Dyne Therapeutics (DYN) risk factors, FY2025 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 future25% rewritten
2. 02We have never generated revenue from product sales and may never achieve or maintain profitability
3. 03We 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 efforts86% rewritten
4. 04As of December 31, 2025, we had cash, cash equivalents and marketable securities of $1.1 billionNew
5. 05Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates52% rewritten
6. 06Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability
7. 07Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be subject to limitations38% rewritten

Risks related to our indebtedness

1. 08Our Loan Agreement contains restrictive and financial covenants that may limit our operating flexibilityNew
2. 09Our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect our businessNew

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. 11Furthermore, 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
3. 12Our 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
4. 13The 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
5. 14If we experience delays or difficulties in the enrollment of patients in clinical trials, our ability to complete clinical trials may be adversely impacted
6. 15We 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
7. 16Clinical 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

Risks related to our dependence on third parties

1. 17We 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. 18We 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
3. 19We 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
4. 20We 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
5. 21We 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
6. 22If 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
7. 23If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans
8. 24Collaborations 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
9. 25We 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. 26We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do31% rewritten
2. 27Even 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. 28The 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
4. 29If 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
5. 30The biologic product candidates for which we intend to seek approval may face competition sooner than anticipated21% rewritten

Risks related to our intellectual property

1. 31We may not be able to protect our intellectual property rights throughout the world
2. 32UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of any potential changesNew
3. 33Obtaining 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. 34We may not be successful in obtaining necessary rights to product candidates we may develop through acquisitions and in-licenses
5. 35Issued 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
6. 36If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
7. 37Third 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
8. 38Intellectual property litigation or other proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities
9. 39We 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 property32% rewritten
10. 40Disputes about the ownership of intellectual property that we own may have a material adverse effect on our business, financial condition, results of operations and prospectsNew
11. 41If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be harmed
12. 42We may be subject to claims challenging the inventorship or ownership of our patent and other intellectual property rights
13. 43If 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
14. 44Intellectual property rights do not necessarily address all potential threats
15. 45Our 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. 46We 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
2. 47Fast 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
3. 48Breakthrough 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
4. 49Priority 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 develop56% rewritten
5. 50We 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
6. 51In 2017, the U.S. Congress passed the FDA Reauthorization Act of 2017, or the FDARA22% rewritten
7. 52We 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
8. 53Legislative 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
9. 54The 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 approved32% rewritten
10. 55Our 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 trading68% rewritten
11. 56Changes in and uncertainty surrounding United States trade policy could have a material adverse impact on our business, financial condition and results of operationsNew
12. 57If 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 costs75% rewritten

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

1. 58Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 59We 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. 60Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations
4. 61Our 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. 62The price of our common stock is volatile and fluctuates substantially, which could result in substantial losses for our stockholders
2. 63If 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
3. 64Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations
4. 65Our 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
5. 66We have broad discretion in the use of our cash, cash equivalents and marketable securities and may not use them effectively
6. 67Because 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 stockholders38% rewritten
7. 68A 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 well27% rewritten
8. 69All of our outstanding shares of common stock are available for sale in the public market, subject to applicable securities laws
9. 70We 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
10. 71Provisions 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

General Risk Factors

1. 72Changes 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
2. 73Changes in tax laws or regulations or in their implementation or interpretation may adversely affect our business and financial condition92% rewritten
3. 74Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud