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• We will continue to require significant funding to maintain our current level of operations and fund the further development of our vaccine candidates.
−Removed: • Our existing collaboration, funding and supply agreements, including the Sanofi CLA and or our APAs, do not assure success of our vaccine candidates or vaccines or that we will be able to fully fund our vaccine candidates or vaccines or our operations, and if we are unable to satisfy the performance obligations under such agreements, we may not be eligible to receive milestone payments under such agreements, the agreements may be terminated, the purchase commitments may be reduced or we may be required to refund advance payments.
+Added: • Our existing collaboration, funding and supply agreements, including the Sanofi CLA and our APAs, do not assure success of our vaccine candidates or vaccines or that we will be able to fully fund our vaccine candidates or vaccines or our operations, and if we are unable to satisfy the performance obligations under such agreements, we may not be eligible to receive milestone payments under such agreements, the agreements may be terminated, the purchase commitments may be reduced or we may be required to refund advance payments.
+Added: • Limitations on the use of our net operating losses and other tax attributes could adversely affect our financial condition.
• Because our vaccine product development and commercialization efforts depend on new and rapidly evolving technologies we cannot be certain that our efforts will be successful.
−Removed: • We are a biotechnology company and face significant risk in developing, manufacturing, and commercializing our products and product candidates.
+Added: • Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and the results of prior clinical trials are not necessarily predictive of our future results.
+Added: • Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
+Added: • We may find it difficult to enroll subjects in our clinical trials.
+Added: If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
+Added: • Use of our vaccine candidates could be associated with adverse side effects, adverse events or other safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a vaccine candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
+Added: • We are a biotechnology company and face significant risk in developing, manufacturing, and commercializing our products and vaccine candidates.
+Added: • We have limited marketing capabilities, and if we are unable to enter into collaborations with marketing partners or develop our own sales and marketing capability, we may not be successful in commercializing any approved products.
+Added: • Current or future regional relationships may hinder our ability to engage in larger transactions.
• We must identify vaccines for development with our technologies and establish successful third-party relationships.
−Removed: • The regulatory and commercial success of our COVID-19 Vaccine remains uncertain.
−Removed: While we have received CMA, EUA or full approval for our prototype COVID-19 Vaccine and our updated COVID-19 vaccine in a number of jurisdictions, we may be unable to obtain full regulatory approvals in the U.S.
−Removed: or other jurisdictions for our updated vaccine or new versions in the future, or produce a successful vaccine in a timely manner, if at all.
−Removed: • Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products and product candidates.
+Added: • We rely on third parties to conduct preclinical studies and clinical trials.
+Added: If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain regulatory approval for or commercialize our vaccine candidates may be delayed.
+Added: • We currently rely on third parties for the manufacture of our vaccine candidates for clinical development and expect to continue to rely on third parties for the foreseeable future.
+Added: This reliance on third parties increases the risk that we will not have sufficient quantities of our vaccine candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or potential commercialization efforts.
+Added: • Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products and vaccine candidates.
• Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.
−Removed: • There is significant competition in the development of a vaccine against COVID-19 and a combined vaccine against COVID-19 and influenza, and we may never see returns on the significant resources we are devoting to our vaccine candidates.
−Removed: • We may not succeed in obtaining full U.S.
−Removed: FDA licensure or foreign regulatory approvals necessary to sell our vaccine candidates.
−Removed: • Our product candidates might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support full regulatory approvals.
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−Removed: • We may fail to obtain regulatory approval for our prototype COVID-19 vaccine and NVX-CoV2601 or for our other current or future product candidates on a timely basis or comply with our continuing regulatory obligations if approval is obtained.
−Removed: • The later discovery of previously unknown problems with a product, manufacturer, or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market.
−Removed: • Our success depends on our ability to maintain the proprietary nature of our technology.
+Added: • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our vaccine candidates, our business will be substantially harmed.
+Added: • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our vaccine candidates, our business will be substantially harmed
• Our business may be adversely affected if we do not successfully execute our business development initiatives.
−Removed: • Servicing our 5.00% convertible senior unsecured notes requires a significant amount of cash, and we may not have sufficient cash flow resources to pay our debt.
+Added: • Servicing our 2031 Notes and our 2027 Notes requires a significant amount of cash, and we may not have sufficient cash flow resources to pay our debt.
+Added: • Our Credit Agreement contains restrictions that limit our flexibility in operating our business.
• Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.
−Removed: • Litigation could have a material adverse impact on our results of operation and financial condition.
−Removed: • We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic.
+Added: • Litigation or regulatory investigations could have a material adverse impact on our results of operation and financial condition.
+Added: • We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies.
Risks Related to Our Financial Condition and Capital Requirements
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For most of our history our expenses have exceeded our revenue, which may occur during most periods in the foreseeable future.
−Removed: Our net losses for the last three fiscal years were $187.5 million in 2024, $545.1 million in 2023, and $657.9 million in 2022.
+Added: Our net income (loss) for the last three fiscal years were $440.3 million of income in 2025, $187.5 million of losses in 2024, and $545.1 million of losses in 2023.
Historically, our losses have resulted predominantly from research and development expenses for our vaccine candidates, manufacturing-related expenses, expenses associated with efforts to obtain regulatory approvals, costs related to protection of our intellectual property, and other general and administrative operating expenses, a significant portion of which have been noncash.
−Removed: We believe our research and development expenses may substantially increase in some years as a result of continuing efforts to develop, test, manufacture and make regulatory filings for our vaccine candidates and our COVID-19 Vaccine.
−Removed: As of the end of fiscal year 2024, our investment in the development and manufacture of our COVID-19 Vaccine has been substantial.
−Removed: As we evolve our operating model to focus on our partnership with Sanofi, the development of our late-stage pipeline, including our CIC and stand-alone influenza vaccine candidates, leveraging our Matrix-M TM technology to drive additional partnerships and deals, and our emerging, early-stage pipeline, we expect to continue to incur significant operating expenses and anticipate significant losses over time as we seek to:
−Removed: • conduct additional clinical trials and continue to seek regulatory approvals for our COVID-19 Vaccine, CIC and stand-alone influenza vaccine candidates, RSV vaccine candidate and other potential vaccine candidates;
+Added: We believe our research and development expenses may substantially increase in some years as a result of continuing efforts to develop, test, manufacture and make regulatory filings for our vaccine candidates.
+Added: As of the end of fiscal year 2025, our investment in the development and manufacture of our COVID-19 Vaccine and our vaccine candidates has been substantial.
+Added: As we evolve our operating model to focus on our partnership with Sanofi, the development of our late-stage pipeline, including our CIC and stand-alone influenza vaccine candidates, leveraging our Matrix-M™ technology to drive additional partnerships and deals, and our emerging, early-stage pipeline, we expect to continue to incur significant operating expenses and anticipate significant losses over time as we seek to:
+Added: • conduct additional clinical trials and continue to seek regulatory approvals for our vaccine candidates;
• conduct preclinical studies for other potential vaccine candidates;
−Removed: • evaluate commercial opportunities for the use of our Matrix-M TM adjuvant alongside vaccine antigens produced by other manufacturers;
+Added: • evaluate commercial opportunities for the use of our Matrix-M™ adjuvant alongside vaccine antigens produced by other manufacturers;
• maintain, expand and protect our intellectual property portfolio.
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As a result, we expect our cumulative operating losses to increase until such time, if ever, that product sales, licensing fees, royalties, milestones, contract research and other sources generate sufficient revenue to fully fund our operations.
2 unchanged sentences
We do not currently generate sufficient revenue from product sales, licensing fees, royalties, milestones, contract research or other sources to fully fund our operations.
−Removed: We, therefore, will use our cash resources, and expect to require additional funds, to maintain our operations, continue our research and development programs, advance preclinical studies and clinical trials, seek regulatory approvals and manufacture and market our COVID-19 Vaccine and any other product candidates that are approved for commercialization.
+Added: We, therefore, will use our cash resources, and expect to require additional funds, to maintain our operations, continue our research and development programs, advance preclinical studies and clinical trials, seek regulatory approvals and manufacture and market any of our vaccine candidates that are approved for commercialization.
To date, we have financed our operations primarily through the sale of equity and debt securities, government funding and grant agreements, non-refundable upfront payment under the Sanofi CLA, revenue from product sales, and upfront payments under APAs for our COVID-19 Vaccine.
19 unchanged sentences
Moreover, we rely and intend to rely on third parties, including clinical research organizations, contract manufacturing organizations and other important vendors and consultants.
−Removed: Global economic conditions may result in a
−Removed: Table o f Contents
−Removed: disruption or delay in the performance of our third-party contractors and suppliers.
+Added: Global economic conditions may result in a disruption or delay in the performance of our third-party contractors and suppliers.
If such third parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.
2 unchanged sentences
Certain of these agreements may contain development, technology transfer, launch, sales and other milestones related to our vaccines or vaccine candidates pursuant to which we may be eligible to receive milestone payments upon the achievement of the requisite milestone.
−Removed: For example, we are eligible to receive future milestone payments under the Sanofi CLA totaling up to $650 million in the aggregate with respect to COVID-19 Vaccine Products, including a payment of $175 million upon the approval of the marketing authorization for a COVID-19 Vaccine Product in a pre-filled syringe from the U.S.
−Removed: FDA, $25 million upon the transfer of such approval to Sanofi, $25 million upon the transfer of EMA approval of a COVID-19 Vaccine Product in a pre-filled syringe to Sanofi, $75 million upon the completion of the technology transfer of our manufacturing process for the COVID-19 Vaccine Products to Sanofi, and up to $350 million in CIC Product-related development and launch milestones.
+Added: For example, we are eligible to receive future milestone payments under the Sanofi CLA totaling up to $350 million in the aggregate with respect to COVID-19 Vaccine products, of which $75 million remains outstanding for the completion of the technology transfer of the Company’s manufacturing process for the COVID-19 Vaccine products to Sanofi, as well as up to $350 million in CIC Product-related development and launch milestones.
We may experience challenges in satisfying our obligations under these agreements, including as a result of delayed performance of our third-party contractors and suppliers, which may impact our ability to achieve such milestones, potentially expose us to damages or other liability pursuant to these agreements, including the Sanofi CLA, and have a material and adverse effect on our financial condition.
2 unchanged sentences
The Company believes it has fulfilled the requirements related to this matter and is evaluating the merits of the claim.
−Removed: The timing to fulfill performance obligations related to supply agreements will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of prototype COVID-19 vaccine under certain of our supply agreements.
−Removed: The supply agreements typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of COVID-19 Vaccine.
+Added: The timing to fulfill performance obligations related to supply agreements will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of COVID-19 Vaccine under certain of our supply agreements.
+Added: The supply agreements typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of a qualifying COVID-19 Vaccine.
Such upfront payments generally become non-refundable upon our achievement of certain development, regulatory and commercial milestones.
We may not achieve such milestones, which could have a material and adverse effect on our financial condition.
−Removed: For example, in September 2022, following a delay in obtaining regulatory approval in the United Kingdom, we entered into the Amended and Restated UK Supply Agreement, which amended and restated in its entirety the Original UK Supply Agreement, which reduced the volume of vaccine doses that the Authority committed to purchase.
−Removed: Under the terms of the Amended and Restated UK Supply Agreement, the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses (the “Conditional Doses”) of our prototype COVID-19 vaccine, with the number of Conditional Doses contingent on, and subject to reduction based on, our timely achievement of supportive recommendations from the JCVI that is approved by the UK Secretary of State for Health.
−Removed: If the Authority did not purchase the Conditional Doses or the number of such Conditional Doses was reduced below 15 million doses of our prototype COVID-19 vaccine, we would have to repay up to $225.0 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement.
−Removed: Under the Amended and Restated UK Supply Agreement, the Authority also had the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024.
−Removed: As of November 30, 2022, the JCVI had not made a supportive recommendation with respect to our prototype vaccine, thereby triggering (i) a reduction of the number of Conditional Doses from 15 million doses to 7.5 million doses, which reduced number of Conditional Doses were contingent on, and subject to further reduction based on, our timely achievement by November 30, 2023 of a supportive recommendation from JCVI that is approved by the UK Secretary of State for Health as described above, and (ii) an obligation for us to repay $112.5 million related to the upfront payment previously received from the Authority under the
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−Removed: Original UK Supply Agreement.
−Removed: In April 2023, we repaid the $112.5 million related to the November 30, 2022 triggering event.
−Removed: As of November 30, 2023, the JCVI had not made a supportive recommendation with respect to the prototype vaccine, thereby triggering a reduction in the number of Conditional Doses from 7.5 million doses to zero.
−Removed: In November 2024, we entered into the Settlement Agreement and the Settlement Agreement Amendment with the Authority, settling the disputes regarding the Amended and Restated UK Supply Agreement and releasing both parties of all claims arising out of or connected with the Amended and Restated UK Supply Agreement.
−Removed: Under the terms of the Settlement Agreement, the Authority and us agreed to terminate the Amended and Restated UK Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million previously received by us from the Authority under the Amended and Restated UK Supply Agreement.
−Removed: Pursuant to the Settlement Agreement, we agreed to pay the Settlement Payment to the Authority in equal quarterly installments of $10.3 million over a three year period, ending in June 2027.
−Removed: The Settlement Payment amount includes a $11.3 million provision for interest over the period and may be avoided if we choose to accelerate payments.
−Removed: Under the terms of the Settlement Agreement Amendment, we made the first quarterly installment in November 2024.
−Removed: In December 2024, we entered into an amendment to the Australia APA.
−Removed: Pursuant to the amendment, we acknowledged the cancellation by Australia of the delivery of certain doses of our COVID-19 Vaccine scheduled for delivery between the fourth quarter of 2023 and the fourth quarter of 2025 and we agreed to credit approximately $31 million of the advanced payment paid by Australia to us against outstanding invoices and invoices for the future delivery of approximately 3 million doses of COVID-19 Vaccine without requiring additional cash payments.
−Removed: We also agreed to an updated delivery schedule providing for the potential delivery of COVID-19 Vaccine or future variant COVID-19 Vaccine through the end of 2029.
−Removed: The amendment further provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we miss or under deliver doses to Australia or fail to receive regulatory approval of a variant COVID-19 vaccine.
+Added: For example, in December 2024, we entered into an amendment to the Australia APA pursuant to which, among other things, we acknowledged the cancellation by Australia of the delivery of certain doses of our COVID-19 Vaccine scheduled for delivery between the fourth quarter of 2023 and the fourth quarter of 2025 and we agreed to credit approximately $31 million of the advanced payment paid by Australia to us against outstanding invoices and invoices for the future delivery of approximately three million doses of COVID-19 Vaccine without requiring additional cash payments.
+Added: In addition, the amendment provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we are unable to gain regulatory approval of a variant COVID-19 vaccine or supply doses per the terms of the agreement Specifically, Australia did not take delivery of doses that were due to be delivered in 2025 and may seek to cancel the future delivery of the 2025 as well as 2026 doses.
+Added: If we are unable to provide doses per the supply schedule as amended, after six months, Australia may seek to terminate the APA.
The amendment also provides Australia with the right to cancel doses if we fail to timely notify Australia of changes to our commercialization plans.
−Removed: Pursuant to the Canada APA, the Canadian government may terminate the Canada APA, as amended, as we failed to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at BMC on or before December 31, 2024.
−Removed: Therefore, we are in discussions with Canada regarding a potential amendment to the Canada APA to address possible alternatives, which may not be achievable on acceptable terms or at all.
−Removed: As of December 31, 2024, $555.7 million was classified as current Deferred revenue with respect to the Canada APA in our consolidated balance sheet.
−Removed: If the Canadian government terminates the Canada APA, $28.0 million of advanced payments previously received would become refundable, which was classified as Other current liabilities in our consolidated balance sheet, and approximately $224 million of the contract value related to future deliverables would no longer be available.
−Removed: In July 2024, Pharmac provided notice of its termination of the New Zealand APA.
−Removed: Pharmac has requested a refund of certain advanced payments, and we are in discussion with Pharmac regarding whether a refund of the advanced payments is appropriate under the New Zealand APA.
−Removed: As of December 31, 2024 , $31.3 million was classified as Other current liabilities with respect to the New Zealand APA in our consolidated balance sheet.
−Removed: Approximately $125 million of the contract value related to future deliverables may no longer be available if the New Zealand APA is terminated.
−Removed: We responded to Pharmac in September 2024 indicating we do not believe Pharmac has the right to unilaterally terminate the contract or receive a refund of any part of the remaining upfront payment.
−Removed: We are in ongoing discussions with Pharmac to resolve this matter, which may not be achievable on acceptable terms or at all.
−Removed: We have identified a material weakness in our internal control over financial reporting, and we may identify additional material weaknesses in the future.
+Added: In the event that we do not, on or before the relevant contractual deadlines, receive regulatory approval for, and deliver, the seasonally updated COVID-19 Vaccine, up to $92.5 million of deferred revenue may become refundable.
+Added: As of December 31, 2025, $48.4 million was classified as current Deferred revenue and $85.4 million was classified as non-current Deferred revenue with respect to the Australia APA on our consolidated balance sheet, which will be recognized in product revenue as doses are delivered to Australia.
+Added: In the third quarter of 2025 we withdrew our application for our COVID-19 Vaccine based on recommendations made by the TGA.
+Added: The parties are in ongoing discussions and have agreed to a meeting to discuss outstanding issues and obligations under the APA.
+Added: In light of these developments, we may seek to further amend the Australian APA, which amendment may not be achievable on acceptable terms or at all.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results and current and potential stockholders may lose confidence in our financial and other public reporting, which would harm our business and have a negative effect on the trading price of our common stock.
1 unchanged sentence
We are likewise required, on an annual basis, to evaluate the effectiveness of our internal controls and to disclose on a quarterly basis any material changes in those internal controls.
−Removed: As described in Item 9A – Controls and Procedures elsewhere in this Annual Report on Form 10-K, in connection with the audit of our financial statements for the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting with regard to deficiencies specifically related to ineffective change management
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−Removed: review and periodic access review controls, with respect to our human resources information system (“HRIS”), which was implemented in 2024.
+Added: As initially disclosed in Item 9A - Controls and Procedures in our Annual Report on Form 10-K for the year ended December 31, 2024, in connection with the audit of our financial statements for the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting with regard to deficiencies specifically related to ineffective change management review and periodic access review controls, with respect to our human resources information system (“HRIS”), which was implemented in 2024.
As a result of the deficiencies, certain change management and user access controls, as well as the related process-level IT dependent manual controls and automated application controls across various processes impacted by the HRIS were also determined to be ineffective.
−Removed: We performed additional substantive procedures and concluded that there were no instances of inappropriate access, unauthorized or inappropriate changes to the system or material misstatements.
−Removed: While this material weakness did not result in a material misstatement of our financial statements, there is a reasonable possibility that business processes that depend on the HRIS or data from the HRIS could be adversely impacted and result in a material misstatement in our annual or interim consolidated financial statements that would not be detected.
−Removed: Accordingly, we determined that the deficiencies when considered in aggregate constituted a material weakness.
−Removed: Our disclosure controls and procedures were also determined to not be effective because of the material weakness.
−Removed: We are in the process of implementing measures designed to remediate the control deficiencies that led to the material weakness as of December 31, 2024.
−Removed: However, our remediation efforts with respect to our identified material weakness may be inadequate.
−Removed: The elements of our remediation plan can only be accomplished over time and our remediation plan may not ultimately have its intended effects.
−Removed: We may have additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future.
−Removed: Any failure to maintain such internal controls could adversely impact our ability to report our financial results on a timely and accurate basis and could restrict our future access to the capital markets.
+Added: While this material weakness was remediated in 2025, we may have additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future.
+Added: Any failure to maintain such internal controls, or to timely remediate any additional material weaknesses or significant deficiencies in the future, could adversely impact our ability to report our financial results on a timely and accurate basis and could restrict our future access to the capital markets.
If our financial statements are not accurate, investors may not have a complete understanding of our operations or may lose confidence in our reported financial information.
1 unchanged sentence
In either case, it could result in a material adverse effect on our business or have a negative effect on the trading price of our common stock.
+Added: Limitations on the use of our net operating losses and other tax attributes could adversely affect our financial condition.
+Added: As of December 31, 2025, we had federal and state net operating loss (“NOL”) carryforwards of $ $2.6 billion and $824.1 million, respectively, a portion of which were generated in taxable years before December 31, 2017.
+Added: Under the Tax Cuts and Jobs Act of 2017, as modified by the CARES Act, U.S.
+Added: federal NOL carryforwards generated in taxable years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such NOL carryforwards is limited to 80% of taxable income.
+Added: A portion of our NOL carryforwards (including federal NOL carryforwards generated in taxable years prior to 2018) are subject to a limited carryforward period, and if we are unable to earn sufficient income or profits to utilize these NOL carryforwards before they expire, they will not be available to offset future taxable income.
+Added: To the extent that we generate future taxable losses in the United States, unused losses will carry forward to offset future taxable
+Added: income (subject to any applicable limitations), if any.
+Added: Our NOL carryforwards are subject to review and possible adjustment by the appropriate taxing authorities.
+Added: In addition, our ability to utilize our NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of certain ownership changes.
+Added: Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), our federal NOL carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in our ownership that constitute an “ownership change” pursuant to Section 382 of the Code.
+Added: An “ownership change” pursuant to Section 382 of the Code generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period.
+Added: Similar provisions of state tax law may also apply to limit the use of our state NOL carryforwards.
+Added: We may have experienced ownership changes in the past and could experience ownership changes in the future, including as a result of future changes in our stock ownership, some of which changes may be outside our control.
+Added: For these reasons, we may not be able to realize a tax benefit from the use of our NOL carryforwards and certain other tax attributes, whether or not we attain or maintain profitability.
+Added: If our ability to use our NOL carryforwards or other tax attributes is limited or deferred, we may incur greater than expected tax liabilities and cash outflows, which could adversely affect our results of operations, liquidity, and overall financial condition.
+Added: As of December 31, 2025, we maintain a full valuation allowance over our deferred tax assets for financial reporting purposes.
Risks Related to Product Development and Commercialization
1 unchanged sentence
Our vaccine development efforts depend on new, rapidly evolving technologies and on the marketability and profitability of our current and future products.
−Removed: The development and commercialization efforts of our COVID-19 Vaccine and royalty and other payments received from Sanofi for their commercialization of our COVID-19 Vaccine and the development and, if successful, commercialization efforts of our other vaccine candidates could fail for a variety of reasons, including if:
+Added: The payments received from Sanofi for their commercialization of our COVID-19 Vaccine and the development and, if successful, commercialization efforts of our other vaccine candidates could fail for a variety of reasons, including if:
• our recombinant nanoparticle vaccine technologies, any or all of the products based on such technologies or our proprietary manufacturing process prove ineffective or unsafe;
−Removed: • new strains of COVID-19 evolve, with respect to which our COVID-19 Vaccine or future COVID-19 variant strain containing formulations prove less effective;
• we or our third-party manufacturer facilities fail to reproducibly scale-up and maintain manufacturing with sufficiently high yields at reasonable cost and on projected timelines, or such manufacturing fails to generate product that consistently satisfies purity, potency, quality, stability, and shelf-life standards necessary for obtaining regulatory approvals or achieving commercial viability;
• the products are uneconomical to market or manufacture;
−Removed: • some or all of the products that we or our third-party partners have manufactured may be determined to be unsalable based on criteria imposed by regulators as they complete regulatory approvals;
+Added: • some or all of the products that we or our third-party partners have manufactured may be determined to be unsalable based on criteria imposed by regulators in connection with potential regulatory approvals;
• our in-house or third-party manufacturing facilities fail regulatory inspections;
• proprietary rights of third-parties prevent us or our collaborators from exploiting technologies, and manufacturing or marketing products;
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• third-party competitors achieve and maintain greater market share due to earlier approvals or superior marketing capabilities.
−Removed: The regulatory and commercial success of our COVID-19 Vaccine remains uncertain.
−Removed: While we have received conditional marketing authorization, emergency use authorization or full approval for our COVID-19 Vaccine in a number of jurisdictions, we may be unable to obtain full regulatory approvals in the U.S.
−Removed: or other jurisdictions for our updated COVID-19 vaccine or new versions in the future or produce a successful vaccine in a timely manner, if at all.
−Removed: In response to the outbreak of COVID-19, we began pursuing, and continue to pursue, the development and manufacture of our COVID-19 Vaccine.
−Removed: Even though we have reported positive data from Phase 1, 2 and 3 clinical trials, and we and our partners have received either conditional marketing authorization, emergency use authorization, or full approval from several jurisdictions or the WHO, suc h results may not be sufficient to support regulatory submissions, authorizations and approvals, accelerated or otherwise, in any other relevant jurisdictions on our projected timelines, if at all.
−Removed: We will continue to commercialize our updated vaccine for the 2024-2025 vaccination season and, beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize our COVID-19 Vaccine worldwide in accordance with a commercialization plan agreed by us and Sanofi.
−Removed: Even though our COVID-19 Vaccine has received regulatory authorizations in certain jurisdictions and may receive further regulatory approval in others, successful commercialization depends on our ability to maintain manufacturing capabilities at our own locations and those of our manufacturing partners and contractors to supply our existing APA partners, including Takeda and SII, our ability to timely and successfully transfer know-how related to our manufacturing process for our COVID-19 Vaccine to Sanofi and our ability to operationalize the Sanofi CLA with Sanofi.
−Removed: We have entered into agreements with third parties to manufacture the antigen component of our COVID-19 Vaccine and our proprietary Matrix-M ™ adjuvant, as well as to distribute our COVID-19 Vaccine.
−Removed: Because of contractual restraints and the limited number of third-party manufacturers with the relevant expertise, required regulatory approvals and facilities to manufacture our COVID-19 Vaccine and its components at commercial scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions in production.
−Removed: Manufacturing of our COVID-19 Vaccine and its components involves a complicated process that requires significant investments of time and financial resources to implement, and our efforts to establish and maintain manufacturing capabilities may not meet expectations as to timing, scale-up, reproducibility, yields, purity, cost, potency or quality.
−Removed: Shortages of raw materials and supplies also negatively impact our manufacturing efforts.
−Removed: We may not be able to timely and effectively produce or receive regulatory approvals for our COVID-19 Vaccine in adequate quantities to address global demand.
−Removed: We have limited experience with the commercial launch of vaccine products.
−Removed: We have historically experienced challenges related to scaling up our manufacturing capabilities, delivering our COVID-19 vaccine on time and in certain product presentations for the beginning of a vaccination season, developing global distribution channels and forming partnerships with third parties worldwide, as well as hiring, training and integrating additional management, administrative and sales and marketing personnel.
−Removed: The emergence and transmissibility of variants of the SARS-CoV-2 virus may affect market acceptance or sales of our COVID-19 Vaccine, and our strategy to develop new versions of our COVID-19 Vaccine to protect against certain variants may not be successful.
−Removed: Our prototype vaccine was a monovalent vaccine developed based upon the genetic sequence of the SARS-CoV-2 virus that was first discovered in December 2019.
−Removed: Our updated vaccine is a monovalent vaccine developed based upon the JN.1 strain for the 2024-2025 vaccination season.
+Added: Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and the results of prior clinical trials are not necessarily predictive of our future results.
+Added: Clinical and preclinical development is expensive and can take many years to complete, and its outcome is inherently uncertain.
+Added: We cannot guarantee that any preclinical studies or clinical trials will be conducted as planned or completed on schedule, if at all, and failure can occur at any time during the trial or study process.
+Added: Despite promising
+Added: preclinical or clinical results, any vaccine candidate can unexpectedly fail at any stage of preclinical or clinical development.
+Added: The historical failure rate for vaccine candidates in our industry is high, particularly in the early stages of development.
+Added: The results from preclinical studies or clinical trials of a vaccine candidate or a competitor’s vaccine candidate in the same class may not predict the results of later clinical trials of such vaccine candidate, and interim, topline, or preliminary results of a clinical trial are not necessarily indicative of final results.
+Added: Vaccine candidates in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed through preclinical studies and initial clinical trials.
+Added: It is not uncommon to observe results in clinical trials that are unexpected based on preclinical studies and early clinical trials.
+Added: Many vaccine candidates fail in clinical trials despite very promising early results, and a number of companies in the biopharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier preclinical studies and clinical trials.
+Added: Based upon negative or inconclusive results, we or any future collaborator may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials, which would cause us to incur additional operating expenses.
+Added: In addition, if our collaborators conduct clinical trials that generate negative results or results that conflict with the results of our clinical trials, the FDA or other regulatory authorities may delay, limit, or deny approval of our vaccine candidates, require us to conduct additional clinical trials as a condition to regulatory approval.
+Added: As a result, we cannot be certain that our planned preclinical studies and clinical trials will be successful.
+Added: Any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of our vaccine candidates, which could have a material adverse effect on our business, financial condition and results of operations.
+Added: In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted.
+Added: For instance, the regulatory landscape related to clinical trials in the EU recently evolved.
+Added: The EU Clinical Trials Regulation (“CTR”), which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022.
+Added: While the EU Clinical Trials Directive required a separate clinical trial application (“CTA”), to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials.
+Added: The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state.
+Added: The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules.
+Added: Each member state’s decision is communicated to the sponsor via the centralized EU portal.
+Added: Once the CTA is approved, clinical study development may proceed.
+Added: The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the provisions of the CTR.
+Added: Furthermore, on April 28, 2025, the UK adopted an amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.
+Added: It also intends to bring the UK regulatory framework for clinical trials, which is still based on the EU Clinical Trials Directive, into closer alignment with the CTR.
+Added: The amendment will become applicable on April 28, 2026 following a one-year transition period.
+Added: If we, or our third-party providers, such as CRO, are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.
+Added: Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
+Added: Before obtaining regulatory approval from regulatory authorities for the sale of our vaccine candidates, we must conduct extensive clinical trials to demonstrate the safety, purity, potency, immunogenicity and efficacy of the vaccine candidates in humans.
+Added: Before we can initiate clinical trials for our vaccine candidates, we must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about vaccine candidate chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an Investigational New Drug Application (“IND”) to the FDA or as part of any similar regulatory submission required for allowance to proceed with clinical development.
+Added: The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies, or added clinical evaluation under any IND, clinical trial application or similar regulatory submission, which may lead to delays and increase the costs of our clinical development program.
+Added: Moreover, even if we commence clinical trials, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials.
+Added: Any such delays in the commencement or completion of our preclinical studies and planned clinical trials for our vaccine candidates could significantly affect our product development timelines and product development costs.
+Added: We do not know whether our planned clinical trials will begin on time or be completed on schedule, if at all.
+Added: The commencement, data readouts and completion of clinical trials can be delayed for a number of reasons, including delays related to:
+Added: • inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;
+Added: • obtaining regulatory authorizations or allowances to commence a trial or reaching a consensus with regulatory authorities on trial design;
+Added: • the FDA or comparable foreign regulatory authorities disagreeing as to the implementation of our clinical trials;
+Added: • any failure or delay in reaching an agreement with contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
+Added: • delays in identifying, recruiting and training suitable clinical investigators;
+Added: • obtaining approval from one or more institutional review boards (“IRBs”) or ethics committees at clinical trial sites;
+Added: • IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
+Added: • major changes or amendments to the clinical trial protocol;
+Added: • clinical sites deviating from the trial protocol or dropping out of a trial;
+Added: • failure by our CROs to perform in accordance with good clinical practice (“GCP”) requirements or applicable regulatory guidelines in other countries;
+Added: • manufacturing sufficient quantities of our vaccine candidates and placebo for use in clinical trials, which could be materially impacted by supply chain disruption or other issues;
+Added: • expiration of the shelf life of clinical material for use in clinical trials prior to the enrollment of any of our clinical trials;
+Added: • subjects failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up, including subjects failing to remain in our trials;
+Added: • insufficient incidence of infection with the applicable disease or condition that would allow us to evaluate the endpoints in our clinical trials of our vaccine candidates;
+Added: • individuals choosing an alternative product for the indication for which we are developing our vaccine candidates, or participating in competing clinical trials;
+Added: • lack of adequate funding to continue the clinical trial;
+Added: • subjects experiencing severe or serious unexpected vaccine-related adverse effects;
+Added: • occurrence of vaccine-related serious adverse events in trials of other vaccine candidates conducted by other companies that could be considered similar to our vaccine candidates;
+Added: • selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data;
+Added: • transfer of manufacturing processes to larger-scale facilities operated by a contract manufacturing organization (“CMO”), delays or failure by our CMOs or us to make any necessary changes to such manufacturing process, or failure of our CMOs to produce clinical trial materials in accordance with current good manufacturing practice (“cGMP”) regulations or other applicable requirements;
+Added: • third parties being unwilling or unable to satisfy their contractual obligations to us in a timely manner.
+Added: We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign regulatory authorities.
+Added: Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a vaccine, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
+Added: In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes.
+Added: Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.
+Added: Further, conducting clinical trials in foreign countries, as we have in the past and may do for our vaccine candidates, presents additional risks that may delay completion of our clinical trials.
+Added: These risks include the failure of enrolled subjects in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, and political and economic risks, including war, relevant to such foreign countries.
+Added: In addition, many of the factors that cause, or lead to, the termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a vaccine candidate.
+Added: We may make formulation or manufacturing changes to our vaccine candidates, in which case we may need to conduct additional preclinical studies to bridge our modified vaccine candidates to earlier versions.
+Added: Any resulting delays to our clinical trials could shorten any period during which we may have the exclusive right to commercialize our vaccine candidates.
+Added: In such cases, our competitors may be able to bring products to market before we do, and the commercial viability of our vaccine candidates could be significantly reduced.
+Added: Any of these occurrences may harm our business, financial condition and prospects.
+Added: We may find it difficult to enroll subjects in our clinical trials.
+Added: If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
+Added: Successful and timely completion of clinical trials will require that we identify and enroll a specified number of subjects for each of our clinical trials.
+Added: We may not be able to initiate or continue clinical trials for our vaccine candidates if we are unable to identify and enroll a sufficient number of eligible subjects to participate in these trials as required by the FDA or similar regulatory authorities outside the United States.
+Added: Subject enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and nature of the subject population, the risks and severity associated the disease under investigation, the proximity of subjects to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the ability to obtain and maintain informed consents, the ability to co-administer a vaccine candidate with other vaccines, the risk that enrolled subjects will not complete a clinical trial, our ability to recruit clinical trial investigators with the appropriate competencies and experience, and competing clinical trials and clinicians’ and subjects’ perceptions as to the potential advantages and risks of the vaccine candidate being studied in relation to other available vaccines or therapies, including any new products that may be approved for the indications we are investigating as well as any vaccine candidates under development.
+Added: We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays in enrollment, which would result in the delay of completion of such trials beyond our expected timelines.
+Added: Use of our vaccine candidates could be associated with adverse side effects, adverse events or other safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a vaccine candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
+Added: Results of our clinical trials could reveal a high and unacceptable severity and prevalence of expected or unexpected side effects.
+Added: Vaccine-related side effects could affect subject recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.
+Added: Undesirable side effects caused by our vaccine candidates when used alone or in combination with approved drugs, biologics or vaccines could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or lead to the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
+Added: For example, in October 2024, the U.S.
+Added: FDA placed a clinical hold on the IND for our CIC and stand-alone influenza vaccine candidates from a spontaneous report of a serious adverse event in a
+Added: participant who received the CIC vaccine candidate in a Phase 2 trial that completed in 2023.
+Added: After providing the FDA with the requested additional information, this event was assessed as not related to vaccination.
+Added: The information provided to the FDA supported our assessment that the serious adverse event was not related to our CIC vaccine candidate, and the FDA removed the clinical hold in November 2024.
+Added: Any of these occurrences could severely harm our business, prospects, operating results and financial condition.
+Added: Moreover, if our vaccine candidates are associated with undesirable side effects in clinical trials or demonstrate characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for the vaccine candidate if approved.
+Added: We may also be required to modify our development and clinical trial plans based on findings after we commence clinical trials.
+Added: Many compounds that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the compounds.
+Added: In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.
+Added: It is possible that as we test our vaccine candidates in larger, longer and more extensive clinical trials, or if the use of these vaccine candidates becomes more widespread following regulatory approval, more illnesses, injuries, discomforts and other adverse events than were observed in earlier trials, as well as new conditions that did not occur or went undetected, may be discovered.
+Added: If such side effects become known later in development or upon approval, if any, such findings may harm our business, financial condition and prospects significantly.
+Added: In addition, if our vaccine candidates receive regulatory approval, and we or others later identify undesirable side effects caused by such vaccine, a number of potentially significant negative consequences could result, including:
+Added: • regulatory authorities may withdraw, suspend or limit approvals of such vaccine or seek an injunction against its manufacture or distribution;
+Added: • we may be required to recall a vaccine or change the way such vaccine is administered to individuals;
+Added: • regulatory authorities may require additional warnings on the label, such as a “black box” warning or a contraindication;
+Added: • we may be required to implement a Risk Evaluation and Mitigation Strategy (“REMS”) or create a medication guide outlining the risks of such side effects for distribution to individuals;
+Added: • we may be required to change the way a vaccine is distributed or administered, conduct additional clinical trials or change the labeling of a vaccine or be required to conduct additional post-marketing studies or surveillance;
+Added: • we could be sued and held liable for harm caused to vaccine recipients;
+Added: • sales of the vaccine may decrease significantly or the vaccine could become less competitive;
+Added: • our reputation may suffer.
+Added: Any of these events could prevent us from achieving or maintaining market acceptance of the particular vaccine candidate, if approved, and could significantly harm our business, results of operations and prospects.
+Added: Interim, “topline” and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
+Added: From time to time, we may publicly disclose interim, topline, or preliminary data from our clinical trials and preclinical studies, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
+Added: We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.
+Added: As a result, the interim, topline, or preliminary results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.
+Added: Topline and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the topline or
+Added: preliminary data we previously published.
+Added: As a result, topline and preliminary data should be viewed with caution until the final data are available.
+Added: Interim data from clinical trials are further subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
+Added: Adverse differences between interim, topline, or preliminary data and final data could significantly harm our business prospects.
+Added: Further, disclosure of such data by us or by our competitors could result in volatility in the price of our common stock.
+Added: Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular vaccine candidate or product and our company in general.
+Added: In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular vaccine candidate or our business.
+Added: If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our vaccine candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
+Added: The emergence and transmissibility of variants of the SARS-CoV-2 virus may affect market acceptance or sales of our COVID-19 Vaccine.
As the SARS-CoV-2 virus continues to evolve, new strains of the virus, or those that are already in circulation, have in the past (in the cases of the Alpha, Beta, Delta and Omicron, including subvariants such as XBB.1.5 and JN.1, variants) and may in the future prove more transmissible or cause more severe forms of COVID-19 disease than the predominant strains to date.
−Removed: Our COVID-19 Vaccine may not be as effective in protecting against these or other future variant strains.
−Removed: Our COVID-19 Vaccine may fail to achieve market acceptance or significant sales, despite gaining regulatory approval, conditional marketing authorization or emergency use authorization in a number of jurisdictions, including emergency use authorization the U.S., as demand for variant-specific vaccines increases.
−Removed: However, if these efforts are unsuccessful, these candidates do not receive regulatory approvals expeditiously, we are slower to develop variant-specific vaccines than
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−Removed: competitors, these vaccine candidates prove less effective than competitors’ vaccines, or we are unable to successfully manufacture, distribute or market such vaccine candidates once approved, these shortcomings may lead to reputational harm, loss of market share, and adverse financial results.
−Removed: Our 2025 revenue depends on our and Sanofi’s ability to successfully develop, manufacture, distribute, and market in accordance with the Sanofi CLA, an updated monovalent formulation of a vaccine candidate for COVID-19 for the 2025-2026 vaccination season, which is inherently uncertain and subject to a number of risks, including regulatory approval.
−Removed: We experienced delays in early 2023 in manufacturing our BA.5 clinical trial materials, which delayed regulatory approval from the U.S.
−Removed: FDA for our vaccine candidate for the 2023-2024 vaccination season.
+Added: Our 2026 revenue depends on Sanofi’s ability to successfully manufacture, distribute, and market in accordance with the Sanofi CLA, an updated monovalent formulation of our COVID-19 Vaccine, marketed as Nuvaxovid™ in the U.S.
+Added: , for the 2025-2026 vaccination season.
+Added: This product may not be as effective in protecting against these or other future variant strains, and it may fail to achieve market acceptance or significant sales, despite gaining any regulatory approval, which may lead to reputational harm, loss of market share, and adverse financial results.
Further, counterparties to certain of our existing APAs may request variant-specific vaccines in place of our COVID-19 Vaccine and, depending on when we are able to offer such variant-specific vaccines, if at all, such counterparties may seek to delay, reduce or otherwise renegotiate their purchase commitments, which may adversely impact our ability to realize the full financial benefit of such APAs.
−Removed: In addition, we may expend significant resources adapting our COVID-19 Vaccine or conducting clinical trials to protect against variants of the SARS-CoV-2 virus, but a market for this adapted vaccine may not develop and demand may not align with our projections or cost expenditures.
We are a biotechnology company and face significant risk in developing, manufacturing and commercializing our products.
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The outcome of any research and development program is highly uncertain.
−Removed: Only a small fraction of biopharmaceutical development programs ultimately result in commercial products or even product candidates and a number of events could delay our development efforts and negatively impact our ability to make regulatory submissions or obtain regulatory approval for, and to manufacture, market and sell, our COVID-19 Vaccine or any other vaccine on our projected timelines, if at all.
−Removed: Vaccine candidates that initially appear promising often fail to yield successful products, and we may not ultimately be able to demonstrate the safety, potency, purity, stability and efficacy necessary to obtain or maintain regulatory authorization to market our product candidates.
−Removed: In many cases, preclinical studies or clinical trials will show that a product candidate is not efficacious or that it raises safety concerns or has other side effects that outweigh its intended benefit.
+Added: Only a small fraction of biopharmaceutical development programs ultimately result in commercial products or even vaccine candidates and a number of events could delay our development efforts and negatively impact our ability to make regulatory submissions or obtain regulatory approval for, and to manufacture, market and sell, our vaccine candidates or any other vaccine on our projected timelines, if at all.
+Added: Vaccine candidates that initially appear promising often fail to yield successful products, and we may not ultimately be able to demonstrate the safety, potency, purity, stability and efficacy necessary to obtain or maintain regulatory authorization to market our vaccine candidates.
+Added: In many cases, preclinical studies or clinical trials will show that a vaccine candidate is not efficacious or that it raises safety concerns or has other side effects that outweigh its intended benefit.
Success in preclinical or early clinical trials may not translate into success in large-scale clinical trials.
−Removed: For example, in October 2024, the U.S.
−Removed: FDA placed a clinical hold on the IND for our CIC and stand-alone influenza vaccine candidates from a spontaneous report of a serious adverse event in a participant who received the CIC vaccine candidate in a Phase 2 trial that completed in 2023.
−Removed: After providing the U.S.
−Removed: FDA with the requested additional information, this event was assessed as not related to vaccination.
−Removed: The information provided to the FDA supported our assessment that the serious adverse event was not related to our CIC vaccine candidate, and the U.S.
−Removed: FDA removed the clinical hold in November 2024.
Further, success in clinical trials often leads to increased investment, accelerating cumulative losses.
−Removed: Even if clinical trial results appear positive, regulatory approval may not be obtained if the U.S.
−Removed: FDA, or a foreign equivalent, does not agree with our interpretation of the results.
+Added: Even if clinical trial results appear positive, regulatory approval may not be obtained if the FDA, or a foreign equivalent, does not agree with our interpretation of the results.
Even after a product is approved and launched, general usage or post-marketing clinical trials may identify safety or other previously unknown problems with the product, or manufacturing issues may emerge, either of which may result in regulatory approvals being suspended, limited to narrow the scope of the approval, or revoked, which may otherwise prevent successful commercialization.
Intense competition in the vaccine industry could also limit the successful commercialization of any products for which we receive commercial approval.
−Removed: We will require approval from the U.S.
−Removed: FDA of any name we intend to use for our products regardless of whether we have secured a trademark registration from the USPTO.
−Removed: FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names.
−Removed: FDA may object to any product name we submit if it believes the name inappropriately implies medical claims.
−Removed: FDA objects to any of our proposed product names, we may be required to adopt an alternative name for our proposed products.
−Removed: If we adopt an alternative name, we would lose the benefit of any existing trademark applications for such developmental candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the U.S.
+Added: We will require approval from the FDA of any name we intend to use for our products regardless of whether we have secured a trademark registration from the USPTO.
+Added: The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names.
+Added: The FDA may object to any product name we submit if it believes the name inappropriately implies medical claims.
+Added: If the FDA objects to any of our proposed product names, we may be required to adopt an alternative name for our proposed products.
+Added: If we adopt an alternative name, we would lose the benefit of any existing trademark applications for such developmental candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.
We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our products, if approved.
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−Removed: Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products.
−Removed: We are highly dependent on third-party organizations to conduct some of our laboratory testing and clinical trials and a significant amount of our vaccine manufacturing activities and distribution.
−Removed: If we are unable to obtain any necessary services on acceptable terms, we may not complete our product development or commercialization efforts in a timely manner.
−Removed: We may lose control over these activities or become too dependent upon these parties.
−Removed: These third parties may not complete testing, manufacturing or distribution activities on schedule, or in satisfaction of regulatory or commercial requirements.
−Removed: In particular, we currently depend significantly on SII for co-formulation, filling, and finishing our COVID-19 Vaccine.
−Removed: If SII is unable to provide sufficient co-formulation, filling, and finishing services to us, fails to meet regulatory requirements, or otherwise defaults on its obligations to us, we may not be able to obtain alternative co-formulation, filling, and finishing services from other providers on acceptable terms in a timely manner or at all, which could prevent or delay delivery of customer orders, or otherwise negatively affect our business.
−Removed: We are responsible for confirming that each of our clinical trials is conducted in accordance with its general investigational plan and protocol.
−Removed: Moreover, the U.S.
−Removed: FDA and foreign regulatory agencies require us to comply with regulations and standards, commonly referred to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, safety and welfare of clinical trial participants are adequately protected.
−Removed: FDA and foreign regulatory agencies also require us to comply with good manufacturing practices.
−Removed: Our reliance on third parties does not relieve us of these responsibilities and requirements.
−Removed: These third parties may not successfully carry out their contractual duties or regulatory obligations.
−Removed: Furthermore, if a third-party manufacturer is producing materials or products for themselves or other companies, that manufacturer is exposed to regulatory risks for the production of such materials and products.
−Removed: As a result, failure to meet the regulatory requirements for the production of those materials and products may generally affect the regulatory status of the third-party manufacturer’s facility, which could impact its ability to produce our materials and products.
−Removed: Any of our third-party service providers may need to be replaced, the quality or accuracy of the data they obtain may be compromised, the services provided to us may be delayed, or the product they manufacture may be contaminated and unusable due to the failure to adhere to our clinical and manufacturing protocols, regulatory requirements or for other reasons.
−Removed: In any such event, our preclinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval of, or successfully commercially manufacture on a timely basis, our vaccine candidates.
We may have product liability exposure.
The administration of drugs or vaccines to humans, whether in clinical trials or after marketing approval, can result in product liability claims.
−Removed: We maintain product liability insurance coverage for our current clinical programs, including our NVX-CoV2373, NVX-CoV2601, CIC and stand-alone influenza and R21/Matrix-M TM adjuvant malaria vaccine trials, and for commercialization of our updated COVID-19 vaccine.
+Added: We maintain product liability insurance coverage for our current clinical programs, and for commercialization of Nuvaxovid TM .
However, we may not be able to obtain additional insurance coverage or maintain insurance coverage on commercially reasonable terms, at a reasonable cost or in sufficient amounts to protect us against losses due to liability.
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Even if a claim is not successful, defending such a claim would be time-consuming and expensive, may damage our reputation in the marketplace and would likely divert management’s attention.
−Removed: In addition, we have received conditional marketing authorization, emergency use authorization, or full approval from the World Health Organization and various jurisdictions, and we have a widely used vaccine as an investigational vaccine or a product authorized for temporary or emergency use prior to our receipt of marketing approval in certain other jurisdictions.
−Removed: Unexpected safety issues in these circumstances could lead to product liability claims and our existing insurance may not be adequate for such claims.
+Added: In addition, regardless of any authorizations we have received supporting the development or commercialization of our vaccine candidates, unexpected safety issues could lead to product liability claims and our existing insurance may not be adequate for such claims.
Regardless of merit or eventual outcome, liability claims may result in:
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• withdrawal of regulatory authorizations and approvals;
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• voluntary or mandatory recalls of our products;
6 unchanged sentences
• inability to commercialize our vaccine candidates.
−Removed: In the U.S., the PREP Act, when applicable, provides immunity for manufacturers from all claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure.” However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances.
−Removed: “Covered countermeasures” include security countermeasures and “qualified pandemic or epidemic products”, including products intended to diagnose or treat pandemic or epidemic disease, such as pandemic vaccines, as well as treatments intended to address conditions caused by such products.
−Removed: For these immunities to apply, the Secretary of DHHS must invoke the PREP Act by issuing a declaration that a public health emergency or “credible risk” of a future public health emergency exists.
−Removed: Such a PREP Act declaration is separate from other declarations such as a PHE or EUA declaration and, among other things, defines the scope and duration of the PREP Act immunities.
−Removed: On March 17, 2020, the Secretary of DHHS issued a declaration under the PREP Act and has issued subsequent amendments thereto to provide liability immunity for activities related to certain countermeasures against the evolving effects of COVID-19.
−Removed: The current declaration will end on December 31, 2029, unless it is renewed.
−Removed: While we believe our products are covered under the current PREP Act declaration, this cannot be assured.
−Removed: Also, the Secretary of the DHHS may not make other declarations in the future that cover any of our other product candidates, and the U.S.
−Removed: Congress may reduce coverage under the PREP Act or repeal it altogether.
−Removed: Product liability lawsuits may result in substantial liabilities and may require us to limit commercialization of our product candidates.
−Removed: If we are unable to effectively manufacture our COVID-19 Vaccine in sufficient quantities or at sufficient yields, we may experience delays or an adverse impact on product development, clinical trials, regulatory approvals and commercial distribution.
−Removed: We are continuing to pursue the manufacture, distribution and clinical testing of our COVID-19 Vaccine for commercialization.
−Removed: Completion of our clinical trials and commercialization of our COVID-19 Vaccine and our other vaccine candidates requires access to, or development of, facilities to effectively manufacture our COVID-19 Vaccine and our other vaccine candidates at sufficient yields and at commercial scale.
−Removed: We have limited experience manufacturing any of our vaccine candidates in the volumes necessary to support commercial sales.
−Removed: While we have increased our global manufacturing capacity for our COVID-19 Vaccine, our efforts to establish and maintain manufacturing capabilities may not meet expectations as to timing, scale-up, reproducibility, yields, purity, cost, potency or quality.
−Removed: We are highly dependent on third-party organizations to conduct a significant amount of our vaccine manufacturing activities.
−Removed: We do not have sufficient internal manufacturing infrastructure to support global commercialization of our COVID-19 Vaccine and we have entered into third-party agreements for the components, as well as for commercial fill-finish manufacturing, for our COVID-19 Vaccine.
−Removed: The antigen component of our COVID-19 Vaccine is currently being manufactured at SII in India, and the Matrix-M TM adjuvant component of our COVID-19 Vaccine is currently being manufactured at Novavax AB as well as our partnered manufacturing site at AGC Biologics in Europe.
−Removed: Challenges in manufacturing either the antigen component or the adjuvant, or issues in later manufacturing stages, could compromise production of our COVID-19 Vaccine.
−Removed: Additionally, we currently
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−Removed: depend substantially on SII for co-formulation, filling, and finishing our COVID-19 Vaccine, and any delays or disruptions in these suppliers’ operations could prevent or delay the delivery of customer orders.
−Removed: Additionally, to ensure adequate inventory supply and manage our operations, we forecast anticipated manufacturing requirements and customer demand to predict inventory needs and place orders with our third-party manufacturers based on such predictions.
−Removed: Our ability to accurately forecast demand for our COVID-19 Vaccine could be negatively affected by many factors, including challenges in managing our commercial strategy, including our commercial strategy with Sanofi for the 2025-2026 vaccination season and for the duration of the Sanofi CLA, unanticipated changes in general market conditions or regulatory matters, and market demand for variant-specific COVID-19 vaccines, among others.
−Removed: If we underestimate our third-party manufacturing requirements, we may not be able to timely meet obligations under our customer supply agreements.
−Removed: Conversely, if we overestimate our third-party manufacturing requirements, we may end up with inventory levels in excess of customer demand that result in a portion of our inventory becoming obsolete or expiring, as well as inventory write-downs or write-offs, or we may need to cancel previously forecasted batches of product from our third-party manufacturers, which may result in material cancellation fees.
−Removed: If we are unable to accurately forecast demand for our COVID-19 Vaccine and the required services from third-party manufacturers, our results of operations could be materially harmed.
−Removed: Manufacturing our COVID-19 Vaccine and our other vaccine candidates involves a complicated process with which we have limited experience compared to some of our competitors.
−Removed: If we and our third-party manufacturers are unable to manufacture our COVID-19 Vaccine and our other vaccine candidates in clinical quantities or, if and when necessary, in commercial quantities and at sufficient yields and at required specifications, then clinical trials and commercialization will be delayed, and we will need to identify and reach supply arrangements with additional third parties.
−Removed: Third-party manufacturers also must receive U.S.
−Removed: FDA or equivalent foreign regulatory body approval before they can produce clinical material or commercial product which could cause delays and alter our production schedule.
−Removed: Our COVID-19 Vaccine is in competition with other products for access to these third-party facilities and may be subject to manufacturing delays if third parties prioritize other products.
−Removed: We may not be able to enter into any necessary additional third-party manufacturing arrangements on acceptable terms or on a timely basis.
−Removed: In addition, we must enter into technical transfer agreements and share our know-how with third-party manufacturers, which can be time-consuming and may result in delays.
−Removed: Because of contractual restraints and the limited number of third-party manufacturers with the expertise, required regulatory approvals and facilities to manufacture bulk vaccines at commercial scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions in the production of our vaccine and negatively impact our ability to timely meet obligations under our customer supply agreements.
−Removed: We and our third-party manufacturers may also encounter production challenges related to:
−Removed: • costs, scale up, and yields;
−Removed: • shortages of raw materials and supplies;
−Removed: • shipment delays or other supply chain disruptions
−Removed: • quality control and assurance;
−Removed: • contamination, lot consistency, potency, and purity;
−Removed: • shortages of qualified personnel and other capacity constraints;
−Removed: • compliance with strictly enforced and evolving federal, state and foreign regulations that vary in each country where products might be sold including nationalization or other territory restrictions placed on our owned and third-party manufacturing sites;
−Removed: • capital funding.
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−Removed: Delays or interruptions could have a material adverse effect on our business, financial condition, results of operations and cash flows.
−Removed: We must identify vaccines for development with our technologies and establish successful third-party relationships.
−Removed: The near and long-term viability of our COVID-19 Vaccine, our CIC vaccine candidate and our other vaccine candidates depends in part on our ability to successfully establish, operationalize and maintain strategic collaborations with pharmaceutical and biotechnology companies and government agencies.
−Removed: Establishing, operationalizing and maintaining strategic collaborations and obtaining government funding is difficult and time-consuming.
−Removed: Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position or based on their internal pipelines;
−Removed: government agencies may reject contract or grant applications based on their assessment of public need, the public interest, our products’ ability to address these areas, or other reasons beyond our expectations or control.
−Removed: Collaborators also may seek to modify or terminate relationships.
−Removed: Past success in establishing strategic collaborations with pharmaceutical and biotechnology companies, non-profit organizations and government agencies is no guarantee of future success in entering into new relationships or in performing under existing relationships.
−Removed: If we fail to establish a sufficient number of collaborations or government relationships on acceptable terms, or fail to perform under collaborations or relationships to the satisfaction of counter-parties, we may not be able to commercialize our vaccine candidates or generate sufficient revenue to fund further research and development efforts.
−Removed: The collaborations we have established or may establish may not result in the successful development or commercialization of any vaccine candidates for several reasons, including the fact that:
−Removed: • we may not have the ability to control the activities of our partners and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development and commercialization of our COVID-19 Vaccine or our vaccine candidates, in a timely manner or at all;
−Removed: • such partners may not devote sufficient resources to our COVID-19 Vaccine or vaccine candidates or properly maintain or defend our intellectual property rights;
−Removed: • our partners could independently develop, or develop with third parties, products that compete directly or indirectly with our COVID-19 Vaccine or vaccine candidates if such partners believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
−Removed: • any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our COVID-19 Vaccine or vaccine candidates and affect our ability to realize product revenue;
−Removed: • disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals and commercialization activities.
−Removed: If we or our collaborators fail to maintain our existing agreements or in the event we fail to establish agreements as necessary, we could be required to undertake research, development, manufacturing and commercialization activities solely at our own expense.
−Removed: These activities would significantly increase our capital requirements and, given our limited sales, marketing and distribution capabilities, significantly delay the commercialization of our vaccine candidates.
+Added: In addition, in the United States, the Public Readiness and Emergency Preparedness Act (the “PREP Act”), when applicable, provides immunity for manufacturers from all claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure.” However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances.
+Added: “Covered countermeasures” include “security countermeasures,” “qualified pandemic or epidemic products,” which include products intended to diagnose or treat pandemic or epidemic disease, such as pandemic vaccines and treatments intended to address conditions caused by such products, and drugs and biological products authorized for emergency use in accordance with sections 564, 564A, and 564B of the FDCA.
+Added: For these immunities to apply, the Secretary of DHHS must invoke the PREP Act by issuing a declaration that
+Added: a public health emergency or “credible risk” of a future public health emergency exists.
+Added: On March 17, 2020, the Secretary of DHHS issued a declaration under the PREP Act for medical countermeasures against COVID-19, effective as of February 4, 2020, and has issued subsequent amendments since then to provide liability immunity for activities related to certain countermeasures against the ongoing COVID-19 pandemic.
+Added: On December 11, 2024, the Secretary of DHHS issued the 12th amendment to the PREP Act declaration to extend time period of PREP Act coverage to December 31, 2029.
+Added: While we believe our products are Covered Countermeasures under the current PREP Act declaration, coverage cannot be assured.
+Added: Further, it remains possible that the HHS Secretary will amend the PREP Act declaration for medical countermeasures against COVID-19 to, among other things, shorten the duration of its coverage.
+Added: Certain members of Congress have also sought to amend or repeal the PREP Act in effort to restrict or eliminate PREP Act immunity.
+Added: As a result, the PREP Act, and any associated immunity, remains subject to significant uncertainty.
Even if we successfully commercialize any of our vaccine candidates, either alone or in collaboration, we face uncertainty with respect to pricing, third-party reimbursement and healthcare reform, all of which could be subject to change and could adversely affect any commercial success of our vaccine candidates.
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−Removed: Our ability to collect revenue from the commercial sale of our vaccines may depend on our ability, and that of any current or potential future collaboration partners or customers, to obtain and if obtained, maintain adequate levels of approval, coverage and reimbursement for such products from third-party payers such as:
−Removed: • government health administration authorities such as the Advisory Committee for Immunization Practices of the Centers for Disease Control and Prevention (“ACIP”);
−Removed: • private health insurers;
−Removed: • managed care organizations;
−Removed: • pharmacy benefit management companies;
−Removed: • other healthcare related organizations.
−Removed: Third-party payers are increasingly challenging the prices charged for medical products and may deny coverage or offer inadequate levels of reimbursement if they determine that a product has not received appropriate clearances from the U.S.
−Removed: FDA, or foreign equivalent, or other government regulators;
+Added: Our ability to collect revenue from the commercial sale of our vaccines may depend on our ability, and that of any current or potential future collaboration partners or customers, to obtain and if obtained, maintain adequate levels of approval, coverage and reimbursement for such products from third-party payers including:
+Added: government health administration authorities such as the Advisory Committee for Immunization Practices of the Centers for Disease Control and Prevention (“ACIP”), private health insurers, managed care organizations, pharmacy benefit management companies, and other healthcare related organizations.
+Added: Third-party payers are increasingly challenging the prices charged for medical products and may deny coverage or offer inadequate levels of reimbursement if they determine that a product has not received appropriate clearances from the FDA, or foreign equivalent, or other government regulators;
is not used in accordance with cost-effective treatment methods as determined by the third-party payer;
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and some foreign jurisdictions, there have been a number of legislative and regulatory proposals and initiatives to change the health care system in ways that could affect our ability to sell vaccines and could adversely affect the prices that we receive for our vaccine candidates, if approved.
−Removed: Some of these proposed and implemented reforms could result in reduced drug pricing or reimbursement rates for medical products, and while we have no current vaccines available for commercial sale other than subject to conditional marketing authorization or emergency use authorization in certain foreign jurisdictions, the impact of such reform could nevertheless adversely affect our business strategy, operations and financial results.
+Added: Some of these proposed and implemented reforms could result in reduced drug pricing or reimbursement rates for medical products.
+Added: The impact of such reform could adversely affect our business strategy, operations and financial results.
Our exposure to price-related regulation could depend on whether our products are reimbursed by Medicare under Part B or Part D.
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Part D vaccine coverage historically included cost-sharing requirements, but, effective January 1, 2023, the IRA provides access to CDC and ACIP-recommended vaccines covered under Medicare Part D without cost-sharing.
−Removed: Since the beginning of the COVID-19 pandemic, the U.S.
−Removed: federal government has been the predominant purchaser of COVID-19 vaccines, making it possible for population-wide access to vaccinations.
−Removed: This population-wide access may change as the pandemic moves past the crisis phase and the market transitions to a third‐party reimbursement model.
−Removed: This transition to a more traditional third‐party reimbursement model is not tied to the ending of the PHE and in part reflects the fact that the U.S.
−Removed: federal government has not received additional funds from Congress to continue to purchase more vaccines.
−Removed: As federal funding declines for COVID-19 vaccines, the USG will most likely transition to standard commercial purchasing through different health care system channels, including commercial insurers and pharmacy benefit managers, and consequently shift the cost of COVID-19 vaccines to insurers and patients (in the form of premiums and out-of-network costs).
−Removed: With respect to the government health care programs and commercial insurance, there may no longer be blanket coverage of COVID-19 vaccines without, in certain instances, accompanying conditions of reimbursement, such as the institution of prior authorization protocols.
−Removed: Medicare (including traditional Medicare and Medicare Advantage) will continue to pay for vaccinations in full;
−Removed: effective January 1, 2023, all Medicare Part D plans are required to cover all adult vaccines recommended by the ACIP, with no cost-sharing, even if the beneficiary is in the deductible phase of the benefit.
−Removed: Provisions in the ARPA and IRA require Medicaid (specifically, with respect to enrollees who receive coverage under traditional Medicaid and all Medicaid medically needy enrollees in specified states) and CHIP programs to cover all ACIP‐recommended vaccines, including COVID‐19 vaccines/boosters with no cost sharing even when the emergency declarations expire and there is no longer any supply of federally purchased vaccines.
−Removed: Under the ACA, people enrolled in non‐grandfathered plans (i.e., the vast majority of people with private insurance) will continue to pay nothing for ACIP‐recommended COVID‐19 vaccines and associated appointments, so long as the enrollee receives this care from an in‐network provider.
−Removed: Even if consumers are guaranteed free access or protected against some costs, they could face access challenges to
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−Removed: our product if sufficient amounts of our product are not available compared to that of our competitors or not procured by pharmacies or other providers.
+Added: Recommendation by ACIP of a vaccine has significant impacts on the coverage and reimbursement of the vaccine from commercial and governmental payers, such as Medicaid and Medicare.
+Added: For example, vaccines that receive ACIP recommendations benefit from enhanced coverage requirements under the Affordable Care Act, the Inflation Reduction Act, and the Social Security Act, among other statutes.
+Added: ACIP’s recommendations therefore directly influence coverage and reimbursement decisions by governments and private payers, in turn influencing healthcare providers and individual decision making.
+Added: Similarly, the absence or withdrawal of an ACIP recommendation for a vaccine can result in increased beneficiary cost-sharing obligations and absence or limitations of coverage and reimbursement.
+Added: For example, under the Trump administration, the COVID-19 vaccine for healthy children and healthy pregnant women was removed from the CDC recommended immunization schedules, and the DHHS Secretarial Directives ratifying CDC recommendations for use of COVID-19 vaccines for children ages six months to 17 years were rescinded.
+Added: Currently, CDC recommends a 2025-2026 COVID-19 vaccine for people ages 6 months and older based on individual-based decision-making, noting that parents of children ages 6 months to 17 years should discuss the benefits of vaccination with a healthcare provider.
+Added: CDC states that it is especially important to get a 2025–2026 COVID-19 vaccine for individuals aged 65 and older, individuals at high risk for severe COVID-19, or individuals who have never received a COVID-19 vaccine.
+Added: It is possible that ACIP may withdraw or further limit its recommendation for COVID-19 vaccines.
+Added: The revised CDC recommendations, as well as any possible future negative actions by ACIP regarding vaccination schedules, may adversely affect demand for our vaccine candidates and have material adverse effects on our business and results of operations.
+Added: We cannot predict the ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us.
+Added: We also cannot predict if the Trump administration’s policies might adversely impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance.
+Added: Department of Health and Human Services (“DHHS”) Secretary Robert F.
+Added: has populated ACIP with members who generally have voiced negative views regarding COVID-19 vaccines.
+Added: The FDA’s Vaccines and Related Biological Products Advisory Committee makes recommendations to FDA regarding novel vaccine products, and the Trump administration has so far removed at least one member from the committee.
+Added: It is possible that further changes to the composition of the committee could result in additional adverse recommendations that negatively affect the development and commercialization of our vaccine candidates.
+Added: The Trump administration’s changes to the immunization schedule for children and adolescents and vaccine recommendations to date, and similar changes that could be adopted in the future, could, among other things, result in adverse recommendations from ACIP or delay ACIP decisions or other elements of the approval pathway, potentially adversely impacting vaccine availability and recommendations, which could have a material adverse effect on our results of operations and financial condition.
Additionally, the pharmaceutical industry has also been the subject of significant publicity in recent years regarding the pricing of pharmaceutical products, including publicity and pressure resulting from prices charged by pharmaceutical companies for new products as well as price increases by pharmaceutical companies on older products that some people have deemed excessive.
−Removed: As a result, pharmaceutical product prices have been the focus of increased scrutiny by the United States government, including certain state attorneys general, members of Congress, presidential candidates and the United States Department of Justice.
−Removed: If reforms in the health care industry make reimbursement for our potential products less likely, the market for our potential products will be reduced, and we could lose potential sources of revenue.
+Added: As a result, pharmaceutical product prices have been the focus of increased scrutiny by the United States government, including certain state attorneys general, members of Congress, the Trump administration, and the United States Department of Justice.
+Added: If reforms in the healthcare industry limit or reduce reimbursement for our vaccine candidates, the market for such vaccine candidates will be reduced, and we could lose potential sources of revenue.
The existence or threat of cost control measures could cause our corporate collaborators to be less willing or able to pursue research and development programs related to our vaccine candidates.
−Removed: Further, it is also possible that additional governmental action is taken in response to the COVID-19 pandemic.
−Removed: We cannot predict the ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us.
−Removed: We also cannot predict changes resulting from the 2024 U.S.
−Removed: election and resulting changes in DHHS leadership, including potential changes that might impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance.
−Removed: DHHS Secretary Robert F.
−Removed: has indicated intentions to overhaul the membership of outside committees that advise the federal government on vaccine recommendations and other public health decisions.
−Removed: This effort may impact the ACIP, which is responsible for making recommendations on vaccine use in the United States and other panels advising the U.S.
−Removed: On February 20, 2025, the first meeting of the ACIP for the year was postponed.
−Removed: These changes and the posture of the current administration could delay ACIP decisions and other elements of the approval pathway, potentially impacting vaccine availability and recommendations.
−Removed: We have limited marketing capabilities, and if we are unable to enter into collaborations with marketing partners or develop our own sales and marketing capability, we may not be successful in commercializing any approved products.
−Removed: Although we initiated commercialization of our COVID-19 Vaccine for the last three vaccination seasons, we are transitioning the commercialization of our COVID-19 Vaccine to Sanofi for the 2025-2026 vaccination season and for the duration of the Sanofi CLA and we otherwise currently have limited dedicated sales, marketing or distribution capabilities.
−Removed: As a result, we depend on collaborations with third parties that have established distribution systems and sales forces, including our collaborations with Sanofi and SII, among others.
−Removed: To the extent that we enter into co-promotion or other licensing arrangements, such as the Sanofi CLA, our revenue will depend upon the efforts of third parties, over which we may have little or no control.
−Removed: If we are unable to reach and maintain agreements with one or more pharmaceutical companies or collaborators, we may be required to market our products directly.
−Removed: Developing a marketing and sales force is expensive and time-consuming and could delay a product launch.
−Removed: We may not be able to attract and retain qualified sales personnel or otherwise develop this capability.
−Removed: Our vaccine candidates may never achieve market acceptance even if we obtain full regulatory approvals.
−Removed: Even if we receive full regulatory approvals for the commercial sale of our vaccine candidates, the commercial success of these vaccine candidates will depend on, among other things, their acceptance by physicians, patients and third-party payers, such as health insurance companies and other members of the medical community, as a vaccine and cost-effective alternative to competing products.
+Added: Our vaccine candidates may never achieve market acceptance even if we obtain regulatory approvals.
+Added: Even if we receive regulatory approvals for the commercial sale of our vaccine candidates, the commercial success of these vaccine candidates will depend on, among other things, their acceptance by physicians, patients and third-party payers, such as health insurance companies and other members of the medical community, as a vaccine and cost-effective alternative to competing products.
If our vaccine candidates fail to gain market acceptance, we may be unable to earn sufficient revenue to continue our business.
Market acceptance of, and demand for, any product that we may develop and commercialize will depend on many factors, including:
−Removed: • our ability to provide acceptable evidence of safety and efficacy (including, for our COVID-19 Vaccine, against emerging COVID-19 variants);
+Added: • our ability to provide acceptable evidence of safety and efficacy;
• the prevalence and severity of adverse side effects;
−Removed: • whether our vaccines are differentiated from other vaccines;
+Added: • whether our vaccines candidates are differentiated from other vaccines;
• availability, relative cost and relative efficacy of alternative and competing treatments;
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• the effectiveness of our marketing and distribution strategy;
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Because an important component of our adjuvant technology is extracted from a species of soap-bark tree (Quillaja saponaria) grown in Chile, we need long term access to quillaja extract with a consistent and sufficiently high quality in order to maintain a secure supply of raw material for the development and manufacture of our adjuvant products.
−Removed: If we are unable to secure long term access to quillaja extract with a consistent and sufficiently high quality, as well as to secure back-up suppliers, the development and manufacture of our adjuvant products may be delayed and we may not be able to meet our obligations under our various collaboration and supply agreements.
+Added: We rely on a single source supplier for quillaja extract, so if we are unable to secure long term access to quillaja extract with a consistent
+Added: and sufficiently high quality, or to secure back-up suppliers, the development and manufacture of our adjuvant products may be delayed and we may not be able to meet our obligations under our various collaboration and supply agreements.
+Added: Our vaccine candidates are sensitive to shipping and storage conditions, which could subject our vaccine candidates to risk of loss or damage.
+Added: Our vaccine candidates are sensitive to storage and handling conditions.
+Added: Loss in vaccine candidates could occur if the product or product intermediates are not stored or handled properly.
+Added: It is possible that our vaccine candidates could be lost due to expiration prior to use.
+Added: If we do not effectively maintain our supply logistics, then we may experience an unusual number of returned or out of date products.
+Added: Failure to effectively maintain our supply logistics, by us or third parties, could lead to additional manufacturing costs and delays in our ability to supply required quantities for clinical trials or otherwise.
+Added: Fast Track Designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure approval.
+Added: The FDA granted Fast Track Designation for our recombinant quadrivalent seasonal influenza vaccine candidate in January 2020 and prototype vaccine in November 2020, and also granted Fast Track Designation to the R21/Matrix-M malaria vaccine .
+Added: Depending on the data from our preclinical and clinical studies, we may decide to seek such designation for some or all of our other vaccine candidates.
+Added: The Fast Track program is intended to expedite or facilitate the process for reviewing candidates that meet certain criteria.
+Added: Specifically, biologics are eligible for Fast Track designation if they are intended, alone or in combination with one or more drugs or biologics, to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
+Added: With respect to our programs, Fast Track Designation would apply to the combination of the vaccine candidate and the specific indication for which it is being studied.
+Added: The sponsor of a Fast Track vaccine candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the application may be eligible for priority review.
+Added: A BLA submitted for a Fast Track candidate may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.
+Added: The FDA has broad discretion whether or not to grant this designation.
+Added: Even if we believe a particular vaccine candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it.
+Added: Even if we do receive Fast Track Designation for any of our vaccine candidates, such vaccine candidates may not experience a faster development process, review or approval compared to conventional FDA procedures.
+Added: The FDA may also withdraw Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development programs.
+Added: Furthermore, such a designation does not increase the likelihood that any vaccine candidate that may be granted Fast Track Designation will receive regulatory approval in the U.S.
+Added: Many candidates that have received Fast Track Designation have ultimately failed to obtain approval.
+Added: Risks Related to Our Dependence on Third Parties
+Added: We need to partner with a collaborator to handle marketing activities, and if we are unable to enter into collaborations with marketing partners, we may not be successful in commercializing any approved products.
+Added: Although we commercialized our COVID-19 Vaccine for the last three vaccination seasons, we have transitioned the commercialization of this product to Sanofi for the 2025-2026 vaccination season and for the duration of the Sanofi CLA and we otherwise currently have limited dedicated sales, marketing or distribution capabilities.
+Added: As a result, we depend on collaborations with third parties that have established distribution systems and sales forces, including our collaborations with Sanofi and SII, among others.
+Added: To the extent that we enter into co-promotion or other licensing arrangements, such as the Sanofi CLA, our revenue will depend upon the efforts of third parties, over which we may have little or no control.
+Added: If we are unable to reach and maintain agreements with one or more pharmaceutical companies or collaborators, we may be required to market our products directly.
+Added: Developing a marketing and sales force is expensive and time-consuming and could delay a product launch.
+Added: We may not be able to attract and retain qualified sales personnel or otherwise develop this capability, which may adversely affect our business.
Current or future regional relationships may hinder our ability to engage in larger transactions.
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Also, these regional relationships may make us an unattractive target for an acquisition.
−Removed: Our product candidates are sensitive to shipping and storage conditions, which could subject our vaccine candidates to risk of loss or damage.
−Removed: Our vaccine candidates are sensitive to storage and handling conditions.
−Removed: Loss in vaccine candidates could occur if the product or product intermediates are not stored or handled properly.
−Removed: It is possible that our vaccine candidates could be lost due to expiration prior to use.
−Removed: If we do not effectively maintain our supply logistics, then we may experience an unusual number of returned or out of date products.
−Removed: Failure to effectively maintain our supply logistics, by us or third parties, could lead to additional manufacturing costs and delays in our ability to supply required quantities for clinical trials or otherwise.
−Removed: Our vaccine candidates could become subject to a product recall which could harm our reputation, business, and financial results.
−Removed: FDA and similar foreign governmental authorities have the authority to require the recall of certain vaccine candidates.
−Removed: Manufacturers may, under their own initiative, recall a product if any material deficiency in a product is found.
−Removed: A government-mandated or voluntary recall by us or our strategic collaborators could occur as a result of manufacturing errors, design or labeling defects or other deficiencies and issues.
−Removed: For example, in May 2023, we extended a credit of $64.7 million to the Australian government under the Australia APA for a single lot of NVX-CoV2373 doses sold to the Australian government in 2022 that, upon pre-planned 6-month stability testing, was found to have fallen below the defined specifications, and the lot was therefore removed from the market.
−Removed: Recalls of our COVID-19 Vaccine or any of our vaccine candidates would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations.
−Removed: Additionally, a recall announcement could harm our reputation with customers and negatively affect our sales.
+Added: We must identify vaccines for development with our technologies and establish successful third-party relationships.
+Added: The near and long-term viability of our other vaccine candidates, including our CIC vaccine candidate, depends in part on our ability to successfully establish, operationalize and maintain strategic collaborations with pharmaceutical and biotechnology companies and government agencies.
+Added: Establishing, operationalizing and maintaining strategic collaborations and obtaining government funding is difficult and time-consuming.
+Added: Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position or based on their internal pipelines;
+Added: government agencies may reject contract or grant applications based on their assessment of public need, the public interest, our products’ ability to address these areas, or other reasons beyond our expectations or control.
+Added: Collaborators also may seek to modify or terminate relationships.
+Added: Past success in establishing strategic collaborations with pharmaceutical and biotechnology companies, non-profit organizations and government agencies is no guarantee of future success in entering into new relationships or in performing under existing relationships.
+Added: If we fail to establish a sufficient number of collaborations or government relationships on acceptable terms, or fail to perform under collaborations or relationships to the satisfaction of counter-parties, we may not be able to commercialize our vaccine candidates or generate sufficient revenue to fund further research and development efforts.
+Added: • The collaborations we have established or may establish may not result in the successful development or commercialization of any vaccine candidates for several reasons, including the fact that:
+Added: • we may not have the ability to control the activities of our partners and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development and commercialization of any approved vaccines or our vaccine candidates, in a timely manner or at all;
+Added: • such partners may not devote sufficient resources to any approved vaccines or our vaccine candidates or properly maintain or defend our intellectual property rights;
+Added: • our partners could independently develop, or develop with third parties, products that compete directly or indirectly with any approved vaccines or our vaccine candidates if such partners believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
+Added: • any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of any approved vaccines or our vaccine candidates and affect our ability to realize product revenue;
+Added: • disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals and commercialization activities.
+Added: If we or our collaborators fail to maintain our existing agreements or in the event we fail to establish agreements as necessary, we could be required to undertake research, development, manufacturing and commercialization activities solely at our own expense.
+Added: These activities would significantly increase our capital requirements and, given our limited sales, marketing and distribution capabilities, significantly delay the commercialization of our vaccine candidates.
+Added: We rely on third parties to conduct preclinical studies and clinical trials.
+Added: If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain regulatory approval for or commercialize our vaccine candidates may be delayed.
+Added: We depend on third parties to conduct our preclinical studies and clinical trials for our vaccine candidates.
+Added: Specifically, we rely on, and will continue to rely on, medical institutions, clinical investigators, CROs and consultants to conduct preclinical studies and clinical trials, in each case in accordance with our clinical protocols and regulatory requirements.
+Added: These CROs, investigators and other third parties play a significant role in the conduct and timing of these trials and subsequent collection and analysis of data.
+Added: Though we expect to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
+Added: Further, while we will have agreements governing the activities of our third-party contractors, we have limited influence over their actual performance.
+Added: Nevertheless, we are responsible for ensuring that each of our preclinical studies and clinical trials are conducted in accordance with the applicable protocol and legal, regulatory and scientific standards and requirements, and our reliance on our CROs and other third parties does not relieve us of our regulatory responsibilities.
+Added: In addition, we and our CROs are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for our vaccine candidates in clinical development.
+Added: Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.
+Added: If we or any of our CROs or trial sites fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
+Added: Furthermore, our clinical trials must be conducted with vaccine candidates and placebo produced under cGMP and similar foreign regulations.
+Added: Failure to comply with these regulations may require us to repeat clinical trials or recall batches of our vaccine candidate or placebo, which would delay the regulatory approval process.
+Added: There is no guarantee that any of our CROs, investigators or other third parties will devote adequate time and resources to our preclinical studies or clinical trials or perform as contractually required.
+Added: If any of these third parties fails to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, or otherwise performs in a substandard manner, our clinical trials may be extended, delayed or terminated.
+Added: In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting preclinical studies, clinical trials or other development activities that could harm our competitive position.
+Added: If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms or at all.
+Added: Switching or adding additional CROs, investigators and other third parties involves additional cost and requires our management’s time and focus.
+Added: In addition, there is a natural transition period when a new CRO commences work.
+Added: As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
+Added: Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
+Added: We currently rely on third parties for the manufacture of our vaccine candidates for clinical development and expect to continue to rely on third parties for the foreseeable future.
+Added: This reliance on third parties increases the risk that we will not have sufficient quantities of our vaccine candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or potential commercialization efforts.
+Added: We rely, and expect to continue to rely in part, on additional third-party manufacturers for the manufacture of our vaccine candidates and related raw materials for clinical development, as well as for commercial manufacture.
+Added: The facilities used by third-party manufacturers to manufacture our vaccine candidates must be approved for the manufacture of such candidate by the FDA and any comparable foreign regulatory authority pursuant to inspections that will be conducted after we submit a BLA to the FDA or any comparable submission to a foreign regulatory authority.
+Added: We do not control the manufacturing process of, and are completely dependent on, third-party manufacturers for compliance with cGMP and similar foreign requirements for manufacture of products.
+Added: Our third-party manufacturers may be unable to successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or any comparable foreign regulatory authority.
+Added: In order for us to use the material manufactured by third-party manufacturers, their manufacturing facilities must comply with applicable legal requirements, including cGMP, and upon a request for marketing
+Added: authorization, these facilities must be authorized for the manufacture of our vaccine candidates in connection with any approval of any marketing application we submit.
+Added: In addition, we have no control over the ability of third-party manufacturers to procure raw material supplies and maintain adequate quality control, quality assurance and qualified personnel.
+Added: Furthermore, the process of manufacturing biologics is complex and highly susceptible to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process.
+Added: Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, other supply disruptions and higher costs.
+Added: If microbial, viral or other contaminations are discovered at the facilities of our third-party manufacturers, such facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials, result in higher costs of drug product and adversely affect our business.
+Added: Further, our clinical supplies have a shelf lives that may expire prior to the full enrollment of our planned clinical trials causing similar delays or other supply disruptions.
+Added: Any performance failure on the part of our third-party manufacturers could delay clinical development or marketing approval of any vaccine candidate, and may adversely affect our future profit margins and our ability to commercialize any vaccines that receive marketing approval on a timely and competitive basis.
+Added: In addition, we may be unable to establish any supply agreements with additional third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to timely obtain sufficient quantities of our vaccine candidates or such quantities at an acceptable cost.
+Added: Even if we are able to establish long-term agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
+Added: • failure of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;
+Added: breach of the manufacturing agreement by the third party;
+Added: • failure to manufacture our product according to our specifications, our schedule, or at all;
+Added: • infringement, misappropriation or other violation of our intellectual property and proprietary information, including our trade secrets and know-how;
+Added: • termination or non renewal of the agreement by the third party at a time that is costly or inconvenient for us.
+Added: There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us, and any vaccine candidates that we may develop may compete with other vaccine candidates and products for access to such manufacturers and manufacturing facilities.
+Added: Increased competition amongst developers to access manufacturers and materials could increase the costs of, or otherwise limit our ability to, manufacture our vaccine candidates.
+Added: Our third-party manufacturers may be unable to successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or any comparable foreign regulatory authority.
+Added: In order for us to use the material manufactured by third-party manufacturers, their manufacturing facilities in which our materials are produced must comply with applicable laws and regulations governing the manufacture of biological products, and upon a request for marketing authorization, these facilities must be authorized for the manufacture of our vaccine candidates in connection with any approval of a marketing application we submit.
+Added: If materials manufactured by our third-party manufacturers do not conform to our specifications or the regulatory requirements necessary for use in clinical trials, we may experience delays in our development efforts or may need to find alternative manufacturing facilities, which would significantly impact our ability to obtain regulatory approval for or commercialize our vaccine candidates, if approved.
+Added: Our third-party manufacturers may be unable to successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or any comparable foreign regulatory authority.
+Added: In order for us to use the material manufactured by third-party manufacturers, their manufacturing facilities in which our materials are produced must comply with applicable laws and regulations governing the manufacture of biological products, and upon a request for marketing authorization, these facilities must be authorized for the manufacture of our vaccine candidates in connection with any approval of a marketing application we submit.
+Added: If the FDA or any comparable foreign regulatory authority determines that such facilities are noncompliant or does not authorize these facilities to manufacture our vaccine candidates or if it withdraws any such authorization in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our vaccine candidates, if
+Added: While we are seeking to identify and secure additional third-party contract manufacturers, we may be unable to do so at an acceptable cost, or at all, which could significantly impact our ability to obtain regulatory approval for or commercialize our vaccine candidates, if approved.
+Added: Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls of vaccine candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.
+Added: Additionally, our third-party manufacturers may rely on single source suppliers for certain of the raw materials for our preclinical and clinical product supplies.
+Added: If current or future suppliers are delayed or unable to supply sufficient raw materials to manufacture product for our preclinical studies and clinical trials, we may experience delays in our development efforts as materials are obtained or we locate and qualify new raw material manufacturers.
+Added: Our or a third party’s failure to execute on our manufacturing requirements on commercially reasonable terms and in compliance with cGMP or other regulatory requirements could adversely affect our business in a number of ways, including:
+Added: • an inability to initiate clinical trials of our vaccine candidates;
+Added: • delay in submitting regulatory applications, or receiving marketing approvals, for our vaccine candidates;
+Added: • subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;
+Added: • requirements to cease development or to recall batches of our vaccine candidates;
+Added: • in the event of approval to market and commercialize our vaccine candidates, an inability to meet commercial demands for such vaccines.
+Added: Any performance failure on the part of our manufacturing partners could delay clinical development or marketing approval, and any related remedial measures may be costly or time consuming to implement.
+Added: In addition, our current and anticipated future dependence upon others for the manufacture of our vaccine candidates may adversely affect our future profit margins and our ability to commercialize any vaccines that receive marketing approval on a timely and competitive basis.
Risks Related to Our Industry and Competition
−Removed: Table o f Contents
Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.
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We will also face competition from these parties in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and participant registration for clinical trials and in acquiring and in-licensing technologies and products complementary to our programs or potentially advantageous to our business.
−Removed: If any of our competitors succeed in obtaining approval from the U.S.
−Removed: FDA or other regulatory authorities for their products sooner than we do or for products that are more effective or less costly than ours, our commercial opportunity could be significantly reduced.
−Removed: Table o f Contents
+Added: If any of our competitors succeed in obtaining approval from the FDA or other regulatory authorities for their products sooner than we do or for products that are more effective or less costly than ours, our commercial opportunity could be significantly reduced.
In order to effectively compete, we will have to make substantial investments in development, testing, manufacturing and sales and marketing or partner with one or more established companies.
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Our technologies and vaccines also may be rendered obsolete or non-competitive as a result of products introduced by our competitors to the marketplace more rapidly and at a lower cost.
−Removed: There is significant competition in the development of a vaccine against COVID-19 and a combined vaccine against COVID-19 and influenza, and we may never see returns on the significant resources we are devoting to our vaccine candidates.
−Removed: Our COVID-19 Vaccine has moved rapidly through the regulatory review and authorization processes in the U.S.
−Removed: and other jurisdictions.
−Removed: The speed at which COVID-19 vaccines and therapeutics are being created and tested is atypical, and evolving or changing plans or priorities within the U.S.
−Removed: FDA or other regulatory authorities, including changes based on new knowledge of COVID-19 and how the disease, and new variants of the virus, affect the human body, may significantly affect our ability to establish a competitive market share for our COVID-19 Vaccine.
−Removed: A large number of vaccine manufacturers, academic institutions and other organizations have developed COVID-19 vaccines or are developing COVID-19 vaccine candidates.
−Removed: In particular, Moderna, and Pfizer/BioNTech have received full regulatory approvals for their COVID-19 vaccines and, along with Johnson & Johnson have received emergency use authorizations for their COVID-19 vaccines in the U.S.
−Removed: and other countries.
−Removed: All of these companies have obtained the relevant Emergency Use Licenses (“EULs”) from the World Health Organization for their respective vaccines to be supplied to the countries or international coalition partners, including the relevant United Nations agencies, which rely upon the World Health Organization’s EULs to support the local immunization programs.
−Removed: Despite funding provided to us to date, many of our competitors pursuing vaccine candidates have significantly greater product candidate development, manufacturing and marketing resources than we do.
+Added: There is significant competition in the development of a vaccine against COVID-19 and a combined vaccine against COVID-19 and influenza, and we may never see returns on the significant resources we have devoted and may continue to devote to our vaccine candidates.
+Added: Despite funding provided to us to date, and although we obtained regulatory approvals for our COVID-19 Vaccine, many of our competitors pursuing vaccine candidates have significantly greater development, manufacturing and marketing resources than we do.
Larger pharmaceutical and biotechnology companies have extensive experience in clinical testing and obtaining regulatory approval for their products and may have the resources to heavily invest to accelerate discovery and development of their vaccine candidates.
−Removed: The success of our COVID-19 Vaccine will depend, in part, on its relative safety, efficacy (including against emerging variant strains), side effect profile, convenience, and cost.
−Removed: COVID-19 vaccines approved prior to our vaccine have developed broad market acceptance that we are challenged to overcome.
−Removed: FDA has also approved Gilead’s Veklury (remdesivir) for treatment of COVID-19 in both adult and pediatric populations, as well as Eli Lilly’s Olumiant (baricitinib) and Genentech’s Actemra (tocilizumab) for treatment of COVID-19 in certain hospitalized adults and Pfizer’s Paxlovid (nirmatrelvir tablets;
−Removed: ritonavir tablets) for certain un-hospitalized adults.
−Removed: Furthermore, if any competitors are successful in producing a more efficacious vaccine or other treatment for COVID-19 (including against emerging variant strains), or if any competitors are able to manufacture and distribute any such vaccines or treatments with greater efficiency there may be a diversion of potential governmental and other funding away from us and toward such other parties.
−Removed: We are allocating significant financial and personnel resources to the development and commercialization of our COVID-19 Vaccine, which may cause delays in or otherwise negatively impact our other development programs.
−Removed: Our business could be negatively impacted by our allocation of significant resources to combating a global health threat that is unpredictable or against which our vaccine may ultimately prove unsuccessful or unprofitable.
+Added: The success of our candidates will depend, in part, on their relative safety, efficacy (including against emerging variant strains), side effect profile, convenience, and cost.
+Added: Furthermore, if any competitors are successful in producing a more efficacious vaccine or other treatment for the diseases we intend to target (including against emerging variant strains), or if any competitors are able to manufacture and distribute any such vaccines or treatments with greater efficiency there may be a diversion of potential governmental and other funding away from us and toward such other parties.
Many seasonal influenza vaccines are currently approved and marketed.
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Risks Related to Regulatory and Compliance Matters
−Removed: We may not succeed in obtaining full U.S.
−Removed: FDA licensure or foreign regulatory approvals necessary to sell our vaccine candidates.
−Removed: Table o f Contents
−Removed: The development, manufacture and marketing of our pharmaceutical and biological products are subject to government regulation by the U.S.
−Removed: FDA and regulatory authorities in other jurisdictions, including the EMA and the Swedish Medical Products Agency (Läkemedelsverket, LV) with respect to our adjuvant product being developed in Sweden, as well as other country authorities into which active pharmaceutical ingredients and excipients are imported and/or manufactured by us or our sub-contracted manufacturers.
−Removed: and most foreign countries, we must complete rigorous preclinical testing and extensive clinical trials that demonstrate the safety and efficacy of a product in order to apply for regulatory approval to market the product.
−Removed: None of our vaccine candidates has yet gained full regulatory approval in the U.S., although our COVID-19 Vaccine has received conditional marketing authorization, emergency use authorization, or full approval in the various jurisdictions.
−Removed: We also have vaccine candidates in clinical trials and preclinical laboratory or animal studies.
−Removed: There is no guarantee that the results obtained in preclinical studies or our clinical trials of our prototype vaccine and NVX-CoV2601, for which we have submitted a BLA that the U.S.
−Removed: FDA has accepted for review, or of our other current and future vaccine candidates will be sufficient to obtain regulatory approval or marketing authorization for such vaccine candidates.
−Removed: Additionally, even if regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or other applicable regulatory submission, such regulatory authorities may change their requirements or recommendations in the future.
−Removed: Any delays or failure to obtain regulatory approvals or clearances to initiate our clinical trials may prevent us from completing our clinical trials or commercializing our current and future product candidates on a timely basis, if at all.
−Removed: Our products might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support regulatory approvals.
−Removed: The steps generally required by the U.S.
−Removed: FDA before our proposed investigational products may be marketed in the U.S.
−Removed: • performance of preclinical (animal and laboratory) tests;
−Removed: • submission to the U.S.
−Removed: FDA of an IND, which must become effective before clinical trials may commence;
−Removed: • performance of adequate and well controlled clinical trials to establish the safety and efficacy of the investigational product in the intended target population;
−Removed: • performance of a consistent and reproducible manufacturing process at commercial scale capable of passing U.S.
−Removed: FDA inspection;
−Removed: • submission to the U.S.
−Removed: FDA of a BLA or a NDA;
−Removed: • U.S.FDA approval of the BLA or NDA before any commercial sale or shipment of the product.
−Removed: Clinical trials that we undertake in other countries will be subject to similar or equivalent processes and requirements, In Europe, as well as an authorization for the trial itself, it is necessary to obtain the consent of a local ethics committee for each trial site and to provide for publication specific information about the trial and its outcome.
−Removed: If endpoints are not met, this information will be made publicly available and could be damaging to the reputation of the Company.
−Removed: These processes are expensive and can take many years to complete, and we may not be able to demonstrate the safety, purity, potency and efficacy of our vaccine candidates to the satisfaction of regulatory authorities.
−Removed: The start of clinical trials can be delayed or take longer than anticipated for many and varied reasons, many of which are out of our control.
−Removed: Safety concerns may emerge that could lengthen the ongoing clinical trials or require additional clinical trials to be conducted.
−Removed: Promising results in early clinical trials may not be replicated in subsequent clinical trials.
−Removed: For example, the first batch of top line results from our Phase 2 CIC clinical trial evaluating safety and immunogenicity of different formulations of CIC may not be consistent with top line results from subsequent batches in such trial.
−Removed: Regulatory authorities may also require additional testing, and we may be required to demonstrate that our proposed products represent an improved form of treatment over existing therapies, which we may be unable to do without conducting further clinical trials.
−Removed: Moreover, if a regulatory authority grants regulatory approval of a product, the approval may be limited to specific indications or limited
−Removed: Table o f Contents
−Removed: with respect to its distribution.
−Removed: Expanded or additional indications for approved products may not be approved, which could limit our revenue.
−Removed: Foreign regulatory authorities may apply similar limitations or may refuse to grant any approval.
−Removed: Consequently, even if we believe that preclinical and clinical data are sufficient to support regulatory approval for our vaccine candidates, the U.S.
−Removed: FDA and foreign regulatory authorities ultimately may not grant approval for commercial sale in their applicable jurisdiction, or may impose regulatory requirements that make further pursuit of approval uneconomical in one or more jurisdictions.
−Removed: If our vaccine candidates are not approved, our ability to generate revenue will be limited, and our business will be adversely affected.
−Removed: We may fail to obtain regulatory approval for our prototype vaccine and for NVX-CoV2601 or for our other current or future product candidates on a timely basis or comply with our continuing regulatory obligations if approval is obtained.
−Removed: In the U.S., we submitted a BLA for our prototype vaccine and NVX-CoV2601, and the U.S.
−Removed: FDA notified us that our BLA was accepted for review with a PDUFA date of April 2025.
−Removed: There is no guarantee that we will obtain approval of our BLA for prototype vaccine and for NVX-CoV2601 within the currently anticipated April 2025 timeline.
−Removed: Although FDA has accepted our BLA for review, we may receive requests for additional information during the U.S.
−Removed: FDA’s review of the BLA, or the U.S.
−Removed: FDA may request advisory committee input, which may be unfavorable to approval.
−Removed: FDA may also determine that additional preclinical studies or clinical trials are needed before our BLA can be approved.
−Removed: If we were to conduct additional preclinical studies or clinical trials, the U.S.
−Removed: FDA may not agree with our interpretation of the results, and we may never receive approval for prototype vaccine and NVX-CoV2601.
−Removed: FDA may extend or be unable to meet its April 2025 PDUFA goal date for completing its review of our BLA.
−Removed: Fluctuations in U.S.
−Removed: FDA funding, staffing, resources, priorities, and practices under the current administration are possible and may lead to variations and challenges in the review process, timeline and outcomes.
−Removed: Delays in obtaining regulatory approval can be extremely costly in terms of lost sales opportunities, loss of any potential marketing advantage of being early to market and increased clinical trial costs.
−Removed: For example, we did not receive EUA from the U.S.
−Removed: FDA for our XBB vaccine for the 2023-2024 vaccination season until several weeks after our competitors, and we were unable to accomplish the timely validation of the single-dose vial or pre-filled syringe presentation we had intended to use with our XBB Vaccine in the U.S.
−Removed: for the 2023-2024 vaccination season, which resulted in our use of a five dose vial presentation for 2023-2024 vaccination season, which we believe harmed our financial condition and results of operations.
−Removed: In addition, certain of our APAs and supply agreements may be terminated by the counterparty if we do not timely achieve requisite regulatory approval for our COVID-19 Vaccine in the relevant jurisdictions under such agreements, which may harm our financial condition and results of operations.
−Removed: Under the Canada APA, we failed to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at BMC and the Canadian government may therefore terminate the Canada APA.
−Removed: In addition, under the Amended and Restated UK Supply Agreement, we failed to receive supportive recommendations from the JCVI, triggering obligations for us to repay the Authority and ultimately leading to our entry into the Settlement Agreement with the Authority in November 2024.
−Removed: The speed with which we begin and complete the preclinical studies necessary to begin clinical trials, the clinical trials themselves and our applications for marketing approval will depend on several factors, including the following:
−Removed: • our ability to scale-up and maintain manufacturing capability that reproducibly generates consistent yields of product with required purity, potency and quality;
−Removed: that such scale-up occurs on a timely basis;
−Removed: and that we have access to sufficient quantities of materials for use in necessary preclinical studies and clinical trials;
−Removed: • regulatory authority review and approval of proposed clinical trial protocols;
−Removed: • approval of clinical trials protocols and informed consent forms by institutional review boards responsible for overseeing the ethical conduct of the trial;
−Removed: • the rate of participant enrollment and retention, which is a function of many factors, including the size of the participant population, the proximity of participants to clinical sites, the eligibility criteria for the clinical trial and the nature of the protocol;
−Removed: • unfavorable test results or side effects experienced by clinical trial participants;
−Removed: Table o f Contents
−Removed: • analysis of data obtained from preclinical and clinical activities, which are susceptible to varying interpretations and which interpretations could delay, limit, result in the suspension or termination of, or prevent further conduct of clinical studies or regulatory approval;
−Removed: • the availability of skilled and experienced staff to conduct and monitor clinical trials and to prepare the appropriate regulatory applications;
−Removed: • changes in the policies of regulatory authorities for drug or vaccine development and approval during the period of product development, including, but not limited to, as a result of the change in presidential administration and leadership of DHHS in January 2025.
−Removed: We have somewhat limited experience in conducting and managing the preclinical studies and clinical trials necessary to obtain regulatory marketing approvals.
−Removed: We may not be permitted to continue or commence additional clinical trials.
−Removed: We also face the risk that the results of our clinical trials may be inconsistent with the results obtained in preclinical studies or clinical trials of similar products or that the results obtained in later phases of clinical trials may be inconsistent with those obtained in earlier phases.
−Removed: A number of companies in the biotechnology and product development industry have suffered significant setbacks in advanced clinical trials, even after experiencing promising results in early animal and human testing.
−Removed: Regulatory agencies may require us or our collaborators to delay, restrict or discontinue clinical trials on various grounds, including a finding that the participants are being exposed to an unacceptable health risk.
−Removed: In addition, we or our collaborators may be unable to submit applications to regulatory agencies within the time frame we currently expect.
−Removed: Once submitted, applications must be approved by various regulatory agencies before we or our collaborators can commercialize the product described in the application.
−Removed: All statutes and regulations governing the conduct of clinical trials are subject to change in the future, which could affect the cost of such clinical trials.
−Removed: Any unanticipated costs or delays in our clinical trials or regulatory submissions could delay our ability to generate revenue and harm our financial condition and results of operations.
−Removed: If we are unable to effectively pursue the manufacture, clinical testing, regulatory authorization, and export of our COVID-19 Vaccine, or COVID-19 vaccines against future strain changes, we may encounter delays or challenges in commercially distributing these vaccines as well as gaining market acceptance for them.
−Removed: We expect that regulatory authorities will continue to monitor and assess SARS-CoV-2 evolution and recommend that manufacturers make corresponding updates to the composition of their COVID-19 vaccines at least annually.
−Removed: Inherent to this evolving approach to manufacturing new strains of COVID-19 vaccines, including our development of our COVID-19 Vaccine, we may encounter regulatory authorization, manufacturing, and distribution challenges, including export challenges.
−Removed: In doing so, we expect to seek alignment and acceptance by regulatory authorities that would allow us to use manufacturing and analytical testing methods employed in earlier COVID-19 vaccine production and commercialization efforts, that support an accurate characterization profile (including purity, potency, stability and like standards) of the relevant COVID-19 vaccine.
−Removed: Our inability to overcome product development challenges and gaining regulatory authority alignment may adversely affect our ability to obtain licensure of our COVID-19 vaccine or future COVID-19 vaccines at all, or in a timely manner.
−Removed: Regarding future COVID-19 vaccine development, we may fail to receive authorization for updated variants of SARS-CoV-2 by regulatory authorities if we are unable to generate sufficient batch analysis data to demonstrate batch-to-batch consistency at commercial scale, if the data generated from our incremental research and development program do not support continued effectiveness of the vaccine to protect individuals against the then-relevant variant of SARS-CoV-2 because the vaccine does not induce an adequate level of neutralization titers against such variant, or if the product otherwise exhibits an unacceptable safety profile, rendering the benefit/risk balance unfavorable.
−Removed: Moreover, the new vaccine lots may not be accepted for distribution if required batch-release testing undertaken by officially designated laboratories does not show that such vaccine is of acceptable quality.
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−Removed: Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally.
−Removed: We intend to have our vaccine candidates marketed outside the U.S.
+Added: The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our vaccine candidates, our business will be substantially harmed.
+Added: The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of our vaccine candidates are subject to extensive regulation by the FDA in the U.S.
+Added: and by comparable foreign regulatory authorities in foreign markets.
+Added: In the U.S., we are not permitted to market our vaccine candidates in the U.S.
+Added: until we receive regulatory approval of a BLA from the FDA.
+Added: The process of obtaining such regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the vaccine candidates involved, as well as the target indications and patient population.
+Added: Approval policies or regulations may change, and the FDA and comparable regulatory have substantial discretion in the approval process, including the ability to delay, limit or deny approval of a vaccine candidate for many reasons.
+Added: Despite the time and expense invested in clinical development of vaccine candidates, regulatory approval of a vaccine candidate is never guaranteed.
+Added: Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized.
+Added: Prior to obtaining approval to commercialize a vaccine candidate in the U.S.
+Added: or abroad, we must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such vaccine candidates are safe and effective for their intended uses, and in the case of vaccines in the U.S., that such vaccine candidates are safe, pure and potent for their intended uses.
+Added: Results from nonclinical studies and clinical trials can be interpreted in different ways.
+Added: Even if we believe available nonclinical or clinical data support the safety purity, potency, or efficacy of our vaccine candidates, such data may not be sufficient to obtain approval from the FDA and comparable foreign regulatory authorities.
+Added: The FDA or comparable foreign regulatory authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our vaccine candidates either prior to or post-approval, or may object to elements of our clinical development program.
+Added: The FDA or comparable foreign regulatory authorities can delay, limit or deny approval of a vaccine candidate for many reasons, including:
+Added: • such authorities may disagree with the design or execution of our clinical trials;
+Added: • negative or ambiguous results from our clinical trials or results may not meet the level of statistical significance or persuasiveness required by the FDA or comparable foreign regulatory agencies for approval;
+Added: • serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using products similar to our vaccine candidates;
+Added: • the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;
+Added: • such authorities may not accept clinical data from trials that are conducted at clinical facilities or in countries where the standard of care is potentially different from that of their own country;
+Added: • we may be unable to demonstrate that a vaccine candidate’s clinical and other benefits outweigh its safety risks;
+Added: • such authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
+Added: • such authorities may not agree that the data collected from clinical trials of our vaccine candidates are acceptable or sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the U.S.
+Added: or elsewhere, and such authorities may impose requirements for additional preclinical studies or clinical trials;
+Added: • such authorities may disagree with us regarding the formulation, labeling and/or the product specifications of our vaccine candidates;
+Added: • approval may be granted only for indications that are significantly more limited than those sought by us, and/or may include significant restrictions on distribution and use;
+Added: • such authorities may find deficiencies in the manufacturing processes or facilities of the third-party manufacturers with which we contract for clinical and commercial supplies;
+Added: • such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission.
+Added: With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities.
+Added: Where if we eventually complete clinical trials and receive approval of a BLA or comparable foreign marketing application for our vaccine candidates, the FDA or comparable foreign regulatory authority may grant approval contingent on the performance of costly additional clinical trials and/or the implementation of a REMS, which may be required because the FDA believes it is necessary to ensure safe use of the product after approval.
+Added: Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of that vaccine candidate and would materially adversely impact our business and prospects.
+Added: Where we receive regulatory approval for our vaccine candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
+Added: Additionally, our vaccine candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our vaccine candidates, when and if any of them are approved.
+Added: Any regulatory approvals that we may receive for our vaccine candidates will require the submission of reports to regulatory authorities, subject us to surveillance to monitor the safety and efficacy of the product, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements.
+Added: For example, the FDA may require a REMS as a condition of approval of our vaccine candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
+Added: In addition, if the FDA or a comparable foreign regulatory authority approves our vaccine candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our products will be subject to extensive and ongoing regulatory requirements.
+Added: These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and similar foreign requirements, and GCP requirements for any clinical trials that we conduct post-approval.
+Added: Failure to comply with regulatory requirements or later discovery of previously unknown problems with our products, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, may result in, among other things:
+Added: • restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;
+Added: • restrictions on product distribution or use, or requirements to conduct post-marketing studies or clinical trials;
+Added: • restrictions on our ability to conduct clinical trials, including full or partial clinical holds on clinical trials;
+Added: • fines, restitutions, disgorgement of profits or revenue, warning letters, untitled letters, adverse publicity requirements or holds on clinical trials;
+Added: • refusal by the FDA or other regulatory authorities to approve pending applications or supplements to approved applications submitted by us or suspension or revocation of approvals;
+Added: • product seizure or detention, or refusal to permit the import or export of our products;
+Added: • injunctions or the imposition of civil or criminal penalties.
+Added: The occurrence of any event or penalty described above may inhibit our ability to commercialize our vaccine candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity.
+Added: Moreover, the FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay marketing authorization of any vaccine candidates we develop.
+Added: For example, the Trump administration may issue executive orders or take other actions that could impose significant burdens on,
+Added: or otherwise materially delay, the FDA’s ability to engage in routine oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.
+Added: The policies and priorities of a presidential administration could materially impact the regulations governing our vaccine candidates.
+Added: In particular, the current DHHS Secretary, Robert F.
+Added: Kennedy, Jr., has previously issued statements expressing skepticism towards the safety and testing of pediatric vaccines, such as those we intend to develop, and has taken actions to modify certain committees and recommendations that could adversely affect the development, approval and/or commercialization of novel vaccines.
+Added: For additional information, see the Risk Factor above entitled:
+Added: “ Even if we successfully commercialize any of our vaccine candidates, either alone or in collaboration, we face uncertainty with respect to pricing, third-party reimbursement and healthcare reform, all of which could be subject to change, and could adversely affect any commercial success of our vaccine candidates.
+Added: If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability.
+Added: Our vaccine candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
+Added: The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product.
+Added: Under the BPCIA, an application for a highly similar or “biosimilar” product may not be submitted to the FDA until four years following the date that the reference product was first approved by the FDA.
+Added: In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first approved.
+Added: During this 12-year period of exclusivity, the FDA may approve a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.
+Added: We believe that any of our vaccine candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity.
+Added: However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our vaccine candidates to be reference products for competing products, potentially creating the opportunity for competition sooner than anticipated.
+Added: Failure to obtain regulatory approval in foreign jurisdictions could prevent us from marketing our products internationally.
+Added: We intend to have our vaccine candidates developed and commercialized outside the U.S.
In furtherance of this objective, we have entered into supply agreements with various foreign governments and international distribution agreements with commercial entities.
1 unchanged sentence
The approval procedure varies among countries and can involve additional testing and data review.
−Removed: The time required to obtain foreign regulatory approval may differ from that required to obtain U.S.
−Removed: FDA approval.
−Removed: The foreign regulatory approval process may include all of the risks associated with obtaining U.S.
−Removed: FDA approval.
+Added: The time required to obtain foreign regulatory approval may differ from that required to obtain FDA approval.
+Added: The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.
Additionally, regulatory authorities outside the U.S.
might not accept data from trials conducted in other countries.
−Removed: Although our COVID-19 Vaccine has received conditional marketing authorization or emergency use authorization in a number of jurisdictions, we may not obtain regulatory approvals in other relevant jurisdictions on a timely basis, if at all.
Approval by one regulatory agency does not ensure approval by regulatory agencies in other jurisdictions.
−Removed: However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in other jurisdictions, including approval by the U.S.
+Added: However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in other jurisdictions, including approval by the FDA.
The failure to obtain regulatory approval in foreign jurisdictions could harm our business.
−Removed: The regulatory pathway for our COVID-19 Vaccine is continually evolving and may result in unexpected or unforeseen challenges.
−Removed: The regulatory pathway for our COVID-19 Vaccine is evolving and failure by us to comply with any laws, rules and standards, some of which may not exist yet or are subject to interpretation and may be subject to change, could result in a variety of adverse consequences, including penalties, fines and delays in vaccine licensure.
−Removed: Efforts to comply with evolving laws, regulations and standards have resulted in, and are likely to continue to result in, increased general and administrative expenses and a diversion of management time and attention to regulatory compliance activities.
−Removed: Such rules or standards may adversely affect our plans to develop our COVID-19 Vaccine and failure by us to comply with any laws, rules or standards, some of which may not exist yet or may change, could result in a range of adverse consequences, such as penalties, fines or failure to receive funding.
−Removed: The speed at which multiple stakeholders are moving to create, test and approve vaccines for COVID-19 is highly unusual and may increase the risks associated with traditional vaccine development, which typically takes between eight and ten years.
−Removed: Given this accelerated timeline, we and regulators, such as the U.S.
−Removed: FDA, the EMA, and the MHRA may make decisions more rapidly than is typical.
−Removed: Evolving or changing plans or priorities at the U.S.
−Removed: FDA or other regulatory bodies to whom we wish to apply for authorization, including based on new knowledge of COVID-19 and how the disease affects the human body, new variants of the virus, and regulatory policy changes (including those at U.S.
−Removed: agencies such as the DHHS, U.S.
−Removed: FDA, and CDC due to the change in U.S.
−Removed: presidential administration in January 2025), may significantly affect the regulatory pathway for our COVID-19 Vaccine.
−Removed: For example, in May 2023, the COVID-19 PHE expired in the U.S.
−Removed: and the WHO determined that the COVID-19 pandemic no longer fit the definition of a Public Health Emergency of National Concern, which removed the justification for shortened regulatory timelines.
−Removed: Results from clinical testing may raise new questions and require us to redesign proposed clinical trials, including revising proposed endpoints or adding new clinical trial sites or cohorts of subjects.
−Removed: In addition, the U.S.
−Removed: FDA’s or other regulatory authorities’ analysis of clinical data may differ from our interpretation, or regulators’ requirements and expectations for vaccine authorization or approval may change over time, with the result that the U.S.
−Removed: FDA or other regulators may require that we conduct additional clinical trials or non-clinical studies.
−Removed: The evolving regulatory pathway may impede the development, commercialization and/or licensure of our COVID-19 Vaccine.
−Removed: In addition, because the path to licensure of any vaccine against COVID-19 is unclear, we may have a widely used vaccine in circulation in certain countries as an investigational vaccine or a product authorized for temporary or emergency use prior to our receipt of full marketing approval.
−Removed: Unexpected safety issues in these circumstances could lead to significant reputational damage for us and our technology platform going forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for significant additional financial resources.
−Removed: For example, although we currently operate under an emergency use authorization provided by the U.S.
−Removed: FDA for our updated COVID-19 Vaccine, the U.S.
−Removed: FDA may revoke such authorization if it determines that the underlying health emergency no longer exists or warrants such authorization, and we cannot predict how long such authorization will remain in place.
−Removed: Such revocation could adversely impact our business in a variety of ways.
−Removed: Table o f Contents
−Removed: We have conducted, continue to conduct and plan to conduct in the future, a number of clinical trials for our COVID-19 Vaccine and other vaccine candidates at sites outside the U.S.
+Added: We have conducted, continue to conduct and plan to conduct in the future, a number of clinical trials for our vaccine candidates at sites outside the U.S.
FDA may not accept data from trials conducted in such locations.
−Removed: We have conducted and are currently conducting several clinical trials of our COVID-19 Vaccine at sites outside the U.S., including a Phase 3 pediatric study (2019nCoV-503) in the Dominican Republic, Guatemala, Honduras, the Philippines, and Mexico.
−Removed: Although the U.S.
−Removed: FDA may accept data from clinical trials conducted outside the U.S., acceptance of these data is subject to conditions imposed by the U.S.
−Removed: For example, the clinical trial must be well designed and conducted and be performed by qualified investigators in accordance with ethical principles.
−Removed: The trial population must also adequately represent the U.S.
−Removed: population, and the data must be applicable to the U.S.
+Added: We have in the past conducted, and may in the future conduct one or more of our clinical trials or a portion of our clinical trials for our vaccine candidates outside the U.S.
+Added: The acceptance of study data from clinical trials conducted outside the U.S.
+Added: or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all.
+Added: In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S.
population and U.S.
−Removed: medical practice in ways that the U.S.
−Removed: FDA deems clinically meaningful.
−Removed: Other regulatory authorities impose equivalent requirements for their countries.
−Removed: In addition, while these clinical trials are subject to the applicable local laws, where the data is to be used to support our BLA, U.S.
−Removed: FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S.
−Removed: laws and regulations.
−Removed: FDA does not accept the data from any trial that we conduct outside the U.S., it could result in delay pending completion of our trials conducted in the U.S.
−Removed: or result in the need for additional trials, which would be costly and time-consuming and could delay or permanently halt our development and commercialization of our COVID-19 Vaccine.
−Removed: The later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market.
−Removed: Even after a product gains regulatory approval, the product and the manufacturer of the product will be subject to continuing regulatory review, including adverse event reporting requirements and prohibitions against promoting products for unapproved uses.
−Removed: Failure to comply with any post-approval requirements can, among other things, result in warning letters, product seizures, recalls, substantial fines, injunctions, suspensions or revocations of marketing authorizations or licenses, operating restrictions and criminal prosecutions.
−Removed: Any such enforcement actions, any unanticipated changes in existing regulatory requirements or the adoption of new requirements, or any safety issues that arise with any approved products, could adversely affect our ability to market products and generate revenue and thus adversely affect our ability to continue our business.
−Removed: We also may be restricted or prohibited from marketing or manufacturing a product, even after obtaining product approval, if previously unknown problems with the product or its manufacture are subsequently discovered.
−Removed: We cannot provide assurance that newly discovered or developed safety issues will not arise following regulatory approval.
−Removed: With the use of any vaccine by a wide patient population, serious adverse events may occur from time to time that did not arise in the clinical trials of the product or that initially appeared to be unrelated to the vaccine itself and only with the collection of subsequent information were found to be causally related to the product.
−Removed: Any such safety issues could cause us to suspend or cease marketing of our approved products, possibly subject us to substantial liabilities, and adversely affect our ability to generate revenue and our financial condition.
−Removed: Inadequate funding for the U.S.
−Removed: FDA, the SEC and other regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, or otherwise perform their normal functions on which the operation of our business may rely, which could negatively impact our ability to develop or commercialize new products or services, access capital markets, or otherwise operate our business.
−Removed: The ability of the U.S.
−Removed: FDA and other regulatory authorities to review and approve new product applications is affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes, including those related to a change in presidential administration.
−Removed: For example, average review times at the U.S.
−Removed: FDA have fluctuated in recent years as a result of such factors.
+Added: medical practice;
+Added: (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations;
+Added: and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.
+Added: In addition, even where the foreign study data are
+Added: not intended to serve as the sole basis for approval, if the study was not otherwise subject to an IND, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
+Added: Many foreign regulatory authorities have similar requirements for clinical data gathered outside of their respective jurisdictions.
+Added: In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted.
+Added: There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S.
+Added: or the relevant jurisdiction.
+Added: If the FDA or any comparable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future vaccine candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
+Added: Inadequate funding for the FDA, the SEC and other regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, or otherwise perform their normal functions on which the operation of our business may rely, which could negatively impact our ability to develop or commercialize new products or services, access capital markets, or otherwise operate our business.
+Added: The ability of the FDA and other regulatory authorities to review and approve new product applications is affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes, including those related to a change in presidential administration.
+Added: For example, average review times at the FDA have fluctuated in recent years as a result of such factors.
In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
−Removed: Disruptions at the U.S.
−Removed: FDA and other agencies may also slow the time necessary for new drugs to be reviewed and approved by necessary government agencies, which would adversely affect our business.
−Removed: For example, over the last several years, the U.S.
−Removed: government has shut down several times and certain regulatory agencies, such as the U.S.
−Removed: FDA and the SEC,
−Removed: Table o f Contents
−Removed: have had to furlough employees and stop or slow the pace of critical activities.
−Removed: Also, the EMA’s relocation to the Netherlands from London caused a significant loss of experienced staff and the MHRA’s loss of funding from the EU has caused a loss of funding and staff.
−Removed: If a prolonged government shutdown or slowdown of the relevant regulatory authority occurs, it could significantly impact the ability of such government or authority to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
+Added: Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and approved by necessary government agencies, which would adversely affect our business.
+Added: For example, in recent years, the U.S.
+Added: government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough employees and stop or slow the pace of critical activities.
+Added: In addition, the current U.S.
+Added: Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S.
+Added: administrative agencies, including the FDA, which have led to substantial personnel changes, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.
+Added: If a prolonged government shutdown or slowdown of the relevant regulatory authority occurs, or if funding shortages, staffing limitations or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events, could significantly impact the ability of such government or authority to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
−Removed: Fast Track Designation by the U.S.
−Removed: FDA, the issue of conditional marketing authorizations by the EMA or MHRA, or other regulatory acceleration options may not actually lead to a faster development or regulatory review or approval process and does not assure approval.
−Removed: If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address an unmet medical need for this condition, the drug sponsor may apply for U.S.
−Removed: FDA Fast Track Designation or similar fast track processes with other regulatory agencies.
−Removed: In the EU and the UK, rolling review procedure was relied upon for conditional marketing authorizations to be granted.
−Removed: However, Fast Track Designation or conditional authorizations do not ensure that the drug sponsor will receive marketing approval or that approval will be granted within any particular timeframe.
−Removed: FDA granted Fast Track Designation for our recombinant quadrivalent seasonal influenza vaccine candidate in January 2020 and prototype vaccine in November 2020.
−Removed: We may also seek Fast Track Designation for more of our other vaccine candidates.
−Removed: If we do seek Fast Track Designation for our other vaccine candidates, we may not receive it, and even if we receive Fast Track Designation, we may not experience a faster development process, review or approval compared to conventional U.S.
−Removed: FDA procedures.
−Removed: In addition, the U.S.
−Removed: FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program.
−Removed: Fast Track Designation alone does not guarantee qualification for the U.S.
−Removed: FDA’s priority review procedures.
−Removed: Obtaining a Fast Track Designation does not change the standards for product approval, but may expedite the development or approval process.
−Removed: Even though the U.S.
−Removed: FDA has granted such designation for our prototype vaccine, it may not actually result in faster clinical development or regulatory review or approval.
−Removed: Furthermore, such a designation does not increase the likelihood that our COVID-19 Vaccine will receive marketing approval in the U.S.
−Removed: We intend to seek accelerated approval from the U.S.
−Removed: FDA for our CIC vaccine.
−Removed: Accelerated approval by the U.S.
−Removed: FDA, even if granted for any of our vaccine candidates, may not lead to a faster development or regulatory review or licensure process, and does not increase the likelihood that our vaccine candidates will receive licensure.
−Removed: We intend to seek accelerated approval for our CIC vaccine, and we may in the future seek accelerated approval for our other current or future product candidates.
−Removed: Under the accelerated approval program, the U.S.
−Removed: FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
−Removed: As a condition of approval, the U.S.
−Removed: FDA requires that a sponsor of a product receiving accelerated approval perform a post-marketing confirmatory clinical trial or trials.
−Removed: In addition, the U.S.
−Removed: FDA requires as a condition for accelerated approval the pre-submission of promotional materials to U.S.
−Removed: FDA for review.
−Removed: We are actively developing a proposal to support a potential accelerated approval pathway for our CIC vaccine.
−Removed: There can be no assurance that after our evaluation of feedback from the U.S.
−Removed: FDA or other factors that we will decide to pursue accelerated approval for this vaccine candidate.
−Removed: Furthermore, if we decide to submit an application for accelerated approval for any vaccine candidate, there can be no assurance that such submission will be accepted or that the U.S.
−Removed: FDA will determine that the vaccine candidate if eligible for grant of accelerated approval.
−Removed: A failure to obtain any planned accelerated approval for our vaccine candidates could result in a longer time period to commercialization for our vaccine candidates, if approved, and could increase the cost of development of our vaccine candidates.
−Removed: If we receive accelerated approval for any of our vaccine candidates, the U.S.
−Removed: FDA may withdraw accelerated approval if, among other things, a confirmatory trial required to verify the predicted clinical benefit of the product fails to verify such benefit or if such trial is not conducted with due diligence.
−Removed: Withdrawal of any accelerated approval could substantially harm our business.
−Removed: Due to the recent change in presidential administration, we face uncertainty regarding potential regulatory developments that may adversely affect our business.
−Removed: Table o f Contents
−Removed: We face uncertainty regarding the potential for changes in the regulatory environment following the change in presidential administration in January 2025.
−Removed: While many of the Trump administration’s proposed policies appear to be focused on deregulation, the new administration and federal government could adopt legislation, regulation, or policy that adversely affects our business or creates a more challenging and costly environment to pursue the development and commercialization of vaccines or other products.
−Removed: For example, the federal government, including the U.S.
−Removed: Department of Health and Human Services, the U.S.
−Removed: FDA, and the Centers for Disease Control and Prevention, may implement legislative, regulatory, or policy changes regarding the standards for approving new or updated vaccines, vaccine safety requirements, recommended immunization schedules for COVID-19 and other vaccinations and other information shared with the public regarding vaccines, vaccine coverage and reimbursement under federal healthcare programs, and manufacturer liability for vaccine-associated injuries.
−Removed: Additionally, because one objective of the current Trump administration appears to be to decrease spending in the federal government, the U.S.
−Removed: FDA could face staff reductions, which could impact the U.S.
−Removed: FDA’s ability to engage in routine regulatory and oversight activities and result in delays or limitations on our ability to proceed with clinical development programs and obtain regulatory approvals.
−Removed: It is difficult to predict how executive actions that may be taken under the current Trump administration may affect the U.S.
−Removed: FDA’s ability to exercise its regulatory authority.
−Removed: If such executive actions impose constraints on the U.S.
−Removed: FDA’s ability to engage in routine oversight and product review activities in the normal course, our business may be negatively impacted.
Because we are subject to environmental, health and safety laws, we may be unable to conduct our business in the most advantageous manner.
13 unchanged sentences
In the event of a lawsuit or investigation, we could be held responsible for any injury we or our collaborators cause to persons or property by exposure to, or release of, any hazardous materials.
−Removed: However, we believe that we are currently in compliance with all material applicable environmental and occupational health and safety regulations.
−Removed: For our product candidates, we will be subject to additional healthcare laws and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.
+Added: For our vaccine candidates, we will be subject to additional healthcare laws and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.
Within the U.S.
−Removed: (and within foreign countries), if we obtain full approval for any of our product candidates and begin commercializing them, our operations may be directly, or indirectly through our arrangements with third-party payors and customers, subject to additional healthcare regulation and enforcement by the federal and state governments (or the regulatory bodies or governments of foreign countries), which may constrain the business or financial arrangements and relationships through which we sell, market and distribute our products.
−Removed: These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive
−Removed: Table o f Contents
−Removed: programs and other business arrangements generally.
+Added: (and within foreign countries), if we obtain full approval for any of our vaccine candidates and begin commercializing them, our operations may be directly, or indirectly through our arrangements with third-party payors and customers, subject to additional healthcare regulation and enforcement by the federal and state governments (or the regulatory bodies or governments of foreign countries), which may constrain the business or financial arrangements and relationships through which we sell, market and distribute our products.
+Added: These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally.
Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.
2 unchanged sentences
• the Federal Food, Drug and Cosmetic Act, which among other things, strictly regulates drug product marketing and promotion and prohibits manufacturers from marketing such products for unapproved uses;
−Removed: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving or providing remuneration, directly or indirectly, to induce the referral for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;
−Removed: • federal false claims laws, including the FCA, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, information or claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;
+Added: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving or providing remuneration, directly or indirectly, to induce the referral for an item or service or the purchase order of a good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid.
+Added: A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
+Added: • federal false claims laws, including the FCA, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, information or claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.
+Added: In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;
• manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims;
1 unchanged sentence
• federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs;
−Removed: • the federal Physician Payment Sunshine Act and its implementing regulations, which require manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the DHHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;
−Removed: effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners;
−Removed: similar reporting requirements have also been enacted on the state level in the U.S., and an increasing number of countries worldwide either have adopted or are considering similar laws requiring disclosure of interactions with health care professionals;
+Added: • the federal Physician Payment Sunshine Act and its implementing regulations, which require manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the DHHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists and chiropractors), certain non-physician providers such as physician assistants and nurse practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;
• the federal law known as HIPAA, which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.
+Added: Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
• federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
• state law equivalents of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state gift ban and transparency laws, many of which state laws differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts;
−Removed: Table o f Contents
• state laws restricting interactions with healthcare providers and other members of the healthcare community or requiring pharmaceutical manufacturers to implement certain compliance standards.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
+Added: It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
+Added: Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs.
+Added: It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
+Added: If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights those actions, our business may be impaired.
If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to, on a corporate or individual basis, penalties, including civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, the exclusion from participation in federal and state healthcare programs and even imprisonment, any of which could materially adversely affect our ability to operate our business and our financial results.
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Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.
−Removed: It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
−Removed: Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs.
−Removed: It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
−Removed: If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights those actions, our business may be impaired.
We are also subject to anti-bribery and anti-corruption laws, including the FCPA, the UK Bribery Act, and other similar worldwide anti-bribery laws, as well as various trade laws and regulations (including economic sanctions, export laws, and customs laws), and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.
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Though we maintain policies, internal controls and other measures reasonably designed to promote compliance with applicable anti-corruption and trade laws and regulations, our employees or agents may nevertheless engage in improper conduct for which we might be held responsible.
−Removed: Any violations of these anti-corruption or trade laws, or even allegations of such violations, can lead to an investigation and/or enforcement action, which
−Removed: Table o f Contents
−Removed: could disrupt our operations, involve significant management distraction, and lead to significant costs and expenses, including legal fees.
+Added: Any violations of these anti-corruption or trade laws, or even allegations of such violations, can lead to an investigation and/or enforcement action, which could disrupt our operations, involve significant management distraction, and lead to significant costs and expenses, including legal fees.
If we, or our employees or agents acting on our behalf, are found to have engaged in practices that violate these laws and regulations, we could be subject to criminal and civil enforcement action, suffer severe fines and penalties, profit disgorgement, injunctions on future conduct, securities litigation, bans on transacting government business, delisting from securities exchanges and other consequences that may have a material adverse effect on our business, financial condition and results of operations.
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Risks Related to our Intellectual Property
−Removed: Our success depends on our ability to maintain the proprietary nature of our technology.
−Removed: Our success in large part depends on our ability to maintain the proprietary nature of our technology and other trade secrets.
+Added: Our success depends on our ability to obtain, maintain, expand, enforce and defend the scope, ownership or control, and validity of intellectual property protections, to maintain the proprietary nature of our technology.
+Added: We rely, and may in the future rely, upon a combination of patent, trade secret and know-how for any of our current and future vaccine candidates, and proprietary technologies to prevent third parties from exploiting our achievements, thus eroding our competitive position in our market.
+Added: These legal measures afford only limited protection, and competitors or others may gain access to or use our intellectual property and proprietary information.
+Added: Our success in large part depends on our ability to obtain, maintain, expand, enforce and defend the scope, ownership or control, and validity of intellectual property, to maintain the proprietary nature of our technology and other trade secrets in the United States and other countries.
To do so, we must prosecute and maintain existing patents, obtain new patents and pursue trade secret and other intellectual property protection.
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To date, no consistent policy has emerged regarding the breadth of biotechnology patent claims that are granted by the U.S.
−Removed: Patent and Trademark Office (“USPTO”) or enforced by the federal courts.
+Added: Patent and Trademark Office (“USPTO”) or similar patent offices in other countries or enforced by the federal courts or agencies in the United States or the courts or administrative bodies in other countries.
Therefore, we do not know whether any particular patent applications will result in the issuance of patents, or that any patents issued to us will provide us with any competitive advantage.
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Furthermore, there is a risk that others will independently develop or duplicate similar technology or products or circumvent the patents issued to us.
+Added: The USPTO and various non-U.S.
+Added: government agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process.
+Added: In addition, the USPTO and various non-U.S.
+Added: government agencies require compliance with certain foreign filing requirements during the patent application process.
+Added: In some circumstances, we are dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual property.
+Added: In some cases, an inadvertent lapse in compliance with these requirements can be cured by payment of a late fee or by other means in accordance with the applicable rules.
+Added: There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application or can be grounds for revoking or invalidating an issued patent, resulting in a partial or complete loss of patent rights in the relevant jurisdiction.
+Added: In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: In addition, we may experience difficulties in enforcing the intellectual property rights in output generated by generative AI Technologies (as defined below).
+Added: The United States Copyright Office has previously denied copyright protection for content generated by AI Technologies, and the United States Patent and Trademark Office has similarly stated that an AI tool cannot be an “inventor” of a patent, rendering it impossible to obtain patent protection for inventions created solely by AI Technologies.
+Added: The Supreme Court of the United Kingdom has reached a similar conclusion, stating that AI systems cannot be named as an “inventor” for UK patent law purposes.
+Added: If we are unable to obtain, maintain, expand, enforce and defend the scope, ownership or control, validity and enforceability of our intellectual property protection, our business, financial condition, results of operations and prospects could be materially harmed.
+Added: If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
+Added: In addition to seeking patent protection for our products, vaccine candidates and proprietary technologies, we may rely on trade secret protection and confidentiality agreements to protect our know-how, technology, and other proprietary information and to maintain our competitive position.
+Added: We seek to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality provisions in agreements with parties who have access to them, such as our employees, licensees, third party collaborators, CROs, contract manufacturers, consultants, advisors and other third parties.
+Added: We also enter into confidentiality and invention or patent assignment agreements with our employees, consultants and advisors.
+Added: Trade secrets and know-how can be difficult to protect.
+Added: We cannot guarantee that we have entered into applicable agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes.
+Added: Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
+Added: Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective.
+Added: We cannot guarantee that any potential trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to trade secrets.
+Added: Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.
+Added: In addition, some courts inside and outside the U.S.
+Added: are less willing or unwilling to protect trade secrets.
+Added: If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we may have no right to prevent them from using that technology or information to compete with us.
+Added: Furthermore, others may independently discover similar trade secrets and proprietary information.
+Added: We may also need to share our trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors.
+Added: As a result, we may encounter significant problems in protecting and defending our intellectual property both in the U.S.
+Added: If any of our trade secrets were to be disclosed or misappropriated or if any such information were to be independently developed by a competitor or other third party, our competitive position could be materially and adversely harmed.
+Added: We may be subject to claims that third parties have an ownership interest in our trade secrets.
+Added: For example, we may have disputes arise from conflicting obligations of our employees, consultants, advisors or others who are involved in our research and development activities or developing our vaccine candidates.
+Added: Litigation may be necessary to defend against these and other claims challenging ownership of our trade secrets.
+Added: If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable trade secret rights, such as exclusive ownership of, or right to use, trade secrets that are important to our vaccine candidates and other proprietary technologies we may develop.
+Added: Such an outcome could have a material adverse effect on our business.
+Added: Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our management and other employees.
+Added: Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: Our former employees, consultants, advisors and collaborators may wrongfully disclose our trade secrets or we may be subject to claims that our employees, consultants, or advisors have misappropriated alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
Although our patent filings include claims covering various features of our vaccine candidates, including composition, methods of manufacture and use, our patents do not provide us with complete protection against the development of competing products.
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To protect our proprietary rights in unpatentable intellectual property and trade secrets, we require employees, consultants, advisors and collaborators to enter into confidentiality agreements.
−Removed: These agreements may not provide meaningful protection for our trade secrets, know-how or other proprietary information, and such risk has been enhanced by the departure of employees in connection with our global restructuring and cost reduction plan.
+Added: These agreements may not provide meaningful protection for our trade secrets, know-
+Added: how or other proprietary information, and such risk has been enhanced by the departure of employees in connection with our global restructuring and cost reduction plan.
+Added: Some of our employees, consultants and advisors are currently or were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
+Added: Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer.
+Added: Litigation may be necessary to defend against these claims.
+Added: If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
+Added: Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our management.
+Added: In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.
+Added: The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property.
+Added: Such claims could have a material adverse effect on our business, financial condition, results of operations and prospects.
+Added: We may not be able to protect our intellectual property and proprietary rights throughout the world.
+Added: Filing, prosecuting, maintaining, enforcing and defending patents on our products and vaccine candidates in all countries throughout the world is expensive, and the laws of foreign countries may not protect our intellectual property rights to the same extent as the laws of the U.S.
+Added: Prosecution of foreign patent applications is often a longer process and patents may grant at a later date, and may have a shorter term, than in the U.S.
+Added: The requirements for patentability differ in certain jurisdictions and countries.
+Added: Additionally, the patent laws of some countries do not afford intellectual property protection to the same extent as the laws of the U.S.
+Added: For example, other countries may impose substantial restrictions on the scope of claims, including limiting patent protection to specifically disclosed embodiments.
+Added: Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our intellectual property in and into the U.S.
+Added: or other jurisdictions.
+Added: Competitors may use our intellectual property in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S.
+Added: These products may compete with our products, and our current or future owned or licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
+Added: Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
+Added: The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our owned or licensed patents or marketing of competing products in violation of our intellectual property and proprietary rights generally.
+Added: In addition, some jurisdictions may have a heightened standard for patentability than in the U.S., including, for example, the requirement of claims having literal support in the original patent filing and the limitation on using supporting data that is not in the original patent filing.
+Added: Under those heightened patentability requirements, we may not be able to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in the U.S.
+Added: and other jurisdictions.
Failure to obtain trademark registrations for proposed product names/brands, in the U.S.
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or in another key international jurisdiction, we may be required to adopt an alternative name for that proposed product.
−Removed: If we adopt an alternative name, we may lose the benefit of any existing trademark applications for such developmental candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the U.S.
−Removed: FDA and other regulatory authorities.
+Added: If we adopt an alternative name, we may lose the benefit of any existing trademark applications for such developmental candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA and other regulatory authorities.
Third parties may claim we infringe their intellectual property rights.
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Further, if a patent or trademark infringement suit were brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the product or biologic drug candidate that is the subject of the suit.
−Removed: Table o f Contents
As a result of patent or trademark infringement claims, or in order to avoid potential claims, we may choose or be required to seek a license from the third party.
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In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover its technology.
−Removed: An adverse determination of any litigation or defense proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at the risk of not issuing.
+Added: An adverse determination of any litigation or defense proceeding could put one or more of our, or our collaborators’ or licensors’, patents at risk of being invalidated or interpreted narrowly and could put our, or our collaborators’ or licensors’, patent applications at the risk of not issuing.
Competitors may infringe our trademarks or the trademarks of collaborators or licensors.
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While we perform inventorship analyses to insure that the correct inventors are listed on our patents, we cannot be certain that a court of competent jurisdiction would arrive at the same conclusions we do.
−Removed: If we are unsuccessful in defending against ownership or inventorship challenges, a court may require us to list additional inventors, may invalidate the patent, or may transfer ownership, or vest joint ownership, of the patent to a third party.
−Removed: Any of these outcomes may harm our ability to exclude competitors and potentially impact our commercial success.
+Added: If we are unsuccessful in defending against
+Added: ownership or inventorship challenges, a court may require us to list additional inventors, may invalidate the patent, or may transfer ownership, or vest joint ownership, of the patent to a third party.
+Added: Any of these outcomes may harm our ability to exclude competitors and potentially impact our success.
Further, if ownership is transferred to a third party we may be required to seek a license to those rights to preserve our exclusive ability to practice the invention.
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If we are unable to obtain a license, we may be required to expend time, effort, and other resources to design around the patent.
−Removed: Any such license may be non-exclusive and if a
−Removed: Table o f Contents
−Removed: competitor is able to obtain a license from the third party, our ability to exclude that competitor from the market may be negatively impacted.
+Added: Any such license may be non-exclusive and if a competitor is able to obtain a license from the third party, our ability to exclude that competitor from the market may be negatively impacted.
Even if we are ultimately successful, defending any such challenges may cause us to incur substantial expenses and may require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
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Even if we are ultimately successful, defending any such challenges may cause us to incur substantial expenses and may require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
−Removed: We may need to license intellectual property from third parties and, if our right to use the intellectual property we license is affected, our ability to develop and commercialize our vaccine candidates may be harmed.
+Added: We may need to license intellectual property from third parties and, if our right to use the intellectual property we license is affected, our ability to develop and outlicense our vaccine candidates may be harmed.
We have in the past, and we expect in the future to license intellectual property from third parties and that these licenses will be material to our business.
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Any of our licenses may be terminated by the licensor if we are in breach of a term or condition of the license agreement, or in certain other circumstances.
−Removed: Further, any disputes regarding obligations in licenses may require us to take expensive and time-consuming legal action to resolve, and, even if we are successful, may delay our ability to commercialize products and generate revenue.
+Added: Further, any disputes regarding obligations in licenses may require us to take expensive and time-consuming legal action to resolve, and, even if we are successful, may delay our ability to outlicense products and generate revenue.
Further, if we are unable to resolve license issues that arise we may lose rights to practice intellectual property that is required to make, use, or sell products.
−Removed: Any such loss could compromise our development and commercialization efforts for current or future product candidates and/or may require additional effort and expense to design around.
+Added: Any such loss could compromise our development and commercialization efforts for current or future vaccine candidates and/or may require additional effort and expense to design around.
Our vaccine candidates and potential vaccine candidates will require several components that may each be the subject of a license agreement.
−Removed: The cumulative license fees and royalties for these components may make the commercialization of these vaccine candidates uneconomical.
−Removed: Table o f Contents
+Added: The cumulative license fees and royalties for these components may make the commercialization efforts of these vaccine candidates uneconomical.
If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries.
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under the Hatch-Waxman Act and similar extensions in foreign countries, our ability to exclude competitors may be harmed.
−Removed: In the U.S., the patent term is 20 years from the earliest U.S.
−Removed: non-provisional filing date.
−Removed: Extensions of patent term may be available under certain circumstances.
−Removed: Depending upon the timing, duration and conditions of U.S.
−Removed: FDA marketing approval of our product candidates, we may be able to extend the term of one patent that covers a marketed product under the Drug Price Competition and Patent Term Restoration Act of 1984, (the “Hatch-Waxman Amendments”) and similar legislation in the European Union and the United Kingdom.
−Removed: The Hatch-Waxman Amendments permit patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the U.S.
−Removed: FDA regulatory review process.
−Removed: We may not receive any extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.
−Removed: Moreover, the length of the extension could be less than we request.
−Removed: If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner.
+Added: Patents have a limited lifespan.
+Added: In the U.S., if all maintenance fees are timely paid, the patent term is generally 20 years from the earliest U.S.
+Added: non-provisional or international patent application filing date.
+Added: Extensions of patent term may be available under certain circumstances, but the life of a patent, and the protection it affords, is limited.
+Added: Given the amount of time required for the development, testing and regulatory review of our vaccine candidates, patents protecting such vaccine candidates might expire before or shortly after such vaccine candidates are commercialized.
+Added: As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
+Added: If we do not have sufficient patent life to protect our products, our business, financial condition, results of operations and prospects will be adversely affected.
+Added: Depending upon the timing, duration and conditions of FDA marketing approval of our vaccine candidates, we may be eligible for a limited extension of the term of one patent that covers a marketed product under the Drug Price Competition and Patent Term Restoration Act of 1984, (the “Hatch-Waxman Amendments”) and similar legislation in the European Union and the United Kingdom.
+Added: The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process.
+Added: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended, and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended.
+Added: We may not be granted an extension for various reasons, including failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy other applicable requirements.
+Added: Moreover, the length of the extension granted could be less than we request.
+Added: In addition, to the extent we wish to pursue patent term extension based on a patent that we in-license from a third party, we may need the cooperation of that third party.
+Added: If we are unable to obtain a patent term extension, or the foreign equivalent, or the term of any
+Added: such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed..
Patent term covering our products may also be extended for time spent during the prosecution of the patent application in the USPTO.
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If we do not prevail under such a challenge, the PTA may be reduced or eliminated, shortening the patent term, which may negatively impact our ability to exclude competitors.
+Added: Intellectual property rights do not necessarily provide protection against all competitive harm to our business.
+Added: The degree of protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage.
+Added: • others may be able to make products that are similar to our product vaccine candidates or utilize similar technology but that are not covered by the claims of the patents that we license or may own;
+Added: • we or our licensors might not have been the first to make the inventions covered by our current or future patents;
+Added: • we or our licensors might not have been the first to file patent applications covering our or their inventions;
+Added: • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
+Added: • our pending and future patent applications that we own or may license may not lead to issued patents;
+Added: • any issued patent that we own or license in the may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties;
+Added: • others may have access to the same intellectual property rights licensed to us in the future on a non-exclusive basis;
+Added: • our competitors or other third parties might conduct research and development activities in countries where we or our licensors do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
+Added: • we may not develop additional proprietary technologies that are patentable;
+Added: • we may fail to identify potential patentable subject matter and/or may fail to file patent applications for such patentable subject matter;
+Added: • the patents or other intellectual property rights of others may restrict our ability to conduct our business;
+Added: • we may choose not to file for patent protection in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property or disclose information resulting in a loss of protection for such trade secret.
+Added: Should any of the foregoing occur, it could adversely affect our business, financial condition, results of operations and prospects.
Risks Related to Employee Matters, Managing Growth and Information Technology
Our business may be adversely affected if we do not successfully execute our business development initiatives.
−Removed: Table o f Contents
−Removed: We anticipate growing through both internal development projects, such as our late-stage pipeline, Matrix-M TM technology and emerging, early-stage pipeline, and external opportunities, such as the entry into strategic alliances and collaborations.
+Added: We anticipate growing through both internal development projects, such as our late-stage pipeline, Matrix-M™ technology and emerging, early-stage pipeline, and external opportunities, such as the entry into strategic alliances and collaborations.
The availability of high quality opportunities is limited, and we may fail to identify candidates that we and our stockholders consider suitable or complete transactions on terms that prove advantageous.
In order to pursue such opportunities, we may require significant additional financing, which may not be available to us on favorable terms, if at all.
−Removed: Strategic transactions involve many risks, including, among others, those related to diversion of management’s attention from other business concerns, unanticipated expenses and liabilities, and increased complexity of our operations, which could prevent us from fully realizing expected synergies.
−Removed: Our announced global restructuring and cost reduction plans may not result in anticipated reductions in combined research and development and selling, general, and administrative expenses and may disrupt our business.
+Added: Strategic transactions involve many risks, including, among others, those related to diversion of management’s attention from
+Added: other business concerns, unanticipated expenses and liabilities, and increased complexity of our operations, which could prevent us from fully realizing expected synergies.
+Added: Our global restructuring and cost reduction plans may disrupt our business.
In May 2023, we announced a global restructuring and cost reduction plan.
−Removed: This plan includes a more focused investment in our COVID-19 commercial program, reduction to our pipeline spending, the continued rationalization of our manufacturing network, a reduction to our global workforce, as well as the consolidation of facilities and infrastructure.
−Removed: The planned workforce reduction includes an approximately 25% reduction in our global workforce, comprised of an approximately 20% reduction in full-time Novavax employees and the remainder comprised of contractors and consultants.
+Added: The planned workforce reduction included an approximately 25% reduction in our global workforce, comprised of an approximately 20% reduction in full-time Novavax employees and the remainder comprised of contractors and consultants.
We realized the full annual impact of the cost savings in 2024.
−Removed: During 2023, we recorded a charge of $4.5 million related to one-time employee severance and benefit costs and $10.1 million of costs related to the consolidation of facilities and infrastructure, the majority of which were incurred in the second quarter of 2023.
Additionally, in January 2024 we announced an additional 12% reduction of our global workforce, comprised of an additional 9% reduction in the Company’s full-time employees and the remainder comprised of contractors and consultants.
−Removed: We expect the full annual impact of the cost savings to be realized in 2025 and approximately 85% of the annual impact, excluding one-time charges, to be realized in 2024 due to timing of implementing the measures and the applicable laws, regulations and other factors in the jurisdictions in which it operates.
We recorded an additional charge of $7.8 million related to one-time employee severance and benefit costs and $102.7 million costs related to the Impairment of long-lived assets during the year ended December 31, 2025.
We may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from these efforts due to unforeseen difficulties, delays or unexpected costs.
−Removed: If we are unable to realize the potential development progress and cost savings from the global restructuring and cost reduction plan, including the reduction to our global workforce, our business strategy, operating results and financial condition would be adversely affected.
Our workforce reductions could yield unanticipated consequences, such as attrition beyond planned workforce reductions or disruptions in our day-to-day operations.
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If we are unable to realize the expected benefits from the restructuring and cost reduction plan, we may decide to undertake additional workforce reductions.
−Removed: Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs.
−Removed: In the ordinary course of our business, we and many of our current and future strategic partners, vendors, contractors, and consultants collect and store sensitive data, including intellectual property, our proprietary business information and data about our clinical participants, suppliers and business partners, including sensitive personally identifiable information.
−Removed: The security of this information is critical to our operations and business strategy.
−Removed: Some of this information represents an attractive target of criminal attack by malicious third parties with a wide range of motives and expertise, including nation-states, organized criminal groups, “hacktivists,” patient groups, disgruntled current or former employees and others.
−Removed: Our ongoing operating activities also depend on functioning information technology systems.
+Added: Security breaches and other disruptions to our IT Systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs.
+Added: We rely on computer systems, hardware, software, technology infrastructure and online sites and networks for both internal and external operations that are critical to our business (collectively, “IT Systems”).
+Added: We own and manage some of these IT Systems but also rely on third parties for a range of IT Systems and related products and services.
+Added: In the ordinary course of our business, we and many of our current and future strategic partners, vendors, contractors, and consultants collect, maintain and process data about customers, employees, business partners and others, including information about individuals, as well as proprietary business information and data about our clinical participants, suppliers and business partners, including sensitive personally identifiable information (collectively, “Confidential Information”).
+Added: We face numerous and evolving cybersecurity risks that threaten the confidentiality, integrity and availability of our IT Systems and Confidential Information, including from diverse threat actors with a wide range of motives and expertise, including nation-states, organized criminal groups, opportunistic hackers and “hacktivists,” patient groups, disgruntled current or former employees and others, as well as through diverse attack vectors, such as social engineering/phishing, malware (including ransomware), malfeasance by insiders, human or technological error, and as a result of malicious code embedded in open-source software, or misconfigurations, bugs or other vulnerabilities in commercial software that is integrated into our (or our suppliers’ or service providers’) IT Systems, products or services..
+Added: Remote and hybrid working arrangements at our company (and at many third-party providers) also increase cybersecurity risks due to the challenges associated with managing remote computing assets and security vulnerabilities that are present in many non-corporate and home networks.
+Added: Additionally, any integration of artificial intelligence in our or any service providers’ operations, products or services is expected to pose new or unknown cybersecurity risks and challenges.
+Added: Our ongoing operating activities also depend on functioning IT Systems.
We are required to expend significant resources in an effort to protect against security incidents, and may be required or choose to spend additional resources or modify our business activities, particularly where required by applicable data privacy and security laws or regulations or industry standards.
−Removed: Cyber attacks are of ever-increasing levels of sophistication and frequency and, despite our security measures, our information technology systems and infrastructure and those of our vendors and partners are not immune to such attacks or breaches.
−Removed: Our development of our COVID-19 Vaccine may result in greater risk of cyber attack.
+Added: Cyberattacks are of ever-increasing levels of sophistication and frequency (and at times involve advanced techniques and tools such as artificial intelligence).
+Added: As a result, we may be unable to detect, investigate, remediate or recover from future attacks or incidents, or to avoid a material adverse impact to our IT Systems, Confidential Information or business.
+Added: Despite our cybersecurity risk management program and processes, including our policies, controls or procedures, our IT Systems and Confidential Information and those of our vendors and partners are not immune to such attacks or breaches.
Any such attack could result in a material compromise of our networks, and the information stored there could be accessed, publicly disclosed, lost, or rendered permanently or temporarily inaccessible.
−Removed: Furthermore, we may not promptly discover a system intrusion.
−Removed: Like other companies in our industry, we have and third parties with connections to our
−Removed: Table o f Contents
−Removed: systems or with data relevant to our business have experienced attacks on our data and systems, including malware and computer viruses.
+Added: Furthermore, given the nature of complex systems, software and services like ours, and the scanning tools that we deploy across our networks and products, we regularly identify and track security vulnerabilities.
+Added: We may not promptly discover a system intrusion and we are unable to comprehensively apply patches or confirm that measures are in place to mitigate all such vulnerabilities, or that patches will be applied before vulnerabilities are exploited by a threat actor.
+Added: Like other companies in our industry, we have and third parties with connections to our systems or with data relevant to our business have experienced attacks on our data and systems, including malware and computer viruses.
Additionally, we partner with sites that store our clinical trial data, and their systems are also subject to the risk of cyberattacks, disruptions, or other security incidents.
Attacks could have a material impact on our business, operations or financial results.
−Removed: Any access, disclosure or other loss of information, whether stored by us or our partners, or other cyberattack causing disruption to our business, including ransomware, could result in reputational, business, and competitive harms, significant costs related to remediation and strengthening our cyber defenses, legal claims or proceedings, governmental investigations, liability including under laws that protect the privacy of personal information, and increased insurance premiums, any of which could have a material adverse effect on our business, operations or financial results.
−Removed: These costs may exceed our insurance.
+Added: Any adverse impact to the availability, integrity or confidentiality of our IT Systems or Confidential Information could result in reputational, business, and competitive harms, significant costs related to remediation and strengthening our cyber defenses, legal claims or proceedings (including class actions), governmental investigations and enforcement actions, fines, penalties, liability including under laws that protect the privacy of personal information, and increased insurance premiums, any of which could have a material adverse effect on our business, operations or financial results.
We also may need to pay a ransom if a “ransomware” infection prevents access or use of our systems and we may face reputational and other harms in addition to the cost of the ransom if an attacker steals certain critical data in the course of such an attack.
+Added: Finally, we cannot guarantee that any costs and liabilities incurred in relation to an attack or incident will be covered by our existing insurance policies or that applicable insurance will be available to us in the future on economically reasonable terms or at all.
Compliance with global privacy and data security requirements could result in additional costs and liabilities or inhibit our ability to collect and process data globally, and our failure to comply with data protection laws and regulations could lead to government enforcement actions, fines, and other harms which would cause our business and reputation to suffer.
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Privacy and data protection laws may be interpreted and applied differently from country to country and may create inconsistent or conflicting requirements, which increases the costs incurred by us in complying with such laws, which may be substantial.
−Removed: For example, the GDPR, which became effective in May 2018, imposes a broad array of requirements for processing personal data, including elevated disclosure requirements regarding collection and use of such data, requirements that companies allow individuals to exercise data protection rights such as their right to obtain copies or demand deletion of personal data held by those companies, limitations on retention of information, and public disclosure of significant data breaches, among other things.
−Removed: The GDPR provides for substantial penalties for non-compliance of up to the greater of €20 million or 4% of global annual revenue for the preceding financial year.
−Removed: From January 1, 2021 the GDPR has been retained in UK, as it forms part of the law of England and Wales, Scotland and Northern Ireland by virtue of section 3 of the European Union (Withdrawal) Act 2018, as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (SI 2019/419) (“UK GDPR”), alongside the UK’s Data Protection Act 2018.
−Removed: The UK GDPR mirrors the fines under the GDPR, i.e., fines up to the greater of €20 million (£17.5 million) or 4% of global turnover.
−Removed: In May 2024, the EU approved a new regulation on AI (the “EU AI Act”), parts of which took effect in late 2024.
−Removed: The EU AI Act is a legal framework that governs the development and deployment of AI in the EU.
−Removed: The framework bans certain uses of AI outright and imposes material obligations on both the providers and deployers of certain other AI activities.
−Removed: Violations are subject to fines, and regulators have powers to remove non-compliant products from the EU market.
−Removed: Our efforts to comply with GDPR, the UK GDPR and other privacy and data protection laws impose significant costs and challenges that are likely to increase over time, and we may be exposed to substantial penalties or litigation related to violations of existing or future data privacy laws and regulations.
−Removed: Furthermore, transferring personal information across international borders is complex and subject to legal and regulatory requirements as well as active litigation and enforcement in a number of jurisdictions around the world, each of which could have an adverse impact on our ability to process and transfer personal data as part of our business operations.
−Removed: For example, the GDPR and UK GDPR impose strict restrictions surrounding the transfer of personal data to countries outside the EEA and the UK The mechanisms that we and many other companies rely upon for European data transfers (for example, Standard Contractual Clauses and the EU - US Data Privacy Framework) are the subject of legal challenge, regulatory interpretation and judicial decisions by the Court of Justice of the European Union.
−Removed: The suitability of Standard Contractual Clauses for data transfer in some scenarios has recently been the subject of legal challenge, and while the United States and the European Union reached agreement on the EU - US Data Privacy Framework, there are legal challenges to that data transfer mechanism as well.
−Removed: We continue to closely monitor for developments related to valid transfer mechanisms available for transferring personal data outside the European Economic Area (including the EU - US Data Privacy Framework) and other countries that have similar trans-border data flow requirements and adjust our practices accordingly.
−Removed: If we are unable to implement a valid compliance mechanism for cross-border personal information transfers, we may face increased exposure to regulatory actions, substantial fines and injunctions against processing or transferring personal information from Europe to the U.S.
−Removed: An inability to import personal information from Europe to the U.S.
−Removed: may significantly and negatively impact our business operations, including by limiting our ability to conduct clinical trials in Europe; limiting our ability to collaborate with contract research organizations, service providers, contractors and other companies subject to the GDPR;
−Removed: or requiring us to increase our data processing capabilities in Europe at significant expense.
−Removed: Several other
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−Removed: countries have also established specific legal requirements for cross-border transfers of personal information and certain countries have also established specific legal requirements for data localization (such as where personal data must remain stored in the country).
+Added: For example, the European Union General Data Protection Regulation (the "EU GDPR") and the United Kingdom General Data Protection Regulation (the “UK GDPR”) (the EU GDPR and UK GDPR together referred to as the “GDPR”),, impose a broad array of requirements for processing personal data, including elevated disclosure requirements regarding collection and use of such data, requirements that companies allow individuals to exercise data protection rights such as their right to obtain copies or demand deletion of personal data held by those companies, limitations on retention of information, and public disclosure of significant data breaches, among other things.
+Added: The GDPR provides for substantial penalties for non-compliance of up to the greater of €20 million / £17.5 million or 4% of global annual revenue for the preceding financial year.
+Added: Furthermore, transferring personal data across international borders is complex and subject to legal and regulatory requirements as well as active litigation and enforcement in a number of jurisdictions around the world, each of which could have an adverse impact on our ability to process and transfer personal data as part of our business operations.
+Added: For example, the EU GDPR and UK GDPR impose strict restrictions surrounding the transfer of personal data to countries outside the EEA and the UK respectively.
+Added: Case law from the Court of Justice of the European Union states that reliance on the standard contractual clauses - a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism - alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis.
+Added: We expect the existing legal complexity and uncertainty regarding international personal data transfers to continue, and international transfers to the United States, China, and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators.
+Added: As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs;
+Added: we may have to make operational changes;
+Added: and/or it could otherwise affect the manner in which we operate our business, and could adversely affect our business, operations and financial condition.
has also enacted the Protecting Americans’ Data from Foreign Adversaries Act of 2024 which establishes new restrictions on transfers of certain personally identifiable sensitive data to foreign adversary countries and entities controlled by a foreign adversary.
−Removed: Similarly, regulations issued pursuant to Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” may restrict data transfers involving countries of concern or covered persons, including the People’s Republic of China (including Hong Kong and Macau), Russia, Iran, North Korea, Cuba, and Venezuela.
+Added: Similarly, in 2024, the National Security Division of the U.S.
+Added: Department of Justice (DOJ) issued a new rule—referred to as the “Data Security Program” (DSP)—to implement Executive Order 14117 aimed at preventing access to “bulk U.S.
+Added: sensitive personal data” and “government-related data” by “countries of concern” (including China, Russia, Iran, North Korea, Cuba, and Venezuela) and “covered persons” (as all such terms are defined in the DSP).
+Added: Effective as of April 8, 2025, and fully enforceable as of July 9, 2025, the DSP imposes stringent obligations on companies within its scope and prohibits or restricts “covered data transactions” that grant countries of concern or covered persons access to bulk U.S.
+Added: sensitive personal data or any amount of government-related data.
+Added: The DSP is new, complex and has yet to be enforced, and as such, there is a risk that our interpretation of its applicability, scope, and requirements is incorrect, incomplete, or misapplied..
If other countries implement more restrictive regulations for cross-border data transfers or do not permit data to leave the country of origin, such developments could adversely impact our business and our enterprise customers’ business, our financial condition and our results of operations in those jurisdictions.
Privacy laws and regulations are also expanding in the U.S.
−Removed: For example, the CCPA requires disclosures to California consumers, imposes rules for collecting or using information about minors and affords consumers abilities, such as the right to know whether their data is sold or disclosed and to whom, the right to request that a company delete their personal information, the right to opt-out of the sale of personal information and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right.
+Added: In the U.S., HIPAA imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable health information.
+Added: Certain states have also adopted other privacy and security laws and regulations that govern the privacy, processing and protection of health-related and other personal information.
+Added: In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA.
+Added: Depending on the facts and circumstances, we could be subject to significant penalties if we violate HIPAA.
+Added: Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners.
+Added: For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act (collectively, the CCPA) requires covered businesses that process the personal information of California residents to, among other things:
+Added: (i) provide certain disclosures to California consumers regarding the business’s collection, use, and disclosure of their personal information;
+Added: (ii) receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt out of certain disclosures of their personal information;
+Added: and (iii) enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf..
Like the GDPR, the CCPA establishes potentially significant penalties for violation.
−Removed: The CCPA also provides a private right of action along with statutory damages for certain data breaches.
−Removed: The California Privacy Rights Act (“CPRA”), which became operational in 2023 and expands on the CCPA, created new consumer rights and protections, including the right to correct personal information, the right to opt out of the use of personal information in automated decision making, the right to opt out of “sharing” consumer’s personal information for cross-context behavioral advertising, and the right to restrict use and disclosure of sensitive personal information.
−Removed: In addition, almost 20 other states have now passed comprehensive privacy laws that have taken effect or will come into effect at various times over the next few years.
−Removed: Several states have passed specific medical and health-data related laws, such as the Washington My Health My Data Act.
−Removed: The Colorado Artificial Intelligence Act, California’s Assembly Bill 2013 on Generative Artificial Intelligence, and other U.S.
−Removed: statutes may also impact our ability to use artificial intelligence, restrict innovations or result in liability for prohibited uses of artificial intelligence technologies.
+Added: In addition, a number of other states have passed similar comprehensive privacy laws that have taken effect, reflecting a trend toward more stringent privacy legislation in the United States.
+Added: We also expect that there will continue to be new laws, regulations and industry standards concerning privacy, data protection and information security proposed and enacted in various jurisdictions, including specific health-data related laws.
+Added: For example, Washington State enacted the Washington My Health My Data Act which broadly defines consumer health data, creates a private right of action to allow individuals to sue for violations of the law, imposes stringent consent requirements and grants consumers certain rights with respect to their health data, including to request deletion of their information.
+Added: Furthermore, the Federal Trade Commission (FTC) and many state Attorneys General continue to enforce federal and state consumer protection laws against companies for online collection, use, dissemination and security practices that appear to be unfair or deceptive.
+Added: In addition, we use artificial intelligence, machine learning and automated decision-making technologies (collectively, “AI Technologies”) in our business.
+Added: The regulatory framework for AI Technologies is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations.
+Added: Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of AI Technologies.
+Added: As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulations.
+Added: It is possible that new laws and regulations will be adopted in the United States and in other non-U.S.
+Added: jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies.
+Added: We may need to expend resources to adjust our products or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions.
+Added: Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI Technologies).
+Added: Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations.
All of these evolving compliance and operational requirements impose significant costs that are likely to increase over time, may require us to modify our data processing practices and policies, divert resources from other initiatives and projects and could restrict the way services involving data are offered, all of which may adversely affect our results of operations.
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State laws are changing rapidly and there is ongoing discussion in Congress of a new federal data protection and privacy law to which we may be subject.
−Removed: We will need to evaluate and update our privacy program to seek to comply with applicable privacy and data security laws, and we expect to incur additional expense in our effort to comply.
−Removed: Such legislation may add additional complexity, variation in requirements, restrictions and potential legal risk, and may require additional investment of resources in compliance programs, impact strategies, reduce the availability of previously useful data and result in increased compliance costs and/or changes in business practices and policies.
+Added: We will need to evaluate and update our privacy program to seek to comply with applicable privacy and data security laws, and we expect to incur additional expenses in our effort to comply.
+Added: Any failure or perceived failure by us to comply with laws, regulations and other requirements relating to the privacy, security and handling of information could result in legal claims or proceedings (including class actions), regulatory investigations or enforcement actions.
Collaborations and contracts of our wholly owned subsidiary Novavax AB with partners such as Sanofi, with regional partners, such as SII, Takeda and SK bioscience, as well as with international providers, expose us to additional risks associated with doing business outside the U.S.
7 unchanged sentences
Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions;
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• new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements;
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We may not be able to attract and retain these individuals on acceptable terms, which could delay our development efforts.
−Removed: Risks Related to Our Convertible Senior Notes
−Removed: Servicing our 5.00% convertible senior unsecured notes due 2027 requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt.
−Removed: In 2022, we issued $175.3 million aggregate principal amount of Notes.
−Removed: Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness, including the Notes, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
−Removed: We do not expect our business to
−Removed: Table o f Contents
−Removed: be able to generate cash flow from operations sufficient to service our debt and make necessary capital expenditures and may therefore be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive.
−Removed: Our ability to refinance our indebtedness, which matures in 2027, unless earlier converted, redeemed, or repurchased, will depend on the capital markets and our financial condition at such time.
+Added: Risks Related to Our Indebtedness
+Added: Servicing our 4.625% Convertible Senior Notes due 2031 and our 5.00% Convertible Secured Notes due 2027 requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt.
+Added: As of December 31, 2025, we had $26.5 million aggregate principal amount of 2027 Notes and $225.0 million aggregate principal amount of 2031 Notes outstanding.
+Added: On February 25, 2026, we entered into a Credit, Security, and Guaranty Agreement (the “Credit Agreement”) and borrowed $50.0 million thereunder.
+Added: We have the ability to incur additional indebtedness under the Credit Agreement, subject to satisfaction of certain conditions.
+Added: Borrowings under the Credit Agreement bear interest at a variable rate based on a floating benchmark rate plus a margin, which exposes us to interest rate volatility which could increase our use of cash to pay interest.
+Added: The term loans under the Credit Agreement mature in 2031 and are interest‑only until maturity, which concentrates principal repayment obligations at maturity.
+Added: The Credit Agreement includes prepayment premiums of up to 3% on certain voluntary repayments, which could increase the cost of refinancing or reducing our indebtedness.
+Added: Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness, including the Notes and borrowing under the Credit Agreement, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
+Added: If we cannot generate cash flow from operations sufficient to service our scheduled debt obligations and make necessary capital expenditures we may need to refinance our debt, sell assets, or obtain additional equity capital on terms that may be onerous or highly dilutive.
+Added: Our ability to refinance our indebtedness at maturity, unless earlier converted, redeemed, repurchased, or repaid, will depend on the capital markets and our financial condition at such time.
We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations, and limit our flexibility in planning for and reacting to changes in our business.
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We cannot assure that we will have sufficient financial resources, or will be able to arrange financing, to pay the fundamental change repurchase price in cash with respect to any Notes surrendered by holders for repurchase upon a fundamental change.
−Removed: In addition, restrictions in our then existing credit facilities or other indebtedness, if any, may not allow us to repurchase the Notes upon a fundamental change.
−Removed: Our failure to repurchase the Notes upon a fundamental change when required would result in an event of default pursuant to the indenture governing the Notes which could, in turn, constitute a default under the terms of our other indebtedness, if any.
−Removed: If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes.
+Added: In addition, restrictions in our Credit Agreement do not allow, and restrictions in any other then existing credit facilities or other indebtedness, if any, may not allow, us to repurchase the Notes upon a fundamental change.
+Added: Our failure to repurchase the Notes upon a fundamental change when required would result in an event of default pursuant to the indenture governing the Notes which could, in turn, constitute a default under the terms of the Credit Agreement and our other indebtedness, if any.
+Added: If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay all of the indebtedness and repurchase the Notes.
+Added: Despite current indebtedness levels, we may incur substantially more indebtedness, which could further exacerbate the risks associated with our indebtedness.
+Added: We may incur significant additional indebtedness in the future.
+Added: If new debt is added to our current indebtedness levels, the related risks that we face could intensify.
+Added: Our Credit Agreement contains restrictions that limit our flexibility in operating our business.
+Added: We entered into a Credit, Security and Guaranty Agreement (the “Credit Agreement”) with MidCap Financial Trust, as administrative agent (“Agent”), and the lenders from time to time party thereto (the “Lenders”).
+Added: The Credit Agreement provides for a senior secured term loan facility of up to $330.0 million, of which $50.0 million was borrowed at closing.
+Added: The Credit Agreement contains various covenants, including covenants regarding minimum cash and royalty revenue amounts, and restrictive covenants that limit our ability to engage in specified types of transactions.
+Added: These covenants limit our ability and the ability of our subsidiaries to, among other things:
+Added: • incur additional indebtedness or liens;
+Added: • make certain investments or acquisitions;
+Added: • make certain restricted payments;
+Added: • enter into affiliate transactions;
+Added: • consolidate, merge, sell assets or engage in change of control transactions,
+Added: in each case subject to customary exceptions and limitations.
+Added: In the event that we breach one or more covenants under the Credit Agreement, the Agent may choose to declare an event of default and require that we immediately repay all amounts outstanding plus accrued interest, and foreclose on the collateral granted to it to secure such indebtedness.
+Added: Such repayment could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Risks Related to Ownership of Our Common Stock
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These broad market fluctuations may cause the market price of our common stock to be lower or more volatile than expected.
−Removed: Furthermore, given the global focus on the COVID-19 pandemic and our investment in developing a COVID-19 vaccine, information in the public arena on this topic, whether or not accurate, has had and will likely continue to have an outsized impact (positive or negative) on our stock price.
+Added: Furthermore, given the current presidential administration’s policies on vaccines, information in the public arena on this topic, whether or not accurate, has had and will likely continue to have an outsized impact (positive or negative) on our stock price.
Information related to our development, manufacturing, regulatory and commercialization efforts with respect to our COVID-19 Vaccine, or information regarding such efforts by competitors with respect to their COVID-19 Vaccines and vaccine candidates, may meaningfully impact our stock price.
6 unchanged sentences
• sale of equity securities or issuance of additional debt;
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• announcement by us of significant strategic partnerships, collaborations, joint ventures, capital commitments or acquisitions;
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They may also have to delay or cancel research and development projects or reduce their overall budgets.
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Provisions of our Second Amended and Restated Certificate of Incorporation and Amended and Restated By-Laws and Delaware law could delay or prevent the acquisition of the Company, even if such acquisition would be beneficial to stockholders, and could impede changes in our Board.
17 unchanged sentences
However, because of uncertainties relating to litigation, the amount of our estimates could be wrong.
−Removed: We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic.
−Removed: Our operations, and those of our clinical research organizations, contract manufacturing organizations, vendors of materials needed in manufacturing, collaboration partners, distributors and other third parties upon whom we depend, could be subject to fires, extreme weather conditions, earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, war, political unrest, sabotage or terrorism and other natural or man-made disasters, as well as public health emergencies, such as the COVID-19 pandemic.
+Added: We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies.
+Added: Our operations, and those of our clinical research organizations, contract manufacturing organizations, vendors of materials needed in manufacturing, collaboration partners, distributors and other third parties upon whom we depend, could be subject to fires, extreme weather conditions, earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, war, political unrest, sabotage or terrorism and other natural or man-made disasters, as well as public health emergencies.
The occurrence of any of these business disruptions could prevent us from using all or a significant portion of our facilities and it may be difficult or impossible for us to continue certain activities for a substantial period of time.
The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event and we may incur substantial expenses and delays as a result.
−Removed: Our ability to manufacture our product candidates and obtain necessary clinical supplies for our product candidates
−Removed: Table o f Contents
−Removed: could be disrupted if the operations of our contract manufacturing organizations or suppliers are affected by a natural or man-made disaster, or a public health emergency.
+Added: Our ability to manufacture our vaccine candidates and obtain necessary clinical supplies for our vaccine candidates could be disrupted if the operations of our contract manufacturing organizations or suppliers are affected by a natural or man-made disaster, or a public health emergency.
We are a target for public scrutiny, and our business may be impacted by unfavorable publicity.
Given that COVID-19 represented an unprecedented urgent public health crisis and that we have received significant funding from the U.S.
−Removed: and foreign governments and other sources to support the development and commercialization of our COVID-19 Vaccine, we have observed and are likely to continue to face significant public attention and scrutiny over the complex decisions we have made and will be making regarding the development, testing, manufacturing, allocation and pricing of our COVID-19 Vaccine.
+Added: and foreign governments and other sources to support the development and commercialization of our COVID-19 Vaccine, we have observed and are likely to continue to face significant public attention and scrutiny over the complex decisions we have made to date.
If we are unable to successfully manage these risks, we could face significant reputational harm, which could negatively affect our stock price.
The intense public interest, including speculation by the media, in the development of our COVID-19 Vaccine has caused significant volatility in our stock price, which we expect to continue as data and other information from our ongoing clinical trials become publicly available.
−Removed: If concerns should arise about the actual or anticipated efficacy or safety of any of our product candidates, such concerns could adversely affect the market’s perception of these candidates, which could lead to a decline in investors’ expectations and a decline in the price of our common stock.
+Added: If concerns should arise about the actual or anticipated efficacy or safety of any of our vaccine candidates, such concerns could adversely affect the market’s perception of these candidates, which could lead to a decline in investors’ expectations and a decline in the price of our common stock.
The increasing use of social media platforms presents new risks and challenges to our business.
3 unchanged sentences
For example, subjects may use social media channels to comment on their experience in an ongoing blinded clinical trial or to report an alleged adverse event.
−Removed: When such events occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our investigational product candidates.
+Added: When such events occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend our business or the public’s legitimate
+Added: interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our vaccine candidates.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social media or networking website.
If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions, or incur reputational or other harm to our business.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.