ZURA

Business Context and Reporting Period

Zura Bio Limited (ZURA) is a clinical-stage biotechnology company developing novel medicines for autoimmune and inflammatory diseases. The company operates as an Emerging Growth Company and Smaller Reporting Company. This 10-K covers the fiscal year ended December 31, 2025. Zura has no products approved for commercial sale and has not generated any revenue to date. Its primary focus is the development of three in-licensed product candidates: tibulizumab (ZB-106), crebankitug (ZB-168), and torudokimab (ZB-880).

Key Financial Metrics

Note: The significant increase in Net Loss Attributable to Shareholders in 2025 includes a $36.4 million non-cash "deemed dividend" resulting from the extinguishment of noncontrolling interests.

Material Changes vs. Prior Period

• Increased Operating Expenses: Total operating expenses rose 36% to $75.2 million. R&D expenses increased 72% primarily due to the advancement of Phase 2 clinical trials for tibulizumab in Hidradenitis Suppurativa (HS) and Diffuse Cutaneous Systemic Sclerosis (dcSSc).
• Cash Burn: Net cash used in operating activities more than doubled to $64.8 million, driven by higher operational costs and a decrease in interest income.
• Settlement of Contingent Liabilities: The company terminated agreements with Stone Peach and BAFFX17 in December 2025. This resulted in the derecognition of a $5.0 million liability (BAFFX17) and the extinguishment of redeemable noncontrolling interests, which impacted the net loss attributable to shareholders but did not affect the core operating loss.
• Capital Structure: The company issued 8.7 million shares to Athanor Capital in connection with the settlement of prior agreements and raised $5.1 million via its At-The-Market (ATM) program in Q1 2025.

Guidance, Outlook, and Risks

Clinical Outlook

• TibuSHIELD (HS): Topline results expected in Q4 2026. Enrollment was expanded to ~225 participants in January 2026.
• TibuSURE (dcSSc): Topline results expected in H1 2027.
• Crebankitug & Torudokimab: The company is assessing future development strategies for these assets based on prior clinical data.

Liquidity and Capital Resources

As of December 31, 2025, Zura held $109.4 million in cash. Management believes existing cash, combined with proceeds from a February 2026 public offering (approx. $135.1 million net), is sufficient to fund operations through at least the end of 2028. The company expects to continue incurring significant losses and will require additional financing to achieve profitability.

Key Risks and Contingencies

• Going Concern: Recurring losses and lack of revenue raise substantial doubt about the ability to continue as a going concern without additional capital.
• Regulatory Approval: No products are approved; success depends on positive Phase 2 and future Phase 3 trial results.
• Third-Party Dependence: Reliance on contract manufacturers (including WuXi Biologics) and licensors (Lilly, Pfizer) for IP and supply chain.
• Internal Review: An Audit Subcommittee investigation into agreements with Stone Peach and BAFFX17 was completed. The review found no impact on financial results under GAAP but led to the termination of those agreements and the execution of the Athanor Agreement.

Investor Verification Checklist

• Cash Runway: Verify the impact of the February 2026 equity offering on the projected 2028 liquidity runway.
• Clinical Timelines: Monitor enrollment progress in TibuSHIELD and TibuSURE to ensure Q4 2026 and H1 2027 data readout dates remain achievable.
• License Obligations: Review the milestone payment structures with Lilly and Pfizer, noting that significant contingent payments (up to $440M and $525M respectively) are due upon regulatory and sales milestones.
• Manufacturing Supply Chain: Assess risks related to the relocation of torudokimab manufacturing from WuXi (China) to the UK and potential geopolitical impacts on supply.
• Share Dilution: Track the impact of the Athanor share issuance and the February 2026 offering on existing shareholder ownership percentages.