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
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.
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🟢 New in Current Filing
We have experienced commercial challenges and are likely to experience additional challenges in the future.
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🟢 New in Current Filing
We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts.
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🟢 New in Current Filing
Inadequate funding for the FDA, CDC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely.
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🔴 No Match in Current Filing
Evolving dynamics in the market for COVID-19 vaccines are likely to impact our financial results, which are likely to result in lower product revenues in 2024 than we have experienced in recent years.
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🔴 No Match in Current Filing
We may encounter difficulties producing or shipping our products consistent with our projections or future contractual commitments.
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🔴 No Match in Current Filing
We have limited sales, distribution and marketing experience and may be unable to effectively establish such capabilities or supplement our capabilities by entering into agreements with third parties.
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🔴 No Match in Current Filing
Emergency authorizations that we have received for our COVID-19 vaccine for certain demographics, including pediatrics, are temporary and could be revoked.
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🟡 Modified
We are dependent on single-source suppliers for some of the components and materials used in, and the manufacturing processes required to develop and commercialize, our products and product candidates.
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🟡 Modified
Clinical development is lengthy and uncertain, and our clinical programs may be delayed or terminated, or may be more costly to conduct than we anticipate.
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🟡 Modified
Engaging in acquisitions, joint ventures or strategic collaborations may increase our capital requirements, dilute our shareholders and cause us to incur debt or assume contingent liabilities.
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🟡 Modified
We may experience delays in enrolling participants in our clinical trials.
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🟡 Modified
We expect to continue to rely on third parties to conduct aspects of our research, preclinical studies, protocol development and clinical trials. If these third parties do not perform satisfactorily or comply with regulatory requirements, we may be unable to obtain regulatory approval for or commercialize our product candidates.
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🟡 Modified
Our by-laws designate the Court of Chancery of the State of Delaware or the U.S. District Court for the District of Massachusetts as the exclusive forum for certain litigation that may be initiated by our shareholders, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
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🟡 Modified
We may use our financial and human capital to pursue a particular research program or product candidate and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.
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🟡 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.
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🟡 Modified
The illegal distribution and sale by third parties of counterfeit or stolen versions of mRNA products could negatively impact our financial performance or reputation.
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🟡 Modified
Provisions in our organizational documents, as well as provisions of Delaware law, could make it more difficult or costly for a third party to acquire us or remove our current management, even if doing so would benefit our shareholders.
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🟡 Modified
We may encounter difficulties in managing the development and expansion of our company.
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🟡 Modified
Our manufacturing facilities or those of our third-party manufacturers or suppliers may fail to meet regulatory requirements. Failure to meet cGMP requirements could delay approval of or increase production costs for our products.
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🟡 Modified
We have entered, and may enter into, strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected.
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🟡 Modified
We are subject to operational risks associated with the physical and digital infrastructure at our manufacturing facilities and those of our external service providers.
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🟡 Modified
Preclinical development is lengthy and uncertain, especially for mRNA medicines.
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🟡 Modified
Our products are, and any future products will be, subject to regulatory scrutiny.
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🟡 Modified
Changes in tax law could adversely affect our business and financial condition.
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🟡 Modified
Our failure to maintain our enterprise resource planning (ERP) system could adversely impact our business and results of operations.
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🟡 Modified
The price of our common stock has been volatile, which could result in substantial losses for shareholders.
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🟡 Modified
We may be subject to claims challenging the inventorship or ownership of our patents and other IP.
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🟡 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.
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🟡 Modified
We could face unfavorable U.S. or global economic conditions, including as a result of disease outbreak, war, conflict or other political instability, or geopolitical risks.
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🟡 Modified
Our principal shareholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval.
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🟡 Modified
The market opportunities for our products and product candidates may be smaller than we believe, or we may be unable to successfully identify clinical trial participants.
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🟡 Modified
Our success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
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🟡 Modified
We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus.
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🟡 Modified
If we cannot obtain, or are delayed in obtaining, regulatory approvals and advisory committee recommendations, we will be unable to effectively commercialize, or will be delayed in commercializing, our product candidates.
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🟡 Modified
The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may not compete effectively in the market for existing or new products, treatment methods or technologies.
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🟡 Modified
We incurred net losses in 2024 and 2023, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability.
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