🟢 New in Current Filing We may encounter difficulties producing or shipping our products consistent with our projections or future contractual commitments. 🔒

🟢 New 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. 🔒

🟢 New in Current Filing Our use of GenAI and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies. 🔒

🟢 New in Current Filing Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations and financial condition. 🔒

🟢 New in Current Filing Ineffective internal controls could adversely impact our business and operating results. 🔒

🔴 No Match in Current Filing We may encounter difficulties producing, shipping or successfully commercializing our COVID-19 vaccines consistent with our existing or potential contractual obligations, including due to delays or difficulties experienced by our third-party commercial partners. 🔒

🔴 No Match in Current Filing We have only recently established capabilities to facilitate our compliance with global pharmacovigilance obligations, and failure to build out and maintain this infrastructure may result in increased costs, reputational harm or the loss of our ability to commercialize our products. 🔒

🔴 No Match in Current Filing The terms of certain of our supply agreements may require us to refund certain prepayments from customers of our COVID-19 vaccines if they reduce purchase commitments or if we fail to deliver the purchased volume. 🔒

🔴 No Match in Current Filing The regulatory pathway for COVID-19 vaccines is continually evolving and may result in unexpected or unforeseen challenges. 🔒

🔴 No Match in Current Filing Our investigational medicines may face competition from biosimilars approved through an abbreviated regulatory pathway. 🔒

🟡 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 We may be subject to claims challenging the inventorship or ownership of our patents and other IP. 🔒

🟡 Modified We may be unable to obtain and enforce patent protection for our discoveries and the intellectual property rights therein, or protect the confidentiality of our trade secrets. 🔒

🟡 Modified Certain mRNA therapies are classified as gene therapies by the FDA and the EMA. The association of our medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines or negatively impact our platform or our business. 🔒

🟡 Modified Preclinical development is lengthy and uncertain, especially for mRNA medicines, and our preclinical programs or product candidates may be delayed or terminated. 🔒

🟡 Modified Our mRNA products and product candidates are based on novel technologies and are complex and difficult to manufacture. We or our third-party manufacturers may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping for any of our products. 🔒

🟡 Modified As we grow as a commercial company and our drug development pipeline increases and matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate. We rely on third-party service providers, all of whom have inherent risks in their operations. 🔒

🟡 Modified We may seek to establish additional strategic alliances and, if we are unable to establish them 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 reliance on government funding and collaboration from governmental and quasi-governmental entities for certain of our programs adds uncertainty to our research and development efforts with respect to those programs and may impose requirements related to intellectual property rights and requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs. 🔒

🟡 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. 🔒

🟡 Modified mRNA drug development has substantial clinical development and regulatory risks due to the novel nature of this new class of medicines, and the negative perception of the efficacy, safety or tolerability profile of any product candidates that we or others develop could adversely affect our ability to conduct our business, advance our product candidates or obtain regulatory approvals. 🔒

🟡 Modified The price of our common stock has been volatile, which could result in substantial losses for stockholders. 🔒

🟡 Modified Our business could be harmed if we suffer damage to our reputation, including as a result of a product recall. 🔒

🟡 Modified If we cannot maintain our corporate culture, we could lose the innovation, teamwork and passion that we believe contribute to our success. 🔒

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

🟡 Modified Changes in U.S. patent and regulatory law could impair our ability to protect our products. 🔒

🟡 Modified If we cannot obtain, or are delayed in obtaining, required regulatory approvals, we will be unable to commercialize, or will be delayed in commercializing, product candidates we may develop. 🔒

🟡 Modified If we are not successful in discovering, developing and commercializing additional products, our ability to expand our business and achieve our strategic objectives would be impaired. 🔒

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

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

🟡 Modified Unfavorable U.S. or global economic conditions, including as a result of disease outbreak, war, conflict or other political instability, or geopolitical risks, could adversely affect our business, financial condition or results of operations. 🔒

🟡 Modified The pharmaceutical market is intensely competitive, and we may not compete effectively in the market for existing products, new treatment methods and new technologies. 🔒

🟡 Modified Our products and product candidates are sensitive to shipping and storage conditions, which, in some cases, requires cold-chain logistics and subjects them to risk of loss or damage. 🔒

🟡 Modified We have entered into, and in the future may enter into, strategic alliances with third parties for the development and commercialization of products and product candidates. If these strategic alliances are not successful, our business could be adversely affected. 🔒

🟡 Modified We are dependent on single-source suppliers for some of the components and materials used in, and the processes required to develop, our products and product candidates. 🔒

🟡 Modified We may encounter difficulties in managing the development and expansion of our company. 🔒

🟡 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. 🔒

🟡 Modified Engaging in acquisitions, joint ventures or strategic collaborations may increase our capital requirements, dilute our stockholders and cause us to incur debt or assume contingent liabilities. 🔒

🟡 Modified Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules. 🔒

🟡 Modified Uncertainty over IP in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes, which is inherently costly and unpredictable and can have adverse financial and freedom-to-operate consequences. 🔒

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

🟡 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. 🔒

🟡 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. 🔒

🟡 Modified 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. 🔒

🟡 Modified Federal legislation and actions by federal, state and local governments may permit reimportation into the United States of drugs from foreign countries where the drugs are sold at lower prices. 🔒

🟡 Modified We incurred net losses in 2023 and we may incur losses again in the future; we have a limited history of recognizing revenue from product sales and may be unable to achieve long-term sustainable profitability. 🔒

🟡 Modified We could be adversely affected by outbreaks of epidemic, pandemic or other contagious diseases. 🔒

🟡 Modified We may be unsuccessful or delayed in updating our COVID-19 vaccine to protect against future variants of the SARS-CoV-2 virus, and updated versions of our COVID-19 vaccine may not protect against such variants. 🔒

🟡 Modified 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. 🔒