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ZURA • CIK 0001855644
7 ITEM 1A. RISK FACTORS 33 ITEM 1B. UNRESOLVED STAFF COMMENTS 77 ITEM 1C. CYBERSECURITY 77 ITEM 2. PROPERTIES 78 ITEM 3. LEGAL PROCEEDINGS 78 ITEM 4. MINE SAFETY DISCLOSURES 78 PART II 79 ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 79 ITEM 6. [RESERVED] 79 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 80 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 97 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 97 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 97 ITEM 9A. CONTROLS AND PROCEDURES 98 ITEM 9B. OTHER INFORMATION 98 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 98 PART III 99 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 99 ITEM 11. EXECUTIVE COMPENSATION 99 ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS 99 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 99 ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 99 PART IV 100 ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 100 ITEM 16. FORM 10-K SUMMARY 102 2 Table of Contents SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our forward-looking statements include, but are not limited to, statements regarding our and our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward- looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “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. These forward-looking statements are based on the current expectations of Zura Bio Limited (the “Company” or “Zura”) and its management thereof and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. Forward-looking statements are not guarantees of performance. You should not put undue reliance on our forward-looking statements. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: ● our expectations regarding our product candidates and their related benefits, and our beliefs regarding competing product candidates and products both in development and approved, may not be achieved; ● our vision and strategy may not be successful; ● the timing of key events and initiation of our studies and release of clinical data may take longer than anticipated or may not be achieved at all; ● expectations regarding the potential general acceptability and maintenance of our product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; ● we may be unable to attract and retain key personnel; ● expectations with respect to our future operating expenses, capital requirements and needs for additional financing may not be achieved; ● we have not completed any clinical trials, not engaged in topline readout activities, and have no products approved for commercial sale; ● 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; ● we require substantial additional capital to finance