Classification is based on semantic text similarity scoring and may include approximations. “No match” means no high-confidence textual match was found — not necessarily that a section was removed.

🟢 New in Current Filing Severity9/10Det 9

Changes in tariffs and other governmental trade policies could negatively affect our business and results of operations.

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Recent governmental actions and proposals relating to tariffs and other trade policies have created uncertainty about future trading arrangements and the possibility of imposing or increasing tariffs on certain goods. For example, certain governments (including the U.S. and other countries where we do business) have imposed or may impose tariffs on a wide range of products, raw materials, and intermediate goods. Additional tariffs, or retaliatory measures by other countries in response, may be implemented at any time. Should these or similar tariffs remain in place (or be re-imposed or increased), or if additional tariffs or trade restrictions are enacted in the future, they could cause us or our customers to face higher supply costs, delays or a need to switch suppliers. These actions could adversely affect our margins, profitability, financial condition, and results of operations. While we have not experienced adverse impacts of tariffs to date, we cannot predict future changes in trade policy or the terms of any renegotiated trade agreements, nor can we determine the impact they may have on our business. Any such changes could have a material adverse effect on our business, financial condition, and results of operations. 75 75 75 75 75 75

🟢 New in Current Filing Regulatory and market uncertainty have and may continue to impact our business and the markets for our products. 🔒

🟢 New in Current Filing We may experience difficulties executing our near-term strategy and prioritized pipeline. 🔒

🟢 New in Current Filing Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models and other, similar regulatory actions could impact our product revenues and materially harm our business. 🔒

🟢 New in Current Filing Although we have obtained rare pediatric disease designation for mRNA-3927, we may not be eligible to receive a priority review voucher in the event the FDA determines we no longer meet the criteria for designation, revokes the designation or FDA approval does not occur by September 30, 2029. 🔒

🟢 New in Current Filing Failure to comply with the covenants in our credit agreement could adversely affect our business 🔒

🟡 Modified We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could result in fines or criminal penalties and damage our reputation. 🔒

🟡 Modified Our use of generative AI ("GenAI") and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies. 🔒

🔴 No Match in Current Filing We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts. 🔒

🟡 Modified Our manufacturing facilities or those of third-party manufacturers or suppliers may fail to meet regulatory requirements, which could delay approval of or increase production costs for our products. 🔒

🟡 Modified We may encounter difficulties in managing changes to the size, structure and scope of our company. 🔒

🔴 No Match in Current Filing Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines, and respiratory vaccines more generally, have in the past impacted and are likely to continue to impact our financial results. 🔒

🔴 No Match in Current Filing We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus. 🔒

🟡 Modified We are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and false claims laws. If we cannot comply, or have not fully complied, with such laws, we could face substantial penalties. 🔒

🟡 Modified The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may be unable to compete effectively in the market for existing or new products, treatment methods or technologies. 🔒

🟡 Modified As we grow as a commercial company and our drug development pipeline matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate. 🔒

🟡 Modified Evolving environmental, social and governance (ESG) standards and expectations may expose us to numerous risks. 🔒

🟡 Modified Our products are, and any future products will be, subject to regulatory scrutiny. 🔒

🟡 Modified There are risks unique to each of our programs and modalities and risks applicable across programs and modalities, which may delay or prevent our ability to advance one or more of our programs in clinical development, obtain regulatory approval or commercialize our products. 🔒

🟡 Modified We may experience delays in enrolling participants in our clinical trials. 🔒

🟡 Modified We incurred net losses in 2025 and 2024, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability. 🔒

🟡 Modified mRNA drug development involves substantial clinical and regulatory risks, and negative perceptions of our platform, products and product candidates could adversely affect our business and ability to obtain regulatory approvals. 🔒

🟡 Modified Our intismeran autogene product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production. 🔒

🟡 Modified We have entered into strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected. 🔒

🟡 Modified We may seek to establish additional strategic alliances and, if we are unable to do so on commercially reasonable terms, we may have to alter our development and commercialization plans. Certain of our strategic alliance agreements may restrict our ability to develop certain products. 🔒

🟡 Modified Our success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel. 🔒

🟡 Modified Changes in tax law could adversely affect our business and financial condition. 🔒

🟡 Modified We do not expect to pay cash dividends for the foreseeable future. 🔒

🟡 Modified Because we are developing some of our product candidates for the treatment of diseases in which there is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA or other regulators may not consider the endpoints of our clinical trials to provide clinically meaningful results. 🔒

🟡 Modified The commercial success of our products depends on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community. 🔒

🟡 Modified We have experienced commercial challenges and may experience additional challenges in the future. 🔒

🟡 Modified Preclinical development is lengthy and uncertain, especially for mRNA medicines. 🔒

31 more changes in this filing

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