UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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| Item 7.01. | Regulation FD Disclosure. |
On December 4, 2023, Zura Bio Limited issued the press release attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this Item 7.01 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release dated December 4, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934 the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: December 4, 2023
| ZURA BIO LIMITED | ||
| By: | /s/ Kim Davis | |
| Kim Davis | ||
| Chief Legal Officer | ||
Exhibit 99.1
Zura Bio Announces Two Immunology Abstracts Presented at the World Allergy Congress in Bangkok
Henderson, Nev – December 4, 2023 - Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a multi-asset clinical-stage biotechnology company focused on developing novel medicines for immune and inflammatory disorders, today announced two abstracts were accepted and presented at World Allergy Congress (WAC), held December 1 – 3, 2023 in Bangkok, Thailand. The abstracts highlight Zura Bio’s informative research for ZB-168, an anti-IL-7Rα monoclonal antibody with potential across a broad set of indications where the IL-7 or TSLP pathways may be involved, and ZB-880 (torudokimab), a fully human, high affinity monoclonal antibody that neutralizes IL-33 and also has potential for a broad range of indications.
“Introducing Zura Bio’s ZB-168 and ZB-880 at World Allergy Congress is an opportunity to share the unique science behind these assets. ZB-168 uniquely inhibits both IL-7 and TSLP, while ZB-880 prevents IL-33 mediated-activation of ST2-dependent and independent inflammation. The unique biology of our assets may give us access to a broad range of biology applicable in a number of autoimmune and inflammatory diseases,” said Michael Howell, Ph.D., Chief Scientific Officer and Head of Translational Science at Zura Bio. “We believe these could have applicability in the dermatological, rheumatological, gastrointestinal and respiratory spaces, and we are very excited about taking these development programs forward.”
Details are as follows:
Abstract: WAC23-0180
Title: Biomarker analysis identifies subset of atopic dermatitis patients that respond to IL-33 blockade
Authors: Michael Howell, Ph.D., Jackson Cabell, Brandon Walsh, Ph.D., Someit Sidhu, M.D., Christopher Cabell, M.D.
Abstract: WAC23-0179
Title: ZB-168 potently inhibits thymic stromal lymphopoietin mediated Inflammation
Authors: Christopher Cabell, M.D., Javier Cote-Sierra, Ph.D., Karl Deacon, Ph.D., Someit Sidhu, M.D., Michael Howell, Ph.D.
Full session details can be accessed via the WAC program.
About Zura Bio
Zura Bio is a multi-asset clinical-stage biotechnology company focused on developing novel medicines for immune and inflammatory disorders. 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 ZB-106 (tibulizumab), ZB-168, and ZB-880 (torudokimab) with a goal of demonstrating their efficacy, safety, and dosing convenience in immune and inflammatory disorders, including systemic sclerosis, hidradenitis suppurativa, and other novel indications with unmet needs.
About ZB-106 (tibulizumab)
ZB-106 (tibulizumab) is a potential first-in-class, anti-IL-17 and anti-BAFF dual antagonist that Zura Bio plans to develop for the treatment of systemic sclerosis and hidradenitis suppurativa. ZB-106 is an IgG-scFv bispecific dual-antagonist antibody engineered by the fusion of Taltz® (ixekizumab) and tabalumab that neutralizes IL-17A and BAFF. ZB-106 has been assessed in two Phase 1b studies completed in rheumatoid arthritis and Sjögren's syndrome. The safety profile to date appears to be acceptable, with no new findings relative to known IL-17 and BAFF inhibitors. Chronic toxicology studies have been completed with no adverse drug-related findings. Phase 2 clinical trials of ZB-106 in systemic sclerosis and hidradenitis suppurativa are planned to initiate 2H-2024.
About ZB-168
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 TSLP), thus inhibiting IL-7Rα has the potential to block activation through both of these pathways. As a result, we believe ZB-168 could be therapeutically beneficial in a broad set of indications where the IL-7 or TSLP pathways may be involved. ZB-168 has been assessed in Phase 1/1b clinical studies in Type 1 diabetes and multiple sclerosis. Safety and pharmacokinetics were evaluated and the safety profiles from these studies support further development. A Phase 2 clinical trial of ZB-168 in alopecia areata is planned to initiate in 2024.
Forward-Looking Statements
This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook” and similar expressions are intended to identify such forward-looking statements. 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 that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability.
Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of Zura Bio’s recent filings with the SEC. These filings would identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Many of these factors are outside Zura Bio’s control and are difficult to predict. Many factors could cause actual future events to differ from the forward-looking statements in this communication, including but not limited to: (1) the outcome of any legal proceedings that may be instituted against Zura Bio; (2) volatility in the price of Zura Bio’s securities; (3) the ability of Zura Bio to successfully conduct research and development activities, grow and manage growth profitably, maintain relationships with customers and suppliers, and retain key employees; (4) the ongoing costs relating to operating as a public company; (5) changes in the applicable laws or regulations; (6) the possibility that Zura Bio may be adversely affected by other economic, business, and/or competitive factors; (7) the risk of downturns and a changing regulatory landscape in the highly competitive industry in which Zura Bio operates; (8) the potential inability of Zura Bio to raise additional capital needed to pursue its business objectives or to achieve efficiencies regarding other costs; (9) the enforceability of Zura Bio’s intellectual property, including its patents, and the potential infringement on the intellectual property rights of others, cyber security risks or potential breaches of data security; and (10) other risks and uncertainties described in the registration statement on Form S-1 filed with the SEC on June 14, 2023, and such other documents filed by Zura Bio from time to time with the SEC. These risks and uncertainties may be amplified by the COVID-19 pandemic or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, including projections, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, or should circumstances change, except as otherwise required by securities and other applicable laws.
Contact
Megan K. Weinshank
Head of Investor Relations
info@zurabio.com