iii) any other documents required by this Letter of Transmittal and Consent.
The term “Agent’s Message” means a message, transmitted by DTC to, and received by, the Exchange Agent and forming a part of a Book-Entry Confirmation, which states that DTC has received an express acknowledgment from the participant in DTC exchanging the IPO warrants that such participant has received and agrees to be bound by the terms of the Letter of Transmittal and Consent and that the Company may enforce such agreement against the participant. If you are tendering by book-entry transfer, you must expressly acknowledge that you have received and agree to be bound by the Letter of Transmittal and Consent and that the Letter of Transmittal and Consent may be enforced against you.
Delivery of a Letter of Transmittal and Consent to the Company or DTC will not constitute valid delivery to the Exchange Agent. No Letter of Transmittal and Consent should be sent to the Company or DTC.
THE METHOD OF DELIVERY OF THIS LETTER OF TRANSMITTAL AND CONSENT, TENDERED IPO WARRANTS, AND ALL OTHER REQUIRED DOCUMENTS, INCLUDING DELIVERY THROUGH DTC AND ANY ACCEPTANCE OR AGENT’S MESSAGE DELIVERED THROUGH ATOP, IS AT THE OPTION AND RISK OF THE TENDERING IPO WARRANT HOLDER, AND, EXCEPT AS OTHERWISE PROVIDED IN THESE INSTRUCTIONS, THE DELIVERY WILL BE DEEMED MADE ONLY WHEN ACTUALLY RECEIVED BY THE EXCHANGE AGENT. IF DELIVERY IS BY MAIL, REGISTERED MAIL WITH RETURN RECEIPT REQUESTED — PROPERLY INSURED — IS RECOMMENDED. THE IPO WARRANT HOLDER HAS THE RESPONSIBILITY TO CAUSE THIS LETTER OF TRANSMITTAL AND CONSENT, THE TENDERED IPO WARRANTS, AND ANY OTHER DOCUMENTS TO BE TIMELY DELIVERED. IN ALL CASES, SUFFICIENT TIME SHOULD BE ALLOWED TO ENSURE TIMELY DELIVERY.
Neither the Company nor the Exchange Agent is under any obligation to notify any tendering holder of the Company’s acceptance of tendered IPO warrants.
2. Guaranteed Delivery. IPO warrant holders desiring to tender IPO warrants pursuant to the Offer but whose IPO warrants cannot otherwise be delivered with all other required documents to the Exchange Agent prior to the Expiration Date may nevertheless tender IPO warrants, as long as all of the following conditions are satisfied:
(i) the tender must be made by or through an “Eligible Institution” (as defined in Instruction 4);
(ii) properly completed and duly executed Notice of Guaranteed Delivery in the form provided by the Company to the undersigned with this Letter of Transmittal and Consent (with any required
signature guarantees) must be received by the Exchange Agent, at its address set forth in this Letter of Transmittal and Consent, prior to the Expiration Date; and
(iii) a confirmation of a book-entry transfer into the Exchange Agent’s account at DTC of all IPO warrants delivered electronically, in each case, together with a properly completed and duly executed Letter of Transmittal and Consent with any required signature guarantees (or, in the case of a book-entry transfer without delivery of a Letter of Transmittal and Consent, an Agent’s Message), and any other documents required by this Letter of Transmittal and Consent, must be received by the Exchange Agent within two days that the Nasdaq is open for trading after the date the exchange agent receives such Notice of Guaranteed Delivery, all as provided in the Prospectus/Offer to Exchange.
An IPO warrant holder may deliver the Notice of Guaranteed Delivery by facsimile transmission or mail to the Exchange Agent.
Except as specifically permitted by the Prospectus/Offer to Exchange, no alternative or contingent exchanges will be accepted.
3. Signatures on Letter of Transmittal and Consent and Other Documents. For purposes of the tender and consent procedures set forth in this Letter of Transmittal and Consent, the term “registered holder” means any person in whose name IPO warrants are registered on the books of the Company or who is listed as a participant in a clearing agency’s security position listing with respect to the IPO warrants.
If this Letter of Transmittal and Consent is signed by a trustee, executor, administrator, guardian, attorney-in-fact, officer of a corporation, or others acting in a fiduciary or representative capacity, such person must so indicate when signing and, unless waived by the Company, must submit to the Exchange Agent proper evidence satisfactory to the Company of the authority so to act.
4. Guarantee of Signatures. No signature guarantee is required if:
(i) this Letter of Transmittal and Consent is signed by the registered holder of the IPO warrants and such holder has not completed the box entitled “Special Issuance Instructions;” or
(ii) such IPO warrants are tendered for the account of an “Eligible Institution.” An “Eligible Institution” is a bank, broker dealer, credit union, savings association, or other entity that is a member in good standing of the Securities Transfer Agents Medallion Program or a bank, broker, dealer, credit union, savings association, or other entity which is an “eligible guarantor institution,” as that term is defined in Rule 17Ad-15 promulgated under the Securities Exchange Act of 1934, as amended.
IN ALL OTHER CASES, AN ELIGIBLE INSTITUTION MUST GUARANTEE ALL SIGNATURES ON THIS LETTER OF TRANSMITTAL AND CONSENT BY COMPLETING AND SIGNING THE TABLE ENTITLED “GUARANTEE OF SIGNATURE(S)” ABOVE.
5. IPO warrants Tendered. Any IPO warrant holder who chooses to participate in the Offer and Consent Solicitation may exchange some or all of such holder’s IPO warrants pursuant to the terms of the Offer and Consent Solicitation.
6. Inadequate Space. If the space provided under “Description of IPO Warrants Tendered” is inadequate, the name(s) and address(es) of the registered holder(s), number of IPO warrants being delivered herewith, and number of such IPO warrants tendered hereby should be listed on a separate, signed schedule and attached to this Letter of Transmittal and Consent.
7. Transfer Taxes. The Company will pay all transfer taxes, if any, applicable to the transfer of IPO warrants to the Company in the Offer and Consent Solicitation. If transfer taxes are imposed for any other reason, the amount of those transfer taxes, whether imposed on the registered holder or any other persons, will be payable by the tendering holder. Other reasons transfer taxes could be imposed include:
(i) if Class A ordinary shares are to be registered or issued in the name of any person other than the person signing this Letter of Transmittal and Consent; or
(ii) if tendered IPO warrants are registered in the name of any person other than the person signing this Letter of Transmittal and Consent.
If satisfactory evidence of payment of or exemption from those transfer taxes is not submitted with this Letter of Transmittal and Consent, the amount of those transfer taxes will be billed directly to the tendering holder and/or withheld from any payment due with respect to the IPO warrants tendered by such holder.
8. Validity of Tenders. All questions as to the number of IPO warrants to be accepted, and the validity, form, eligibility (including time of receipt), and acceptance of any tender of IPO warrants will be determined by the Company in its reasonable discretion, which determinations shall be final and binding on all parties. The Company reserves the absolute right to reject any or all tenders of IPO warrants it determines not to be in proper form or to reject those IPO warrants, the acceptance of which may, in the opinion of the Company’s counsel, be unlawful. The Company also reserves the absolute right to waive any defect or irregularity in the tender of any particular IPO warrants, whether or not similar defects or irregularities are waived in the case of other tendered IPO warrants. The Company’s interpretation of the terms and conditions of the Offer and Consent Solicitation (including this Letter of Transmittal and Consent and the instructions hereto) will be final and binding on all parties. Unless waived, any defects or irregularities in connection with tenders of IPO warrants must be cured within such time as the Company shall determine. None of the Company, the Exchange Agent, the information agent, the dealer manager, or any other person is or will be obligated to give notice of any defects or irregularities in tenders of IPO warrants, and none of them will incur any liability for failure to give any such notice. Tenders of IPO warrants will not be deemed to have been validly made until all defects and irregularities have been cured or waived. Any IPO warrants received by the Exchange Agent that are not validly tendered and as to which the defects or irregularities have not been cured or waived will be returned by the Exchange Agent to the holders, unless otherwise provided in this Letter of Transmittal and Consent, as soon as practicable following the Expiration Date. IPO warrant holders who have any questions about the procedure for tendering IPO warrants in the Offer and Consent Solicitation should contact the information agent at the address and telephone number indicated herein. IPO warrants properly tendered and not validly withdrawn that are accepted for exchange constitute the holder’s validly delivered consent to the Warrant Amendment.
9. Waiver of Conditions. The Company reserves the absolute right to waive any condition, other than as described in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — General Terms — Conditions to the Offer and Consent Solicitation.”
10. Withdrawal. Tenders of IPO warrants may be withdrawn only pursuant to the procedures and subject to the terms set forth in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Withdrawal Rights.” IPO warrant holders can withdraw tendered IPO warrants at any time prior to the Expiration Date, and IPO warrants that the Company has not accepted for exchange by , 2024 may thereafter be withdrawn at any time after such date until such IPO warrants are accepted by the Company for exchange pursuant to the Offer and Consent Solicitation. Except as otherwise provided in the Prospectus/Offer to Exchange, in order for the withdrawal of IPO warrants to be effective, a written notice of withdrawal satisfying the applicable requirements for withdrawal set forth in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Withdrawal Rights” must be timely received from the holder by the exchange agent at its address stated herein, together with any other information required as described in such section of the Prospectus/Offer to Exchange. All questions as to the form and validity (including time of receipt) of any notice of withdrawal will be determined by the Company, in its reasonable discretion, and its determination shall be final and binding. None of the Company, the Exchange Agent, the information agent, the dealer manager, or any other person is under any duty to give notification of any defect or irregularity in any notice of withdrawal or will incur any liability for failure to give any such notification. Any IPO warrants properly withdrawn will be deemed not to have been validly tendered for purposes of the Offer and Consent Solicitation. However, at any time prior to the Expiration Date, an IPO warrant holder may re-tender withdrawn IPO warrants by following the applicable procedures discussed in the Prospectus/Offer to Exchange and this Letter of Transmittal and Consent. Consents may be revoked only by withdrawing the related IPO warrants, and the withdrawal of any IPO warrants will automatically constitute a revocation of the related consents.
11. IRS Form W-9 or IRS Form W-8. Failure to provide a properly completed and signed IRS Form W-9 or applicable IRS Form W-8 (and any required attachments thereto) may result in U.S. federal backup withholding with respect to any cash paid in lieu of fractional shares and may result in a penalty
imposed by the U.S. Internal Revenue Service. If the tendering IPO warrant holder is a U.S. person, complete and sign the accompanying IRS Form W-9 to certify (i) such holder’s tax identification number, generally the holder’s social security or employer identification number and (ii) that such holder is not subject to U.S. federal backup withholding. If the tendering holder is not a U.S. person, complete and sign an applicable IRS Form W-8 (and any required attachments thereto) to certify such holder’s non-U.S. status. The applicable IRS Form W-8 and instructions for completing such form may be obtained at www.irs.gov. Tendering IPO warrant holders should consult their tax advisors regarding the completion of IRS Form W-9 or an applicable IRS Form W-8 and the application of the backup withholding rules.
12. Questions and Requests for Assistance and Additional Copies. Please direct questions or requests for assistance, or additional copies of the Prospectus/Offer to Exchange, Letter of Transmittal and Consent, or other materials, in writing to the information agent for the Offer and Consent Solicitation at:
The Information Agent for the Offer and Consent Solicitation is:
Alliance Advisors
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
IMPORTANT: THIS LETTER OF TRANSMITTAL AND CONSENT, OR THE “AGENT’S MESSAGE” (IF TENDERING PURSUANT TO THE PROCEDURES FOR BOOK-ENTRY TRANSFER WITHOUT EXECUTION AND DELIVERY OF A LETTER OF TRANSMITTAL AND CONSENT), TOGETHER WITH THE TENDERED IPO WARRANTS AND ALL OTHER REQUIRED DOCUMENTS, MUST BE RECEIVED BY THE EXCHANGE AGENT ON OR PRIOR TO 11:59 P.M., EASTERN TIME, ON THE EXPIRATION DATE, UNLESS A NOTICE OF GUARANTEED DELIVERY IS RECEIVED BY THE EXCHANGE AGENT BY SUCH DATE.
Form W-9(Rev. March 2024)Department of the Treasury Internal Revenue Service Request for Taxpayer Identification Number and CertificationGo to www.irs.gov/FormW9 for instructions and the latest information. Give form to the requester. Do not send to the IRS. Before you begin. For guidance related to the purpose of Form W-9, see Purpose of Form, below.1Name of entity/individual. An entry is required. (For a sole proprietor or disregarded entity, enter the owner’s name on line 1, and enter the business/disregarded entity’s name on line 2.)2Business name/disregarded entity name, if different from above. 3a Check the appropriate box for federal tax classification of the entity/individual whose name is entered on line 1. Check only one of the following seven boxes.Individual/sole proprietorC corporationS corporationPartnershipTrust/estate LLC. Enter the tax classification (C = C corporation, S = S corporation, P = Partnership)....Note: Check the “LLC” box above and, in the entry space, enter the appropriate code (C, S, or P) for the tax classification of the LLC, unless it is a disregarded entity. A disregarded entity should instead check the appropriate box for the tax classification of its owner.Other (see instructions)3b If on line 3a you checked “Partnership” or “Trust/estate,” or checked “LLC” and entered “P” as its tax classification, and you are providing this form to a partnership, trust, or estate in which you have an ownership interest, check this box if you have any foreign partners, owners, or beneficiaries. See instructions . . . . . . . . . 4 Exemptions (codes apply only to certain entities, not individuals; see instructions on page 3):Exempt payee code (if any)Exemption from Foreign Account Tax Compliance Act (FATCA) reporting code (if any)(Applies to accounts maintained outside the United States.) 5Address (number, street, and apt. or suite no.). See instructions.Requester’s name and address (optional)6City, state, and ZIP code7List account number(s) here (optional)Part ITaxpayer Identification Number (TIN) Enter your TIN in the appropriate box. The TIN provided must match the name given on line 1 to avoid backup withholding. For individuals, this is generally your social security number (SSN). However, for a resident alien, sole proprietor, or disregarded entity, see the instructions for Part I, later. For other entities, it is your employer identification number (EIN). If you do not have a number, see How to get a TIN, later.Note: If the account is in more than one name, see the instructions for line 1. See also What Name and Number To Give the Requester for guidelines on whose number to enter. Social security number––or Part IICertificationUnder penalties of perjury, I certify that:1.The number shown on this form is my correct taxpayer identification number (or I am waiting for a number to be issued to me); and2.I am not subject to backup withholding because (a) I am exempt from backup withholding, or (b) I have not been notified by the Internal Revenue Service (IRS) that I am subject to backup withholding as a result of a failure to report all interest or dividends, or (c) the IRS has notified me that I am no longer subject to backup withholding; and3.I am a U.S. citizen or other U.S. person (defined below); and4.The FATCA code(s) entered on this form (if any) indicating that I am exempt from FATCA reporting is correct.Certification instructions. You must cross out item 2 above if you have been notified by the IRS that you are currently subject to backup withholding because you have failed to report all interest and dividends on your tax return. For real estate transactions, item 2 does not apply. For mortgage interest paid, acquisition or abandonment of secured property, cancellation of debt, contributions to an individual retirement arrangement (IRA), and, generally, payments other than interest and dividends, you are not required to sign the certification, but you must provide your correct TIN. See the instructions for Part II, later. General InstructionsSection references are to the Internal Revenue Code unless otherwise noted.Future developments. For the latest information about developments related to Form W-9 and its instructions, such as legislation enacted after they were published, go to www.irs.gov/FormW9.What’s NewLine 3a has been modified to clarify how a disregarded entity completes this line. An LLC that is a disregarded entity should check the appropriate box for the tax classification of its owner. Otherwise, it should check the “LLC” box and enter its appropriate tax classification. New line 3b has been added to this form. A flow-through entity is required to complete this line to indicate that it has direct or indirect foreign partners, owners, or beneficiaries when it provides the Form W-9 to another flow-through entity in which it has an ownership interest. This change is intended to provide a flow-through entity with information regarding the status of its indirect foreign partners, owners, or beneficiaries, so that it can satisfy any applicable reporting requirements. For example, a partnership that has any indirect foreign partners may be required to complete Schedules K-2 and K-3. See the Partnership Instructions for Schedules K-2 and K-3 (Form 1065).Purpose of FormAn individual or entity (Form W-9 requester) who is required to file an information return with the IRS is giving you this form because they Cat. No. 10231XForm W-9 (Rev. 3-2024)
must obtain your correct taxpayer identification number (TIN), which may be your social security number (SSN), individual taxpayer identification number (ITIN), adoption taxpayer identification number (ATIN), or employer identification number (EIN), to report on an information return the amount paid to you, or other amount reportable on an information return. Examples of information returns include, but are not limited to, the following.•Form 1099-INT (interest earned or paid).•Form 1099-DIV (dividends, including those from stocks or mutual funds).•Form 1099-MISC (various types of income, prizes, awards, or gross proceeds).•Form 1099-NEC (nonemployee compensation).•Form 1099-B (stock or mutual fund sales and certain other transactions by brokers).•Form 1099-S (proceeds from real estate transactions).•Form 1099-K (merchant card and third-party network transactions).•Form 1098 (home mortgage interest), 1098-E (student loan interest), and 1098-T (tuition).•Form 1099-C (canceled debt).•Form 1099-A (acquisition or abandonment of secured property).Use Form W-9 only if you are a U.S. person (including a resident alien), to provide your correct TIN.Caution: If you don’t return Form W-9 to the requester with a TIN, you might be subject to backup withholding. See What is backup withholding, later.By signing the filled-out form, you:1.Certify that the TIN you are giving is correct (or you are waiting for a number to be issued);2.Certify that you are not subject to backup withholding; or3.Claim exemption from backup withholding if you are a U.S. exempt payee; and4.Certify to your non-foreign status for purposes of withholding under chapter 3 or 4 of the Code (if applicable); and5.Certify that FATCA code(s) entered on this form (if any) indicating that you are exempt from the FATCA reporting is correct. See What Is FATCA Reporting, later, for further information.Note: If you are a U.S. person and a requester gives you a form other than Form W-9 to request your TIN, you must use the requester’s form if it is substantially similar to this Form W-9.Definition of a U.S. person. For federal tax purposes, you are considered a U.S. person if you are:•An individual who is a U.S. citizen or U.S. resident alien;•A partnership, corporation, company, or association created or organized in the United States or under the laws of the United States;•An estate (other than a foreign estate); or•A domestic trust (as defined in Regulations section 301.7701-7).Establishing U.S. status for purposes of chapter 3 and chapter 4 withholding. Payments made to foreign persons, including certain distributions, allocations of income, or transfers of sales proceeds, may be subject to withholding under chapter 3 or chapter 4 of the Code (sections 1441–1474). Under those rules, if a Form W-9 or other certification of non-foreign status has not been received, a withholding agent, transferee, or partnership (payor) generally applies presumption rules that may require the payor to withhold applicable tax from the recipient, owner, transferor, or partner (payee). See Pub. 515, Withholding of Tax on Nonresident Aliens and Foreign Entities.The following persons must provide Form W-9 to the payor for purposes of establishing its non-foreign status.•In the case of a disregarded entity with a U.S. owner, the U.S. owner of the disregarded entity and not the disregarded entity.•In the case of a grantor trust with a U.S. grantor or other U.S. owner, generally, the U.S. grantor or other U.S. owner of the grantor trust and not the grantor trust.•In the case of a U.S. trust (other than a grantor trust), the U.S. trust and not the beneficiaries of the trust.See Pub. 515 for more information on providing a Form W-9 or a certification of non-foreign status to avoid withholding. Foreign person. If you are a foreign person or the U.S. branch of a foreign bank that has elected to be treated as a U.S. person (under Regulations section 1.1441-1(b)(2)(iv) or other applicable section for chapter 3 or 4 purposes), do not use Form W-9. Instead, use the appropriate Form W-8 or Form 8233 (see Pub. 515). If you are a qualified foreign pension fund under Regulations section 1.897(l)-1(d), or a partnership that is wholly owned by qualified foreign pension funds, that is treated as a non-foreign person for purposes of section 1445 withholding, do not use Form W-9. Instead, use Form W-8EXP (or other certification of non-foreign status).Nonresident alien who becomes a resident alien. Generally, only a nonresident alien individual may use the terms of a tax treaty to reduce or eliminate U.S. tax on certain types of income. However, most tax treaties contain a provision known as a saving clause. Exceptions specified in the saving clause may permit an exemption from tax to continue for certain types of income even after the payee has otherwise become a U.S. resident alien for tax purposes.If you are a U.S. resident alien who is relying on an exception contained in the saving clause of a tax treaty to claim an exemption from U.S. tax on certain types of income, you must attach a statement to Form W-9 that specifies the following five items.1.The treaty country. Generally, this must be the same treaty under which you claimed exemption from tax as a nonresident alien.2.The treaty article addressing the income.3.The article number (or location) in the tax treaty that contains the saving clause and its exceptions.4.The type and amount of income that qualifies for the exemption from tax.5.Sufficient facts to justify the exemption from tax under the terms of the treaty article.Example. Article 20 of the U.S.-China income tax treaty allows an exemption from tax for scholarship income received by a Chinese student temporarily present in the United States. Under U.S. law, this student will become a resident alien for tax purposes if their stay in the United States exceeds 5 calendar years. However, paragraph 2 of the first Protocol to the U.S.-China treaty (dated April 30, 1984) allows the provisions of Article 20 to continue to apply even after the Chinese student becomes a resident alien of the United States. A Chinese student who qualifies for this exception (under paragraph 2 of the first Protocol) and is relying on this exception to claim an exemption from tax on their scholarship or fellowship income would attach to Form W-9 a statement that includes the information described above to support that exemption.If you are a nonresident alien or a foreign entity, give the requester the appropriate completed Form W-8 or Form 8233.Backup WithholdingWhat is backup withholding? Persons making certain payments to you must under certain conditions withhold and pay to the IRS 24% of such payments. This is called “backup withholding.” Payments that may be subject to backup withholding include, but are not limited to, interest, tax-exempt interest, dividends, broker and barter exchange transactions, rents, royalties, nonemployee pay, payments made in settlement of payment card and third-party network transactions, and certain payments from fishing boat operators. Real estate transactions are not subject to backup withholding.You will not be subject to backup withholding on payments you receive if you give the requester your correct TIN, make the proper certifications, and report all your taxable interest and dividends on your tax return.Payments you receive will be subject to backup withholding if:1.You do not furnish your TIN to the requester;2.You do not certify your TIN when required (see the instructions for Part II for details);3.The IRS tells the requester that you furnished an incorrect TIN;4.The IRS tells you that you are subject to backup withholding because you did not report all your interest and dividends on your tax return (for reportable interest and dividends only); or5.You do not certify to the requester that you are not subject to backup withholding, as described in item 4 under “By signing the filled- out form” above (for reportable interest and dividend accounts opened after 1983 only).
Certain payees and payments are exempt from backup withholding. See Exempt payee code, later, and the separate Instructions for the Requester of Form W-9 for more information.See also Establishing U.S. status for purposes of chapter 3 and chapter 4 withholding, earlier.What Is FATCA Reporting?The Foreign Account Tax Compliance Act (FATCA) requires a participating foreign financial institution to report all U.S. account holders that are specified U.S. persons. Certain payees are exempt from FATCA reporting. See Exemption from FATCA reporting code, later, and the Instructions for the Requester of Form W-9 for more information.Updating Your InformationYou must provide updated information to any person to whom you claimed to be an exempt payee if you are no longer an exempt payee and anticipate receiving reportable payments in the future from this person. For example, you may need to provide updated information if you are a C corporation that elects to be an S corporation, or if you are no longer tax exempt. In addition, you must furnish a new Form W-9 if the name or TIN changes for the account, for example, if the grantor of a grantor trust dies.PenaltiesFailure to furnish TIN. If you fail to furnish your correct TIN to a requester, you are subject to a penalty of $50 for each such failure unless your failure is due to reasonable cause and not to willful neglect.Civil penalty for false information with respect to withholding. If you make a false statement with no reasonable basis that results in no backup withholding, you are subject to a $500 penalty.Criminal penalty for falsifying information. Willfully falsifying certifications or affirmations may subject you to criminal penalties including fines and/or imprisonment.Misuse of TINs. If the requester discloses or uses TINs in violation of federal law, the requester may be subject to civil and criminal penalties.Specific InstructionsLine 1You must enter one of the following on this line; do not leave this line blank. The name should match the name on your tax return.If this Form W-9 is for a joint account (other than an account maintained by a foreign financial institution (FFI)), list first, and then circle, the name of the person or entity whose number you entered in Part I of Form W-9. If you are providing Form W-9 to an FFI to document a joint account, each holder of the account that is a U.S. person must provide a Form W-9.•Individual. Generally, enter the name shown on your tax return. If you have changed your last name without informing the Social Security Administration (SSA) of the name change, enter your first name, the last name as shown on your social security card, and your new last name.Note for ITIN applicant: Enter your individual name as it was entered on your Form W-7 application, line 1a. This should also be the same as the name you entered on the Form 1040 you filed with your application.•Sole proprietor. Enter your individual name as shown on your Form 1040 on line 1. Enter your business, trade, or “doing business as” (DBA) name on line 2.•Partnership, C corporation, S corporation, or LLC, other than a disregarded entity. Enter the entity’s name as shown on the entity’s tax return on line 1 and any business, trade, or DBA name on line 2.•Other entities. Enter your name as shown on required U.S. federal tax documents on line 1. This name should match the name shown on the charter or other legal document creating the entity. Enter any business, trade, or DBA name on line 2.•Disregarded entity. In general, a business entity that has a single owner, including an LLC, and is not a corporation, is disregarded as an entity separate from its owner (a disregarded entity). See Regulations section 301.7701-2(c)(2). A disregarded entity should check the appropriate box for the tax classification of its owner. Enter the owner’s name on line 1. The name of the owner entered on line 1 should never be a disregarded entity. The name on line 1 should be the name shown on the income tax return on which the income should be reported. For example, if a foreign LLC that is treated as a disregarded entity for U.S. federal tax purposes has a single owner that is a U.S. person, the U.S. owner’s name is required to be provided on line 1. If the direct owner of the entity is also a disregarded entity, enter the first owner that is not disregarded for federal tax purposes. Enter the disregarded entity’s name on line 2. If the owner of the disregarded entity is a foreign person, the owner must complete an appropriate Form W-8 instead of a FormW-9. This is the case even if the foreign person has a U.S. TIN.Line 2If you have a business name, trade name, DBA name, or disregarded entity name, enter it on line 2.Line 3aCheck the appropriate box on line 3a for the U.S. federal tax classification of the person whose name is entered on line 1. Check only one box on line 3a.IF the entity/individual on line 1 is a(n) . . .THEN check the box for . . .•CorporationCorporation.•Individual or•Sole proprietorshipIndividual/sole proprietor.•LLC classified as a partnership for U.S. federal tax purposes or•LLC that has filed Form 8832 or 2553 electing to be taxed as a corporationLimited liability company and enter the appropriate tax classification:P = Partnership,C = C corporation, or S = S corporation.•PartnershipPartnership.•Trust/estateTrust/estate.Line 3bCheck this box if you are a partnership (including an LLC classified as a partnership for U.S. federal tax purposes), trust, or estate that has any foreign partners, owners, or beneficiaries, and you are providing this form to a partnership, trust, or estate, in which you have an ownership interest. You must check the box on line 3b if you receive a Form W-8 (or documentary evidence) from any partner, owner, or beneficiary establishing foreign status or if you receive a Form W-9 from any partner, owner, or beneficiary that has checked the box on line 3b.Note: A partnership that provides a Form W-9 and checks box 3b may be required to complete Schedules K-2 and K-3 (Form 1065). For more information, see the Partnership Instructions for Schedules K-2 and K-3 (Form 1065).If you are required to complete line 3b but fail to do so, you may not receive the information necessary to file a correct information return with the IRS or furnish a correct payee statement to your partners or beneficiaries. See, for example, sections 6698, 6722, and 6724 for penalties that may apply.Line 4 ExemptionsIf you are exempt from backup withholding and/or FATCA reporting, enter in the appropriate space on line 4 any code(s) that may apply to you.Exempt payee code.•Generally, individuals (including sole proprietors) are not exempt from backup withholding.•Except as provided below, corporations are exempt from backup withholding for certain payments, including interest and dividends.•Corporations are not exempt from backup withholding for payments made in settlement of payment card or third-party network transactions.•Corporations are not exempt from backup withholding with respect to attorneys’ fees or gross proceeds paid to attorneys, and corporations that provide medical or health care services are not exempt with respect to payments reportable on Form 1099-MISC.The following codes identify payees that are exempt from backup withholding. Enter the appropriate code in the space on line 4.1—An organization exempt from tax under section 501(a), any IRA, or a custodial account under section 403(b)(7) if the account satisfies the requirements of section 401(f)(2).
2—The United States or any of its agencies or instrumentalities.3—A state, the District of Columbia, a U.S. commonwealth or territory, or any of their political subdivisions or instrumentalities.4—A foreign government or any of its political subdivisions, agencies, or instrumentalities.5—A corporation.6—A dealer in securities or commodities required to register in the United States, the District of Columbia, or a U.S. commonwealth or territory.7—A futures commission merchant registered with the Commodity Futures Trading Commission.8—A real estate investment trust.9—An entity registered at all times during the tax year under the Investment Company Act of 1940.10—A common trust fund operated by a bank under section 584(a). 11—A financial institution as defined under section 581.12—A middleman known in the investment community as a nominee or custodian.13—A trust exempt from tax under section 664 or described in section 4947.The following chart shows types of payments that may be exempt from backup withholding. The chart applies to the exempt payees listed above, 1 through 13.IF the payment is for . . .THEN the payment is exempt for . . .•Interest and dividend paymentsAll exempt payees except for 7.•Broker transactionsExempt payees 1 through 4 and 6 through 11 and all C corporations. S corporations must not enter an exempt payee code because they are exempt only for sales of noncovered securities acquired prior to 2012.•Barter exchange transactions and patronage dividendsExempt payees 1 through 4.•Payments over $600 required to be reported and direct sales over$5,0001Generally, exempt payees 1 through 5.2•Payments made in settlement of payment card or third-party network transactionsExempt payees 1 through 4.1 See Form 1099-MISC, Miscellaneous Information, and its instructions.2 However, the following payments made to a corporation and reportable on Form 1099-MISC are not exempt from backup withholding: medical and health care payments, attorneys’ fees, gross proceeds paid to an attorney reportable under section 6045(f), and payments for services paid by a federal executive agency.Exemption from FATCA reporting code. The following codes identify payees that are exempt from reporting under FATCA. These codes apply to persons submitting this form for accounts maintained outside of the United States by certain foreign financial institutions. Therefore, if you are only submitting this form for an account you hold in the United States, you may leave this field blank. Consult with the person requesting this form if you are uncertain if the financial institution is subject to these requirements. A requester may indicate that a code is not required by providing you with a Form W-9 with “Not Applicable” (or any similar indication) entered on the line for a FATCA exemption code.A—An organization exempt from tax under section 501(a) or any individual retirement plan as defined in section 7701(a)(37).B—The United States or any of its agencies or instrumentalities.C—A state, the District of Columbia, a U.S. commonwealth or territory, or any of their political subdivisions or instrumentalities.D—A corporation the stock of which is regularly traded on one or more established securities markets, as described in Regulations section 1.1472-1(c)(1)(i).E—A corporation that is a member of the same expanded affiliated group as a corporation described in Regulations section 1.1472-1(c)(1)(i). F—A dealer in securities, commodities, or derivative financial instruments (including notional principal contracts, futures, forwards, and options) that is registered as such under the laws of the United States or any state.G—A real estate investment trust.H—A regulated investment company as defined in section 851 or an entity registered at all times during the tax year under the Investment Company Act of 1940.I—A common trust fund as defined in section 584(a). J—A bank as defined in section 581.K—A broker.L—A trust exempt from tax under section 664 or described in section 4947(a)(1).M—A tax-exempt trust under a section 403(b) plan or section 457(g) plan.Note: You may wish to consult with the financial institution requesting this form to determine whether the FATCA code and/or exempt payee code should be completed.Line 5Enter your address (number, street, and apartment or suite number). This is where the requester of this Form W-9 will mail your information returns. If this address differs from the one the requester already has on file, enter “NEW” at the top. If a new address is provided, there is still a chance the old address will be used until the payor changes your address in their records.Line 6Enter your city, state, and ZIP code.Part I. Taxpayer Identification Number (TIN)Enter your TIN in the appropriate box. If you are a resident alien and you do not have, and are not eligible to get, an SSN, your TIN is your IRS ITIN. Enter it in the entry space for the Social security number. If you do not have an ITIN, see How to get a TIN below.If you are a sole proprietor and you have an EIN, you may enter either your SSN or EIN.If you are a single-member LLC that is disregarded as an entity separate from its owner, enter the owner’s SSN (or EIN, if the owner has one). If the LLC is classified as a corporation or partnership, enter the entity’s EIN.Note: See What Name and Number To Give the Requester, later, for further clarification of name and TIN combinations.How to get a TIN. If you do not have a TIN, apply for one immediately. To apply for an SSN, get Form SS-5, Application for a Social Security Card, from your local SSA office or get this form online at www.SSA.gov. You may also get this form by calling 800-772-1213. Use Form W-7, Application for IRS Individual Taxpayer Identification Number, to apply for an ITIN, or Form SS-4, Application for Employer Identification Number, to apply for an EIN. You can apply for an EIN online by accessing the IRS website at www.irs.gov/EIN. Go to www.irs.gov/Forms to view, download, or print Form W-7 and/or Form SS-4. Or, you can go to www.irs.gov/OrderForms to place an order and have Form W-7 and/or Form SS-4 mailed to you within 15 business days.If you are asked to complete Form W-9 but do not have a TIN, apply for a TIN and enter “Applied For” in the space for the TIN, sign and date the form, and give it to the requester. For interest and dividend payments, and certain payments made with respect to readily tradable instruments, you will generally have 60 days to get a TIN and give it to the requester before you are subject to backup withholding on payments. The 60-day rule does not apply to other types of payments. You will be subject to backup withholding on all such payments until you provide your TIN to the requester.Note: Entering “Applied For” means that you have already applied for a TIN or that you intend to apply for one soon. See also Establishing U.S. status for purposes of chapter 3 and chapter 4 withholding, earlier, for when you may instead be subject to withholding under chapter 3 or 4 of the Code.Caution: A disregarded U.S. entity that has a foreign owner must use the appropriate Form W-8.
Part II. CertificationTo establish to the withholding agent that you are a U.S. person, or resident alien, sign Form W-9. You may be requested to sign by the withholding agent even if item 1, 4, or 5 below indicates otherwise.For a joint account, only the person whose TIN is shown in Part I should sign (when required). In the case of a disregarded entity, the person identified on line 1 must sign. Exempt payees, see Exempt payee code, earlier.Signature requirements. Complete the certification as indicated in items 1 through 5 below.1.Interest, dividend, and barter exchange accounts opened before 1984 and broker accounts considered active during 1983. You must give your correct TIN, but you do not have to sign the certification.2.Interest, dividend, broker, and barter exchange accounts opened after 1983 and broker accounts considered inactive during 1983. You must sign the certification or backup withholding will apply. If you are subject to backup withholding and you are merely providing your correct TIN to the requester, you must cross out item 2 in the certification before signing the form.3.Real estate transactions. You must sign the certification. You may cross out item 2 of the certification.4.Other payments. You must give your correct TIN, but you do not have to sign the certification unless you have been notified that you have previously given an incorrect TIN. “Other payments” include payments made in the course of the requester’s trade or business for rents, royalties, goods (other than bills for merchandise), medical and health care services (including payments to corporations), payments to a nonemployee for services, payments made in settlement of payment card and third-party network transactions, payments to certain fishing boat crew members and fishermen, and gross proceeds paid to attorneys (including payments to corporations).5.Mortgage interest paid by you, acquisition or abandonment of secured property, cancellation of debt, qualified tuition program payments (under section 529), ABLE accounts (under section 529A), IRA, Coverdell ESA, Archer MSA or HSA contributions or distributions, and pension distributions. You must give your correct TIN, but you do not have to sign the certification.What Name and Number To Give the RequesterFor this type of account:Give name and SSN of:1. IndividualThe individual2. Two or more individuals (joint account) other than an account maintained by an FFIThe actual owner of the account or, if combined funds, the first individual on the account13. Two or more U.S. persons(joint account maintained by an FFI)Each holder of the account4. Custodial account of a minor (Uniform Gift to Minors Act)The minor25. a. The usual revocable savings trust (grantor is also trustee)The grantor-trustee1b. So-called trust account that is not a legal or valid trust under state lawThe actual owner16. Sole proprietorship or disregarded entity owned by an individualThe owner37. Grantor trust filing under Optional Filing Method 1 (see Regulations section 1.671-4(b)(2)(i)(A))**The grantor* For this type of account:Give name and EIN of:8. Disregarded entity not owned by an individualThe owner9. A valid trust, estate, or pension trustLegal entity410. Corporation or LLC electing corporate status on Form 8832 or Form 2553The corporation11. Association, club, religious, charitable, educational, or other tax-exempt organizationThe organization12. Partnership or multi-member LLCThe partnership13. A broker or registered nomineeThe broker or nominee14. Account with the Department of Agriculture in the name of a public entity (such as a state or local government, school district, or prison) that receives agricultural program paymentsThe public entity15. Grantor trust filing Form 1041 or under the Optional Filing Method 2, requiring Form 1099 (see Regulations section 1.671-4(b)(2)(i)(B))**The trust1 List first and circle the name of the person whose number you furnish. If only one person on a joint account has an SSN, that person’s number must be furnished.2 Circle the minor’s name and furnish the minor’s SSN.3 You must show your individual name on line 1, and enter your business or DBA name, if any, on line 2. You may use either your SSN or EIN (if you have one), but the IRS encourages you to use your SSN.4 List first and circle the name of the trust, estate, or pension trust. (Do not furnish the TIN of the personal representative or trustee unless the legal entity itself is not designated in the account title.)* Note: The grantor must also provide a Form W-9 to the trustee of the trust.** For more information on optional filing methods for grantor trusts, see the Instructions for Form 1041.Note: If no name is circled when more than one name is listed, the number will be considered to be that of the first name listed.Secure Your Tax Records From Identity TheftIdentity theft occurs when someone uses your personal information, such as your name, SSN, or other identifying information, without your permission to commit fraud or other crimes. An identity thief may use your SSN to get a job or may file a tax return using your SSN to receive a refund.To reduce your risk:•Protect your SSN,•Ensure your employer is protecting your SSN, and•Be careful when choosing a tax return preparer.If your tax records are affected by identity theft and you receive a notice from the IRS, respond right away to the name and phone number printed on the IRS notice or letter.If your tax records are not currently affected by identity theft but you think you are at risk due to a lost or stolen purse or wallet, questionable credit card activity, or a questionable credit report, contact the IRS Identity Theft Hotline at 800-908-4490 or submit Form 14039.For more information, see Pub. 5027, Identity Theft Information for Taxpayers.
Victims of identity theft who are experiencing economic harm or a systemic problem, or are seeking help in resolving tax problems that have not been resolved through normal channels, may be eligible for Taxpayer Advocate Service (TAS) assistance. You can reach TAS by calling the TAS toll-free case intake line at 877-777-4778 or TTY/TDD 800-829-4059.Protect yourself from suspicious emails or phishing schemes. Phishing is the creation and use of email and websites designed to mimic legitimate business emails and websites. The most common act is sending an email to a user falsely claiming to be an established legitimate enterprise in an attempt to scam the user into surrendering private information that will be used for identity theft.The IRS does not initiate contacts with taxpayers via emails. Also, the IRS does not request personal detailed information through email or ask taxpayers for the PIN numbers, passwords, or similar secret access information for their credit card, bank, or other financial accounts.If you receive an unsolicited email claiming to be from the IRS, forward this message to phishing@irs.gov. You may also report misuse of the IRS name, logo, or other IRS property to the Treasury Inspector General for Tax Administration (TIGTA) at 800-366-4484. You can forward suspicious emails to the Federal Trade Commission at spam@uce.gov or report them at www.ftc.gov/complaint. You can contact the FTC at www.ftc.gov/idtheft or 877-IDTHEFT (877-438-4338). If you have been the victim of identity theft, see www.IdentityTheft.gov and Pub. 5027.Go to www.irs.gov/IdentityTheft to learn more about identity theft and how to reduce your risk. Privacy Act NoticeSection 6109 of the Internal Revenue Code requires you to provide your correct TIN to persons (including federal agencies) who are required to file information returns with the IRS to report interest, dividends, or certain other income paid to you; mortgage interest you paid; the acquisition or abandonment of secured property; the cancellation of debt; or contributions you made to an IRA, Archer MSA, or HSA. The person collecting this form uses the information on the form to file information returns with the IRS, reporting the above information.Routine uses of this information include giving it to the Department of Justice for civil and criminal litigation and to cities, states, the District of Columbia, and U.S. commonwealths and territories for use in administering their laws. The information may also be disclosed to other countries under a treaty, to federal and state agencies to enforce civil and criminal laws, or to federal law enforcement and intelligence agencies to combat terrorism. You must provide your TIN whether or not you are required to file a tax return. Under section 3406, payors must generally withhold a percentage of taxable interest, dividends, and certain other payments to a payee who does not give a TIN to the payor. Certain penalties may also apply for providing false or fraudulent information.
The Exchange Agent for the Offer and Consent Solicitation is:
Continental Stock Transfer & Trust Company
1 State Street, 30th Floor
New York, NY 10004
Attention: Corporate Actions Department
Questions or requests for assistance may be directed to the information agent at the address and telephone number listed below. Additional copies of the Prospectus/Offer to Exchange, this Letter of Transmittal and Consent, and the Notice of Guaranteed Delivery may also be obtained from the information agent. Any IPO warrant holder may also contact its broker, dealer, commercial bank, or trust company for assistance concerning the Offer and Consent Solicitation.
The Information Agent for the Offer and Consent Solicitation is:
Alliance Advisors
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
tm2418824-1_s4_DIV_14-exh99x2 - none - 1.9843825s
Exhibit (a)(1)(C)
NOTICE OF GUARANTEED DELIVERY
OF WARRANTS
OF
ZURA BIO LIMITED
Pursuant to the Prospectus/Offer to Exchange, dated July 11, 2024
Instructions for Use
Unless defined herein, terms used in this notice of guaranteed delivery (this “Notice of Guaranteed Delivery”) shall have the definitions set forth in the prospectus/offer to exchange, dated July 11, 2024 (as amended or supplemented from time to time, the “Prospectus/Offer to Exchange”).
This Notice of Guaranteed Delivery, or one substantially in the form hereof, may be used to accept the Offer if:
•
the procedure for book-entry transfer cannot be completed on a timely basis; or
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time will not permit all required documents, including a properly completed and duly executed Letter of Transmittal and Consent (as defined below) and any other required documents, to reach Continental Stock Transfer & Trust Company (the “Exchange Agent”) prior to the Expiration Date.
This Notice of Guaranteed Delivery, properly completed and duly executed, must be delivered by hand, mail, overnight courier, or facsimile transmission to the Exchange Agent, as described in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Procedure for Tendering IPO Warrants for Exchange and Consenting to the Warrant Amendment.” The method of delivery of all required documents is at the holder’s option and risk.
For this Notice of Guaranteed Delivery to be validly delivered, it must be received by the Exchange Agent at the address below before the Expiration Date. Delivery of this notice to another address will not constitute a valid delivery. Delivery to Zura Bio Limited (the “Company”), the information agent, or the book-entry transfer facility will not be forwarded to the Exchange Agent and will not constitute a valid delivery.
The holder’s signature on this Notice of Guaranteed Delivery must be guaranteed by an “Eligible Institution,” and the Eligible Institution must also execute the Guarantee of Delivery attached hereto. An “Eligible Institution” is a bank, broker, dealer, credit union, savings association, or other entity that is a member in good standing of the Securities Transfer Agents Medallion Program or a bank, broker, dealer, credit union, savings association, or other entity which is an “eligible guarantor institution,” as that term is defined in Rule 17Ad-15 promulgated under the Securities Exchange Act of 1934, as amended.
In addition, if the instructions to the Letter of Transmittal and Consent require a signature on a Letter of Transmittal and Consent to be guaranteed by an Eligible Institution, such signature guarantee must appear in the applicable space provided in the signature box on the Letter of Transmittal and Consent.
TO: CONTINENTAL STOCK TRANSFER & TRUST COMPANY
One State Street Plaza, 30th Floor
New York, New York 10004
Attention: Corporate Actions Department
The undersigned acknowledges receipt of the prospectus/offer to exchange, dated July 11, 2024 (the “Prospectus/Offer to Exchange”), and the related letter of transmittal and consent (as it may be amended and supplemented from time to time, the “Letter of Transmittal and Consent”).
By signing this Notice of Guaranteed Delivery, the holder tenders for exchange, upon the terms and subject to the conditions described in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent, the number of IPO warrants specified below, and provides consent to the Warrant Amendment (as defined in the Prospectus/Offer to Exchange), pursuant to the guaranteed delivery procedures described
in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — Procedure for Tendering IPO Warrants for Exchange and Consenting to the Warrant Amendment.”
DESCRIPTION OF IPO WARRANTS TENDERED
List below the IPO warrants to which this Notice of Guaranteed Delivery relates.
Name(s) and Address(es) of Registered Holder(s) of
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IPO Warrants
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Number of IPO Warrants Tendered
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Total:
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(1)
Unless otherwise indicated above, it will be assumed that all IPO warrants listed above are being tendered pursuant to this Notice of Guaranteed Delivery.
☐
CHECK HERE IF THE IPO WARRANTS LISTED ABOVE WILL BE DELIVERED BY BOOK-ENTRY TRANSFER MADE TO THE ACCOUNT MAINTAINED BY THE EXCHANGE AGENT WITH THE DEPOSITORY TRUST COMPANY (“DTC”) AND COMPLETE THE FOLLOWING (FOR USE BY ELIGIBLE INSTITUTIONS ONLY):
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Name of Tendering Institution:
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Account Number:
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SIGNATURES
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Signature(s) of IPO Warrant Holder(s)
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Name(s) of IPO Warrant Holder(s) (Please Print)
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Address
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City, State, Zip Code
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Telephone Number
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Date
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GUARANTEE OF SIGNATURES
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Authorized Signature
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Name (Please Print)
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Title
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Name of Firm (must be an Eligible Institution as defined in this Notice of Guaranteed Delivery)
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City, State, Zip Code
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Date
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GUARANTEE OF DELIVERY
(Not to be used for Signature Guarantee)
The undersigned, a bank, broker, dealer, credit union, savings association, or other entity that is a member in good standing of the Securities Transfer Agents Medallion Program or a bank, broker, dealer, credit union, savings association, or other entity which is an “eligible guarantor institution,” as that term is defined in Rule 17Ad-15 promulgated under the Securities Exchange Act of 1934, as amended (each of the foregoing constituting an “Eligible Institution”), guarantees delivery to the Exchange Agent of the IPO warrants tendered and consents given, in proper form for transfer, or a confirmation that the IPO warrants tendered have been delivered pursuant to the procedure for book-entry transfer described in the Prospectus/Offer to Exchange and the Letter of Transmittal and Consent into the Exchange Agent’s account at the book-entry transfer facility, in each case together with a properly completed and duly executed Letter(s) of Transmittal and Consent, or an Agent’s Message (as defined in the Prospectus/Offer to Exchange) in the case of a book-entry transfer, and any other required documents, all within one trading day on The Nasdaq Capital Market after the date of receipt by the Exchange Agent of this Notice of Guaranteed Delivery.
The Eligible Institution that completes this form must communicate the guarantee to the Exchange Agent and must deliver the Letter of Transmittal and Consent to the Exchange Agent, or confirmation of receipt of the IPO warrants pursuant to the procedure for book-entry transfer and an Agent’s Message, within the time set forth above. Failure to do so could result in a financial loss to such Eligible Institution.
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Authorized Signature Name (Please Print)
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Title
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Name of Firm
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tm2418824-1_s4_DIV_15-exh99x3 - none - 1.5937577s
Exhibit (a)(1)(D)
LETTER TO BROKERS, DEALERS,
COMMERCIAL BANKS, TRUST COMPANIES, AND OTHER NOMINEES
Offer to Exchange Warrants to Acquire Class A Ordinary Shares
of
Zura Bio Limited
for
Class A Ordinary Shares
of
Zura Bio Limited
and
Consent Solicitation
THE OFFER AND CONSENT SOLICITATION (EACH AS DEFINED BELOW) AND WITHDRAWAL RIGHTS WILL EXPIRE AT 11:59 P.M., EASTERN TIME, ON AUGUST 8, 2024, OR SUCH LATER TIME AND DATE TO WHICH THE COMPANY MAY EXTEND THE OFFER. IPO WARRANTS (AS DEFINED BELOW) TENDERED PURSUANT TO THE OFFER AND CONSENT SOLICITATION MAY BE WITHDRAWN PRIOR TO THE EXPIRATION DATE (AS DEFINED BELOW). CONSENTS MAY BE REVOKED ONLY BY WITHDRAWING THE TENDER OF THE RELATED WARRANTS AND THE WITHDRAWAL OF ANY IPO WARRANTS WILL AUTOMATICALLY CONSTITUTE A REVOCATION OF THE RELATED CONSENTS.
July 11, 2024
To Brokers, Dealers, Commercial Banks, Trust Companies, and Other Nominees:
Enclosed are the prospectus/offer to exchange, dated July 11, 2024 (as it may be amended and supplemented from time to time, the “Prospectus/Offer to Exchange”), and the related letter of transmittal and consent (as it may be amended and supplemented from time to time, the “Letter of Transmittal and Consent”), which together set forth the offer of Zura Bio Limited, a Cayman Islands exempted company (the “Company”), to each holder of the Company’s outstanding public warrants and private placement warrants that were issued in connection with our initial public offering to purchase the Company’s Class A Ordinary Shares, par value $0.0001 per share (“Class A Ordinary Shares”), to receive 0.30 Class A Ordinary Shares in exchange for each warrant tendered by the holder and exchanged pursuant to the offer (the “Offer”). The Offer is made solely upon the terms and conditions in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent. The Offer will be open until 11:59 p.m., Eastern Time, on August 8, 2024 or such later time and date to which the Company may extend the Offer. The period during which the Offer is open, giving effect to any withdrawal or extension, is referred to as the “Offer Period.” The date and time at which the Offer Period ends is referred to as the “Expiration Date.”
The Offer is being made to all holders of:
•
the warrants that were (i) sold as part of the units in connection with the initial public offering of JATT Acquisition Corp (“JATT”), the Company’s predecessor and a Cayman Islands exempted company consummated on July 16, 2021 (the “IPO”) (whether they were purchased in the IPO or thereafter in the open market) or (ii) initially issued as private placement warrants to certain parties in connection with the IPO that have been transferred to any person other than permitted transferees (collectively, the “public warrants”); and
•
the warrants that were issued to certain parties in a private placement in connection with the closing of the IPO that have not become public warrants as a result of being transferred to any person other than permitted transferees (the “private placement warrants” and, together with the public warrants, the “IPO warrants”). For the avoidance of doubt, the IPO warrants do not include the pre-funded warrants the Company issued in 2023 and 2024.
Each IPO warrant entitles the holder to purchase one Class A Ordinary Share at a price of $11.50 per share, subject to adjustment. The public warrants are quoted on The Nasdaq Capital Market (the “Nasdaq”)
under the symbol “ZURAW.” As of July 10, 2024 a total of 12,809,996 IPO warrants were outstanding, including our public warrants and private placement warrants. Pursuant to the Offer, the Company is offering up to an aggregate of 3,842,999 Class A Ordinary Shares in exchange for the IPO warrants.
Each holder whose IPO warrants are exchanged pursuant to the Offer will receive 0.30 Class A Ordinary Shares for each IPO warrant tendered by such holder and exchanged. Any IPO warrant holder that participates in the Offer may tender less than all of its IPO warrants for exchange.
No fractional shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of Class A Ordinary Shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes. The Company’s obligation to complete the offer is not conditioned on the receipt of a minimum number of tendered public warrants.
Concurrently with the Offer, the Company is also soliciting consents from holders of the IPO warrants to amend that certain warrant agreement, dated as of July 16, 2021, by and between the Company (as successor to JATT) and Continental Stock Transfer & Trust Company (“CST”), as warrant agent (together, the “Warrant Agreement”) to permit the Company to require that each IPO warrant that is outstanding upon the closing of the Offer be exchanged for 0.27 Class A Ordinary Shares, which is a ratio 10% less than the exchange ratio applicable to the Offer.
Pursuant to the terms of the Warrant Agreement, the proposed Warrant Amendment requires the vote or written consent of holders of at least a majority of the outstanding public warrants and a majority of the outstanding private placement warrants.
Parties representing approximately 40.7% of the outstanding public warrants and 65.3% of the outstanding private placement warrants have agreed to tender their public warrants and private placement warrants (as applicable) in the Offer and consent to the Warrant Amendment in the Consent Solicitation pursuant to a tender and support agreement. Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants agree to consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described on the Offer and Consent Solicitation are satisfied or waived, then the Warrant Amendment will be adopted.
Holders of IPO warrants may not consent to the Warrant Amendment without tendering IPO warrants in the Offer and holders may not tender such IPO warrants without consenting to the Warrant Amendment. The consent to the Warrant Amendment is a part of this Letter of Transmittal and Consent relating to the IPO warrants and, therefore, by tendering IPO warrants for exchange, holders will be delivering to us their consent to the Warrant Amendment. Warrant holders may revoke consent at any time prior to the Expiration Date by withdrawing the IPO warrants holders have tendered in the Offer.
Warrants not exchanged for our Class A Ordinary Shares pursuant to the Offer will remain outstanding subject to their current terms, or amended terms if the Warrant Amendment is approved. If the Warrant Amendment is approved, the Company intends to require the exchange of all outstanding IPO warrants for Class A Ordinary Shares as provided in the Warrant Amendment.
THE OFFER AND CONSENT SOLICITATION IS NOT MADE TO THOSE HOLDERS WHO RESIDE IN STATES OR OTHER JURISDICTIONS WHERE AN OFFER, SOLICITATION, OR SALE WOULD BE UNLAWFUL.
Enclosed with this letter are copies of the following documents:
(1) the Prospectus/Offer to Exchange;
(2) the Letter of Transmittal and Consent, for your use in accepting the Offer, providing your consent to the Warrant Amendment, and tendering IPO warrants for exchange and for the information of your clients for whose accounts you hold IPO warrants registered in your name or in the name of your nominee. Manually signed copies of the Letter of Transmittal and Consent may be used to tender IPO warrants and provide consent;
(3) the Notice of Guaranteed Delivery to be used to accept the Offer in the event (i) the procedure for book-entry transfer cannot be completed on a timely basis or (ii) time will not permit all required documents to reach Continental Stock Transfer & Trust Company (the “Exchange Agent”) prior to the Expiration Date;
(4) a form of letter which may be sent by you to your clients for whose accounts you hold IPO warrants registered in your name or in the name of your nominee, including an Instructions Form provided for obtaining each such client’s instructions with regard to the Offer; and
(5) a return envelope addressed to Continental Stock Transfer & Trust Company.
Certain conditions to the Offer are described in the section of the Prospectus/Offer to Exchange entitled “The Offer and Consent Solicitation — General Terms — Conditions to the Offer and Consent Solicitation.”
We urge you to contact your clients promptly. Please note that the Offer and withdrawal rights will expire at 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which the Company may extend the Offer.
The Company will not pay any fees or commissions to any broker, dealer, or other person (other than the Exchange Agent, the information agent, dealer manager, and certain other persons, as described in the section of the Prospectus/Offer to Exchange entitled “Market Information, Dividends, and Related Stockholder Matters — Fees and Expenses”) for soliciting tenders of IPO warrants pursuant to the Offer. However, the Company will, on request, reimburse you for customary clerical and mailing expenses incurred by you in forwarding copies of the enclosed materials to your clients for whose accounts you hold IPO warrants.
Any questions you have regarding the Offer should be directed to, and additional copies of the enclosed materials may be obtained from, the information agent in the Offer:
The Information Agent for the Offer and Consent Solicitation is:
Alliance Advisors
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
Very truly yours,
Zura Bio Limited
Nothing contained in this letter or in the enclosed documents shall constitute you or any other person the agent of the Company, the Exchange Agent, the dealer manager, the information agent, or any affiliate of any of them, or authorize you or any other person to give any information or use any document or make any statement on behalf of any of them in connection with the Offer and Consent Solicitation other than the enclosed documents and the statements contained therein.
tm2418824-1_s4_DIV_16-exh99x4 - none - 1.9531335s
Exhibit (a)(1)(E)
LETTER TO CLIENTS OF BROKERS, DEALERS, COMMERCIAL BANKS, TRUST
COMPANIES, AND OTHER NOMINEES
Offer to Exchange Warrants to Acquire Class A Ordinary Shares
of
Zura Bio Limited
for
Class A Ordinary Shares
of
Zura Bio Limited
and
Consent Solicitation
THE OFFER AND CONSENT SOLICITATION (EACH AS DEFINED BELOW) AND WITHDRAWAL RIGHTS WILL EXPIRE AT 11:59 P.M., EASTERN TIME, ON AUGUST 8, 2024, OR SUCH LATER TIME AND DATE TO WHICH THE COMPANY MAY EXTEND THE OFFER. IPO WARRANTS (AS DEFINED BELOW) TENDERED PURSUANT TO THE OFFER AND CONSENT SOLICITATION MAY BE WITHDRAWN PRIOR TO THE EXPIRATION DATE (AS DEFINED BELOW). CONSENTS MAY BE REVOKED ONLY BY WITHDRAWING THE TENDER OF THE RELATED WARRANTS AND THE WITHDRAWAL OF ANY IPO WARRANTS WILL AUTOMATICALLY CONSTITUTE A REVOCATION OF THE RELATED CONSENTS.
July 11, 2024
To Our Clients:
Enclosed are the prospectus/offer to exchange, dated July 11, 2024 (as it may be amended and supplemented from time to time, the “Prospectus/Offer to Exchange”), and the related letter of transmittal and consent (as it may be amended and supplemented from time to time, the “Letter of Transmittal and Consent”), which together set forth the offer of Zura Bio Limited, a Cayman Islands exempted company (the “Company”), to each holder of the Company’s outstanding public warrants and private placement warrants that were issued in connection with our initial public offering to purchase the Company’s Class A Ordinary Shares, par value $0.0001 per share (“Class A Ordinary Shares”), to receive 0.30 Class A Ordinary Shares in exchange for each warrant tendered by the holder and exchanged pursuant to the offer (the “Offer”). The Offer is made solely upon the terms and conditions in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent. The Offer will be open until 11:59 p.m., Eastern Time, on August 8, 2024 or such later time and date to which the Company may extend the Offer. The period during which the Offer is open, giving effect to any withdrawal or extension, is referred to as the “Offer Period.” The date and time at which the Offer Period ends is referred to as the “Expiration Date.”
The Offer is being made to all holders of:
•
the warrants that were (i) sold as part of the units in connection with the initial public offering of JATT Acquisition Corp (“JATT”), the Company’s predecessor and a Cayman Islands exempted company consummated on July 16, 2021 (the “IPO”) (whether they were purchased in the IPO or thereafter in the open market) or (ii) initially issued as private placement warrants to certain parties in connection with the IPO that have been transferred to any person other than permitted transferees (collectively, the “public warrants”); and
•
the warrants that were issued to certain parties in a private placement in connection with the closing of the IPO that have not become public warrants as a result of being transferred to any person other than permitted transferees (the “private placement warrants” and, together with the public warrants, the “IPO warrants”). For the avoidance of doubt, the IPO warrants do not include the pre-funded warrants the Company issued in 2023 and 2024.
Each IPO warrant entitles the holder to purchase one Class A Ordinary Share at a price of $11.50 per share, subject to adjustment. The public warrants are quoted on The Nasdaq Capital Market (the “Nasdaq”)
under the symbol “ZURAW.” As of July 10, 2024 a total of 12,809,996 IPO warrants were outstanding, including our public warrants and private placement warrants. Pursuant to the Offer, the Company is offering up to an aggregate of 3,842,999 Class A Ordinary Shares in exchange for the IPO warrants.
Each holder whose IPO warrants are exchanged pursuant to the Offer will receive 0.30 Class A Ordinary Shares for each IPO warrant tendered by such holder and exchanged. Any IPO warrant holder that participates in the Offer may tender less than all of its IPO warrants for exchange.
No fractional shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of Class A Ordinary Shares on the Nasdaq on the last trading day of the Offer Period, less any applicable withholding taxes. The Company’s obligation to complete the offer is not conditioned on the receipt of a minimum number of tendered public warrants.
Concurrently with the Offer, the Company is also soliciting consents from holders of the IPO warrants to amend that certain warrant agreement, dated as of July 16, 2021, by and between the Company (as successor to JATT) and Continental Stock Transfer & Trust Company (“CST”), as warrant agent (together, the “Warrant Agreement”) to permit the Company to require that each IPO warrant that is outstanding upon the closing of the Offer be exchanged for 0.27 Class A Ordinary Shares, which is a ratio 10% less than the exchange ratio applicable to the Offer.
Pursuant to the terms of the Warrant Agreement, the proposed Warrant Amendment requires the vote or written consent of holders of at least a majority of the outstanding public warrants and a majority of the outstanding private placement warrants.
Parties representing approximately 40.7% of the outstanding public warrants and 65.3% of the outstanding private placement warrants have agreed to tender their public warrants and private placement warrants (as applicable) in the Offer and consent to the Warrant Amendment in the Consent Solicitation pursuant to a tender and support agreement. Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants agree to consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described on the Offer and Consent Solicitation are satisfied or waived, then the Warrant Amendment will be adopted.
Holders of IPO warrants may not consent to the Warrant Amendment without tendering IPO warrants in the Offer and holders may not tender such IPO warrants without consenting to the Warrant Amendment. The consent to the Warrant Amendment is a part of this Letter of Transmittal and Consent relating to the IPO warrants and, therefore, by tendering IPO warrants for exchange, holders will be delivering to us their consent to the Warrant Amendment. Warrant holders may revoke consent at any time prior to the Expiration Date by withdrawing the IPO warrants holders have tendered in the Offer.
Warrants not exchanged for our Class A Ordinary Shares pursuant to the Offer will remain outstanding subject to their current terms, or amended terms if the Warrant Amendment is approved. If the Warrant Amendment is approved, the Company intends to require the exchange of all outstanding IPO warrants for Class A Ordinary Shares as provided in the Warrant Amendment.
THE OFFER AND CONSENT SOLICITATION IS NOT MADE TO THOSE HOLDERS WHO RESIDE IN STATES OR OTHER JURISDICTIONS WHERE AN OFFER, SOLICITATION, OR SALE WOULD BE UNLAWFUL.
Please follow the instructions in this document and the related documents, including the accompanying Letter of Transmittal and Consent, to cause your IPO warrants to be tendered for exchange pursuant to the Offer and provide consent to the Warrant Amendment.
On the terms and subject to the conditions of the Offer, the Company will allow the exchange of all IPO warrants properly tendered before the Expiration Date and not properly withdrawn, at an exchange rate of 0.30 Class A Ordinary Shares for each IPO warrant so tendered.
We are the owner of record of IPO warrants held for your account. As such, only we can exchange and tender your IPO warrants, and then only pursuant to your instructions. We are sending you the Letter of Transmittal and Consent for your information only; you cannot use it to exchange and tender IPO warrants we hold for your account, nor to provide consent to the Warrant Amendment.
Please instruct us as to whether you wish us to tender for exchange any or all of the IPO warrants we hold for your account, on the terms and subject to the conditions of the Offer.
Please note the following:
(1) Your IPO warrants may be exchanged at the exchange rate of 0.30 Class A Ordinary Shares for every one of your IPO warrants properly tendered for exchange.
(2) The Offer is made solely upon the terms and conditions set forth in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent. In particular, please see “The Offer and Consent Solicitation — General Terms — Conditions to the Offer and Consent Solicitation” in the Prospectus/Offer to Exchange.
(3) By tendering your IPO warrants for exchange, you are concurrently consenting to the Warrant Amendment. You may not consent to the Warrant Amendment without tendering your IPO warrants in the Offer and you may not tender your IPO warrants without consenting to the Warrant Amendment.
(4) The Offer and withdrawal rights will expire at 11:59 p.m., Eastern Time, on August 8, 2024 or such later time and date to which the Company may extend the Offer.
If you wish to have us tender any or all of your IPO warrants for exchange pursuant to the Offer and Consent Solicitation, please so instruct us by completing, executing, detaching, and returning to us the attached Instructions Form. If you authorize us to tender your IPO warrants, we will tender for exchange all of your IPO warrants unless you specify otherwise on the attached Instruction Form.
Your prompt action is requested. Your Instruction Form should be forwarded to us in ample time to permit us to submit a tender on your behalf before the Expiration Date. Please note that the Offer and withdrawal rights will expire at 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which the Company may extend the Offer.
The board of directors of the Company has approved the Offer and Consent Solicitation. However, neither the Company nor any of its management, its board of directors, the dealer manager, the information agent, or the exchange agent for the Offer is making any recommendation as to whether holders of IPO warrants should tender IPO warrants for exchange in the Offer and Consent Solicitation. The Company has not authorized any person to make any recommendation. You should carefully evaluate all information in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent, and should consult your own investment and tax advisors. You must decide whether to have your IPO warrants exchanged and, if so, how many IPO warrants to have exchanged. In doing so, you should read carefully the information in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent.
Instructions Form
Offer to Exchange Warrants to Acquire Class A Ordinary Shares
of
Zura Bio Limited
for
Class A Ordinary Shares
of
Zura Bio Limited
and
Consent Solicitation
The undersigned acknowledges receipt of your letter and the enclosed prospectus/offer to exchange dated July 11, 2024 (the “Prospectus/Offer to Exchange”), and the related letter of transmittal and consent (as it may be amended and supplemented from time to time, the “Letter of Transmittal and Consent”), which together set forth the offer of Zura Bio Limited, a Cayman Islands exempted company (the “Company”), to each holder of the Company’s outstanding public warrants and private placement warrants that were issued in connection with our initial public offering (collectively, the “IPO warrants”) to purchase the Company’s Class A Ordinary Shares, par value $0.0001 per share (“Class A Ordinary Shares”).
The undersigned hereby instructs you to tender for exchange the number of IPO warrants indicated below or, if no number is indicated, all IPO warrants you hold for the account of the undersigned, on the terms and subject to the conditions set forth in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent.
By participating in the Offer, the undersigned acknowledges that: (i) the Offer and Consent Solicitation are made solely only upon the terms and conditions in the Prospectus/Offer to Exchange and in the Letter of Transmittal and Consent; (ii) upon and subject to the terms and conditions set forth in the Prospectus/Offer to Exchange and the Letter of Transmittal and Consent, IPO warrants properly tendered and accepted and not validly withdrawn constitute the undersigned’s validly delivered consent to the Warrant Amendment; (iii) the Offer will be open until 11:59 p.m., Eastern Time, on August 8, 2024 or such later time and date to which the Company may extend the Offer (the period during which the Offer is open, giving effect to any withdrawal or extension, is referred to as the “Offer Period”); (iv) the Offer is established voluntarily by the Company, it is discretionary in nature, and it may be extended, modified, suspended, or terminated by the Company as provided in the Prospectus/Offer to Exchange; (v) the undersigned is voluntarily participating in the Offer and is aware of the conditions of the Offer; (vi) the future value of the Class A Ordinary Shares and the IPO warrants is unknown and cannot be predicted with certainty; (vii) the undersigned has received and read the Prospectus/Offer to Exchange and the Letter of Transmittal and Consent; and (viii) regardless of any action that the Company takes with respect to any or all income/capital gains tax, social security or insurance, transfer tax, or other tax-related items (“Tax Items”) related to the Offer and the disposition of IPO warrants, the undersigned acknowledges that the ultimate liability for all Tax Items is and remains the responsibility solely of the undersigned. In that regard, the undersigned authorizes the Company to withhold all applicable Tax Items legally payable by the undersigned.
Number of IPO warrants to be exchanged by you for the account of the undersigned:
*
No fractional shares will be issued pursuant to the Offer. In lieu of issuing fractional shares, any holder of IPO warrants who would otherwise have been entitled to receive fractional shares pursuant to the Offer will, after aggregating all such fractional shares of such holder, be paid cash (without interest) in an amount equal to such fractional part of a share multiplied by the last sale price of the Class A Ordinary Shares on The Nasdaq Capital Market on the last trading day of the Offer Period, less any applicable withholding taxes. The Company’s obligation to complete the offer is not conditioned on the receipt of a minimum number of tendered IPO warrants.
**
Unless otherwise indicated it will be assumed that all IPO warrants held by us for your account are to be exchanged.
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Exhibit (a)(5)
Zura Bio Commences Warrant Exchange Offer and
Consent Solicitation
Henderson, NV, July 12, 2024 – Zura
Bio Limited (NASDAQ: ZURA) (“Zura Bio” or the “Company”), a clinical-stage immunology company developing novel
dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that it has commenced an exchange offer (the “Offer”)
and consent solicitation (the “Consent Solicitation”) relating to its outstanding (i) public warrants that were issued in
connection with its initial public offering to purchase Class A ordinary shares of the Company, par value $0.0001 per share (the “Class
A ordinary shares”), which warrants trade on The Nasdaq Capital Market under the symbol “ZURAW” (the “public
warrants”), and (ii) private placement warrants that were issued in connection with its initial public offering to purchase Class
A ordinary shares (the “private placement warrants” and, together with the public warrants, the “IPO warrants”).
The purpose of the Offer and Consent Solicitation is to simplify the Company’s capital structure and reduce the potential dilutive
impact of the IPO warrants.
Exchange Offer and Consent Solicitation Relating to Warrants
The Company is offering to all holders of the
IPO warrants the opportunity to receive 0.30 Class A ordinary shares in exchange for each outstanding IPO warrant tendered by the
holder and exchanged pursuant to the Offer. Pursuant to the Offer, the Company is offering up to an aggregate of 3,842,999 Class A ordinary
shares in exchange for the IPO warrants.
Concurrently with the Offer, the Company is also
soliciting consents from holders of the IPO warrants to amend the warrant agreement that governs all of the IPO warrants (the “Warrant
Agreement”) to permit the Company to require that each warrant that is outstanding upon the closing of the Offer be exchanged for
0.27 Class A ordinary shares, which is a ratio 10% less than the exchange ratio applicable to the Offer (such amendment, the “Warrant
Amendment”). Pursuant to the terms of the Warrant Agreement, all except certain specified modifications or amendments require the
vote or written consent of holders of at least a majority of the outstanding public warrants and a majority of the private placement warrants.
Parties representing approximately 40.7% of the outstanding public warrants and 65.3% of the outstanding private placement warrants have
agreed to tender their IPO warrants in the Offer and to consent to the Warrant Amendment in the Consent Solicitation pursuant to a tender
and support agreement. Accordingly, if holders of an additional approximately 9.3% of the outstanding public warrants consent to the Warrant
Amendment in the Consent Solicitation, and the other conditions described herein are waived, then the Warrant Amendment will be adopted.
The offering period will continue until 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date to which the Company
may extend (the “Expiration Date”), as described in the Company’s Schedule TO and Prospectus/Offer to Exchange (each
as defined below). Tendered IPO warrants may be withdrawn by holders at any time prior to the Expiration Date.
The Offer and Consent Solicitation are being made
pursuant to a prospectus/offer to exchange, dated July 11, 2024 (the “Prospectus/Offer to Exchange”), and Schedule TO, dated
July 12, 2024 (the “Schedule TO”), each of which has been filed with the U.S. Securities and Exchange Commission (the “SEC”)
and more fully set forth the terms and conditions of the Offer and Consent Solicitation.
The Company’s Class A ordinary shares and
public warrants are listed on The Nasdaq Capital Market under the symbols “ZURA” and “ZURAW,” respectively. As
of July 10, 2024, there were (i) 63,746,453 Class A ordinary shares outstanding, and (ii) a total of 12,809,996 IPO warrants were outstanding,
including our public warrants and private placement warrants. Assuming all IPO warrant holders tender their IPO warrants for exchange
in the Offer, the Company would expect to issue up to 3,842,999 Class A ordinary shares, resulting in 67,589,452 Class A ordinary shares
outstanding (an increase of approximately 6%), and no public or private placement warrants outstanding.
The Company has engaged Cantor Fitzgerald &
Co. as the dealer manager for the Offer and Consent Solicitation (the “Dealer Manager”). Any questions or requests for assistance
concerning the Offer and Consent Solicitation may be directed to the Dealer Manager at (212) 915-1800 (toll-free).
Alliance Advisors has been appointed as the information
agent for the Offer and Consent Solicitation (the “Information Agent”), and Continental Stock Transfer & Trust Company
has been appointed as the exchange agent (the “Exchange Agent”). Any questions or requests for assistance concerning the Offer
and Consent Solicitation may be directed to the Information Agent at:
Alliance Advisors, LLC
200 Broadacres Drive, 3rd Floor
Bloomfield, New Jersey 07003
Call Toll Free: 1-844-717-2302
Email: zura@allianceadvisors.com
Important Additional Information Has Been Filed
with the SEC
Copies of the Schedule TO and Prospectus/Offer
to Exchange will be available free of charge at the website of the SEC at www.sec.gov. Requests for documents may also be directed to
the Information Agent at 1-844-717-2302 or via the following email address: zura@allianceadvisors.com. A registration statement on Form
S-4 relating to the securities to be issued in the Offer has been filed with the SEC but has not yet become effective. Such securities
may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.
This announcement is for informational purposes
only and shall not constitute an offer to purchase or a solicitation of an offer to sell the IPO warrants or an offer to sell or a solicitation
of an offer to buy any Class A ordinary shares in any state in which such offer, solicitation, or sale would be unlawful before registration
or qualification under the laws of any such state. The Offer and Consent Solicitation are being made only through the Schedule TO and
Prospectus/Offer to Exchange, and the complete terms and conditions of the Offer and Consent Solicitation are set forth in the Schedule
TO and Prospectus/Offer to Exchange.
Holders of the IPO warrants are urged to read
the Schedule TO and Prospectus/Offer to Exchange carefully before making any decision with respect to the Offer and Consent Solicitation
because they contain important information, including the various terms of, and conditions to, the Offer and Consent Solicitation.
None of the Company, any of its management or
its board of directors, or the Information Agent, the Exchange Agent, or the Dealer Manager makes any recommendation as to whether or
not holders of IPO warrants should tender IPO warrants for exchange in the Offer or consent to the Warrant Amendment in the Consent Solicitation.
About Zura Bio
Zura Bio is a clinical-stage,
multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio
is developing three assets which have completed Phase 1/1b studies and are Phase 2 ready. The company is developing a portfolio of therapeutic
indications for tibulizumab (ZB-106), ZB-168, and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing
convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements
within the meaning of the federal securities laws, including statements regarding the expected timing of the Offer and Consent Solicitation.
These forward-looking statements generally are identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,”
“plan,” “may,” “should,” “will,” “would,” “will be,” “will
continue,” “will likely result,” and similar expressions, but the absence of these words does not mean that a statement
is not forward-looking. Forward-looking statements are predictions, projections, and other statements about future events that are based
on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future
events to differ materially from the forward-looking statements in this press release, including, but not limited to those described under
the section entitled “Risk Factors” in the Company’s Registration Statement on Form S-4, filed with the SEC on July
11, 2024, as such factors may be updated from time to time in the Company’s periodic filings with the SEC, which are accessible
on the SEC’s website at www.sec.gov.
New risks emerge from time to time. It is not
possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any
factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press
release may not occur and actual results could differ materially and adversely from those anticipated.
Forward-looking statements speak only as of the
date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and we assume no obligation and do
not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. We
do not give any assurance that we will achieve our expectations.
CONTACT
Megan K. Weinshank
Head of Investor Relations
ir@zurabio.com
Exhibit (d)(xxxxxxii)
DEALER MANAGER AGREEMENT
July 11, 2024
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
Ladies and Gentlemen:
Zura Bio Limited, a Cayman Islands exempted company
(the “Company” or “we”), plans to make an offer (such offer as described in the Prospectus (as defined
below), together with the related Consent Solicitation (as defined below), the “Exchange Offer”), for any and all of
its outstanding public warrants and private placement warrants, in each case, issued in connection with the Company’s initial public
offering (as set forth in the Prospectus) (“IPO Warrants”) in exchange for consideration consisting of 0.3 Class A
ordinary shares, par value $0.0001 per share (the “Shares”), of the Company for each IPO Warrant tendered, on the terms
and subject to the conditions set forth in the Offering Documents. Certain terms used herein are defined in Section 19 of this Dealer
Manager and Solicitation Agent Agreement (this “Agreement”).
Concurrently with making the offer to exchange
described in the preceding paragraph, the Company plans to solicit consents (the “Consents”) from the holders of IPO
Warrants (as described in the Offering Documents, the “Consent Solicitation”) to make certain amendments to the terms
of the IPO Warrants. Subject to the terms and conditions set forth in the Offering Documents, if Consents are received from the holders
of a majority of the outstanding public warrants and a majority of the outstanding private warrants (which is the minimum number required
to amend that certain warrant agreement, dated as of July 16, 2021, by and between the Company (as successor to JATT Acquisition
Corp, a Cayman Islands exempted company and the Company’s predecessor) and Continental Stock Transfer & Trust Company (the
“Warrant Agreement”) as contemplated in the Offering Documents), the proposed amendment to the Warrant Agreement set
forth in the Offering Documents shall be adopted.
Any reference herein to the Pre-Effective Registration
Statement, the Registration Statement, the Preliminary Prospectus or the Prospectus shall be deemed to refer to and include the documents
incorporated by reference therein pursuant to Item 13 of Form S-4, if applicable, which were filed under the Exchange Act on or before
the filing of the Pre-Effective Registration Statement, the Effective Date or the issue date of the Preliminary Prospectus or the Prospectus,
as the case may be; and any reference herein to the terms “amend,” “amendment” or “supplement” with
respect to the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus or the Prospectus shall be
deemed to refer to and include the filing of any document under the Exchange Act after the initial filing of the Pre-Effective Registration
Statement, the Effective Date or the issue date of the Preliminary Prospectus or the Prospectus, as the case may be, deemed to be incorporated
therein by reference.
| 1) | Appointment as Dealer Manager and Solicitation Agent. |
| (a) | Cantor Fitzgerald & Co. will act as the exclusive dealer manager and solicitation agent for the
Exchange Offer and the Consent Solicitation (the “Dealer Manager” or “you”) in accordance with your
customary practices, including, without limitation, to use commercially reasonable efforts to solicit tenders pursuant to the Exchange
Offer, the solicitation of Consents pursuant to the Consent Solicitation and assisting in the distribution of the Offering Documents and
to perform such services as are customarily performed by investment banking firms acting as dealer managers and solicitation agents of
an exchange offer of like nature. |
| (b) | You agree that all actions taken by you as Dealer Manager have complied and will comply in all material
respects with all applicable laws, regulations and rules of the United States, including, without limitation, the applicable rules and
regulations of the registered national securities exchanges of which you are a member and of FINRA. |
| (c) | The Dealer Manager, in its sole discretion, may continue to own or dispose of, in any manner it may elect,
any IPO Warrants it may beneficially own at the date hereof or hereafter acquire, in any such case, subject to applicable law. The Dealer
Manager has no obligation to the Company, pursuant to this Agreement or otherwise, to tender or refrain from tendering IPO Warrants beneficially
owned by it in any Exchange Offer (or to deliver Consents in any related Consent Solicitation). The Dealer Manager acknowledges and agrees
that if any Exchange Offer is not consummated for any reason, the Company shall have no obligation, pursuant to this Agreement or otherwise,
to acquire any IPO Warrants from the Dealer Manager or otherwise to hold the Dealer Manager harmless with respect to any losses it may
incur in connection with the resale to any third parties of any IPO Warrants. |
| (d) | The Company agrees that it will not file, use or publish any material in connection with the Exchange
Offer, use the name Cantor, Cantor Fitzgerald or Cantor Fitzgerald & Co. or refer to you or your relationship with the Company,
without your prior written consent to the form of such use or reference. There shall be no fee for any such permitted use or reference
other than as set forth herein. |
| 2) | Compensation. The Company shall pay to you, promptly after the Expiration Date or as otherwise
set forth in that certain engagement letter, dated July 1, 2024 (the “Engagement Letter”), in respect of your
services as Dealer Manager, the fee set forth in the Engagement Letter. All costs and expenses of the Company associated with the Exchange
Offer are for the account of the Company whether or not the Exchange Offer is consummated. These expenses will include, but are not limited
to, expenses relating to the preparation, printing and delivery of any offering materials, tender offer materials and registration statement
for the Exchange Offer, and trustee, depositary, exchange and information agent, transfer agent or registrar’s fees, listing or
filing fees, roadshow expenses, and the fees and expenses of accountants, rating agencies, and legal counsel to the Company, as applicable.
In addition, the Company shall also promptly reimburse you, upon a request made, for the reasonable fees, costs and out-of-pocket expenses
as set forth in the Engagement Letter. |
| 3) | Representations and Warranties. The Company represents and warrants to, and agrees with, you as
set forth below in this Section 3: |
| (a) | Form S-4. The Company has prepared and, on or about the date hereof, has filed with the Commission
the Pre-Effective Registration Statement on Form S-4, including a related Preliminary Prospectus, for registration under the Securities
Act of the Shares in connection with the Exchange Offer. If the Exchange Offer is to be consummated, the Pre-Effective Registration Statement,
as amended, will have been declared effective by the Commission prior to the Expiration Date and any request on the part of the Commission
or any other federal, state or local or other governmental or regulatory agency, authority or instrumentality or court or arbitrator for
the amending or supplementing of the Offering Documents or for additional information will have been complied with in all material respects
prior to the Expiration Date. The Company meets the conditions for the use of Form S-4 with respect to the Pre-Effective Registration
Statement and the Registration Statement in connection with the Exchange Offer as contemplated by this Agreement. |
| (b) | Pre-Effective Registration Statement, Registration Statement, Preliminary Prospectus and Prospectus.
(i) The Pre-Effective Registration Statement and any amendment thereto, as of the Commencement Date, the Registration Statement,
as of the Effective Date, the Expiration Date and the Exchange Date, and the Preliminary Prospectus and any amendments and supplements
thereto, as of its date, the Commencement Date and the Exchange Date, comply, or will comply, as applicable, in all material respects
with the Securities Act and the Exchange Act and the rules and regulations of the Commission thereunder (including Rule 13e-4
and Rule 14e under the Exchange Act), (ii) the Prospectus (together with any supplement and amendment thereto), as of the date
it is first filed in accordance with Rule 424(b) under the Securities Act (if it is so filed) and the Exchange Date, will comply
in all material respects with the Securities Act and the Exchange Act and the rules and regulations of the Commission thereunder
(including Rule 13e-4 and Rule 14e under the Exchange Act), (iii) the Pre-Effective Registration Statement together with
any amendment thereto as of the Commencement Date did not contain, and the Registration Statement, as of the Effective Date, the Expiration
Date and the Exchange Date, will not contain, any untrue statement of a material fact and did not omit, or will not omit, as applicable,
to state a material fact required to be stated therein or necessary to make the statements therein not misleading, (iv) the Preliminary
Prospectus as of its date did not contain any untrue statement of a material fact and did not omit to state a material fact necessary
to make the statements therein, in the light of the circumstances under which they were made, not misleading and (v) the Prospectus
(together with any supplement or amendment thereto), as of the date it is first filed in accordance with Rule 424(b) (if required),
the Expiration Date and the Exchange Date, will not contain any untrue statement of a material fact and will not omit to state a material
fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided,
however, that the Company makes no representations or warranties as to the information contained in or omitted from the Pre-Effective
Registration Statement, the Registration Statement, any Preliminary Prospectus or the Prospectus (or any supplement or amendment thereto)
in reliance upon and in conformity with information furnished to the Company in writing by or on behalf of the Dealer Manager expressly
for inclusion therein (the “Dealer Manager Information”), it being understood that the Dealer Manager Information shall
include only the name and the contact information of the Dealer Manager. |
| (c) | Documents Incorporated by Reference. The documents incorporated by reference in the Schedule TO,
other than the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, which
are addressed in the prior paragraph, when they became effective or were filed with the Commission, as the case may be, conformed in all
material respects to the requirements of the Securities Act or the Exchange Act, as applicable, and the rules and regulations of
the Commission thereunder, and none of such documents contained an untrue statement of a material fact or omitted to state a material
fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided,
however, that this representation and warranty shall not apply to those portions of any documents so incorporated by reference
that are not specifically incorporated by reference therein and or to any statements or omissions made in reliance upon and in conformity
with the Dealer Manager Information. |
| (d) | Schedule TO. (i) On the Commencement Date, the Company will duly file with the Commission
the Schedule TO pursuant to Rule 13e-4 promulgated by the Commission under the Exchange Act, a copy of which Schedule TO (including
the documents required by Item 12 thereof to be filed as exhibits thereto) in the form in which it is to be so filed has been or will
be furnished to the Dealer Manager; (ii) any amendments to the Schedule TO and the final form of all such documents filed with the
Commission or published, sent or given to holders of IPO Warrants will be furnished to you prior to any such amendment, filing, publication
or distribution; (iii) the Schedule TO as so filed and as amended or supplemented from time to time will comply in all material respects
with the provisions of the Exchange Act and the rules and regulations thereunder; and (iv) the Schedule TO as filed or as amended
or supplemented from time to time will not contain any untrue statement of a material fact or omit to state a material fact necessary
in order to make the statements made therein, in light of the circumstances under which they are made, not misleading, except that the
Company makes no representation or warranty with respect to any statement contained in, or any matter omitted from, the Schedule TO made
in reliance upon and in conformity with the Dealer Manager Information. |
| (e) | No Stop Orders. No stop order suspending the effectiveness of the Registration Statement is in
effect, and no proceedings for such purpose or pursuant to Section 8A under the Securities Act are pending before or, to the knowledge
of the Company, threatened by the Commission. |
| (f) | Emerging Growth Company. From the time of initial filing of the Pre-Effective Registration Statement
with the Commission through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of
the Securities Act (an “Emerging Growth Company”). |
| (g) | Testing-the-Waters Materials. The Company (i) has not alone engaged in any Testing-the-Waters
Communication with any person other than Testing-the-Waters Communications with the consent of the Dealer Manager with entities that are
reasonably believed to be qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions
that are reasonably believed to be accredited investors within the meaning of Rule 501 under the Securities Act and (ii) has
not authorized anyone other than the Dealer Manager to engage in Testing-the-Waters Communications. The Company reconfirms that the Dealer
Manager has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed or
approved for distribution any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under
the Securities Act. “Testing-the-Waters Communication” means any communication with potential investors undertaken
in reliance on Section 5(d) or Rule 163B of the Securities Act. |
| (h) | Financial Statements. The financial statements included in each of the Pre-Effective Registration
Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, together with the related schedules and notes thereto,
comply as to form in all material respects with the applicable accounting requirements of the Securities Act and the Exchange Act, as
applicable, and present fairly in all material respects the consolidated financial position of the Company and its subsidiaries as of
the dates shown and its results of operations and cash flows for the periods shown, and such financial statements have been prepared in
conformity with generally accepted accounting principles in the United States (“U.S. GAAP”) applied on a consistent
basis throughout the periods covered thereby except for any normal year-end adjustments in the Company’s quarterly financial statements.
The other financial information included in each of the Pre-Effective Registration Statement, the Registration Statement, the Preliminary
Prospectus and the Prospectus has been derived from the accounting records of the Company and its consolidated subsidiaries and presents
fairly in all material respects the information shown thereby. The statistical, industry-related and market-related data included in each
of the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus are based on or
derived from sources which the Company reasonably and in good faith believes are reliable and accurate and such data is consistent with
the sources from which they are derived, in each case, in all material respects. |
| (i) | No Material Adverse Effect. Neither the Company nor any of its subsidiaries has, since the date
of the latest audited financial statements included or incorporated by reference in the Preliminary Prospectus, sustained any loss or
interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute
or court or governmental action, order or decree that is material to the Company and its subsidiaries, taken as a whole, otherwise than
as set forth or contemplated in the Preliminary Prospectus; and, since the respective dates as of which information is given or incorporated
by reference in the Preliminary Prospectus, there has not been any change in the capital stock (other than as a result of (x) the
exercise of stock options, the vesting of restricted stock or restricted stock units or the granting of stock options, restricted stock
or restricted stock units in the ordinary course of business pursuant to the Company’s equity plans that are described in the Preliminary
Prospectus or (y) the repurchase of Shares which were issued pursuant to the early exercise of stock options by option holders or
restricted stock awards issued pursuant to the Company’s equity plans that are described in the Preliminary Prospectus or (z) the
exercise of warrants or the issuance, if any, of Shares upon the conversion, exchange or exercise of Company securities) or long-term
debt of the Company and its subsidiaries, taken as a whole, or as would reasonably be expected, individually or in the aggregate, to have
a Material Adverse Effect, other than, in each case, as set forth or contemplated in the Preliminary Prospectus, or the ability of the
Company to perform its obligations under this Agreement, the consummation of the Exchange Offer and the consummation by the Company of
any other transactions contemplated by the Offering Documents. |
| (j) | Title to Real and Personal Property. The Company and its subsidiaries have good and marketable
title to all real property and good and marketable title to all personal property owned by them, in each case (other than, for the avoidance
of doubt, intellectual property, which is covered exclusively in subsection (aa) below), free and clear of all liens, encumbrances and
defects except such as do not materially affect the value of such property and do not materially interfere with the use made and proposed
to be made of such property by the Company and its subsidiaries; and any real property and buildings held under lease by the Company and
its subsidiaries are, to the Company’s knowledge, held by them under valid, subsisting and enforceable leases (subject to the effects
of (i) bankruptcy, insolvency, fraudulent conveyance, fraudulent transfer, reorganization, moratorium or similar laws relating to
or affecting the rights or remedies of creditors generally; (ii) the application of general principles of equity; and (iii) applicable
law and public policy with respect to rights to indemnity and contribution) with such exceptions as are not material and do not materially
interfere with the use made and proposed to be made of such property and buildings by the Company and its subsidiaries, taken as a whole. |
| (k) | Organization and Good Standing. The Company and each of its subsidiaries (i) has been duly
organized and is validly existing and in good standing under the laws of their respective jurisdiction of organization, with power and
authority (corporate and other) to own or lease its properties and conduct its business as described in each of the Pre-Effective Registration
Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, and (ii) where applicable, has been duly qualified
as a foreign corporation or other business entity for the transaction of business and is in good standing (to the extent that the concept
of good standing is applicable under the law of the relevant jurisdiction) under the laws of each other jurisdiction in which it owns
or leases properties or conducts any business so as to require such qualification, except where the failure to be so qualified or in good
standing or have such power or authority would not, individually or in the aggregate, have a Material Adverse Effect. |
| (l) | Capitalization. The Company has an authorized capitalization as set forth in the Pre-Effective
Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, and all of the outstanding shares of
capital stock of the Company have been duly and validly authorized and issued and are fully paid and non-assessable and (other than subsequent
issuances, if any, pursuant to reservations, agreements or employee benefit plans referred to in the Pre-Effective Registration Statement,
the Registration Statement, the Preliminary Prospectus and the Prospectus or pursuant to the exercise of convertible securities, warrants
or options referred to in the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus,
in each case as permitted pursuant to this Agreement) conform in all material respects to the description of the capital stock of the
Company contained in the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus;
and all of the outstanding shares of capital stock and equity interests of each subsidiary of the Company have been duly and validly authorized
and issued, are fully paid and non-assessable and (except, in the case of any foreign subsidiary, for directors’ qualifying shares)
are owned directly or indirectly by the Company, free and clear of all liens, encumbrances, equities or claims. |
| (m) | Required Filings. The Company has filed with the Commission pursuant to Rule 13e-4(c)(1) under
the Exchange Act (or Rule 425 under the Securities Act) or otherwise all written communications made by the Company or any Affiliate
of the Company in connection with or relating to the Exchange Offer or the Consent Solicitation that are required to be filed with the
Commission, in each case, on the date of their first use. |
| (n) | Compliance. The Company has complied in all material respects with the Securities Act and the Exchange
Act and the rules and regulations of the Commission thereunder in connection with the Exchange Offer, the Consent Solicitation, the
Offering Documents and the transactions contemplated hereby and thereby. The Company is subject to and in full compliance with the reporting
requirements of Section 13 or Section 15(d) of the Exchange Act. The Company has not received from the Commission any written
comments, questions or requests for modification of disclosure in respect of any Commission Reports, except for comments, questions or
requests (i) that have been satisfied by the provision of supplemental information to the staff of the Commission or (ii) in
respect of which the Company has agreed with the staff of the Commission to make a prospective change in future Commission Reports, of
which agreement the Dealer Manager and its counsel have been made aware. |
| (o) | Due Authorization. The Company has all requisite corporate power to execute, deliver and perform
its obligations under this Agreement. This Agreement has been duly and validly authorized, executed and delivered by the Company. |
| (p) | No Violation or Default. Neither the Company nor any of its subsidiaries is (i) in violation
of its Memorandum and Articles of Association (or equivalent organizational document) or (ii) in default in the performance or observance
of any material obligation, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement, lease or other
agreement or instrument to which it is a party or by which it or any of its properties may be bound, except, in the case of clause (ii) above,
for any such violation or default that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse
Effect. |
| (q) | No Conflicts. The execution, delivery and performance by the Company of this Agreement, the conduct
and consummation of the Exchange Offer and the consummation by the Company of any other transactions contemplated by this Agreement or
the Preliminary Prospectus and the Prospectus will not (i) conflict with or result in a breach or violation of any of the terms or
provisions of, or constitute a default under, any indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument
to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound or to which any
of the property or assets of the Company or any of its subsidiaries is subject, (ii) violate the provisions of the Memorandum and
Articles of Association (or equivalent organizational documents) of the Company or (iii) violate any statute or any order, rule or
regulation of any court or governmental agency or body having jurisdiction over the Company or any of its subsidiaries or any of their
properties, except, in the case of sub-clauses (i) and (iii), as would not reasonably be expected, individually or in the aggregate,
to have a Material Adverse Effect; and no consent, approval, authorization, order, registration or qualification of or with any such court
or governmental agency or body is required for the execution, delivery and performance by the Company of the Shares, the consummation
of the Exchange Offer and the consummation by the Company of any other transactions contemplated by this Agreement, except such consents,
approvals, authorizations, order, registrations or qualifications as would not, individually or in the aggregate, have a Material Adverse
Effect or as may be required by The Nasdaq Capital Market (“Nasdaq”) or under the securities or Blue Sky laws of the various
states or the rules and regulations of FINRA in connection with the offer and sale of the Shares. |
| (r) | No Legal Proceedings. There are no legal or governmental proceedings pending to which the Company
or any of its subsidiaries is a party or of which any property of the Company or any of its subsidiaries is the subject which, if determined
adversely to the Company or any of its subsidiaries, would reasonably be expected, individually or in the aggregate, to have a Material
Adverse Effect; and, to the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities
or threatened by others. |
| (s) | Investment Company Act. The Company is not, and after giving effect to the consummation of the
Exchange Offer and the Consent Solicitation will not be, an “investment company”, as such term is defined in the United States
Investment Company Act of 1940, as amended (the “Investment Company Act”). |
| (t) | No Solicitation. Neither the Company nor any person acting on its or their behalf (other than the
Dealer Manager, as to which no representation is made) has (i) solicited another to purchase any of its securities or (ii) soliciting
tenders or Consents by holders of IPO Warrants pursuant to the Exchange Offer (except as contemplated in this Agreement). |
| (u) | Integration. Within the preceding six months, neither the Company nor any other person acting on
behalf of the Company has offered or sold to any person any Securities, or any securities of the same or a similar class as the Shares,
that is or will be integrated with the sale of the Shares in a manner that would require registration of the Shares under the Securities
Act; |
| (v) | Sarbanes-Oxley; Internal Accounting Controls. Except as disclosed in the Pre-Effective Registration
Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, (A) the Company and its subsidiaries are in
compliance with the applicable requirements of the Sarbanes-Oxley Act of 2002, as amended, that are effective as of the date hereof, and
the applicable rules and regulations promulgated by the Commission thereunder that are effective as of the date hereof, as of the
Commencement Date and as of the Exchange Date; (B) the Company maintains a system of internal control over financial reporting (as
such term is defined in Rule 13a-15(f) of the Exchange Act) that complies with the requirements of the Exchange Act applicable
to the Company, and has been designed by the Company’s principal executive officer and principal financial officer, or under their
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles. Except as disclosed in the Pre-Effective
Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, the Company’s internal control
over financial reporting is effective and the Company is not aware of any material weaknesses in its internal control over financial reporting;
(C) since the date of the latest audited financial statements included or incorporated by reference in the Preliminary Prospectus,
and except as disclosed in the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus,
there has been no change in the Company’s internal control over financial reporting that has had a Material Adverse Effect, or is
reasonably likely to have a Material Adverse Effect, on the Company’s internal control over financial reporting; and (D) the
Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) of the Exchange Act) that comply
with the applicable requirements of the Exchange Act; such disclosure controls and procedures have been designed to provide reasonable
assurance that material information relating to the Company and its subsidiaries is made known to the Company’s principal executive
officer and principal financial officer by others within those entities; and, except as disclosed in the Pre-Effective Registration Statement,
the Registration Statement, the Preliminary Prospectus and the Prospectus, such disclosure controls and procedures are effective. |
| (w) | Independent Accountants. WithumSmith+Brown, PC, which has audited the consolidated financial statements
of the Company, is an independent registered public accounting firm as required by the Securities Act and the rules and regulations
of the Commission thereunder. |
| (x) | Foreign Corrupt Practices Act and UK Bribery Act 2010. None of the Company, any of its subsidiaries
or any director, officer (each in their capacity as such), nor, to the knowledge of the Company, any agent or employee (each in their
capacity as such) acting on behalf of the Company or any of its subsidiaries has (i) made any unlawful contribution, gift, entertainment
or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic
government official or employee from corporate funds; (iii) violated or is in violation of any applicable provision of the Foreign
Corrupt Practices Act of 1977; (iv) violated or is in violation of any provision of the Bribery Act 2010 of the United Kingdom; or
(v) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. |
| (y) | Compliance with Anti-Money Laundering Laws. The operations of the Company and its subsidiaries
are and have been conducted at all times in compliance with the requirements of applicable anti-money laundering laws, including, but
not limited to, the Bank Secrecy Act of 1970, as amended by the USA PATRIOT ACT of 2001, and the rules and regulations promulgated
thereunder, and the anti-money laundering laws of the various jurisdictions in which the Company and its subsidiaries conduct business
(collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental
agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws
is pending or, to the knowledge of the Company, threatened. |
| (z) | OFAC. None of the Company or any of its subsidiaries or, to the knowledge of the Company, any director,
officer, agent, employee or controlled affiliate of the Company or any of its subsidiaries is currently the subject or the target of any
sanctions administered or enforced by the U.S. Government, including, without limitation, the Office of Foreign Assets Control of the
U.S. Department of the Treasury (“OFAC”), or other relevant sanctions authority (collectively, “Sanctions”),
and the Company will not directly or indirectly use the proceeds of the offering of the Securities hereunder, or lend, contribute or otherwise
make available such proceeds to any subsidiary, joint venture partner or other person or entity (i) to fund or facilitate any activities
of or business with any person, or in any country or territory, that, at the time of such funding, is the subject or the target of Sanctions
or (ii) in any other manner that will result in a violation by any person (including any person participating in the transaction,
whether as underwriter, advisor, investor or otherwise) of Sanctions. |
| (aa) | Intellectual Property. Except as disclosed in the Pre-Effective Registration Statement, the Registration
Statement, the Preliminary Prospectus and the Prospectus, the Company and its subsidiaries own, possess, license or have other adequate,
valid and enforceable rights to use all foreign and domestic patents, patent applications, trade and service marks, trade and service
mark registrations, trade names, copyrights, licenses, inventions, trade secrets, technology, Internet domain names, know-how, other
unpatented or unpatentable proprietary or confidential information, systems or procedures, and other intellectual property (including
all registrations and applications for registration of the foregoing, as applicable) (collectively, the “Intellectual Property”)
used in, held for use in or necessary for the conduct of their respective businesses as now conducted except to the extent that the failure
to own, possess, license or otherwise hold adequate, valid and enforceable rights to use such Intellectual Property would not, individually
or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Pre-Effective Registration Statement,
the Registration Statement, the Preliminary Prospectus and the Prospectus, (i) to the Company’s knowledge, there is no infringement,
misappropriation, breach or default, or other violation by third parties of any Intellectual Property owned by, or purported to be owned
by, the Company or any of its subsidiaries; (ii) there is no pending or, to the Company’s knowledge, threatened action, suit,
proceeding or claim by any third party challenging the Company’s or any of its subsidiaries’ rights in or to any Intellectual
Property owned by, or purported to be owned by, or licensed to, the Company; (iii) there is no pending or, to the Company’s
knowledge, threatened action, suit, proceeding or claim by any third party challenging the validity, scope or enforceability of any Intellectual
Property owned by, or purported to be owned by, the Company or any of its subsidiaries; (iv) there is no pending or, to the Company’s
knowledge, threatened action, suit, proceeding or claim by any third party alleging that the Company or any of its subsidiaries has infringed,
misappropriated or otherwise violated any Intellectual Property of any third party, and in the case of each of clauses (ii)-(iv) above,
the Company is unaware of any facts which could form a reasonable basis for any such action, suit, proceeding or claim; (v) to the
Company’s knowledge, there are no rights of third parties (including any liens or encumbrances) to any Intellectual Property owned
by, or purported to be owned by, the Company or any of its subsidiaries, other than non-exclusive licenses granted in the ordinary course
of business; (vi) to the Company’s knowledge, there is no third-party U.S. patent or published U.S. patent application which
contains claims for which an Interference Proceeding (as defined in 35 U.S.C. § 135) has been commenced against any patent or patent
application described in the Offering Memorandum as being owned by or exclusively licensed to the Company; (vii) to the Company’s
knowledge, the Company and its subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property has
been licensed to the Company or such subsidiary, and, to the Company’s knowledge, all such agreements are in full force and effect;
(viii) the Company and its subsidiaries have at all times taken reasonable steps in accordance with normal industry practice to maintain
the confidentiality of all Intellectual Property, including confidential information and trade secrets, the value of which to the Company
or any subsidiary of the Company is contingent upon maintaining the confidentiality thereof; and (ix) to the Company’s knowledge,
all founders, current and former employees, consultants, and other parties involved in the development of Intellectual Property for the
Company or any of its subsidiaries have signed confidentiality and invention assignment agreements with the Company or any of its subsidiaries
pursuant to which the Company or any of its subsidiaries either (1) has obtained ownership of and is the exclusive owner of such
Intellectual Property, or (2) has obtained a valid right to exploit such Intellectual Property, sufficient for the conduct of the
respective business as currently conducted, except, in the case of any of clauses (i)-(ix) above, as would not, individually or in
the aggregate, result in a Material Adverse Effect. |
| (bb) | Taxes. The Company and each of its subsidiaries have filed all federal, state, local and foreign
tax returns which have been required to be filed, or have properly requested extensions thereof, and paid all taxes due thereon through
the date hereof, to the extent that such taxes have become due and are not being contested in good faith, except where the failure to
so file or pay would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. Except as disclosed
in the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus and the Prospectus, no tax deficiency
has been determined adversely to the Company or any of its subsidiaries which has had, or could have, individually or in the aggregate,
a Material Adverse Effect. The Company has no knowledge of any federal, state or other governmental tax deficiency, penalty or assessment
which has been or might be asserted or threatened against it which would reasonably be expected to have a Material Adverse Effect. |
| (cc) | Certain Environmental Matters. The Company and its subsidiaries (i) are in compliance with
any and all applicable federal, state, local and foreign laws, rules, regulations, decisions and orders relating to the protection of
human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental
Laws”); (ii) have received and are in compliance with all permits, licenses or other approvals required of them under applicable
Environmental Laws to conduct their respective businesses as described in the Prospectus; and (iii) have not received notice of any
actual or potential liability for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes,
pollutants or contaminants, except, in the case of any of clauses (i), (ii) or (iii) above, for any such failure to comply or
failure to receive required permits, licenses, other approvals or liability as would not, individually or in the aggregate, reasonably
be expected to have a Material Adverse Effect. The Company and its subsidiaries are not aware of any facts or issues regarding compliance
with Environmental Laws, or liabilities or other obligations under Environmental Laws, including the release or threat of release of hazardous
or toxic substances or wastes, pollutants or contaminants, that would reasonably be expected to have a material effect on the capital
expenditures, earnings or competitive position of the Company and its subsidiaries, and none of the Company and its subsidiaries anticipates
material capital expenditures relating to any Environmental Laws. |
| (dd) | Data Security. (i) To the Company’s knowledge, there has been no material security breach,
attack or other compromise of or relating to any of the Company’s or its subsidiaries’ information technology, computer systems,
networks, hardware, software, data (including the data of their respective customers, employees, suppliers, vendors or any third party
data collected, stored, maintained, or otherwise used or processed by or on behalf of them), equipment or technology (collectively, “IT
Systems and Data”), (ii) the Company and its subsidiaries have not been notified of, and have no knowledge of any event
or condition that would reasonably be expected to result in, any material security breach, attack or compromise to their IT Systems and
Data, (iii) the Company and its subsidiaries have complied, and are presently in compliance with, in all material respects, all applicable
laws, statutes or any judgment, order, rule or regulation of any court or arbitrator or governmental or regulatory authority and
all industry guidelines, standards, internal policies and contractual obligations relating to the use, processing, privacy and security
of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification,
and (iv) the Company and its subsidiaries have implemented backup and disaster recovery technology consistent with industry standards
and practice |
| (ee) | Data Privacy. The Company and its subsidiaries are, and at all prior times were, in material compliance
with (i) all applicable local, state, federal, and foreign data privacy and security laws, statutes, judgments, orders, and rules and
regulations of any court or arbitrator or any other governmental or regulatory authority, including, without limitation, all applicable
laws and regulations regarding the collection, use, transfer, export, storage, protection, disposal, disclosure or other processing by
or on behalf of the Company or any of its subsidiaries of Personal Data collected from or provided by third parties, including, without
limitation and to the extent applicable, the California Consumer Privacy Act of 2018, the European Union General Data Protection Regulation
(“GDPR”) (EU 2016/679) and the GDPR as it forms part of UK law by virtue of section 3 of the European Union (Withdrawal)
Act 2018 (collectively, the “Privacy Laws”), and (ii) all binding contractual obligations and binding industry
standards relating to any of the foregoing. To ensure compliance with the Privacy Laws, the Company and its subsidiaries have in place,
comply with and take commercially appropriate steps to ensure compliance in all material respects with their policies and procedures relating
to data privacy and security and the collection, storage, use, processing, disclosure, handling, and analysis of Personal Data (defined
below) (the “Policies”). “Personal Data” means (1) a natural person’s name, street address,
telephone number, e-mail address, photograph, social security number or tax identification number, driver’s license number, passport
number, credit card number, bank information, or customer or account number; (2) any information which would qualify as “personally
identifying information” under the Federal Trade Commission Act, as amended; (3) “personal data” as defined by
GDPR; and (4) any other piece of information that allows the identification of such natural person, or his or her family, or permits
the collection or analysis of any data related to an identified person’s health or sexual orientation. The Company has at all times
made all disclosures to users or customers required by applicable laws and regulatory rules or requirements, and none of such disclosures
made or contained in any Policy have been inaccurate, misleading, deceptive or in violation of any applicable laws and regulatory rules or
requirements in any material respect. The Company further certifies that neither it nor any subsidiary: (A) has received notice of
any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge
of any event or condition that would reasonably be expected to result in any such notice; (B) is currently conducting or paying for,
in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (C) is a party to
any order, decree, or agreement that imposes any obligation or liability under any Privacy Law. |
| (ff) | Consents and Permits. The Company and its subsidiaries have
made all filings, applications and submissions required by, possess and are operating in compliance with, all approvals, licenses, certificates,
certifications, clearances, consents, grants, exemptions, marks, notifications, orders, permits and other authorizations issued by, the
appropriate federal, state, provincial or foreign Governmental Authority (including, without limitation, the United States Food and Drug
Administration (the “FDA”), the European Medicines Agency (the “EMA”), the United Kingdom Medicines
and Healthcare products Regulatory Agency (the “MHRA”), or any other foreign, federal, state, provincial, court or
local government or regulatory authorities including self-regulatory organizations engaged in the regulation of clinical trials, pharmaceuticals,
biologics or biohazardous substances or materials) necessary for the ownership or lease of their respective properties or to conduct businesses
as described in the Preliminary Prospectus and Prospectus (collectively, “Permits”),
except for such Permits the failure of which to possess, obtain or make the same would not have a Material Adverse Effect; the Company
and its subsidiaries are in compliance with the terms and conditions of all such Permits, except where the failure to be in compliance
would not have a Material Adverse Effect; all of the Permits are valid and in full force and effect, except where any invalidity, individually
or in the aggregate, would not be reasonably expected to have a Material Adverse Effect; and neither the Company nor any of its subsidiaries
has received any written notice relating to the limitation, revocation, cancellation, suspension, modification or non-renewal of
any such Permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a Material
Adverse Effect, or has any reason to believe that any such license, certificate, permit or authorization will not be renewed in the ordinary
course. To the extent required by applicable laws and regulations of the FDA, the Company or the applicable subsidiary has submitted to
the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial is conducting or sponsoring;
all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies
have been asserted by the FDA with respect to any such submissions. The Company and each subsidiary possess such valid and current certificates,
authorizations or permits issued by the appropriate federal, state, provincial or foreign regulatory agencies or bodies necessary to conduct
their respective businesses, and neither the Company nor any subsidiary has received, or has any reason to believe that it will receive,
any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such certificate, authorization
or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could result in a Material
Adverse Effect. |
| (gg) | Regulatory Filings. Neither the Company nor any of its subsidiaries has failed to file with the
applicable governmental authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local governmental
authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report
or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; all such filings,
declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have
been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports
or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company
has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all
applicable rules and regulations of the FDA and other federal, state, local and foreign governmental authority exercising comparable
authority. |
| (hh) | Compliance with Health Care Laws. The Company and its directors,
officers and employees, and to the Company’s knowledge, its respective agents, affiliates and representatives, are, and at all times
have been, in material compliance with all Health Care Laws (as defined below), including, but not limited to, the rules and regulations
of the FDA, EMA and MHRA. For purposes of this Agreement, “Health Care Laws” shall mean the Federal Food, Drug and
Cosmetic Act (21 U.S.C. § 301 et seq.) as amended, and the Public Health Service Act (42 U.S.C. § 256b). The Company
is not a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement,
monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any Governmental Authority.
The Company has not received any notification, correspondence or any other written or oral communication, including, without limitation,
any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any
similar regulatory authority, or any notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation,
arbitration or other action, from any Governmental Authority of non-compliance by, or liability of, the Company or its subsidiaries
under any Health Care Laws. |
| (ii) | Clinical Studies. To the Company’s knowledge: the preclinical
studies and tests and clinical trials described in the Preliminary Prospectus and the Prospectus were and, if still pending, are being
conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant to, where applicable,
accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company;
and the descriptions of such studies, tests and trials, and the results thereof, contained in the Preliminary Prospectus and the Prospectus
are accurate in all material respects. The Company is not aware of any tests, studies or trials not described in the Preliminary Prospectus
and the Prospectus, the results of which reasonably call into question the descriptions of the tests, studies and trials as described
in the Preliminary Prospectus and the Prospectus; and the Company has not received any written notice or correspondence from the FDA or
any governmental authority exercising comparable authority or any institutional review board or comparable authority requiring the termination,
suspension, clinical hold or material modification of any tests, studies or trials. |
| (jj) | No Ratings. There is no debt of, or guaranteed by, the Company or any of its subsidiaries that
are rated by a “nationally recognized statistical rating organization,” as that term is defined in Section 3(a)(62) of
the Exchange Act. |
| (kk) | No Undisclosed Relationships. No relationship, direct or indirect, exists between or among the
Company or any of its subsidiaries, on the one hand, and the directors, officers, shareholders or other Affiliates of the Company or any
of its subsidiaries, on the other, that is required by the Securities Act to be described in each of the Pre-Effective Registration Statement,
the Registration Statement, the Preliminary Prospectus and the Prospectus and that is not so described in such documents. |
| (ll) | Compliance with ERISA. (i) Each employee benefit plan, within the meaning of Section 3(3) of
the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), that is sponsored or maintained by the Company
or with respect to which the Company would have any liability (each, a “Plan”) has been maintained in compliance with
its terms and the requirements of any applicable statutes, orders, rules and regulations, including, but not limited to, ERISA and
the Code; (ii) no prohibited transaction, within the meaning of Section 406 of ERISA or Section 4975 of the Code, has occurred
with respect to any Plan, excluding transactions effected pursuant to a statutory or administrative exemption; and (iii) each Plan
that is intended to be qualified under Section 401(a) of the Code is subject to a favorable determination, advisor or opinion
letter, as applicable, from the Internal Revenue Service, and nothing has occurred, whether by action or by failure to act, that, to the
knowledge of the Company, is reasonably likely to result in the revocation of any such determination, advisor or opinion letter, as applicable,
except in each case with respect to the events or conditions set forth in (i) through (iii) hereof, as would not reasonably
be expected to have a Material Adverse Effect. The Company does not have any obligations or liabilities with respect to any Plan that
is (i) a “pension plan” within the meaning of Section 3(2) of ERISA that is subject to Section 412 of
the Code or Title IV of ERISA or Section 302 of ERISA, or (ii) a “multiemployer plan” within the meaning of Section 3(37)
of ERISA. |
| (mm) | No Registration Rights. Except as disclosed in the Pre-Effective Registration Statement, the Registration
Statement, the Preliminary Prospectus and the Prospectus, no person has the right to require the Company or any of its subsidiaries to
register any securities for sale under the Securities Act by reason of the filing of the Pre-Effective Registration Statement or the Registration
Statement with the Commission. |
| (nn) | No Stabilization. Prior to the date hereof, the Company has not, and to its knowledge, none of
its affiliates acting on its behalf has, taken any action which is designed to or which has constituted or which would reasonably be expected
to cause or result in stabilization or manipulation of the price of any security of the Company in connection with the Exchange Offer
and in violation of Regulation M. |
| (oo) | Registration Fees. The Company has paid the registration fee for Registration Statement pursuant
to Rule 456(a) under the Securities Act or will pay such fee within the time period required by such rule and in any event
prior to the Exchange Date. |
Any certificate signed by any officer
of the Company and delivered to the Dealer Manager or counsel for the Dealer Manager in connection with the Exchange Offer shall be deemed
a representation and warranty by the Company as to matters covered thereby to the Dealer Manager. The Company acknowledges that, for purposes
of the opinions to be delivered pursuant to Section 6 hereof, counsel to the Company and counsel to the Dealer Manager will rely
upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
| 4) | Representations, Warranties and Agreements of the Dealer Manager. The Dealer Manager hereby represents,
warrants and agrees that the Dealer Manager will not (1) cause to be disseminated to holders, dealers or the public any written material
for or in connection with the Exchange Offer or Consent Solicitation other than one or more of the Offering Documents, or (2) make
any public oral communications relating to the Exchange Offer or the Consent Solicitation that have not been previously approved by the
Company except as contemplated in the penultimate sentence of Section 6 of this Agreement. |
| 5) | Agreements. The Company agrees with the Dealer Manager that: |
| (a) | The Company will furnish to the Dealer Manager and to counsel for the Dealer Manager, without charge,
during the period beginning on the Commencement Date and continuing to and including the Exchange Date, copies of the Offering Documents
and any amendments and supplements thereto in such quantities as the Dealer Manager may reasonably request. |
| (b) | Prior to the termination of the Exchange Offer and the Consent Solicitation, the Company will not file
any amendment to the Pre-Effective Registration Statement or the Registration Statement or supplement to the Preliminary Prospectus or
the Prospectus (other than an amendment or supplement as a result of filings by the Company under the Exchange Act of documents incorporated
by reference therein) unless the Company has furnished the Dealer Manager a copy of such proposed amendment or supplement, as applicable,
for its review prior to filing and will not file any such proposed amendment or supplement to which the Dealer Manager reasonably objects.
Subject to the foregoing sentence, if the Registration Statement has become or becomes effective, or filing of the Preliminary Prospectus
or the Prospectus is otherwise required under the Securities Act or the Exchange Act and the rules and regulations of the Commission
thereunder, the Company will cause the Preliminary Prospectus or the Prospectus, properly completed, and any supplement thereto to be
filed with the Commission pursuant to the applicable paragraph of Rule 424(b) or in an amendment to the Registration Statement,
whichever is applicable, within the time period prescribed. The Company will promptly advise the Dealer Manager (i) when the Registration
Statement, and any amendment thereto, shall have become effective, (ii) when the Preliminary Prospectus or the Prospectus, and any
supplement thereto, shall have been filed (if required) with the Commission, (iii) when, prior to termination of the Exchange Offer
and the Consent Solicitation, any amendment to the Registration Statement shall have been filed or become effective, (iv) of any
request by the Commission or its staff for any amendment of the Pre-Effective Registration Statement or the Registration Statement or
supplement to the Preliminary Prospectus or the Prospectus or for any additional information, (v) of the issuance by the Commission
of any stop order or of any order preventing or suspending the use of the Preliminary Prospectus or the Prospectus, or the initiation
or threatening of any proceeding for any such purpose, and (vi) of the receipt by the Company of any notification with respect to
the suspension of the qualification of the Shares for sale in any jurisdiction within the United States or the initiation or threatening
of any proceeding for such purpose. In the event of the issuance of any such stop order or of any such order preventing or suspending
the use of the Preliminary Prospectus or the Prospectus, the Company will use its reasonable best efforts to obtain its withdrawal. The
Company agrees to use its reasonable best efforts to cause the Registration Statement to become effective as soon as practicable and as
much in advance of the Expiration Date as practicable. |
| (c) | The Company will comply with the Securities Act and the Exchange Act and the rules and regulations
of the Commission thereunder so as to permit the completion of the distribution of the Shares issued in the Exchange Offer and Consent
Solicitation, as contemplated by this Agreement, the Registration Statement and the Prospectus. If, at any time when a prospectus relating
to the Exchange Offer or Consent Solicitation is required to be delivered under the Securities Act or the Exchange Act and the rules and
regulations of the Commission thereunder, any event occurs as a result of which the Offering Documents, as then amended or supplemented,
would include any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein, in
the light of the circumstances under which they were made, not misleading, or if it should be necessary to amend or supplement the Offering
Documents to comply with applicable law, the Company will promptly: (i) notify the Dealer Manager of any such event or non-compliance
at which time the Dealer Manager shall be entitled to cease soliciting tenders until such time as the Company has complied with clause
(iii) of this sentence; (ii) subject to the requirements of the first sentence of the above paragraph (b), prepare an amendment
or supplement that will correct such statement or omission or effect such compliance; and (iii) supply any such amendment or supplement
to the Dealer Manager and counsel for the Dealer Manager without charge in such quantities as the Dealer Manager may reasonably request.
The Company will also promptly inform the Dealer Manager of any litigation or administrative action with respect to the Exchange Offer. |
| (d) | The Company agrees to advise the Dealer Manager promptly of (i) any proposal by the Company to withdraw,
rescind or modify the Offering Documents or to withdraw, rescind or terminate the Exchange Offer or the Consent Solicitation or the exercise
by the Company of any right not to exchange the IPO Warrants pursuant to the Exchange Offer or the Consent Solicitation, (ii) its
awareness of the issuance of a stop order suspending the effectiveness of the Registration Statement or of any notice objecting to its
use by the Commission or any other regulatory authority, or the institution or threatening of any proceedings for that purpose (and will
promptly furnish the Dealer Manager with a copy of any such order), (iii) its awareness of the occurrence of any development that
could reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect relating to or affecting the Exchange
Offer or the Consent Solicitation and (iv) any other non-privileged information relating to the Exchange Offer, the Consent Solicitation,
the Offering Documents or this Agreement which the Dealer Manager may from time to time reasonably request. |
| (e) | The Company will make generally available (which may be satisfied by filing with the Commission’s
Electronic Data Gathering Analysis and Retrieval System) to its security holders and the Dealer Manager as soon as practicable an earning
statement (which need not be audited) that satisfies the provisions of Section 11(a) of the Securities Act and Rule 158
of the Commission promulgated thereunder covering a period of at least 12 months beginning with the first fiscal quarter of the Company
occurring after the “effective date”(as defined in Rule 158) of the Registration Statement. |
| (f) | The Company will arrange, if necessary, for the qualification of the Shares for offer or sale in connection
with the Exchange Offer under the laws of such jurisdictions as the Dealer Manager may designate and will maintain such qualifications
in effect so long as required for such offer or sale; provided that in no event shall the Company be obligated to qualify to do
business in any jurisdiction in which it is not now so qualified or to take any action that would subject it to service of process in
suits, other than those arising out of the offering or sale of the Shares in connection with the Exchange Offer, in any jurisdiction in
which it is not now so subject or to subject itself to taxation in any jurisdiction in which it is not now so subject. The Company will
promptly advise the Dealer Manager of the receipt by the Company of any notification with respect to the suspension of the qualification
of the Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose. |
| (g) | Prior to the termination of the Exchange Offer, the Company will not, and will not permit any of its Affiliates
to, resell any Shares that have been acquired by them. The Company will cause all IPO Warrants accepted in the Exchange Offer to be cancelled. |
| (h) | The Company will cooperate with the Dealer Manager to permit the Shares to be eligible for clearance and
settlement through The Depository Trust Company. |
| (i) | The Company agrees not to exchange any IPO Warrants during the period beginning on the Commencement Date
and ending on the Exchange Date except pursuant to and in accordance with the Exchange Offer, the Consent Solicitation or as otherwise
agreed to in writing by the parties hereto and permitted under applicable laws and regulations. |
| (j) | None of the Company, its Affiliates or any person acting on its or their behalf will take, directly or
indirectly, any action that is designed to cause or result, or which might reasonably be expected to cause or result, under the Exchange
Act or otherwise, in stabilization or manipulation of the price of any security of the Company to facilitate the sale of the Shares or
the tender of IPO Warrants in the Exchange Offer. |
| (k) | The Company has arranged for Alliance Advisors, LLC to serve as Information Agent and for Continental
Stock Transfer & Trust Company to serve as Exchange Agent and authorizes the Dealer Manager to communicate with each of the Information
Agent and the Exchange Agent to facilitate the Exchange Offer and the Consent Solicitation. |
| (l) | The Company will comply in all material respects with the Securities Act and the Exchange Act and the
rules and regulations of the Commission thereunder, including Rule 13e-4 and Rule 14e-1 under the Exchange Act (including
taking the actions necessary to ensure that the procedural requirements of Rule 14e-1 are satisfied), in connection with the Exchange
Offer, the Consent Solicitation, the Offering Documents and the transactions contemplated hereby and thereby. The Company will file with
the Commission pursuant to Rule 13e-4(c)(1) under the Exchange Act (or Rule 425 under the Securities Act) or otherwise
all written communications made by the Company or any Affiliate of the Company in connection with or relating to the Exchange Offer or
the Consent Solicitation that are required to be filed with the Commission, in each case on the date of their first use. |
| (m) | The Company agrees to pay the costs and expenses relating to the transactions contemplated hereunder,
including, without limitation, the following: (i) the preparation of this Agreement, the issuance of the Shares and the fees of the
Information Agent and the Exchange Agent; (ii) the preparation, printing or reproduction of the Offering Documents and each amendment
or supplement thereto; (iii) the printing (or reproduction) and delivery (including postage, air freight charges and charges for
counting and packaging) of such copies of the Offering Documents (and all amendments or supplements thereto) as may, in each case, be
reasonably requested for use in connection with the Exchange Offer; (iv) the preparation, authentication, issuance and delivery of
the Shares, including any stamp or transfer taxes in connection with the original issuance and sale of the Shares; (v) the printing
(or reproduction) and delivery of this Agreement, any blue sky memorandum and all other agreements or documents printed (or reproduced)
and delivered in connection with the Exchange Offer; (vi) any registration or qualification of the Shares for offer and sale under
the blue sky laws of the several states or any non-U.S. jurisdiction; (vii) transportation and other expenses incurred by or on behalf
of Company representatives in connection with presentations to prospective participants in the Exchange Offer; (viii) the fees and
expenses of the Company’s accountants and the fees and expenses of counsel (including local and special counsel) for the Company;
(ix) the fees and expenses incurred in connection with listing the Shares on Nasdaq; (x) the reasonable and documented fees,
costs and out-of-pocket expenses of counsel for the Dealer Manager as provided for in Section 2 hereof; and (xi) all other costs
and expenses incident to the performance by the Company of its obligations hereunder and in connection with the Exchange Offer. |
| (n) | The Company will promptly notify the Dealer Manager if the Company ceases to be an Emerging Growth Company
at any time prior to the Exchange Date. |
| 6) | Conditions to the Obligations of the Dealer Manager. The obligations of the Dealer Manager under
this Agreement shall be subject to the accuracy of the representations and warranties on the part of the Company contained herein at the
Commencement Date, any date on which Offering Documents are distributed to holders of the IPO Warrants, the Effective Date, the Expiration
Date and the Exchange Date, to the accuracy of the statements of the Company made in any certificates pursuant to the provisions hereof,
to the performance by the Company of its obligations hereunder and to the following additional conditions: |
| (a) | The Registration Statement shall have become effective on or prior to the Expiration Date. |
| (b) | As of the Exchange Date, no stop order suspending the effectiveness of the Registration Statement or any
notice objecting to its use shall have been issued and no proceedings for that purpose shall have been instituted or, to the knowledge
of the Company, threatened by the Commission; and the Prospectus shall have been timely filed with the Commission under the Securities
Act; and all requests by the Commission for additional information shall have been complied with to the reasonable satisfaction of the
Dealer Manager. |
| (c) | At the Commencement Date and the Exchange Date, the Company shall have requested and caused (i) an
opinion and negative assurance letter of Loeb & Loeb LLP, US counsel to the Company and (ii) an opinion of Ogier (Cayman)
LLP, Cayman Islands counsel to the Company, each dated as of the Commencement Date or Exchange Date, as applicable, to have been delivered
to the Dealer Manager, in each case addressed to, and in form and substance reasonably satisfactory to, the Dealer Manager. |
| (d) | At the Commencement Date and the Exchange Date, the Dealer Manager shall have received from DLA Piper
LLP (US), counsel for the Dealer Manager, such opinion and negative assurance letter, in each case addressed to the Dealer Manager with
respect to the Exchange Offer, as the Dealer Manager may reasonably require, and the Company shall have furnished to such counsel such
documents as they request for the purposes of enabling them to pass upon such matters. |
| (e) | At the Exchange Date, the Company shall have furnished to the Dealer Manager a certificate of the Company,
signed by the chief executive officer and the principal financial or accounting officer of the Company, dated as of the Exchange Date,
to the effect that the signers of such certificate have carefully examined the Offering Documents, any amendment or supplement to the
Offering Documents and this Agreement and that: |
| (i) | the representations and warranties of the Company in this Agreement are true and correct as of the Exchange
Date with the same effect as if made on the Exchange Date, and the Company has complied with all the agreements and satisfied all the
conditions on its part to be performed or satisfied hereunder at or prior to the Exchange Date; |
| (ii) | no stop order suspending the effectiveness of the Registration Statement has been issued and no proceedings
for that purpose have been instituted or threatened by the Commission; and |
| (iii) | since the date of the most recent financial statements included or incorporated by reference in the Offering
Documents, there has been no Material Adverse Effect, except as disclosed in the Pre-Effective Registration Statement, the Registration
Statement, the Preliminary Prospectus and the Prospectus. |
| (f) | At each of the Commencement Date and the Exchange Date, the Company shall have furnished to the Dealer Manager certificates of the Company,
signed by the Chief Financial Officer and the Chief Legal Officer of the Company, with respect to certain financial and regulatory data,
respectively, in form and substance reasonably satisfactory to the Dealer Manager. |
| | |
| (g) | At each of the Commencement Date and the Exchange Date, the Company shall have requested and caused WithumSmith+Brown,
PC to furnish to the Dealer Manager comfort letters, dated respectively as of the Commencement Date and the Exchange Date, in form and
substance reasonably satisfactory to the Dealer Manager. |
| (h) | Subsequent to the Commencement Date or, if earlier, the dates as of which information is given in the
Offering Documents, there shall not have been any change, or any development involving a prospective change, in or affecting the condition
(financial or otherwise), prospects, earnings, business or properties the Company and its subsidiaries, taken as a whole, whether or not
arising from transactions in the ordinary course of business, except as disclosed in the Pre-Effective Registration Statement, the Registration
Statement, the Preliminary Prospectus and the Prospectus, the effect of which, in any case referred to in clause (i) or (ii) above,
is, in the reasonable judgment of the Dealer Manager, so material and adverse as to make it impractical or inadvisable to market or deliver
the Shares or solicit tenders of IPO Warrants as contemplated by the Offering Documents. |
| (i) | Prior to the Exchange Date, the Company shall have obtained all consents, approvals, authorizations and
orders of, and shall have duly made all registrations, qualifications and filing with, any court or regulatory authority or other governmental
agency or instrumentality required in connection with the making and consummation of the Exchange Offer and the execution, delivery and
performance of this Agreement. |
| (j) | Prior to the Exchange Date, the Company shall have delivered to the Dealer Manager and its counsel such
further information, certificates and documents as they may reasonably request. |
| (k) | Prior to the Exchange Date, the Company shall have filed a listing of additional shares notification form
with Nasdaq for the listing of the Shares. |
If (i) any of the conditions specified
in this Section 6 shall not have been fulfilled when and as provided in this Agreement or (ii) any of the opinions and certificates
mentioned above or elsewhere in this Agreement shall not be reasonably satisfactory in form and substance to the Dealer Manager and its
counsel, this Agreement and all obligations of the Dealer Manager hereunder may be cancelled by the Dealer Manager at, or at any time
prior to, the Exchange Date. In such event, the Dealer Managers shall be entitled to publicly disclose the cancellation of its participation
in the Exchange Offer via press release, subject to prior notification of the Company. Notice of such cancellation shall be given to the
Company in writing or by telephone or facsimile confirmed in writing.
| 7) | Indemnification and Contribution. |
| (a) | The Company agrees to indemnify and hold harmless the Dealer Manager, the directors, officers, employees,
agents and Affiliates of the Dealer Manager and each person who controls the Dealer Manager within the meaning of either the Securities
Act or the Exchange Act against any and all losses, claims, damages or liabilities, joint or several, to which the Dealer Manager may
become subject under the Securities Act, the Exchange Act or other federal, state or foreign statutory law or regulation, at common law
or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) relate to, arise out of or are based
upon (1) any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement (or any amendment
or supplement thereto), or the omission or alleged omission therefrom of a material fact required to be stated therein or necessary in
order to make the statements therein not misleading, (2) any untrue statement or alleged untrue statement of a material fact contained
in the Preliminary Prospectus, the Prospectus, the accompanying letter of transmittal and consent, the Schedule TO, the notice of guaranteed
delivery and all other documents filed or to be filed with any federal, state or local government or regulatory agency or authority in
connection with the Exchange Offer or the Consent Solicitation, each as prepared or approved by the Company, or the omission or alleged
omission therefrom of a material fact necessary in order to make the statements therein, in the light of the circumstances under which
they were made, not misleading, (3) the Company’s failure to make or consummate the Exchange Offer or the withdrawal, rescission,
termination, amendment or extension of the Exchange Offer or any failure on the Company’s part to comply with the terms and conditions
contained in the Offering Documents, (4) any action or failure to act by the Company or its respective directors, officers, agents
or employees or by any indemnified party at the request or with the consent of the Company in connection with the consummation of the
Exchange Offer in accordance with the terms and conditions contained in the Offering Documents or (5) otherwise related to or arising
out of the Dealer Manager’s engagement hereunder or any transaction or conduct in connection therewith, except that clauses (3),
(4) and (5) shall not apply with respect to the portion of any losses that are finally judicially determined by a court of competent
jurisdiction to have resulted from the bad faith, gross negligence or willful misconduct of such indemnified party, and in the case of
clause (1), (2), (3) or (4) of this sentence, the Company agrees to reimburse each such indemnified party, as incurred, for
any legal or other expenses reasonably incurred by it in connection with investigating or defending any such loss, claim, damage, liability
or action; provided, however, that the Company will not be liable in any such case to the extent that any such loss, claim, damage
or liability arises out of or is based upon any such untrue statement or alleged untrue statement or omission or alleged omission made
in the Offering Documents, or in any amendment thereof or supplement thereto, in reliance upon and in conformity with the Dealer Manager
Information. This indemnity agreement will be in addition to any liability that the Company may otherwise have. |
| (b) | The Dealer Manager agrees to indemnify and hold harmless the Company, each of its directors, officers,
employees and agents and each person who controls the Company within the meaning of the Securities Act or the Exchange Act to the same
extent as the foregoing indemnity from the Company to the Dealer Manager, but only with reference to the Dealer Manager Information. This
indemnity agreement will be in addition to any liability that the Dealer Manager may otherwise have. |
| (c) | Promptly after receipt by an indemnified party under this Section 7 of notice of the commencement
of any action, such indemnified party will, if a claim in respect thereof is to be made against the indemnifying party under this Section 7,
notify the indemnifying party in writing of the commencement thereof; but the failure so to notify the indemnifying party (i) will
not relieve it from liability under paragraph (a) or (b) above unless and to the extent it did not otherwise learn of such action
and such failure results in the forfeiture by the indemnifying party of substantial rights and defenses and (ii) will not, in any
event, relieve the indemnifying party from any obligations to any indemnified party other than the indemnification obligation provided
in paragraph (a) or (b) above. The indemnifying party shall be entitled to appoint counsel (including local counsel) of the
indemnifying party’s choice at the indemnifying party’s expense to represent the indemnified party in any action for which
indemnification is sought (in which case the indemnifying party shall not thereafter be responsible for the fees and expenses of any separate
counsel, other than local counsel if not appointed by the indemnifying party, retained by the indemnified party or parties except as set
forth below); provided, however, that such counsel shall be reasonably satisfactory to the indemnified party. Notwithstanding the
indemnifying party’s election to appoint counsel (including local counsel) to represent the indemnified party in an action, the
indemnified party shall have the right to employ separate counsel (including local counsel), and the indemnifying party shall bear the
reasonable and documented fees, costs and expenses of such separate counsel if: (i) the use of counsel chosen by the indemnifying
party to represent the indemnified party would present such counsel with a conflict of interest; (ii) the actual or potential defendants
in, or targets of, any such action include both the indemnified party and the indemnifying party and the indemnified party shall have
reasonably concluded that there may be legal defenses available to it and/or other indemnified parties that are different from or additional
to those available to the indemnifying party; (iii) the indemnifying party shall not have employed counsel satisfactory to the indemnified
party to represent the indemnified party within a reasonable time after notice of the institution of such action; or (iv) the indemnifying
party shall authorize the indemnified party to employ separate counsel at the expense of the indemnifying party. An indemnifying party
will not, without the prior written consent of the indemnified parties, settle or compromise or consent to the entry of any judgment with
respect to any pending or threatened claim, action, suit or proceeding in respect of which indemnification or contribution may be sought
hereunder (whether or not the indemnified parties are actual or potential parties to such claim or action) unless such settlement, compromise
or consent includes an unconditional release of each indemnified party from all liability arising out of such claim, action, suit or proceeding. |
| (d) | In the event that the indemnity provided in paragraph (a) or (b) of this Section 7 is unavailable
to or insufficient to hold harmless an indemnified party for any reason, the Company and the Dealer Manager agree to contribute to the
aggregate losses, claims, damages and liabilities (including legal or other expenses reasonably incurred in connection with investigating
or defending same) (collectively, the “Losses”) to which the Company and the Dealer Manager may be subject in such
proportion as is appropriate to reflect the relative benefits received by the Dealer Manager on the one hand and the Company on the other
from the Exchange Offer. If the allocation provided by the immediately preceding sentence is unavailable for any reason, the Company and
the Dealer Manager shall contribute in such proportion as is appropriate to reflect not only such relative benefits but also the relative
fault of the Company on the one hand and of the Dealer Manager on the other in connection with the statements, omissions, actions or failure
to act that resulted in such Losses, as well as any other relevant equitable considerations. The relative benefits received by the Company
on the one hand and the Dealer Manager on the other shall be deemed to be in the same proportion as the total value paid or proposed to
be paid to holders of IPO Warrants pursuant to the Exchange Offer and the Consent Solicitation (whether or not consummated) bears to the
fees actually received by the Dealer Manager pursuant to Section 2 hereof (exclusive of amounts paid for reimbursement of expenses
or paid under this Agreement). For purposes of the preceding sentence, the total value paid or proposed to be paid to holders of IPO Warrants
pursuant to the Exchange Offer and the Consent Solicitation shall equal (i) if the Exchange Offer or the Consent Solicitation is
consummated, the total market value of the Shares (as of the Expiration Date) issued (plus any cash in lieu of fractional shares paid)
in the Exchange Offer and the Consent Solicitation, or (ii) if the Exchange Offer and the Consent Solicitation is not consummated,
the total market value (as of the date when the Exchange Offer is terminated or otherwise withdrawn by the Company) of the Shares issuable
in the Exchange Offer and the Consent Solicitation, based on the maximum number of IPO Warrants that could be exchanged in the Exchange
Offer and the Consent Solicitation as described in the Preliminary Prospectus or Prospectus immediately before the termination or withdrawal
of the Exchange Offer and the Consent Solicitation. Relative fault shall be determined by reference to, among other things, whether any
untrue or any alleged untrue statement of a material fact or the omission or alleged omission to state a material fact or any other alleged
conduct relates to information provided by the Company or other conduct by the Company on the one hand or the Dealer Manager on the other,
the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such untrue statement
or omission. The Company and the Dealer Manager agree that it would not be just and equitable if contribution were determined by pro rata
allocation or any other method of allocation that does not take account of the equitable considerations referred to above. Notwithstanding
anything to the contrary above (other than with respect to uncovered losses), in no event shall the Dealer Manager. be responsible under
this paragraph for any amounts in excess of the amount of the compensation actually paid by the Company to the Dealer Manager in connection
with the engagement (exclusive of amounts paid for reimbursement of expenses under the Agreement, including this Section 7, and amounts
paid under this Section 7). Notwithstanding the provisions of this paragraph (d), no person guilty of fraudulent misrepresentation
(within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty
of such fraudulent misrepresentation. For purposes of this Section 7, each person who controls the Dealer Manager within the meaning
of either the Securities Act or the Exchange Act and each director, officer, employee, agent and Affiliate of the Dealer Manager shall
have the same rights to contribution as such Dealer Manager, and each person who controls the Company within the meaning of either the
Securities Act or the Exchange Act and each director, officer, employee and agent of the Company shall have the same rights to contribution
as the Company, subject in each case to the applicable terms and conditions of this paragraph (d). |
| 8) | Certain Acknowledgments. The Company understands that you and your Affiliates (together, the “Group”)
are engaged in a wide range of financial services and businesses (including investment management, financing, securities trading, corporate
and investment banking and research). Members of the Group and businesses within the Group generally act independently of each other,
both for their own account and for the account of clients. Accordingly, there may be situations where parts of the Group and/or their
clients either now have or may in the future have interests, or take actions, that may conflict with our interests. For example, the Group
may, in the ordinary course of business, engage in trading in financial products or undertake other investment businesses for their own
account or on behalf of other clients, including, but not limited to, trading in or holding long, short or derivative positions in securities,
loans or other financial products of the Company or other entities connected with the Exchange Offer. |
In recognition of the foregoing, the
Company agrees that the Group is not required to restrict its activities as a result of this engagement, and that the Group may undertake
any business activity without further consultation with or notification to the Company. Neither this Agreement, the receipt by the Group
of confidential information nor any other matter shall give rise to any fiduciary, equitable or contractual duties (including, without
limitation, any duty of trust or confidence) that would prevent or restrict the Group from acting on behalf of other customers or for
its own account. Furthermore, the Company agrees that neither the Group nor any member or business of the Group is under a duty to disclose
to the Company or use on behalf of the Company any information whatsoever about or derived from those activities or to account for any
revenue or profits obtained in connection with such activities. However, consistent with the Group’s long-standing policy to hold
in confidence the affairs of its customers, the Group will not use confidential information obtained from the Company except in connection
with its services to, and its relationship with the Company.
The Company hereby acknowledges that
you are acting as principal and not as a fiduciary of the Company and the Company’s engagement of you in connection with the transactions
contemplated herein is as an independent contractor, on an arms-length basis under this Agreement with duties solely to the Company, and
not in any other capacity including as a fiduciary. Neither this Agreement, your performance hereunder nor any previous or existing relationship
between the Company and any member of or business within the Group will be deemed to create any fiduciary relationship. Neither this engagement,
nor the delivery of any advice in connection with this engagement, is intended to confer rights upon any persons not a party hereto (including
security holders, employees or creditors of the Company) as against the Group or their respective directors, officers, agents and employees.
Furthermore, the Company agrees that it is solely responsible for making its own judgments in connection with the transactions contemplated
herein (irrespective of whether any member of or business within the Group has advised or is currently advising the Company on related
or other matters).
| 9) | Termination; Representations, Acknowledgments and Indemnities to Survive. |
| (a) | Subject to clause (c) below, this Agreement may be terminated by the Company, at any time upon notice
to the Dealer Manager, if (i) at any time prior to the Exchange Date, the Exchange Offer and the Consent Solicitation is terminated
or withdrawn by the Company for any reason, or (ii) the Dealer Manager does not comply with all of its covenants under this Agreement. |
| (b) | Subject to clause (c) below, this Agreement may be terminated by the Dealer Manager, at any time
upon notice to the Company, if (i) at any time prior to the Exchange Date, the Exchange Offer and the Consent Solicitation is terminated
or withdrawn by the Company for any reason, (ii) the Company does not comply in all material respects with any covenant specified
in Section 1, (iii) the Company shall publish, send or otherwise publicly distribute any amendment or supplement to the Offering
Documents to which the Dealer Manager shall reasonably object or which shall be reasonably disapproved by the counsel to the Dealer Manager
or (iv) the Dealer Manager cancels the Agreement pursuant to Section 6. |
| (c) | The respective agreements, representations, warranties, acknowledgments, indemnities and other statements
of the Company or its officers and of the Dealer Manager set forth in or made pursuant to this Agreement will remain in full force and
effect, regardless of any investigation made by or on behalf of the Dealer Manager or the Company or any of the officers, directors or
controlling person of the Company, and will survive delivery of and payment for the Shares. The provisions of Section 2, Section 5(m),
Section 7, and Section 18 hereof, and this Section 9(c), shall survive the termination or cancellation of this Agreement. |
| 10) | Compliance with USA PATRIOT Act. In accordance with the requirements of the USA PATRIOT Act (Title
III of Pub. L. 107-56 (signed into law October 26, 2001)), the Dealer Manager is required to obtain, verify and record information
that identifies its clients, including the Company, which information may include the name and address of its clients, as well as other
information that will allow the Dealer Manager to properly identify its clients. |
| 11) | Notices. All communications hereunder will be in writing and effective only on receipt, and, if
sent to the Dealer Manager, will be mailed or delivered to |
Cantor Fitzgerald & Co.
110 East 59th Street
New York, NY 10022
Email: Legal-IBD@cantor.com
Attention: General Counsel
with a copy to (which shall not constitute notice):
DLA Piper LLP (US)
1251 Avenue of the Americas, 27th Floor
New York, New York 10020
Email: stephen.alicanti@us.dlapiper.com
Attention: Stephen P. Alicanti
or, if sent to the Company, will be mailed or delivered to
Zura Bio Limited
1489 W. Warm Springs Rd. #110
Henderson, NV 89014
Email: verender.badial@zurabio.com
Attention: Verender Badial
Loeb & Loeb LLP
345 Park Avenue
New York, NY 10154
Email: gcaruso@loeb.com
Attention: Giovanni Caruso
| 12) | Successors. This Agreement will inure to the benefit of and be binding upon the parties hereto
and their respective successors and the officers and directors and controlling persons referred to in Section 7 hereof, and no other
person will have any right or obligation hereunder. |
| 13) | Entire Agreement. Except for the Engagement Letter, this Agreement, and any documents referred
to in it, constitute the whole agreement between the parties and supersede any arrangements, understanding or previous agreement between
them relating to the subject matter they cover. In the event of any inconsistency between this Agreement and any documents referred to
in it, the terms of this Agreement shall prevail. |
| 14) | Submission to Jurisdiction. Each party hereby submits to the jurisdiction of the U.S. federal and
New York state courts in the Borough of Manhattan in The City of New York in any suit or proceeding arising out of or relating to this
Agreement or the transactions contemplated hereby. Each party waives any objection which it may now or hereafter have to the laying of
venue of any such suit or proceeding in such courts. Each party agrees that final judgment in any such suit, action or proceeding brought
in such court shall be conclusive and binding upon such party and may be enforced in any court to the jurisdiction of which such party
is subject by a suit upon such judgment. Each party hereby irrevocably waives personal service of process and consents to process being
served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence
of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall be deemed
in every respect effective service of process upon such party in any such suit or proceeding. |
| 15) | Applicable Law. This Agreement will be governed by and construed in accordance with the laws of
the State of New York applicable to contracts made and to be performed within the State of New York. |
| 16) | Waiver of Jury Trial. Each of the parties hereto hereby waives any right to trial by jury
in any suit or proceeding arising out of or relating to this Agreement. |
| 17) | Counterparts. This Agreement may be executed in any number of counterparts, each of which shall
be deemed to be an original, but all such counterparts shall together constitute one and the same Agreement. Electronic signatures complying
with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other
applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission
method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart. |
| 18) | Headings. The headings of the sections of this Agreement have been inserted for convenience of
reference only and shall not be deemed a part of this Agreement. |
| 19) | Definitions. The following terms, when used in this Agreement, shall have the meanings indicated. |
“Affiliate” shall
have the meaning specified in Rule 501(b) of Regulation D.
“Commencement Date”
shall mean the date of commencement (as defined in Rule 13e-4 under the Exchange Act) of the Exchange Offer.
“Commission” shall
mean the U.S. Securities and Exchange Commission.
“Commission Reports”
shall mean any reports the Company files with the Commission pursuant to the Exchange Act.
“Effective Date”
shall mean the time the Registration Statement is declared effective under the Securities Act.
“Exchange Act” shall
mean the U.S. Securities Exchange Act of 1934, as amended, and the rules and regulations of the Commission promulgated thereunder.
“Exchange Agent”
shall mean Continental Stock Transfer & Trust Company.
“Exchange Date”
shall mean the date on which the Company issues the Shares in exchange for the tendered IPO Warrants pursuant to the Exchange Offer.
“Expiration Date”
shall mean one minute after 11:59 p.m., Eastern Time, on August 8, 2024, or such later time and date as may be extended by the Company
in its sole discretion.
“FINRA” shall mean
the Financial Industry Regulatory Authority, Inc.
“Information Agent”
shall mean Alliance Advisors, LLC.
“Material Adverse Effect”
means any material adverse change, or any development involving a prospective material adverse change, in or affecting the general affairs,
management, financial position, shareholders’ equity or results of operations of the Company and its subsidiaries, taken as a whole.
“Offering Documents”
shall mean the Pre-Effective Registration Statement, the Registration Statement, the Preliminary Prospectus, the Prospectus, the accompanying
letter of transmittal and consent, the Schedule TO, the notice of guaranteed delivery and all other documents filed or to be filed with
any federal, state or local government or regulatory agency or authority in connection with the Exchange Offer or the Consent Solicitation,
each as prepared or approved by the Company.
“Pre-Effective Registration
Statement” shall mean the registration statement, filed by the Company with the Commission registering the Exchange Offer under
the Securities Act, including exhibits thereto and any documents deemed part of or incorporated by reference into such registration statement
pursuant to Rule 430C under the Securities Act, in the form in which it is initially filed with the Commission on or about the date
hereof.
“Preliminary Prospectus”
shall mean the preliminary prospectus that is used prior to the filing of the Prospectus, as amended or supplemented from time to time,
including the documents incorporated or deemed to be incorporated by reference therein.
“proceeding” means
an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such
as a deposition), whether commenced or threatened.
“Prospectus” shall
mean the final prospectus included in the Registration Statement (together with any supplement and amendment thereto and including the
documents incorporated or deemed to be incorporated by reference therein), except that if the final prospectus furnished to the Dealer
Manager for use in connection with the Exchange Offer differs from the prospectus set forth in the Registration Statement (whether or
not such prospectus is required to be filed pursuant to Rule 424(b) under the Securities Act), the term “Prospectus”
shall refer to the final prospectus furnished to the Dealer Manager for such use.
“Registration Statement”
shall mean the registration statement filed by the Company with the Commission registering the Exchange Offer under the Securities Act,
including exhibits thereto and any documents deemed part of or incorporated by reference into such registration statement pursuant to
Rule 430C under the Securities Act, in the form in which it becomes effective and, in the event of any amendment or supplement thereto
or the filing of any abbreviated registration statement pursuant to Rule 462(b) under the Securities Act relating thereto after
the effective date of such registration statement, shall mean such registration statement as so amended or supplemented, together with
any such abbreviated registration statement.
“Schedule TO” shall
mean the tender offer statement filed with the Commission on Schedule TO, including any documents incorporated by reference therein, with
respect to the Exchange Offer, including any amendment or supplement thereto.
“Securities Act”
shall mean the U.S. Securities Act of 1933, as amended, and the rules and regulations of the Commission promulgated thereunder.
“U.S.” or the “United
States” shall mean the United States of America.
[Signature Pages to Follow]
If the foregoing is in accordance with your understanding
of our agreement, please sign and return to us the enclosed duplicate hereof, whereupon this Agreement and your acceptance shall represent
a binding agreement between the Company and the Dealer Manager.
|
Very truly yours, |
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Zura Bio Limited |
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By: |
/s/ Verender Badial |
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Name: Verender Badial |
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Title: Chief Financial Officer |
The foregoing Agreement is hereby confirmed and accepted as of the
date first above written:
|
Cantor Fitzgerald & Co. |
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By: |
/s/ Jason Fenton |
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Name: Jason Fenton |
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Title: Global Co-Head of
ECM |
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[Signature
Page to Dealer Manager and Solicitation Agent Agreement]
Exhibit (d)(xxxxxxiii)
TENDER AND SUPPORT AGREEMENT
This TENDER AND SUPPORT AGREEMENT (this “Agreement”),
dated as of July 11, 2024, is entered into by and among Zura Bio Limited, a Cayman Islands exempted company (the “Company”),
each of the persons listed on Schedule A hereto (each, a “Public Warrant Holder”) and each of the
persons listed on Schedule B hereto (each, a “Private Warrant Holder” and, together with the Public
Warrant Holders, the “IPO Warrant Holders,” and each, an “IPO Warrant Holder”).
WHEREAS,
as of the date hereof, (a) each Public Warrant Holder is the beneficial owner of warrants sold as part of the units in the initial
public offering (the “IPO”) (whether they were purchased in the IPO or thereafter in the open market) (the “Public
Warrants”) of JATT Acquisition Corp, a Cayman Islands exempted company and the Company’s predecessor (“JATT”),
and (b) each Private Warrant Holder is the beneficial owner of warrants issued in a private placement in connection with the closing
of the IPO that have not become public warrants as a result of being transferred to any person other than permitted transferees (the “Private
Placement Warrants” and, together with the Public Warrants, the “IPO Warrants”), in each case
governed by the Warrant Agreement by and between the Company (as successor to JATT Acquisition Corp) and Continental Stock Transfer &
Trust Company (the “Warrant Agent”), as warrant agent, dated July 16, 2021 (the “Warrant Agreement”)
(and for the avoidance of doubt, the IPO Warrants do not include the pre-funded
warrants the Company issued in 2023 and 2024);
WHEREAS,
as of the date hereof, the Public Warrants are listed on The Nasdaq Capital Market under the symbol “ZURAW” and there are
a total of approximately 6,899,996 Public Warrants and approximately 5,910,000 Private Placement Warrants outstanding;
WHEREAS,
each IPO Warrant entitles its holder to purchase one Class A ordinary share,
par value $0.0001 per share, of the Company (the “Class A Ordinary Shares”) for a purchase price of $11.50,
subject to certain adjustments;
WHEREAS, the Company is initiating an exchange
offer (the “Exchange Offer”) pursuant to a registration statement on Form S-4 to be filed with the U.S. Securities
and Exchange Commission (as may be amended and supplemented, the “Registration Statement”) to offer all IPO
Warrant Holders the opportunity to exchange their IPO Warrants for Class A Ordinary Shares at an exchange ratio of 0.3 Class A Ordinary
Shares per IPO Warrant and subject to other customary terms and conditions to be disclosed in the Registration Statement;
WHEREAS, concurrently with the Exchange
Offer and as part of the Registration Statement, the Company is initiating a consent solicitation (the “Solicitation”)
to solicit the consent of the holders of the IPO Warrants to amend (the “Warrant Amendment”), effective upon
the completion of the Exchange Offer, the terms of the Warrant Agreement to permit the Company to require that each IPO Warrant that is
outstanding upon the closing of the Exchange Offer be converted into 0.27 Class A Ordinary Shares, which is a ratio of 10.0% less than
the exchange ratio applicable to the Exchange Offer, subject to the terms and conditions to be disclosed in the Registration Statement;
and
WHEREAS,
as an inducement to the Company’s willingness to initiate the Exchange Offer and the Solicitation, each IPO Warrant Holder has agreed
to enter into this Agreement.
NOW,
THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth
herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto,
intending to be legally bound, do hereby agree as follows:
Section 1.01 Agreement to Tender. Each IPO Warrant Holder shall
validly tender or cause to be tendered to the Company all IPO Warrants beneficially owned by such IPO Warrant Holder as of the date hereof,
free and clear of any liens, options, rights or other encumbrances, limitations or restrictions whatsoever (except those identified in
Section 1.03), pursuant to and in accordance with the terms of the Exchange Offer as described in the Registration Statement, no later
than the scheduled or extended expiration time of the Exchange Offer at a ratio of 0.3 Class A Ordinary Shares per IPO Warrant. For the
avoidance of doubt, nothing in this Agreement shall restrict the IPO Warrant Holder from acquiring additional IPO Warrants subsequent
to the date hereof and such additional IPO Warrants shall not be subject to the terms of this Agreement.
Section 1.02 Agreement to Consent. Each
IPO Warrant Holder shall deliver to the Company its timely consent with respect to the Solicitation with respect to all of such IPO Warrant
Holder’s IPO Warrants in accordance with the terms and conditions of the Solicitation as described in the Registration Statement.
Section 1.03 Ownership of IPO Warrants.
Each IPO Warrant Holder represents and warrants to the Company, as of the date hereof and as of the date of tender of such IPO Warrant
Holder’s IPO Warrants in accordance with this Agreement, that such IPO Warrant Holder is the sole beneficial owner of the number
of IPO Warrants set forth opposite such IPO Warrant Holder’s name on Schedule A or Schedule B hereto, as applicable,
and has good and marketable title to such IPO Warrants, free and clear of any liens, options, rights or other encumbrances, limitations
or restrictions whatsoever (other than liens imposed under typical prime brokerage agreements and those restrictions imposed by applicable
securities laws, this Agreement and the Warrant Agreement). Each IPO Warrant Holder shall not transfer any IPO Warrants owned by such
IPO Warrant Holder as of the date hereof to any person (other than the Company in connection with the Exchange Offer) unless such person
acquiring such IPO Warrants signs a joinder to this Agreement agreeing to be bound by all terms and conditions of this Agreement.
Section 1.04 Company Covenants. The Company
agrees that it shall take all steps reasonably necessary or desirable to commence the Exchange Offer and Solicitation as soon as practicable,
consistent with this Agreement, and agrees to take all steps necessary to update the Registration Statement as required by applicable
laws and regulations, and that the Registration Statement, when declared effective, will comply with all applicable U.S. Securities and
Exchange Commission requirements.
Section 1.05 Conditions to Tender and Consent.
Notwithstanding anything herein to the contrary, each IPO Warrant Holder’s obligation to tender (or cause to be tendered) and to
consent under this Agreement is conditioned on there being no amendment to the terms of the Exchange Offer that is materially adverse
to such IPO Warrant Holder.
Section 1.06 Specific Performance. The
parties hereto agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the
terms hereof and that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement or to enforce
specifically the performance of the terms and provisions hereof, in addition to any other remedy to which they are entitled at law or
in equity.
Section 1.07 Termination. This Agreement
shall terminate as to all IPO Warrant Holders (a) upon written notice to all the IPO Warrant Holders by the Company, (b) upon the earlier
of (i) the date the Company’s board of directors or a committee thereof determines to no longer pursue the Exchange Offer and the
Solicitation and (ii) September 30, 2024 and (c) if the Company fails to commence the Exchange Offer and Solicitation by July 19, 2024.
Section 1.08 IPO Warrant Holder Obligations
Several and Not Joint. The obligations of each IPO Warrant Holder hereunder shall be several and not joint, and no IPO Warrant Holder
shall be liable for any breach of the terms of this Agreement by any other IPO Warrant Holder. Nothing contained herein, and no action
taken by any IPO Warrant Holder pursuant hereto, shall be deemed to constitute the IPO Warrant Holders as a partnership, an association,
a joint venture or any other kind of entity, or create a presumption that the IPO Warrant Holders are in any way acting in concert or
as a group with respect to such obligations or the transactions contemplated herein.
Section 1.09 Governing Law. The validity,
interpretation and performance of this Agreement and of the IPO Warrants shall be governed in all respects by the laws of the State of
New York, without giving effect to conflicts of law principles that would result in the application of the substantive laws of another
jurisdiction. The Company hereby agrees that any action, proceeding or claim against it arising out of or relating in any way to this
Agreement shall be brought and enforced in the courts of the State of New York or the United States District Court for the Southern District
of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection
to such exclusive jurisdiction and that such courts represent an inconvenient forum.
Section 1.10 Counterparts. This Agreement may be signed in counterparts
(which may include counterparts delivered by any standard form of telecommunication), each of which shall be an original and all of which
together shall constitute one and the same instrument. The words “execution,” “signed,” “signature”
and words of like import in this Agreement or in any other certificate, agreement or document related to this Agreement, if any, shall
include images of manually executed signatures transmitted by facsimile or other electronic format (including, without limitation, “pdf,”
“tif” or “jpg”) and other electronic signatures (including, without limitation, DocuSign and AdobeSign). The use
of electronic signatures and electronic records (including, without limitation, any contract or other record created, generated, sent,
communicated, received or stored by electronic means) shall be of the same legal effect, validity and enforceability as a manually executed
signature or use of a paper-based record-keeping system to the fullest extent permitted by applicable law, including the Federal Electronic
Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act and any other applicable law,
including, without limitation, any state law based on the Uniform Electronic Transactions Act or the Uniform Commercial Code.
[Signature Pages Follow]
IN WITNESS WHEREOF, the parties hereto have caused
this Agreement to be duly executed as of the date first above written.
|
COMPANY: |
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ZURA BIO LIMITED |
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By: |
/s/ Verender S.Badial |
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Name: |
Verender S.Badial |
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Title: |
CFO |
[Signature Page to Tender and Support Agreement]
IN WITNESS WHEREOF, the parties hereto have caused
this Agreement to be duly executed as of the date first above written.
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PUBLIC WARRANT HOLDERS: |
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By: |
Someit Sidhu |
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/s/Someit Sidhu |
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Name: |
Someit Sidhu |
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Title: |
in his individual capacity |
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Highbridge Tactical Credit Master Fund, L.P. |
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By: |
Highbridge Capital Management, LLC, |
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as Trading Manager and not in its individual capacity |
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/s/ Steve Ardovini |
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Name: |
Steve Ardovini |
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Title: |
Managing Director Head of Operations |
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HIGHBRIDGE CAPITAL MANAGEMENT, LLC |
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Highbridge Tactical Credit Institutional Fund, Ltd. |
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By: |
Highbridge Capital Management, LLC, |
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as Trading Manager and not in its individual capacity |
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/s/ Steve Ardovini |
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Name: |
Steve Ardovini |
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Title: |
Managing Director Head of Operations |
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HIGHBRIDGE CAPITAL MANAGEMENT, LLC |
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By: |
BG Master Fund ICAV |
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/s/Rubens Serenade |
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Name: |
Rubens Serenade |
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Title: |
Director of Boussard & Gavaudan Partners Limited, Managing Member of Boussard & Gavaudan
Investment Management LLP, Investment Manager |
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By: |
Pandora Select Partners, L.P |
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|
|
/s/ Peter Vance |
|
Name: |
Peter Vance |
|
Title: |
Portfolio Manager |
|
By: |
Whitebox Relative Value Partners, L.P. |
|
|
|
/s/ Peter Vance |
|
Name: |
Peter Vance |
|
Title: |
Portfolio Manager |
|
By: |
Whitebox GT Fund, L.P. |
|
|
|
/s/ Peter Vance |
|
Name: |
Peter Vance |
|
Title: |
Portfolio Manager |
|
|
|
|
By: |
Whitebox Multi-Strategy Partners, L.P. |
|
|
|
/s/ Peter Vance |
|
Name: |
Peter Vance |
|
Title: |
Portfolio Manager |
[Signature Page to Tender and Support Agreement]
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be duly executed as of the date first above written.
|
PRIVATE WARRANT HOLDERS: |
|
|
|
By: |
JATT Ventures, Ltd. |
|
|
|
|
/s/ Someit Sidhu |
|
Name: |
Someit Sidhu |
|
Title: |
Director |
|
|
|
|
By: |
Someit Sidhu |
|
|
|
|
/s/ Someit Sidhu |
|
Name: |
Someit Sidhu |
|
Title: |
in his individual capacity |
|
|
|
|
By: |
Verender S.Badial |
|
|
|
|
/s/ Verender S.Badial |
|
Name: |
Verender S.Badial |
|
Title: |
in his individual capacity |
[Signature Page to Tender and Support Agreement]
Schedule A
Name of Public Warrant Holder |
|
Number of Public Warrants |
Someit Sidhu |
|
1,750,000 |
Highbridge Tactical Credit Master Fund, L.P. |
|
660,619 |
Highbridge Tactical Credit Institutional Fund, Ltd. |
|
138,417 |
BG Master Fund ICAV |
|
187,500 |
Pandora Select Partners, L.P |
|
5,250 |
Whitebox Relative Value Partners, L.P. |
|
27,750 |
Whitebox GT Fund, L.P. |
|
3,000 |
Whitebox Multi-Strategy Partners, L.P. |
|
39,000 |
Schedule B
Name of Private Warrant Holder |
|
Number of Private Placement Warrants |
JATT Ventures, Ltd. |
|
2,783,701 |
Someit Sidhu |
|
656,572 |
Verender Badial |
|
420,519 |
Exhibit (h)
|
Loeb & Loeb
LLP
10100 Santa Monica Blvd.
Suite 2200
Los Angeles, CA 90067 |
Main 310.282.2000
Fax 310.282.2200 |
July 11, 2024
Zura Bio Limited
1489 W. Warm Springs Rd. #110
Henderson, NV 89014
| Re: | Registration Statement on Form S-4 |
Ladies and Gentlemen:
We have acted as counsel to Zura
Bio Limited (“Company”), a Cayman Islands exempted company, in connection with the Registration Statement on Form S-4
under the Securities Act of 1933, as amended (the “Securities Act”), filed on July 11, 2024 (the “Registration
Statement”), relating to (i) the Company’s offer to exchange (the “Exchange Offer”) any and all of the Company’s
outstanding public and private warrants that were issued in connection with its initial public offering (the “IPO Warrants”)
to purchase Class A ordinary shares, par value $0.0001 per share (“Class A Ordinary Shares”), of the Company for 0.3 Class A Ordinary Shares per IPO Warrant and (ii) the solicitation of consents (the “Consent Solicitation”)
from the holders of all outstanding IPO Warrants to amend that certain warrant agreement, dated as of July 16, 2021, by and between
the Company (as successor to JATT Acquisition Corp, the Company’s predecessor and a Cayman Islands exempted company (“JATT”))
and Continental Stock Transfer & Trust Company (“CST”), as warrant agent(the “Warrant Agreement”), which
governs all of the IPO Warrants, to permit the Company to require that each IPO Warrant that is outstanding upon the closing of the Exchange
Offer be converted into 0.27 Class A Ordinary Shares pursuant to a proposed amendment to the Warrant Agreement described in the
Registration Statement. For the avoidance of doubt, the IPO warrants do not include the pre-funded warrants the Company issued in 2023
and 2024.
In providing our opinion, we have examined
the Registration Statement, and such other documents as we have deemed necessary or appropriate for purposes of this opinion.
In connection
with rendering our opinion, we have assumed (without any independent investigation or review thereof) that (i) all original documents
submitted to us (including signatures thereto) are authentic, all documents submitted to us as copies conform to the original documents,
all such documents have been duly and validly executed and delivered where due execution and delivery are a prerequisite to the effectiveness
thereof, and all parties to such documents had or will have, as applicable, the requisite corporate powers and authority to enter into
such documents and to undertake and consummate the Exchange Offer and the Consent Solicitation, (ii) all factual representations,
warranties and statements made or agreed to by the Company and by its management, employees, officers, directors, and shareholders in
connection with the Exchange Offer, including, but not limited to, those set forth in the Registration Statement, are true, correct and
complete as of the date hereof without regard to any qualification as to knowledge, belief, or otherwise and will remain true, correct,
and complete at all relevant times, and (iii) the description of the Exchange Offer and the Consent Solicitation in the Registration
Statement is accurate, complete, and correct, the Exchange Offer and the Consent Solicitation will be consummated in accordance with such
description without any waiver or breach of any material provision thereof, and the Exchange Offer will be effective under applicable
corporate law as described in the Registration Statement.
Los Angeles New York Chicago Nashville Washington, DC San Francisco
Beijing Hong Kong www.loeb.com
For the United States offices, a limited liability partnership
including professional corporations. For Hong Kong office, a limited liability partnership. |
|
Zura Bio Limited
July 11, 2024
Page 2 |
Based on the foregoing and subject to
the assumptions, limitations and qualifications stated in the Registration Statement and herein, we hereby confirm and adopt as our opinion
the statements of United States federal income tax law on the date hereof as set forth in the Registration Statement under the caption
“Market Information, Dividends, and Related Shareholder Matters—Material U.S. Federal Income Tax Consequences."
This opinion is based upon the existing provisions of the Internal
Revenue Code of 1986, as amended, Treasury Regulations promulgated thereunder, published revenue rulings and procedures from the United
States Internal Revenue Service (“IRS”) and judicial decisions, all as in effect on the date hereof. Any such authority is
subject to change, and any change may be retroactive in effect and may affect our opinion as set forth herein. Our opinion is based on
the facts, assumptions and representations set forth in the Registration Statement and this opinion. If any of the facts, assumptions
or representations is not true, correct or complete, our opinion may not be applicable. We undertake no responsibility to update this
opinion or to advise you of any developments or changes as a result of a change in legal authority, fact, representation, assumption or
document, or any inaccuracy in any fact, representation or assumption, upon which this opinion is based, or otherwise.
Our opinion is not binding on the IRS or a court. The IRS may disagree
with one or more of our conclusions, and a court may sustain the IRS’s position.
Except as expressly provided herein, we express no opinion with respect
to any tax matter. For the avoidance of doubt, we express no opinion with respect to the passive foreign investment company status of
the Company.
We hereby consent to the filing of this letter as an exhibit to the
Registration Statement and to the reference to this firm as counsel to Company under the caption “Market Information, Dividends,
and Related Shareholder Matters—Material U.S. Federal Income Tax Consequences” in the Registration Statement, without implying
or admitting that we are “experts” within the meaning of the Securities Act or the rules and regulations promulgated
thereunder, with respect to any part of the Registration Statement, including this exhibit.
Very truly yours,
/s/ Loeb & Loeb LLP
Loeb & Loeb LLP
Exhibit 107
Calculation of Filing Fee Table
SC TO-I
(Form Type)
Zura Bio Limited
(Exact Name of Registrant as Specified in its Charter)
Table 1: Transaction Valuation
|
|
Transaction Valuation |
|
|
Fee Rate |
|
|
Amount of Filing Fee |
|
Fees to Be Paid |
|
$ |
6,086,000 |
(1) |
|
|
0.00014760 |
|
|
$ |
898.29 |
|
Fees Previously Paid |
|
|
- |
|
|
|
|
|
|
|
- |
|
Total Transaction Value |
|
$ |
6,086,000 |
|
|
|
|
|
|
|
|
|
Total Fees Due for Filing |
|
|
|
|
|
|
|
|
|
$ |
898.29 |
|
Total Fees Previously Paid |
|
|
|
|
|
|
|
|
|
|
- |
|
Total Fee Offsets |
|
|
|
|
|
|
|
|
|
|
- |
|
Net Fee Due |
|
|
|
|
|
|
|
|
|
$ |
898.29 |
|
(1) |
The transaction valuation is estimated solely for purposes of calculating the amount of the filing fee. Zura Bio Limited (the “Company”) is offering holders of a total of 12,809,996 IPO warrants to purchase the Company Class A ordinary shares, par value $0.0001 per share (“Class A Ordinary Shares”), outstanding as of July 10, 2024, the opportunity to exchange such IPO warrants and receive 0.3 Class A Ordinary Shares for each IPO warrant. The transaction value was determined by using the average of the high and low prices of the public warrants on The Nasdaq Capital Market on July 5, 2024, which was $0.51 per warrant. |