Assembly Biosciences (ASMB) risk factors, FY2024 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 future
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
5. 05The results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of our clinical studies. In addition, the results of early clinical studies of product candidates may not be predictive of the results of later-stage clinical studies
6. 06government 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
7. 07We 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 China
8. 08foreign taxes, including withholding of payroll taxes; and
9. 09Top-line, preliminary or interim data may not accurately reflect the final results of a particular study
10. 10We 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
11. 11We will need to identify manufacturers for commercial supply on acceptable terms, which we may be unable to do because the number of potential manufacturers is limited, and the FDA must evaluate and approve any new or replacement contractor
12. 12We 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
13. 13When 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 given
14. 14If we lose key management personnel and cannot recruit and retain similarly qualified replacements, our business may materially suffer
15. 15Our collaboration partners might delay, prevent or undermine the success of our product candidates
16. 16We may not be successful in establishing and maintaining collaborations, which could adversely affect our ability to develop certain of our product candidates
17. 17We rely on data provided by third parties that has not been independently verified and could prove to be false, misleading, or incomplete
18. 18Significant 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 condition
19. 19incidents or cyber intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization
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. 23Our 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. 24We 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. 25The 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 harmed
3. 26Because 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. 27We face the risk of product liability claims and might not be able to obtain insurance
5. 28We might be exposed to liability claims associated with the use of hazardous materials and chemicals
6. 29Our employees, independent contractors, consultants, collaborators and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could result in significant liability for us and harm our reputation
7. 30disclose unauthorized activities

Risks Related to Our Intellectual Property

1. 31Our business depends on protecting our intellectual property
2. 32our product if the product is formulated differently than the patented formulation. We rely on a combination of these and other types of patents to protect our product candidates, and there can be no assurance that our intellectual property will create and sustain the competitive position of our product candidates
3. 33We may incur substantial costs as a result of litigation or other proceedings relating to our patents and other intellectual property rights
4. 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 candidates
5. 35The 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. 36Intellectual property rights do not address all potential threats to any competitive advantage we may have
7. 37Others 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. 38Patent 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. 39The price of our common stock might fluctuate significantly, and you could lose all or part of your investment