UNITED STATES
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Washington, D.C. 20549
FORM
Current Report
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| Item 7.01 | Regulation FD Disclosure. |
On January 11, 2024, representatives of Zura Bio Limited, a Cayman Islands exempted company (the “Company”), began making presentations to banks and analysts using slides containing the information attached to this Current Report on Form 8-K as Exhibit 99.1 (the “Investor Presentation”), which is incorporated herein by reference. The Company has filed the Investor Presentation on its website and expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others during the fiscal year ending December 31, 2024.
By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The information presented in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed to be “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, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Number | Description | |
| 99.1 | Investor Presentation dated January 2024. | |
| 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.
Dated: January 11, 2024
| ZURA BIO LIMITED | ||
| By: | /s/ Kim Davis | |
| Kim Davis | ||
| Chief Legal Officer | ||
Exhibit 99.1
| ©2024 Zura Bio Ltd. Nasdaq Ticker: ZURA Building the Next Immunology Leader 42nd Annual J.P. Morgan Healthcare Conference January 11, 2024 San Francisco, California |
| ©2024 Zura Bio Ltd. 2 Forward Looking Statements Disclaimer 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) costs related to financing transactions and 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 impact of the global COVID-19 pandemic; (9) the potential inability of Zura Bio to raise additional capital needed to pursue its business objectives or to achieve efficiencies regarding other costs; (10) 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 (11) other risks and uncertainties described in the Registration Statement 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. |
| © 2024 Zura Bio Ltd. ©2024 Zura Bio Ltd. 3 Began trading on Nasdaq under “ZURA” ticker ZB-106 in-licensed from Eli Lilly and Company and PIPE announced $80M PIPE closed Entered into sponsored research agreement with Benaroya Research Institute Arnout Ploos van Amstel joined Board Rob Lisicki and Dr. Kiran Nistala join Zura Bio Executive Leadership Inclusion into the Russell 2000® and 3000® Indexes 2023 2024 In 2023, Zura established a strong foundation to enable focused execution into 2024 2024 Key Objectives: On time clinical trial execution Build leadership team with specific expertise Translational excellence & validating external clinical readouts COVERING ANALYSTS (as of 08-Jan): Daniil Gataulin, PhD, Chardan; Yatin Suneja, Guggenheim Securities; Aydin Huseynov, MD, CFA, Ladenburg Thalmann & Co. Inc.; Justin Kim, Oppenheimer; Steven Seedhouse, PhD, Raymond James |
| ©2024 Zura Bio Ltd. 4 Experienced management team with proven ability to successfully execute and build a leading market position Nasdaq: ZURA Board of Directors Executive Team Amit Munshi Arnout Ploos van Amstel Jennifer Jarrett Neil Graham, M.D. Parvinder Thiara Sandeep Kulkarni, M.D. Someit Sidhu, M.D. Steve Schoch Chairman Independent Director Independent Director Independent Director Independent Director Independent Director Director Independent Director Mike Howell Ph.D. Chief Scientific Officer and Head of Translational Medicine Kim Davis Chief Legal Officer Kiran Nistala M.D., Ph.D. Chief Medical Officer and Head of Development Gary Whale Ph.D. Chief Technology Officer Someit Sidhu M.D. Founder, Chief Executive Officer and Director Verender Badial Chief Financial Officer Robert Lisicki President and Chief Operating Officer |
| ©2024 Zura Bio Ltd. 5 Our Strategic Approach Our approach could signify a paradigm shift for patients suffering from severe and intricate autoimmune diseases. These patients currently find their needs unmet by the conventional "single” pathway approach. We are pioneering dual pathway biology by integrating two validated mechanisms in disease indications where each has demonstrated individual efficacy Our clinical-stage assets are positioned as potentially best-in-class in pathways driving efficacy, aiming to profoundly alter the trajectory of chronic autoimmune diseases. Pioneering dual pathway biology Potential best-in-class potency on clinically validated pathways Paradigm shift for complex diseases |
| ©2024 Zura Bio Ltd. 6 Systemic sclerosis is a rare & life-threatening disease with no approved therapy ~200,000 people with SSc in US, EU and Japan 1 40-60% mortality in 10 years 2 Zero SSc-specific * drugs approved $2B+ annual potential market opportunity Sources: Medscape, BMJ best practice 1 Health Advanced, LLC; Lenabasum Commercial Market Assessment. 2 Tyndall et al, 2010 3 Bergamasco, A. et al., Clin Epidemiol. 2019 Apr 18;11:257-273 4 Zura Bio internal analysis and benchmarking, 5 Internal assumption based on demand research and rare disease analogues (*) no effective treatment exists that combats the disease across organ systems Paradigm shifting not incrementalism Nasdaq: ZURA Systemic sclerosis is characterized by tissue inflammation and fibrosis No effective treatment exists that combats the disease across organ systems Lung Skin Other Organs *Two disease-modifying drugs are approved for severe lung complications of the disease (SSc-ILD) ZB-106 has the potential to provide broader efficacy, working in more patients not just certain subsets |
| ©2024 Zura Bio Ltd. Pioneering Dual Pathway Biology 7 Sources: 1 Liu, Ling, et al. Journal of Inflammation Research, doi:10.2147/jir.s100940. 2 Manetta, Joseph et al. Journal of Inflammation Research, doi:10.2147/jir.s67751. 3 Benschop, Robert J., et al. mAbs, doi:10.1080/19420862.2019.1624463. (*) Figure Generated with BioRender Nasdaq: ZURA ZB-106 is an IgG-scFv engineered by the fusion of ixekizumab (TALTZ®) and tabalumab 1, 2, 3 BAFF IL-17 Anti-IL-17 scFv TALTZ® Anti-BAFF Ab tabalumab tibulizumab Anti BAFF x IL-17 ZB-106 neutralizes IL-17A or BAFF regardless of whether the other binding sites are occupied ZB-106 binds in the same way as TALTZ® and tabalumab with the same number of binding sites Activity is mediated through direct target engagement and not ADCC t1/2 is 26.9 days * * tabalumab tabalumab + IL- 17A ZB-106 ZB-106 + IL- 17A TALTZ® TALTZ® + BAFF ZB-106 ZB-106 + BAFF ZB-106 inhibits BAFF-mediated proliferation in T1165 cells in an IL-17 independent manner 3 ZB-106 inhibits IL-17 mediated CXCL1 in epithelial cells in a BAFF independent manner 3 nM |
| ©2024 Zura Bio Ltd. Anti-IL-17 scFv TALTZ® Anti-BAFF Ab tabalumab BAFF IL-17 tibulizumab: BAFF / IL-17 ZB-168: IL-7R / TSLP torudokimab: IL-33 / RAGE Potent molecules with highly validated pathways Nasdaq: ZURA 78 Participants Dosed Across Three Ph1/1b studies 57 participants with single dose 21 participants with multiple dose up to 12 weeks 93 Participants Dosed 60 participants with single dose 33 participants with multiple doses up to 12 weeks 244 Participants Dosed 81 participants with single dose 163 participants with multiple doses up to 52 weeks IL-17 binds to IL-17A preventing IL-17A/A and IL-17A/F heterodimerization1 • ZB-168 is nearly 10-fold more potent than AZ/AMG’s tezepelumab, and tezepelumab does not inhibit IL-7 signaling • ZB-168 is >300-fold more potent than Q32Bio’s bempikibart in TSLP-induced markers, but similar in IL-7-induced pSTA58 Torudokimab was 2.9 and 5.5-fold more potent than etokimab and itepekimab, respectively, inhibiting IL-33-induced GM-CSF production by human mast cells POTENCY DOSING TO DATE 2 half-life ( t1/2 ) tibulizumab 26.9 days sonelokimab 11-12 days izokibep ~11 days Sources: 1 Liu, Ling, et al. Journal of Inflammation Research, doi:10.2147/jir.s100940. 2 IB and CSR, 3 Manetta, Joseph et al. Journal of Inflammation Research, doi:10.2147/jir.s67751. 4 Benschop, Robert J., et al. mAbs, doi:10.1080/19420862.2019.1624463. 5 Zura Internal Data. 6 Herold, Kevan C., et al. JCI Insight, doi:10.1172/jci.insight.126054. 7 Numazaki, Mako, et al. Journal of Pharmacology and Experimental Therapeutics, doi:10.1124/jpet.121.000686. 8.BMS patent https://patents.google.com/patent/WO2020154293A1/en UPB-101 (α-TSLPR) tezepelumab (TSLP) bempikibart (IL-7Rα) ZB-168 (IL-7Rα) α-TSLPR mAb TSLP mAb IL-7Rα mAb IL-7Rα mAb TSLP-Induced Signals 16.1 ng / ml / 0.1nM (CCL17)(7) 67 ng / ml / 0.44nM (CCL17)(7) 24 nM (CCL2)(8) 7.5 ng / ml / 0.05nM (CCL17)(5) 11 ng / ml / 0.07nM (CCL22)(5) 0.08 nM (CCL2)(8) IL-7-Induced Signals Neg Neg 0.6 nM (IL-7 at 0.25ng/ml)(8) 2.1 nM (IL-7 at 2.5ng/ml)(8) 0.46nM (pSTAT5)(6) Antibody kon (M-1 s-1 ) koff (s-1 ) kd (pM) torudokimab Potency torudokimab (LY3375880) 1.7 x 106 6.7 x 10-5 39 etokimab (AnaptysBio) 9.4 x 105 1.2 x 10-4 112 2.9x itepekimab (Regeneron) 7.6 x 105 1.6 x 10-4 215 5.5x IL-7R γc TSLPR 8 |
| ©2024 Zura Bio Ltd. Clinical stage pipeline targeting key immunology pathways 9 Pioneering dual pathway biology Paradigm shift for complex diseases Potential best-in-class potency on clinically validated pathways ZURA BIO PROGRAM INDICATION NEXT CLINICAL PHASE EXPECTED KEY MILESTONES Preclinical Phase 1 Phase 2 Phase 3 ZB-106 tibulizumab Anti-BAFF x IL-17 systemic sclerosis Phase 2 study initiation, to enable seamless transition to Ph3 2024 hidradenitis suppurativa Open IND dermatology division 2024 Phase 2 initiation* 2024 ZB-168 Anti-IL-7R alopecia areata Phase 2 initiation* 2024 ZB-880 torudokimab Anti-IL-33 allergy / respiratory Conduct all necessary CMC and regulatory tasks to prepare the asset for Phase 2 readiness* (*) pending expected phase 2 / 3 external catalysts Nasdaq: ZURA |
| ©2024 Zura Bio Ltd. 10 ZB-106 Program: External Catalyst ZB-168 Program: External Catalyst ZB-880 Program: External Catalyst LEGEND: Sources: ClinicalTrial.gov, Company Press Release Abbreviations: AA, alopecia areata; AD, atopic dermatitis; COPD, chronic obstructive pulmonary disease; HS, hidradenitis suppurativa, PsA, psoriatic arthritis; SLE, systemic lupus erythematosus; UC, ulcerative colitis 2024 2025 Q1 Q2 Q3 Q4 Q1 Q2 (1Q-2024) Topline data from Ph2b/3 in PsA Acelyrin, izokibep (IL-17) (4Q-2024) Topline Ph2b/3 in Uveitis Acelyrin, izokibep (IL-17) (3Q-2024) Topline Ph2 in Plaque psoriasis Dice (part of Eli Lilly), DC-806 (IL-17) (3Q-2024) Topline Ph3 in Asthma Astra Zeneca / Amgen, tezepelumab (TSLP) (3Q-2024) Ph2 in SLE Novartis, Ianalumab (VAY736) (BAFF) & iscalimab (CFZ533) (anti-CD40) (1Q-2024) Topline Ph2 in COPD Astra Zeneca / Amgen, tezepelumab (TSLP) (1Q-2024) Topline data from Ph2b in PsA MoonLake, sonelokimab (IL-17) (3Q-2024) Topline in Ph2a in AA Q32 Bio, bempikibart (IL-7 / TSLP) (1Q/2Q-2024) Topline in Ph2 in AD Q32 Bio, bempikibart (IL-7 / TSLP) (1Q/2Q-2024) Initiate Ph1/2 trial in AA Nektar Therapeutics, rezpegaldesleukin (2Q-2025) Ph3 in COPD (AERIFY-1 / AERIFY-II) Sanofi/Regeneron, itepekimab (anti-IL-33 mAb) Nasdaq: ZURA Key External Catalysts Through 1H-2025 (4Q-2023 to 1Q-2024) Topline Ph2 in UC OSE Immunotherapeutics , OSE-127 (anti-IL-7R mAb) (Ongoing through Q4-2026) Topline Readouts in Multi-year B-cell Platform Study in HS Novartis, CFZ533, LYS006, MAS825, LOU064 and VAY736 |
| ©2024 Zura Bio Ltd. Potential First-in-Class, Dual Antagonist Combining tabalumab and TALTZ® systemic sclerosis (SSc) ZB-106 tibulizumab Anti-BAFF x IL-17 |
| ©2024 Zura Bio Ltd. ZB-106 is Clinically De-Risked Through Ph1b 12 78 Participants Dosed Across Three Ph1/1b studies 57 participants with single dose; 21 participants with multiple dose up to 12 weeks SAD Studies: No deaths or SAEs MAD study: No deaths, single related SAE of neutropenia with resolution Most frequent TEAE: Headache, transient neutropenia, nausea, diarrhea No TEAE of infection at target doses In the MAD study, one participant had TE-ADAs detected at a low titer SAFETY and ADA t1/2 is 26.9 days Bioavailability after SC doses was 62.9% At doses tested there is evidence of maximum target engagement with clinical safety supporting 6-fold “window” between max target engagement and max human dose tested PHARMACOKINETICS Established dosing regimen In Phase 1b studies in both RA and Sjögren’s there were multiple impacts on PD markers: - Decrease in CD20+ B-cells with higher doses generally associated with larger changes from baseline - Decrease in hs-CRP AUC was associated with higher ZB-106 AUCs PHARMACODYNAMICS Demonstrated PD in participants in Ph1b Safety / ADA profile in line with TALTZ® ZB-106 is a highly validated molecule that enables the opportunity to deliver on the promise of both IL-17 and BAFF inhibition in autoimmune disease Nasdaq: ZURA Abbreviations: MAD, multiple ascending dose; SAD, single ascending dose |
| ©2024 Zura Bio Ltd. Synergistic benefit of IL-17 and BAFF Neutralization in Collagen Induced Arthritis model 13 Rheumatoid arthritis is a prototypic autoimmune disease where individually targeting IL-17-mediated inflammation or depleting B cells has been clinically validated The collagen-induced arthritis (CIA) murine model is similarly characterized by increased IL-17 production and B cells that drive disease pathogenesis Surrogate antibodies were used to evaluate whether neutralization of IL-17 and BAFF was superior to targeting individual pathways Mice were injected with anti-IL-17A and/or anti-BAFF on days 22, 29, and 36 Blockade of both IL-17A and BAFF was associated with reduced: Disease severity Inflammation in the hind paw (histology score) Anti-collagen antibodies histology score anti-collagen antibody (mg/mL) anti-BAFF + anti-IL-17 Sources: Zura Internal Data, IND Briefing |
| ©2024 Zura Bio Ltd. IL-17 efficacy in SSc Role of BAFF in SSc IL-17 and BAFF drive disease pathogenesis in systemic sclerosis (SSc) 14 Strom al cells T1-IFN BAFF Plasm a cell CXCR5+ Tfh cell TLS GC B cell CXCL13 Brodalumab treatment in SSc leads to improved clinical outcomes 1 IL-17 known to play key role in the fibrotic process of various organs like lung, kidney, heart and skin Th17 cell–derived IL-17 was significantly higher in the skin and serum of SSc patients 2 Sources: 1 Fukasawa, T., et al. Annals of the Rheumatic Diseases, doi:10.1136/annrheumdis-2022-eular.2519. 2 Yang, Xiaoqin, et al. Arthritis Research Therapy, doi:10.1186/ar4430. 3 Ebata, Satoshi, et al. The Lancet Rheumatology, doi:10.1016/s2665-9913(21)00107-7. 4 Sato, Shinichi, et al. Molecular Immunology, doi:10.1016/j.molimm.2004.06.025. 5 Senécal, Jean-Luc, et al. Journal of Scleroderma and Related Disorders, doi:10.1177/2397198319870667. 6 Sato, Shinichi,, et al. The Journal of Immunology, doi:10.4049/jimmunol.165.11.6635. 7 Gordon, Jessica K., et al. Arthritis Rheumatology, doi:10.1002/art.40358. Belimumab therapy shows efficacy in open label studies and one single center PBO study 7 Belimumab has been granted ODD by FDA and a Phase 2/3 had been initiated in SSc-ILD by GSK SSc patients have B cell abnormalities characterized by chronic hyper-reactivity of memory B cells 4 BAFF and auto-antibodies are key biomarkers in SSc 5,6 ZB-106 has the potential to treat the Th17 and BAFF components of SSc ZB-106 | SSc Stromal cells Plasma cell CXCR5+Tfh cell |
| ©2024 Zura Bio Ltd. IL-17 and BAFF Inhibition Have Shown Efficacy in Placebo Controlled Trials in systemic sclerosis (SSc) 15 ZB-106 | SSc Brodalumab IL-17 receptor antagonist Achieved primary endpoint of treatment difference of least square mean: −21.2 [95% CI -23.9, 18.5]; P<0.0001), and demonstrated a rapid, sustained reduction in mRSS over 52 weeks1 Demonstrated therapeutic effects on lung/respiratory functions, digital ulcers, the symptoms of gastroesophageal reflux disease, and QOL without noteworthy safety concerns Belimumab BAFF antagonist 52-week, investigator initiated, single center, double blind, placebo-controlled pilot study in 20 participants with dcSSC on MMF Both treatment groups experienced improvements in mRSS favoring belimumab (-10 vs -3; p=NS) All secondary endpoints favored belimumab with statistical significance in 2 endpoints: SHAQ DI and VAS Raynaud’s phenomenon Sources: 1 Fukasawa, T., et al. Annals of the Rheumatic Diseases, doi:10.1136/annrheumdis-2022-eular.2519. 2 Gordon, Jessica K., et al. Arthritis Rheumatology, doi:10.1002/art.40358. CLINICAL PRECEDENT Phase 2 belimumab IIT study - 15 - 10 - 5 0 5 10 Δ mRSS mRSS Belimumab n = 9 -10.0 Placebo n = 9 -3.0 Δ +7.0 points Δ FVC FVC (% predicted) Belimumab n = 9 5.0 Placebo n = 9 -2.0 Δ +7.0% - 15 - 10 - 5 0 5 10 |
| ©2024 Zura Bio Ltd. Phase 2 SSc Trial Design* 16 ZB-106 | SSc KEY EFFICACY ENDPOINTS • mRSS- primary • HAQ-DI (Function) • Clinician Global • Patient Global • FVC • Modified CRISS (Ph3 endpoint) (*) Trial design is subject to change due to factors such as regulatory feedback PART A: RANDOMIZED TRIAL (mRSS) EFFICACY PERIOD (24 WEEKS) PLACEBO ZB-106 DOSE LEVEL 1 R PART B: OPEN LABEL EXTENSTION (FVC) EFFICACY PERIOD (24 WEEKS) E ZB-106 DOSE LEVEL 1 KEY INCLUSION CRITERIA • Diffuse cutaneous SSc • mRSS 10-29 • First symptoms of sclerosis other than RP within 5 years • Evidence of recent disease progression* • HAQ-DI >0.25 • Stable background therapy, including MMF Potential trigger for pivotal study |
| ©2024 Zura Bio Ltd. Additional Indications Under Consideration for ZB-106 17 ZB-106 | SSc BAFF pathway IL-17 pathway Rheumatology systemic sclerosis 1 Sjögren’s syndrome 1 systemic lupus erythematosus 1 rheumatoid arthritis 1 Dermatology hidradenitis suppurativa 1 Sources: 1 ClinicalTrials.gov BAFF IL-17 Anti-IL-17 scFv TALTZ® Anti-BAFF Ab tabalumab tibulizumab Anti BAFF x IL-17 * * Clinical Validation |
| ©2024 Zura Bio Ltd. 18 Development opportunities exist across Rheumatology, Respiratory and Dermatology ZURA ASSETS Rheumatology systemic sclerosis, Sjögren's syndrome, lupus, rheumatoid arthritis Respiratory asthma, chronic obstructive pulmonary disease Dermatology alopecia areata, hidradenitis suppurativa, atopic dermatitis ZB-168 Anti-IL-7R ZB-106 tibulizumab Anti-BAFF x IL-17 ZB-880 torudokimab Anti-IL-33 ZB-106 is Zura’s lead asset and a key value driver in rheumatology ZB-168 and ZB-880 have potential in respiratory and dermatology |
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