ArriVent BioPharma (AVBP) risk factors, FY2025 10-K

Other

1. 01clinical trials, abandon a product candidate, limit the commercial profile of an approved drug label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial conditionNew

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

1. 02We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability
2. 03Operating our business requires substantial additional capital to finance our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations
3. 04Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

Risks Related to the Development and Regulatory Approval of Our Product Candidates

1. 05We currently depend significantly on the success of our product candidates If we are unable to advance our product candidates in clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmedNew
2. 06If we are unable to develop, receive marketing approval for and successfully commercialize our product candidates, or if we experience delays as a result of any of the above factors or otherwise, our business would be significantly harmed
3. 07Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials or nonclinical studies could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects79% rewritten
4. 08In addition, disruptions caused by future public health concerns may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing clinical trials
5. 09Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, which could adversely affect our business, operating results and prospects
6. 10Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects
7. 11We may in the future develop our product candidates in combination with other therapies, and safety or supply issues with combination-use products may delay or prevent development and approval of our product candidates73% rewritten
8. 12described for our products currently in development and clinical trials that result from the fact that such cancer therapies are unapproved, such as the potential for serious adverse effects, delay in their clinical trials and lack of FDA approvalNew
9. 13Interim, topline and preliminary data from our clinical trials and nonclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data26% rewritten
10. 14determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our businessNew
11. 15The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to timely submit for and obtain regulatory approval for our product candidates, our business will be substantially harmed
12. 16With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities
13. 17Obtaining and maintaining marketing approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions59% rewritten
14. 18If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed

Risks Related to Our Reliance on Third Parties

1. 19reason, including as a result of our failure to meet our obligations under the Allist License Agreement to make any milestone payments or royalties to Allist, our business and operations would be materially harmedNew
2. 20Reported data or other clinical development announcements by third parties, including Allist, may adversely affect our clinical development plan65% rewritten
3. 21regulatory authority, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilitiesNew
4. 22In addition, our current and anticipated future dependence upon others for the manufacture of our product candidates and any future product candidates may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basisNew
5. 23Furthermore, we may not be able to maintain such collaborations if, for example, the development or approval of a product candidate is delayed, the safety of a product candidate is questioned or the sales of an approved product candidate are unsatisfactory

Risks Related to Commercialization of Firmonertinib, Our Other Product Candidates, and any Future Product Candidates

1. 24The occurrence of any event or penalty described above may inhibit our ability to commercialize our current or future product candidates and to generate revenue, could require us to expend significant time and resources in response and could generate negative publicity34% rewritten
2. 25The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses48% rewritten
3. 26rules and regulations regarding reimbursement change frequently and, in some cases, at short notice, and we believe that changes in these rules and regulations are likelyNew
4. 27If the market opportunities for our current or future product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer
5. 28Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
6. 29We may not successfully identify, acquire, develop or commercialize new potential product candidates

Risks Related to Our Business Operations and Industry

1. 30Our 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 any guidance we may provide
2. 31We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer
3. 32We will need to develop and expand our organization, and we may encounter difficulties in managing our growth and expanding our operations successfully, which could disrupt our operations
4. 33Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize firmonertinib, our other product candidates, and any future product candidates and may affect the prices we may set28% rewritten
5. 34If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit, delay or cease commercialization of any products we may develop74% rewritten
6. 35Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities31% rewritten
7. 36In the ordinary course of our business, we, and the third parties upon which we rely, process sensitive data and as a result, we and the third parties upon which we rely face a variety of evolving threats which could cause cybersecurity incidents73% rewritten
8. 37intelligence (AI) and machine learning provide threat actors with the capability to use more sophisticated means to attack our systems and may exacerbate cybersecurity risk. There can be no assurance that we will be successful in preventing cybersecurity incidents or successfully mitigating their effectsNew
9. 38Additionally, remote work has become more common and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations
10. 39Our business, operations and clinical development timelines and plans are subject to risks arising from epidemic or pandemic diseases
11. 40Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any
12. 41Our business could be affected by litigation, government investigations and enforcement actions
13. 42We may engage in strategic transactions that could increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, subject us to other risks, adversely affect our liquidity, increase our expenses and present significant distractions to our management
14. 43Our ability to use net operating loss carryforwards and other tax attributes may be limited in connection our initial public offering completed in January 2024 or other ownership changes
15. 44New tax legislation may impact our results of operations and financial condition
16. 45Inflation could adversely affect our business and results of operations

Risks Related to Our Intellectual Property

1. 46whether patent application our licensor is currently pursuing or patent application we may in the future pursue or in-license will issue as patents in any particular jurisdictionNew
2. 47We may not be able to protect our intellectual property and proprietary rights throughout the world
3. 48Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
4. 49Changes in patent laws or their interpretations could diminish the value of patents in general, thereby impairing our ability to protect our products46% rewritten
5. 50surrounding the prosecution of our patent applications and the enforcement or defense of patents issuing from those patent applications, all of which could have a material adverse effect on our business, financial condition, results of operations and prospectsNew
6. 51Issued patents covering our current product candidates or our future product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
7. 52We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that our patents will not be challenged and rendered invalid and/or unenforceable
8. 53Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time
9. 54If we do not obtain patent term extension in the United States and equivalent extensions outside of the United States for our product candidates, our business may be materially harmed
10. 55We may be subject to claims challenging the inventorship of our patents and other intellectual property
11. 56We 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 our products and product candidates
12. 57Third-party claims of intellectual property infringement, misappropriation or other violations against us or our collaborators could be expensive and time consuming and may prevent or delay the development and commercialization of our product candidates
13. 58We may become involved in lawsuits to protect or enforce our patent and other intellectual property rights, which could be expensive, time-consuming and unsuccessful
14. 59If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected36% rewritten
15. 60We may not be successful in obtaining or maintaining necessary rights to technology for our development pipeline through acquisitions and in-licenses55% rewritten
16. 61which means that our competitors may also receive access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technologyNew
17. 62Our intellectual property licensed from third parties may be subject to retained rights
18. 63Intellectual property rights do not necessarily address all potential threats to our competitive advantage
19. 64We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
20. 65Our reliance on third parties requires us to share potential trade secrets, which increases the possibility that a competitor or other third party will discover them or that potential trade secrets will be misappropriated or disclosed
21. 66If we are unable to protect the confidentiality of any potential trade secrets, our business and competitive position would be harmed

Risks Related to Our Common Stock

1. 67An active, liquid and orderly market for our common stock may not develop, or we may in the future fail to satisfy the continued listing requirements of Nasdaq and our stock may be delisted, and you may not be able to resell your common stock at your purchase price or at all
2. 68The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses
3. 69Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval and may prevent new investors from influencing significant corporate decisions
4. 70We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock
5. 71Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur could significantly reduce the market price of our common stock and impair our ability to raise adequate capital through the sale of additional equity or equity-linked securities
6. 72We are an emerging growth company and a smaller reporting company, and the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors
7. 73Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management
8. 74Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
9. 75We incur significantly increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives
10. 76If we fail to maintain effective internal control over financial reporting, we may not be able to accurately report our financial results, which may cause investors to lose confidence in our reported financial information and may lead to a decline in the market price of our stock
11. 77for enforcing the FCPA. It is unclear how this presidential directive and the DOJ guidelines may affect the biopharmaceutical industry as a whole or our business in particularNew
12. 78Our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time-consuming or costly
13. 79Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
14. 80Unfavorable macroeconomic conditions, political instability and geopolitical events could adversely affect our business, financial condition, stock price, and results of operationsNew
15. 81Changes in tax law may materially adversely affect our financial condition, results of operations and cash flows, or adversely impact the value of an investment in our common stock
16. 82If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline
17. 83We could be subject to securities class action litigation