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| PART I | FINANCIAL INFORMATION | | 5 |
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| Item 1. | Financial Statements | | 5 |
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| | Condensed Consolidated Balance Sheets | | 5 |
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| | Condensed Consolidated Statements of Operations | | 6 |
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| | Condensed Consolidated Statements of Changes in Convertible Preferred Shares, Redeemable Noncontrolling Interest and Shareholders’ Equity (Deficit) | | 7 |
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| | Condensed Consolidated Statements of Cash Flows | | 9 |
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| | Notes to Condensed Consolidated Financial Statements | | 10 |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 24 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | | 39 |
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| Item 4. | Controls and Procedures | | 39 |
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| PART II | OTHER INFORMATION | | 40 |
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| Item 1. | Legal Proceedings | | 40 |
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| Item 1A. | Risk Factors | | 40 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | | 40 |
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| Item 3. | Defaults Upon Senior Securities | | 40 |
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| Item 4. | Mine Safety Disclosures | | 40 |
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| Item 5. | Other Information | | 40 |
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| Item 6. | Exhibits | | 41 |
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| Signatures | | | 42 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q 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.
The forward-looking statements are based on the current expectations of the Company 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. There can be no assurance that future developments will be those that have been anticipated. 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, 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 our operations, and if we are unable to raise such capital when needed or on acceptable terms, we may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; |
| ● | we may be unable to renew existing contracts or enter into new contracts; |
| ● | we rely on third-party contract development manufacturing organizations for the manufacture of clinical materials; |
| ● | we rely on contract research organizations, clinical trial sites, and other third parties to conduct our preclinical studies and clinical trials; |
| ● | we may be unable to obtain regulatory approval for our product candidates, and there may be related restrictions or limitations of any approved products; |
| ● | we may be unable to successfully respond to general economic and geopolitical conditions; |
| ● | we may be unable to effectively manage growth; |
| ● | we face competitive pressures from other companies worldwide; |
| ● | we may be unable to adequately protect our intellectual property rights; and |
| ● | other factors set forth in documents filed, or to be filed, with the SEC. |
Additional discussion of the risks, uncertainties and other factors described above, as well as other risks material to our business, can be found under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can Zura assess the impact of all such risk factors on the business of Zura or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other transactions we may execute.
Forward-looking statements are not guarantees of performance. You should not put undue reliance on our forward-looking statements. Forward-looking statements, reflect the beliefs and opinions of Zura on the relevant subject. These statements are based upon information available to Zura as of the date of this Quarterly Report on Form 10-Q, and while Zura believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and statements should not be read to indicate that Zura has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. All forward-looking statements attributable to Zura or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. Zura undertakes no obligations to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
