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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 Redeemable Noncontrolling Interest, Convertible Preferred Shares, and Shareholders’ Equity (Deficit) | | 7 |
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| | Condensed Consolidated Statements of Cash Flows | | 8 |
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| | Notes to Condensed Consolidated Financial Statements | | 9 |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 21 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | | 33 |
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| Item 4. | Controls and Procedures | | 33 |
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| PART II | OTHER INFORMATION | | 34 |
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| Item 1. | Legal Proceedings | | 34 |
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| Item 1A. | Risk Factors | | 34 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | | 34 |
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| Item 3. | Defaults Upon Senior Securities | | 34 |
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| Item 4. | Mine Safety Disclosures | | 34 |
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| Item 5. | Other Information | | 34 |
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| Item 6. | Exhibits | | 34 |
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| Signatures | | | 35 |
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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. Forward-looking statements in this Quarterly Report on Form 10-Q may include, for example, statements about:
| ● | Our expectations regarding our product candidates and their related benefits; |
| ● | Our beliefs regarding potential benefits or limitations of competing products both in development and approved; |
| ● | Information regarding our vision and strategy; |
| ● | The anticipated timing of key events and initiation of our studies and release of clinical data; |
| ● | Our expectations regarding the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients; |
| ● | Our ability to attract and retain key personnel; |
| ● | The accuracy of our future operating expenses, capital requirements, and needs for additional financing; |
| ● | Our ability to obtain funding for operations, including funds that may be necessary to complete development of our product candidates; |
| ● | The fact that we have not completed any clinical trials, and have no products approved for commercial sale; |
| ● | The fact that 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; |
| ● | The fact that 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 our development programs or future commercialization efforts; |
| ● | Our ability to renew existing contracts; |
| ● | Our reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials; |
| ● | Our ability to obtain regulatory approval for our products, and any related restrictions or limitations of any approved products; |
| ● | Our ability to respond to general economic conditions; |
| ● | Our ability to effectively manage growth; |
| ● | Competitive pressures from other companies; and |
| ● | Litigation and the ability to adequately protect our intellectual property rights. |
These and other factors that could cause actual results to differ from those implied by the forward-looking statements in this Quarterly Report on Form 10-Q are more fully described under the heading “Risk Factors” in the Company’s Registration Statement on Form 10-K filed with the SEC on March 28, 2024. 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 our business 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. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. 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.
In addition, statements of belief and similar 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. These statements are inherently uncertain and you should not put undue reliance on these statements, including, for example, statements about:
| ● | Potential liquidity and trading of our public securities; |
| ● | Our ability to raise financing in the future; |
| ● | Our attraction and retention of qualified directors, officers, employees, and key personnel; |
| ● | Our ability to compete effectively in a highly competitive market; |
| ● | The competition from larger pharmaceutical and biotechnology companies that have greater resources, technology, relationships, and/or expertise; |
| ● | The ability to protect and enhance our corporate reputation and brand; |
| ● | The impact from future regulatory, judicial, and legislative changes in our industry; |
| ● | Our ability to obtain and maintain regulatory approval of any product candidates; |
| ● | Our ability to research, discover and develop additional product candidates; |
| ● | Our ability to grow and manage growth; |
| ● | Our ability to obtain and maintain intellectual property protection and not infringe on the rights of others; |
| ● | Our ability to execute business plans and strategy; |
| ● | Those factors set forth in our documents filed, or to be filed, with the SEC. |
Should one or more of these risks or uncertainties materialize or should any of the assumptions made by the management of Zura prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.
All subsequent written and oral forward-looking statements concerning Zura or other matters addressed in this Quarterly Report on Form 10-Q and attributable to Zura or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Quarterly Report on Form 10-Q. Except to the extent required by applicable law or regulations, Zura undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events.
