Dyne Therapeutics (DYN) risk factors, 2025 10-K

Risks related to our financial position and need for additional capital

1. 01We have incurred significant losses since our inception, have no products approved for sale and we expect to incur losses for the foreseeable future
2. 02add operational, legal, compliance, financial and management information systems and personnel to support our research, product development and future commercialization efforts, as well as to support our operations as a public company
3. 03We have never generated revenue from product sales and may never achieve or maintain profitability
4. 04satisfying any post-marketing requirements
5. 05We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development activities or commercialization efforts
6. 06the costs of operating as a public company
7. 07Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
8. 08Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability
9. 09Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be subject to limitations

Risks related to discovery and development

1. 10There are equivalent processes and risks applicable to clinical trial applications in other countries, including countries in the European Union
2. 11establishment and maintenance of healthcare coverage and adequate reimbursement by payers
3. 12Furthermore, product candidates are subject to continued preclinical safety studies, which may be conducted concurrently with our clinical testing. The outcomes of these safety studies may delay the launch of or enrollment in clinical trials and could impact our ability to continue to conduct our clinical trials
4. 13lack of adequate funding to continue the clinical trial
5. 14experience damage to our reputation
6. 15Our approach to the discovery and development of product candidates based on our FORCE platform is unproven, and we may not be successful in our efforts to identify, discover or develop potential product candidates
7. 16The outcome of preclinical studies and data from earlier-stage clinical trials may not be predictive of final results or future results of clinical trials or the success of later clinical trials and data from clinical trials in one indication may not be predictive of results of clinical trials in other indications
8. 17If we experience delays or difficulties in the enrollment of patients in clinical trials, our ability to complete clinical trials may be adversely impacted
9. 18ability to monitor patients adequately during and after treatment
10. 19We may expend our limited resources to pursue a particular program, product candidate or indication and fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success
11. 20Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of our product candidates
12. 21the inability to commercialize any product candidates we may develop

Risks related to our dependence on third parties

1. 22We rely, and expect to continue to rely, on third parties to conduct some or all aspects of our product manufacturing, or our research and preclinical and clinical testing, and these third parties may not perform satisfactorily
2. 23form relationships with other entities, some of which may be our competitors
3. 24We currently depend on a small number of third-party suppliers for the manufacture of our Fab, the linkers and payloads. The loss of these or future third-party suppliers, or their inability to provide us with sufficient supply, could harm our business
4. 25in the event of approval to market and commercialize any product, an inability to meet commercial demands for the product
5. 26We do not currently have arrangements in place for redundant supply or a second source for all required raw materials. If our existing or future third-party manufacturers cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace them on a timely basis or at all
6. 27We may from time to time be dependent on single-source suppliers for some of the components and materials used in the product candidates we may develop
7. 28We may enter into collaborations with third parties for the research, development and commercialization of certain of the product candidates we may develop. If any such collaborations are not successful, we may not be able to capitalize on the market potential of those product candidates
8. 29collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all
9. 30If conflicts arise between us and our potential collaborators, these parties may act in a manner adverse to us and could limit our ability to implement our strategies
10. 31If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans
11. 32Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators
12. 33We are dependent on third-party vendors to provide certain licenses, products and services and our business and operations, including clinical trials, could be disrupted by any problems with our significant third-party vendors

Risks related to commercialization

1. 34We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do
2. 35Even if any product candidate that we may develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success
3. 36any restrictions on the use of our products, if approved, together with other medications
4. 37The pricing, insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our future product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue
5. 38If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing any product candidates we may develop if and when they are approved
6. 39efforts may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel
7. 40unforeseen costs and expenses associated with creating an independent sales and marketing organization
8. 41The biologic product candidates for which we intend to seek approval may face competition sooner than anticipated

Risks related to our intellectual property

1. 42the priority of invention of patented technology
2. 43We may not be able to protect our intellectual property rights throughout the world
3. 44intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license
4. 45Obtaining 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
5. 46We may not be successful in obtaining necessary rights to product candidates we may develop through acquisitions and in-licenses
6. 47Issued patents covering any product candidates we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
7. 48If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
8. 49Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business
9. 50Intellectual property litigation or other proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities
10. 51We 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
11. 52condition and prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our scientific and management personnel
12. 53If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be harmed
13. 54We may be subject to claims challenging the inventorship or ownership of our patent and other intellectual property rights
14. 55If 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 affected
15. 56Intellectual property rights do not necessarily address all potential threats
16. 57Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover our trade secrets or that our trade secrets will be misappropriated or disclosed

Risks related to regulatory approval and other regulatory and legal compliance matters

1. 58applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates
2. 59Additionally, we could face heightened risks with respect to seeking marketing approval in the United Kingdom as a result of the withdrawal of the United Kingdom from the European Union, commonly referred to as Brexit
3. 60We are conducting and intend to conduct certain of our clinical trials globally. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business
4. 61Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of any product candidates we may develop
5. 62Breakthrough or RMAT therapy designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval of any product candidates we may develop
6. 63Priority review designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval of any product candidates we may develop
7. 64We may not be able to obtain orphan drug exclusivity for product candidates we may develop, and even if we do, that exclusivity may not prevent regulatory authorities from approving other competing products
8. 65criteria for orphan drug designation, in particular if the product is sufficiently profitable so that market exclusivity is no longer justified
9. 66refuse to allow us to enter into supply contracts, including government contracts
10. 67we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition
11. 68injunctions or the imposition of civil or criminal penalties
12. 69We and our contract manufacturers are subject to significant regulation. The manufacturing facilities on which we rely may not continue to meet regulatory requirements, which could materially harm our business
13. 70anti-bribery laws of European Union Member States and the United Kingdom, such as the UK Bribery Act 2010. Violation of these laws could result in substantial fines and imprisonment
14. 71Legislative and regulatory changes may increase the difficulty and cost for us and any future collaborators to obtain reimbursement for our product candidates, if and when approved
15. 72a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research
16. 73The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when approved
17. 74the availability of capital
18. 75obligations can be complex and may be subject to changing interpretation. These obligations may be applicable to some or all of our business activities now or in the future
19. 76Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
20. 77Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs
21. 78If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur significant costs

Risks related to employee matters, managing growth and other operational matters

1. 79Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 80We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 81Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations
4. 82litigation or other claims in connection with the acquired company, including claims from terminated employees, customers, former stockholders or other third parties
5. 83Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic or other catastrophic event

Risks related to ownership of our common stock and our status as a public company

1. 84The price of our common stock is volatile and fluctuates substantially, which could result in substantial losses for our stockholders
2. 85the other factors described in this “Risk Factors” section
3. 86If securities analysts do not publish or cease publishing research or reports or publish misleading, inaccurate or unfavorable research about our business or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline
4. 87Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations
5. 88Our executive officers and directors and their affiliates, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval
6. 89We have broad discretion in the use of our cash, cash equivalents and marketable securities and may not use them effectively
7. 90Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders
8. 91A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to drop significantly, even if our business is doing well
9. 92All of our outstanding shares of common stock are available for sale in the public market, subject to applicable securities laws
10. 93We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has devoted and will continue to be required to devote substantial time to new compliance initiatives and corporate governance practices
11. 94could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices
12. 95Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management
13. 96require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal specified provisions of our certificate of incorporation or bylaws
14. 97any action asserting a claim arising pursuant to any provision of our certificate of incorporation or bylaws (in each case, as they may be amended from time to time) or governed by the internal affairs doctrine
15. 98Changes in patent law in the United States or worldwide could diminish the value of patents in general, thereby impairing our ability to protect any product candidates we may develop and our technology
16. 99Changes in tax laws or regulations or in their implementation or interpretation may adversely affect our business and financial condition
17. 100Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud