Company: ZURA
Filing Date: 2025-03-25
Form Type: 10-K
Source: 0001410578-25-000443
Chunk: 6

Company: Zura Bio Ltd
Filing Date: 2025-03-25
Form: 10-K
Item: Item 1A
Chunk 6
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SUMMARY OF RISK FACTORS

Our business is subject to numerous risks and uncertainties, including those described in Item 1A “Risk Factors”. These risks include, but are not limited to the following:

●We have a limited operating history, have not initiated, conducted or completed any clinical trials, and have not taken a product through to commercialization.

●We have incurred losses since inception, and we expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have not generated any revenue from the ZB Assets and may never generate revenue or become profitable.

●Our recurring losses from operations and financial condition could raise substantial doubt about our ability to continue.

●If we are unable to raise 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. We have never successfully completed the regulatory approval process for any product candidates, and we may be unable to do so for any product candidates we develop.

●We are substantially dependent on the success of the ZB Assets, and our anticipated clinical trials of the ZB Assets may not be successful.

●We may find it difficult to enroll participants in our clinical trials. If we experience delays or difficulties in the enrollment of participants in clinical trials, our successful completion of clinical trials, our receipt of marketing approvals could be delayed or prevented.

●The results of preclinical testing and early clinical trials may not be predictive of the success of our later clinical trials, and the results of our clinical trials may not satisfy the requirements of the United States Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”), or other foreign regulatory authorities.

●Preclinical and clinical development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.

●Preliminary, interim data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures.

●We may develop the ZB Assets in combination with other therapies, which exposes us to additional risks related to other agents or active pharmaceutical or biological ingredients used in combination with our product candidates.

●If the FDA or other regulatory authorities revoke their approval of these other therapies or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the therapies we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.

●We