Zura Bio (ZURA) risk factors, FY2024 10-K

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

1. 01We have a limited operating history, have not initiated, conducted, or 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 profitable
3. 03near-term. We cannot assure you that any additional financing that we are able to raise would not have a dilutive impact on your ownership interest in the Company
4. 04We 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
5. 05If 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
6. 06We 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. 07We 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. 08We 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. 09Our future success is substantially dependent on our ability to successfully develop the ZB Assets for future marketing approval, and then successful commercialization
3. 10We may find it difficult to enroll patients in our clinical trials. If we experience delays or difficulties in the enrollment of patients in clinical trials, our successful completion of clinical trials, our receipt of marketing approvals could be delayed or prevented
4. 11The 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 authorities
5. 12Preclinical 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. 13Preliminary, 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. 14We 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. 15If 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. 16The 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. 17We 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. 18We 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. 19Our 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. 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
2. 21If we fail to comply with any of our obligations under the Lilly-Z33 License, Lilly may have the right to terminate the license agreement, in which event we would not be able to market any torudokimab product
3. 22If we fail to comply with any of our obligations under the Lilly-ZB17 License, Lilly may have the right to terminate the license agreement, in which event we would not be able to market any tibulizumab product
4. 23Intellectual property disputes may impact our business and/or our ability to develop and commercialize the ZB Assets
5. 24Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage
6. 25We 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. 26Our 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. 27Obtaining 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. 28Issued patents covering one or more of our product candidates could be found invalid or unenforceable
10. 29We may not be able to maintain or enforce trade secret protection for our product candidates
11. 30We 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. 31Patent terms may not protect our competitive position with respect to the ZB Assets for an adequate amount of time
13. 32If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, our business may be materially harmed
14. 33It is possible that we will not obtain patent term extension for a U.S. patent covering one or more of the ZB Assets even where that patent is eligible for patent term extension, or if we obtain such an extension, it may be for a shorter period than we had sought
15. 34Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect the ZB Assets
16. 35may impact the value of our patents. Similarly, changes in the patent laws of other jurisdictions could adversely affect our ability to obtain and effectively enforce our patent rights, which would have a material adverse effect on our business and financial condition
17. 36We 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
18. 37We may be subject to claims challenging the inventorship of our patents and other intellectual property
19. 38We 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 Assets
20. 39Our license from Pfizer is subject to retained rights
21. 40Pfizer 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
22. 41Our licenses from Lilly are subject to retained rights
23. 42We may not be able to effectively secure first-tier technologies when competing against other companies or investors
24. 43Numerous factors may limit any potential competitive advantage provided by our intellectual property rights
25. 44If 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. 45We 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. 46Due 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 business
3. 47The FDA, EMA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
4. 48Our 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 requirements
5. 49Our 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. 50The 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. 51Healthcare 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 business
8. 52If 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. 53We 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 business

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

1. 54We 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 strategy
2. 55In 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 growth
3. 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
4. 57The increasing use of social media platforms presents new risks and challenges
5. 58Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
6. 59As 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
7. 60Increasing regulatory focus on privacy and security issues and expanding laws and regulatory requirements could impact our business models and expose us to increased liability
8. 61We face substantial competition, which may result in others discovering, developing, licensing or commercializing products before or more successfully than we do
9. 62Public 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
10. 63Our business, operations, financial position, and clinical development plans and timelines could be materially adversely affected by international conflict

Risks Related to Ownership of Our Class A Ordinary Shares

1. 64The market price of our securities may be volatile and may decline in the future
2. 65We 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 Zura Class A Ordinary Shares
3. 66Future 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 fall
4. 67Rights Agreement”), certain shareholders are entitled to have a registration statement kept effective for a prolonged period of time such that registered resales of their Class A Ordinary Shares can be made
5. 68If certain holders of our Class A Ordinary Shares sell a significant portion of their securities, it may negatively impact the market price of the shares of our Class A Ordinary Shares and such holders still may receive significant proceeds
6. 69Our operating results have and may continue to fluctuate significantly
7. 70If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our share, our share price and trading volume could decline
8. 71Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require it to relinquish rights to the ZB Assets
9. 72Anti-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
10. 73We are an emerging growth company, and it cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our securities less attractive to investors
11. 74We 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 initiatives
12. 75A failure to meet Nasdaq’s continued listing requirements could result in a delisting of ordinary shares
13. 76If a United States person is treated as owning at least 10% of our Class A Ordinary Shares, such holder may be subject to adverse U.S. federal income tax consequences