Zura Bio (ZURA) risk factors, FY2025 10-K

Risks Related to Our Limited Operating History, Financial Position and Capital Requirements

1. 01We have a limited operating history, have not completed any clinical trials, and have not taken a product through to commercialization
2. 02We 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 profitable51% rewritten
3. 03We expect to fund our operations from existing proceeds as well as through the future sale of equity, debt, borrowing under credit facilities or through potential collaborations with other companies or other strategic transactions
4. 04If 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 efforts33% rewritten
5. 05We may in the future license additional assets, which may require us to expend additional resources and raise additional capital

Risks Related to Anticipated Timing for Initiation, Enrollment, and Completion of Any Planned or Future Clinical Trials

1. 06We may not be able to initiate clinical trials if drug product is not timely available at clinical trial sites

Risks Related to the Clinical Development and Commercialization of Our Product Candidates

1. 07We 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
2. 08Our future success is substantially dependent on our ability to successfully develop the ZB Assets for future marketing approval, and then successful commercialization60% rewritten
3. 09The results of preclinical studies and early clinical trials of the ZB Assets 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 FDA, EMA, or other foreign regulatory authorities79% rewritten
4. 10conduct may fail. For instance, we do not know whether the ZB Assets will perform in future preclinical studies or clinical trials as the ZB Assets have performed in preclinical studies and early clinical trials conducted by Pfizer and/or Lilly, as applicableNew
5. 11Preclinical 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
6. 12Preliminary, 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
7. 13We 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
8. 14If 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
9. 15The ZB Assets may have a safety profile that could prevent regulatory approval, marketing approval or market acceptance, or limit commercial potential

Risks Related to our Dependence on Third Parties or Their Actions

1. 16We intend to rely on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business
2. 17We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of our product candidates. Reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost
3. 18Our current and anticipated future dependence upon others for the manufacture of our product candidates or drugs may adversely affect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis

Risks Related to Our Intellectual Property

1. 19If we fail to comply with any of our obligations under the 2023 Lilly License, Lilly may have the right to terminate the license agreement, in which event we would not be able to market any tibulizumab product74% rewritten
2. 20If we fail to comply with any of our obligations under the Pfizer Agreement, or we are subject to a bankruptcy or dissolution, Pfizer may have the right to terminate the license agreement, in which event we would not be able to market any crebankitug product
3. 21If we fail to comply with any of our obligations under the 2022 Lilly License, Lilly may have the right to terminate the license agreement, in which event we would not be able to market any torudokimab product74% rewritten
4. 22Intellectual property disputes may impact our business and/or our ability to develop and commercialize the ZB Assets
5. 23Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage
6. 24We have limited geographical protection with respect to our licensed patents and may not be able to protect our intellectual property rights throughout the world
7. 25Our competitors may operate in countries where we do not have patent protection and can freely use our technologies and discoveries. For example, we may lack patent protection or pending patent applications in manufacturing countries such as China, India, and Singapore
8. 26Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements
9. 27Issued patents covering one or more of our product candidates could be found invalid or unenforceable
10. 28We may not be able to maintain or enforce trade secret protection for our product candidates
11. 29We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
12. 30Patent terms may not protect our competitive position with respect to the ZB Assets for an adequate amount of time
13. 31If we do not obtain patent term extensions in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, our business may be materially harmed
14. 32Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect or capitalize on the ZB Assets26% rewritten
15. 33We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market the ZB Assets
16. 34We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property21% rewritten
17. 35We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing the ZB Assets36% rewritten
18. 36Our license from Pfizer is subject to retained rights
19. 37Pfizer may also use for any purpose information in non-tangible form which may be retained by persons who have had access to crebankitug and the licensed know-how, including ideas, concepts or techniques contained therein
20. 38Our licenses from Lilly are subject to retained rights
21. 39We may not be able to effectively secure first-tier technologies when competing against other companies or investors
22. 40Numerous factors may limit any potential competitive advantage provided by our intellectual property rights
23. 41If approved, our product candidates that are regulated as biologics may face competition from biosimilars or interchangeables approved through an abbreviated regulatory pathway

Risks Related to Regulatory and Legal Compliance

1. 42We will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with the ZB Assets
2. 43Due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer the ZB Assets at competitive prices which would seriously harm our business35% rewritten
3. 44The FDA, EMA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses32% rewritten
4. 45Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements41% rewritten
5. 46Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties
6. 47The size of the potential market for the ZB Assets is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates
7. 48Healthcare legislative and regulatory reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business89% rewritten
8. 49If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
9. 50We are subject to laws and regulations related to privacy, data protection, information security and consumer protection across different markets where we conduct our business. Our actual or perceived failure to comply with such obligations could harm our business25% rewritten
10. 51International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew

Risks Related to Our Business Operations, Employee Matters, and Managing Growth

1. 52We are dependent on our key personnel and anticipate hiring additional key personnel. If we are not successful in attracting and retaining qualified personnel, including consultants, we may not be able to successfully implement our business strategy74% rewritten
2. 53preclinical and clinical programs. While we have, or will have, agreements governing the activities of such third parties, we will control only certain aspects of their activities and have limited influence over their actual performanceNew
3. 54In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth97% rewritten
4. 55experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnelNew
5. 56We may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements
6. 57Our financial condition, results of operations and business reputation could be adversely affected by our recent internal review of certain agreements and other mattersNew
7. 58The increasing use of social media platforms presents new risks and challenges
8. 59Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
9. 60As a public company, we are required to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act and make an ongoing, formal assessment of the effectiveness of our internal controls over financial reporting
10. 61Increasing regulatory focus on privacy and security issues and expanding laws and regulatory requirements could impact our business models and expose us to increased liability
11. 62We face substantial competition, which may result in others discovering, developing, licensing or commercializing products before or more successfully than we do25% rewritten
12. 63Public health crises such as pandemics or similar outbreaks have affected and could continue to seriously and adversely affect our preclinical studies and anticipated clinical trials, business, financial condition and results of operations
13. 64Our business, operations, financial position, and clinical development plans and timelines could be materially adversely affected by international conflicts and economic sanctions

Risks Related to Ownership of Our Class A Ordinary Shares

1. 65The market price of our securities may be volatile and may decline in the future
2. 66We have not paid cash dividends in the past and we do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of our Class A Ordinary Shares
3. 67Future sales and/or issuances of our securities could result in additional dilution of the percentage ownership of our existing shareholders and could cause our share price to fall73% rewritten
4. 68may be beyond our control, and which could cause actual results from the sale of our Class A Ordinary Shares to differ materially from expectationsNew
5. 69If certain holders of our Class A Ordinary Shares sell a significant portion of their securities, it may negatively impact the market price of our Class A Ordinary Shares and such holders still may receive significant proceeds88% rewritten
6. 70Our operating results have and may continue to fluctuate significantly
7. 71The absence, reduction, or unfavorable nature of securities or industry analyst coverage of our business, as well as unfavorable third‑party reports or commentary and the existence of pre‑funded warrants, could adversely affect the market price and trading volume of our Class A ordinary sharesNew
8. 72We may also be referenced in reports, analyses or other publications by third parties that do not formally cover us, including industry reports or market commentary. The content, accuracy and timing of information contained in such publications is outside of our controlNew
9. 73Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to the ZB Assets28% rewritten
10. 74Anti-takeover provisions in the MAA and under Cayman Islands law could make an acquisition, which may be beneficial to our shareholders, more difficult and may prevent attempts by our shareholders to replace or remove our current management
11. 75We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our securities less attractive to investors28% rewritten
12. 76We have and will continue to incur increased costs as a result of operating as a public company, and our management will devote substantial time to related compliance initiatives23% rewritten
13. 77A failure to meet Nasdaq’s continued listing requirements could result in a delisting of ordinary shares