Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40598 ZURA BIO LIMITED (Exact name of Registrant as specified in its Charter) Cayman Islands 98-1725736 (State or o ...

Offering Details - Zura Bio Limited is offering 18,200,000 Class A Ordinary Shares and pre-funded warrants to purchase up to 1,800,000 Class A Ordinary Shares[1] - The offering includes an option for underwriters to purchase an additional 3,000,000 Ordinary Shares[1] - The purchase price for the Pre-Funded Warrants is set at $6.249 per warrant, with a withholding of $0.375 per warrant for offsets[83] - The initial public offering price per Ordinary Share is set at $6.25, while the price per Pre-Funded Warrant is $6.249[160] - The purchase price per Ordinary Share for the Underwriters is $5.875, which is $0.375 less than the initial public offering price[161] - The company has granted an option to the Underwriters to purchase up to an additional 3,000,000 Ordinary Shares[164] - The total number of shares allocated to Leerink Partners LLC is 7,280,000, while Piper Sandler & Co. and Cantor Fitzgerald & Co. received 5,278,000 and 4,550,000 shares respectively[162] - The total number of Pre-Funded Warrants allocated is 1,800,000, with 720,000 going to Leerink Partners LLC[162] Regulatory Compliance - The company has filed a shelf registration statement on Form S-3, which was declared effective on September 17, 2024[2] - The Ordinary Shares are registered under Section 12(b) of the 1934 Act and listed on the Nasdaq Stock Market[19] - The company has complied with the reporting requirements of Section 13 or Section 15(d) of the 1934 Act[19] - The company has filed a Notification of Listing of Additional Shares with Nasdaq regarding the Securities[19] - The interactive data included in the Registration Statement has been prepared in accordance with the Commission's rules and guidelines[17] - The Company is not classified as an "investment company" under the Investment Company Act of 1940[28] - There are no registration rights for any equity or debt securities of the Company that would affect the current offering[36] - The Company is in compliance with all material aspects of the Employee Retirement Income Security Act (ERISA) and has no reportable events expected regarding its employee benefit plans[52] - The Company is compliant with the Sarbanes-Oxley Act of 2002, with no known failures in compliance by its directors or officers[53] - The Company and its Subsidiaries are in compliance with all applicable laws and regulations, including those from the FDA and EMA, with no material adverse effects expected[61] - The Company has filed all required documents with the Commission pursuant to the 1934 Act within the specified time periods[94] Financial Condition - There has been no material adverse change in the Company's business or financial condition since the last reporting date[35] - No material liabilities or obligations have been incurred by the Company that would adversely affect its financial condition[35] - The financial statements of the Company and its Subsidiaries present a fair consolidated financial position and results of operations in compliance with GAAP[37] - The Company has filed all required tax returns and paid all taxes due, with no material tax deficiencies asserted against it[42] - The Company has no material outstanding loans or related party transactions that have not been disclosed[65] - The Underwriters have the right to terminate the Agreement if there is a material adverse change in the Company's financial condition or market conditions[134] Corporate Structure and Governance - The Company is duly incorporated and in good standing under the laws of the Cayman Islands, with full corporate power to conduct its business[21] - Each Subsidiary is validly existing and in good standing under its jurisdiction, with all issued share capital fully paid and owned by the Company[23] - The Company has authorized and outstanding capitalization as described in the Registration Statement, with all shares validly issued and free of encumbrances[24] - The Securities to be purchased by the Underwriters have been duly authorized and will be validly issued and fully paid upon delivery[25] - The Company has established effective internal accounting controls and disclosure controls, with no material weaknesses reported[48] - The Company has good and marketable title to all material properties, free of encumbrances that would affect their value[45] Legal and Insurance Matters - There are no pending legal proceedings that could materially affect the Company's ability to perform its obligations[38] - The Company and its Subsidiaries maintain adequate insurance coverage for their businesses, including clinical trial liability claims[44] - There are no ongoing legal proceedings that could materially affect the Company or its Subsidiaries[64] - The Company has not received any adverse findings or notices from governmental authorities regarding compliance with applicable laws[61] Intellectual Property - The Company owns or possesses rights to all necessary intellectual property for its business operations, with no known challenges to its rights[59] - The Company's patents have been duly maintained and are in full force, with no adjudged invalid or unenforceable patents since in-licensing[59] - The Company has taken reasonable steps to secure its interests in intellectual property and protect confidential information[59] - The Company is not bound by any agreements that materially restrict its use of intellectual property[59] Operational Compliance - The Company has conducted all non-clinical studies and clinical trials in accordance with applicable laws and protocols, with no material serious adverse events reported[62][63] - The Company has maintained compliance with privacy and data protection laws, with no significant security breaches reported in the past three years[68] - The Company has established disaster recovery and security plans for its IT assets, consistent with industry standards[68] - The Company is in compliance with all applicable health care laws and has not received any claims or actions alleging violations[73] Agreement and Indemnity - The Company agrees to indemnify Underwriters against any losses arising from untrue statements or omissions in the Registration Statement[120] - The Company must provide additional documents and opinions as required by the Underwriters to ensure compliance with the issuance and sale of Securities[118] - The Company is obligated to provide a Bring-down Comfort Letter if requested by the Underwriters[116] - The Underwriters may seek contribution from the Company for any losses incurred due to untrue statements or omissions[126] - The Company must notify the Underwriters of any actions commenced against it for which indemnity may be sought[123] - The Company must ensure that all proceedings related to the issuance and sale of Securities are satisfactory to the Underwriters[118] Miscellaneous - The agreement includes provisions for default by Underwriters, allowing for arrangements to be made within 24 hours if any Underwriter fails to purchase the Securities[137] - The agreement is governed by the laws of the State of New York, and any legal proceedings must be instituted in specified courts in New York[148][149] - The time of the agreement is of the essence, with specified times referring to New York City time[150]

Summary of Zura Bio Conference Call Company Overview - **Company**: Zura Bio (NasdaqCM: ZURA) - **CEO**: Sandeep Kulkarni, co-founder, recently returned to the CEO role after Tourmaline Bio acquisition - **Founded**: 2022 - **Pipeline**: Three programs, with a focus on tibulizumab as the lead program [5][6][7] Key Programs and Developments - **Tibulizumab**: A bispecific antibody targeting IL-17 and BAFF, with potential first-in-class status - **Indications**: Focused on hidradenitis suppurativa (HS) and systemic sclerosis (SSc) - **Phase 2 Trials**: Two important readouts expected in 2026 and 2027 [6][10][12] Hidradenitis Suppurativa (HS) - **Mechanism**: Combines IL-17A blockade with BAFF inhibition, targeting multiple pathways to improve efficacy - **Clinical Data**: Previous studies showed high target engagement (98% for IL-17 and BAFF) [15] - **Trial Design**: TibuSHIELD study with 225 patients, randomized to two active drug arms and placebo, primary endpoint at week 16 [29][30] - **Expected Outcomes**: Aiming for a HiSCR75 delta of 20%-25% compared to placebo, reflecting clinically meaningful effects [30][42] Systemic Sclerosis (SSc) - **Opportunity**: No approved treatments for totality of SSc, presenting a significant market opportunity - **Trial Design**: TibuSURE study with 80 patients, focusing on modified Rodnan skin score and CT scans for lung function [60][62] - **Regulatory Flexibility**: Agency recognizes challenges in SSc, showing willingness for new treatment options [62] Market Context and Competitive Landscape - **Unmet Need**: HS affects approximately 8% of the population, with current treatment options being suboptimal [42] - **Competitive Edge**: Zura Bio's tibulizumab is positioned as a first-in-class drug targeting two different pathways, potentially offering a unique treatment profile [43][44] Additional Insights - **Placebo Response Management**: Over-enrollment in trials to mitigate placebo effects, careful site selection, and training for accurate measurement of clinical endpoints [38][39] - **Future Directions**: Data from phase 2 trials will inform phase 3 trial design, with a focus on refining treatment strategies based on patient responses [45][62] Conclusion Zura Bio is strategically positioned in the biotech space with its innovative approach to treating complex autoimmune disorders through bispecific antibodies. The upcoming phase 2 trial results for tibulizumab in HS and SSc will be critical in validating its therapeutic potential and shaping future development plans.

Core Insights - Zura Bio Limited is set to present the design of its Phase 2 TibuSURE clinical trial for tibulizumab in systemic sclerosis at the 9th Systemic Sclerosis World Congress in March 2026 [1] - The TibuSURE trial aims to evaluate the dual inhibition of IL-17A and BAFF, targeting a rare autoimmune disease with limited treatment options [1] - The study will enroll approximately 80 adults, randomized to receive either tibulizumab or placebo, with primary endpoints focused on skin score changes [1] Company Overview - Zura Bio is a clinical-stage biotechnology company focused on developing innovative treatments for autoimmune and inflammatory diseases [1] - The company's lead product candidate, tibulizumab (ZB-106), is also being evaluated in another Phase 2 study for hidradenitis suppurativa [1] - Zura's pipeline includes additional candidates targeting various autoimmune conditions, with a goal of improving treatment efficacy and safety [1] Clinical Trial Details - The TibuSURE trial is a multi-center, randomized, double-blind, placebo-controlled study with an open-label extension [1] - The primary endpoint is the change in modified Rodnan Skin Score at Week 24, with topline results expected in the first half of 2027 [1] - The trial represents a novel approach by targeting both inflammatory and fibrotic processes in systemic sclerosis [1]

Group 1 - Zura Bio Limited, a clinical-stage biotechnology company, focuses on developing novel medicines for patients with serious autoimmune and inflammatory diseases [1] - The company successfully closed its underwritten public offering of Class A ordinary shares and prefunded warrants on February 26, 2026 [1] - The offering included 21,200,000 Class A ordinary shares [1]

Core Viewpoint - Zura Bio Limited, a clinical-stage biotechnology company, announced the appointment of two new members to its Board of Directors, indicating a strategic move to enhance its leadership team as it develops treatments for autoimmune and inflammatory diseases [1] Group 1: Company Developments - Mark Eisner, M.D., M.P.H., and Ajay Nirula, M.D., Ph.D., have been appointed to the Board of Directors, effective February 21, 2026 [1] - This transition in leadership may reflect the company's commitment to advancing its clinical programs and improving patient outcomes in serious diseases [1] Group 2: Industry Context - The appointments come at a time when the biotechnology sector is increasingly focused on innovative treatments for autoimmune and inflammatory conditions, highlighting the competitive landscape in which Zura operates [1]

Summary of Zura Bio Limited Conference Call Company Overview - **Company Name**: Zura Bio Limited - **Focus**: Autoimmune inflammatory disorders - **Lead Program**: Tibulizumab, a bispecific antibody targeting IL-17A and BAFF [3][4] Key Points Transition and Leadership - Newly appointed CEO Sandeep Kulkarni emphasizes the transition from an execution-focused company to a data-driven one, with significant readouts expected in the next 12-18 months [4][5] - Kulkarni has been involved with Zura since its founding in 2022 and has a long history with the company [4] Product Pipeline - **Tibulizumab**: - First readout expected in Q4 2023 for hidradenitis suppurativa (HS) [6] - Second readout in the first half of 2027 for systemic sclerosis (SSc) [6] - Unique in its dual targeting mechanism, addressing unmet needs in complex autoimmune disorders [5][6] - **Additional Assets**: - IL-7 receptor antibody (crebankitug) from Pfizer - IL-33 (torudokimab) from Lilly - Focus remains primarily on tibulizumab due to resource constraints [10] Clinical Development Strategy - Emphasis on recruiting the right patients and ensuring high-quality execution of clinical trials [9] - The HS study has been expanded to 225 patients to enhance statistical power, with a primary endpoint of abscess and nodule (AN) count [24][29] - Secondary focus on HiSCR (Hidradenitis Suppurativa Clinical Response) with a target delta of 20%-25% over placebo [31] Mechanism of Action and Efficacy - Tibulizumab combines the properties of two established antibodies, targeting both IL-17 and BAFF, which are implicated in HS and SSc [11][12] - Evidence suggests B-cell involvement in HS, with elevated BAFF levels in lesions, supporting the rationale for targeting this pathway [18][19] Challenges and Considerations - High placebo response rates in HS necessitate careful study design and monitoring [24] - The complexity of SSc presents challenges, but the dual-target approach may offer new therapeutic avenues [36] Future Directions - Zura is exploring additional indications beyond HS and SSc, focusing on areas with significant unmet needs and potential for clinical validation [44][46] - The company is cautious with capital allocation and prioritization of future studies [10][45] Additional Insights - The bispecific nature of tibulizumab is seen as a potential breakthrough in treating autoimmune disorders, which often involve multiple pathways [5][6] - The company is committed to rigorous data quality and monitoring throughout clinical trials to maximize the chances of success [25][26] This summary encapsulates the key points discussed during the conference call, highlighting Zura Bio Limited's strategic focus, product pipeline, and future directions in the context of autoimmune disorder treatment.

February 11, 2026 Nasdaq Ticker: ZURA Forward-looking statements disclaimer Corporate overview Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio's expectations regarding its product candidates and their related benefits, and Zura Bio's beliefs regarding competing product candidates and products both in development and ...

Core Insights - Zura Bio Limited is a clinical-stage biotechnology company focused on developing innovative treatments for serious autoimmune and inflammatory diseases [1][3] - The company will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026, and will hold one-on-one investor meetings on the same day [1] Company Overview - Zura is developing dual-pathway antibodies aimed at addressing unmet needs in autoimmune and inflammatory diseases [3] - The company's pipeline includes candidates targeting immune system imbalances to enhance efficacy, safety, and dosing convenience [3] Product Pipeline - Zura's lead product candidate, tibulizumab (ZB-106), is currently in two Phase 2 clinical studies: TibuSHIELD for hidradenitis suppurativa and TibuSURE for systemic sclerosis [4] - Additional candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for various autoimmune and inflammatory conditions [4]

Core Viewpoint - Zura Bio Limited has appointed Dr. Sandeep Kulkarni as the new CEO, effective January 21, 2026, succeeding Kim Davis, who served as Interim CEO since October 2025 [1][2][3] Leadership Transition - Dr. Kulkarni will also continue his role as a Director of Zura, while Kim Davis will retain her positions as Chief Operating Officer, Chief Legal Officer, and Corporate Secretary [2] - Robert Lisicki, the previous CEO, is resigning effective January 21, 2026, after taking a medical leave of absence [2] Dr. Kulkarni's Background - Dr. Kulkarni has over two decades of experience in biotechnology, investment, entrepreneurship, and medicine, previously serving as co-founder and CEO of Tourmaline Bio [3][5] - His leadership at Tourmaline Bio included guiding the company through its acquisition by Novartis, which was completed in October 2025 [3] Company Strategy and Pipeline - Zura is entering a critical period with two potentially transformative readouts expected over the next 18 months [3] - The lead program, tibulizumab, is a bispecific antibody targeting IL-17 and BAFF pathways, validated in multiple autoimmune diseases, and is among the most advanced in development for such conditions [4][7] - Zura's pipeline includes additional candidates like crebankitug and torudokimab, which have completed Phase 1/1b studies and are being evaluated for various autoimmune and inflammatory conditions [7]