Barinthus Biotherapeutics (BRNS) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Capital Needs

1. 01We have not yet generated any material revenue from our current product candidates
2. 02If we engage in acquisitions or future strategic partnerships, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks
3. 03Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability
4. 04We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations
5. 05Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
6. 06We may require substantial additional funding in the future. If we are unable to raise capital when needed, we would be compelled to delay, reduce or eliminate our product development programs or commercialization efforts

Risks Related to Our Business and Industry and Risks Related to Clinical Development

1. 07If we are unable to advance our current or future product candidates into and through clinical trials, obtain marketing approval or reimbursement and ultimately commercialize any product candidates we develop, or experience significant delays in doing so, our business will be materially harmed
2. 08Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more participant data becomes available and are subject to audit and verification procedures that could result in material changes in the final data
3. 09Our product candidates are based on a novel approach to the treatment of infectious disease and autoimmunity, which makes it difficult to predict the time and cost of product candidate development
4. 10Difficulty in enrolling participants could delay or prevent clinical trials of our product candidates and prevent us from realizing the full commercial potential of any products we may develop
5. 11Our product candidates may cause serious adverse events, serious side effects or have other properties that could halt their clinical development, prevent their marketing authorization, require expansion of the trial size, limit their commercial potential or result in significant negative consequences
6. 12We intend to develop certain of our product candidates in combination with other therapies, which exposes us to additional risks

Risks Related to Our Approach

1. 13The market opportunities for certain of our product candidates may be relatively small as it may be limited to those patients who are ineligible for or have failed prior treatments and our estimates of the prevalence of our target patient populations may be inaccurate
2. 14Negative developments in the field of immunotherapeutics could damage public perception of any of our product candidates and negatively affect our business
3. 15We may not be successful in our efforts to identify and successfully commercialize additional product candidates
4. 16We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success

Risks Related to Sales, Marketing and Competition

1. 17inhibitors, or other small molecules, RNA, DNA, nanoparticle, VLP, peptide, protein, whole-killed vaccines or other technologies

Risks Related to the Development of Our Product Candidates

1. 18Even if we obtain marketing authorization for our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community
2. 19If our product candidates are licensed but fail to achieve market acceptance among physicians, patients, hospitals or others in the medical community, we will not be able to generate significant revenue
3. 20We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue
4. 21We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include general liability, employment practices liability, property, umbrella, and directors’ and officers’ insurance

Risks Related to Our Reliance on Third Parties

1. 22We may form or seek additional collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements
2. 23If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages

Risks Related to Government Regulation

1. 24A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
2. 25A Fast Track designation by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval
3. 26Accelerated approval by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
4. 27If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
5. 28If competitors are able to obtain marketing approval for biosimilars referencing our products, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences
6. 29Future changes to tax laws could materially adversely affect our financial condition and results of operations, and reduce net returns to our shareholders
7. 30Tax authorities may disagree with our positions and conclusions regarding certain tax positions, or may apply existing rules in an unforeseen manner, resulting in unanticipated costs, taxes or non-realization of expected benefits
8. 31We may be unable to use net operating loss and tax credit carryforwards and certain built-in losses or tax credits to reduce future tax payments or to benefit from favorable U.K. tax legislation

Risks Related to Ongoing Regulatory Obligations

1. 32The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses
2. 33The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain adequate coverage and reimbursement for any of our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue
3. 34Healthcare legislative or regulatory reform measures may have a material adverse effect on our business and results of operations
4. 35Our business activities will be subject to the Foreign Corrupt Practices Act ("FCPA"), and similar anti-bribery and anti- corruption laws in other jurisdictions
5. 36Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
6. 37If 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
7. 38The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business

Risks Related to Our Intellectual Property

1. 39If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
2. 40We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
3. 41We may be involved in lawsuits to protect or enforce our intellectual property rights, including any patents we may own or in- license in the future, which could be expensive, time-consuming and unsuccessful
4. 42Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection could be reduced or eliminated for non- compliance with these requirements
5. 43Any issued patents we in-license or may own now or in the future covering our product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO
6. 44commercialize our product candidates or other technologies and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights
7. 45We may be subject to claims challenging the inventorship or ownership of any intellectual property, including any patents we may in-license or own in the future
8. 46We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non- solicitation agreements with our competitors or other third parties
9. 47If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates we may develop, our business may be materially harmed
10. 48Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
11. 49We may not be able to protect our intellectual property and proprietary rights throughout the world
12. 50If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected
13. 51Numerous factors may limit any potential competitive advantage provided by the relevant patent rights

Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Employee Matters

1. 52The pipeline prioritization and restructuring may be unsuccessful, lead to additional costs, disrupt our operations, create unintended problems in our workforce, or increase litigation risk, in which case our business could be harmed
2. 53We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy

Risks Related to Our Business Operations and Growth

1. 54We will need to grow the size of our organization, and we may experience difficulties in managing this growth
2. 55Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
3. 56If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
4. 57Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations

Risks Related to Our International Operations

1. 58A variety of risks associated with operating our business internationally could materially adversely affect our business
2. 59Our business is subject to economic, political, regulatory and other risks associated with international operations
3. 60Claims of U.S. civil liabilities may not be enforceable against us
4. 61Fluctuations in the exchange rate between the U.S. dollar and the pound sterling may increase the risk of holding our ADSs and may materially affect our results of operations and financial condition

Risks Related to Ownership of Our ADSs

1. 62An active trading market for our ADSs may not be sustained
2. 63Our principal shareholders and management own a significant percentage of our stock and exert significant influence over matters subject to shareholder approval
3. 64The price of our ADSs is volatile and holders of our ADSs could lose all or part of their investment
4. 65Holders of our ADSs are not treated as holders of our ordinary shares
5. 66Holders of ADSs may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying ordinary shares
6. 67ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action
7. 68If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
8. 69We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our ADSs less attractive to investors
9. 70We will incur increased costs as a result of operating as an English public company listed in the U.S., and our board of directors will be required to devote substantial time to new compliance initiatives and corporate governance practices
10. 71Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance
11. 72Holders of our ADSs may not receive distributions on our ordinary shares represented by the ADSs or any value for them if it is illegal or impractical to make them available to holders of ADSs
12. 73We do not intend to pay dividends on our ADSs, so any returns will be limited to the value of our ordinary shares
13. 74As an English public limited company, certain capital structure decisions require shareholder approval, which limits our flexibility to manage our capital structure
14. 75English law also generally prohibits a public company from repurchasing its own shares without the prior approval of shareholders by ordinary resolution, being a resolution passed by a simple majority of votes cast, and other formalities. Such approval may be for a maximum period of up to five years
15. 76The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation
16. 77Changes in U.S. tax law could adversely affect our financial condition and results of operations
17. 78Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
18. 79We could be subject to securities class action litigation
19. 80The United Kingdom’s withdrawal from the European Union could increase the regulatory burden of product development and authorization in the United Kingdom and European Union