Assembly Biosciences (ASMB) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01In addition to our current product pipeline, we may identify, license or otherwise acquire rights to other technologies or product candidates. Any such transactions would involve numerous risks, and we may be unsuccessful in entering into any such transactions or developing any such technologies or product candidates
2. 02We are not currently profitable and might never become profitable, and we will need additional financing to complete the development of any product candidates and fund our activities into the future27% rewritten
3. 03We expect our collaboration with Gilead to be a critical part of the development, manufacture and commercialization of our product candidates. If this collaboration is unsuccessful, our business could be adversely affected
4. 04We will be heavily dependent on Gilead for further development and commercialization of the investigational products from the programs that it opts into, including our HPI program, and transition of these programs to Gilead could delay these programs' clinical and approval timelines20% rewritten
5. 05Before we or any commercial partners can obtain FDA approval (or other foreign approvals) necessary to sell any of our product candidates, we must show that each potential product is safe and effective. To meet these requirements, we must conduct extensive nonclinical and sufficient, well-controlled clinical studiesNew
6. 06varies substantially according to the type, complexity, novelty, and intended use of the product candidate, and often can be several years or more. In addition, failure or delays can occur at any time during the nonclinical and clinical study process, resulting in additional operating expenses or harm to our businessNew
7. 07government or other regulatory agency delays or clinical holds requiring suspension or termination of our clinical studies due to safety, tolerability or other issues related to our product candidates
8. 08We rely on CROs to conduct some of our nonclinical and clinical studies due to our lack of suitable facilities and resources. In addition, parts of our business are reliant on CROs, vendors, suppliers and other service providers in locations outside of the United States, including China26% rewritten
9. 09foreign currency fluctuations and compliance with foreign currency exchange rules, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another countryNew
10. 10The ongoing DHS shutdown has resulted in agencies, such as CBP, have been deemed “essential” and are continuing to operate. Disruptions at the CBP and other agencies, including furloughs and reductions in workforce, are subject to the political process, which is inherently unpredictableNew
11. 11Top-line, preliminary or interim data may not accurately reflect the final results of a particular study
12. 12We rely on third parties to formulate and manufacture our product candidates and products that we study in combination with our product candidates. Our use of third parties may increase the risk that we will not have sufficient quantities of our product candidates or other products on time or at an acceptable cost
13. 13Any third-party manufacturers with whom we contract might be unable to formulate and manufacture our product candidates in the volume and quality required to meet our nonclinical, clinical and, if approved, commercial needs in a timely mannerNew
14. 14We do not have complete control over, and cannot ensure, any third-party manufacturers’ compliance with cGMP and other government regulations and corresponding foreign requirements, including periodic FDA and state regulatory inspections
15. 15When contracting with third-party manufacturers, we might compete with other companies for access to these manufacturers’ facilities and might be subject to manufacturing delays if the manufacturers give other clients higher priority than we are given25% rewritten
16. 16If we lose key management personnel and cannot recruit and retain similarly qualified replacements, our business may materially suffer
17. 17Our collaboration partners might delay, prevent or undermine the success of our product candidates
18. 18We may not be successful in establishing and maintaining collaborations, which could adversely affect our ability to develop certain of our product candidates
19. 19We rely on data provided by third parties that has not been independently verified and could prove to be false, misleading, or incomplete
20. 20Research, development and commercialization goals, including data releases, may not be achieved in the timeframes that we publicly estimate, which could have an adverse impact on our business and could cause our stock price to decline
21. 21Developments by competitors might render our product candidates or technologies obsolete or non-competitive
22. 22Negative data from clinical studies using a competitor’s product candidates with the same or similar mechanisms of action (MOA) as ours could adversely impact the perception of the therapeutic use of our product candidates and our ability to enroll individuals in clinical studies
23. 23Significant disruptions of information technology systems or breaches of data security, including cybersecurity incidents, could materially and adversely affect our business, results of operations and financial condition93% rewritten
24. 24Our ability to use our net operating loss and credit carryforwards and certain other tax attributes may be limited

Risks Related to Our Regulatory and Legal Environment

1. 25We are and will be subject to extensive and costly government regulation, and the failure to comply with these regulations may have a material adverse effect on our operations and business
2. 26The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we or our collaborators are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed75% rewritten
3. 27Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws
4. 28We face the risk of product liability claims and might not be able to obtain insurance
5. 29We might be exposed to liability claims associated with the use of hazardous materials and chemicals
6. 30Our employees, independent contractors, consultants, collaborators and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements for which we may be held responsible and which could result in significant liability for us and harm our reputation
7. 31disclose unauthorized activities

Risks Related to Our Intellectual Property

1. 32Our business depends on protecting our intellectual property55% rewritten
2. 33We may incur substantial costs as a result of litigation or other proceedings relating to our patents and other intellectual property rights
3. 34We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates77% rewritten
4. 35obtain rights from third parties to issued patents covering such products and technologies. We cannot guarantee that the manufacture, use or marketing of any product candidates that we develop will not infringe third-party patentsNew
5. 36The cost of maintaining our patent protection globally is high and requires continuous review and compliance. We may not be able to effectively maintain our intellectual property position throughout the major markets of the world
6. 37Intellectual property rights do not address all potential threats to any competitive advantage we may have
7. 38Others may be able to make compounds that are the same as, or similar to, our current or future product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed
8. 39Patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product

Risks Related to Our Common Stock

1. 40The price of our common stock has in the past and may continue to fluctuate significantly, and you could lose all or part of your investment