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To date, we have devoted substantially all of our resources to performing research and development, undertaking preclinical studies, advancing our vaccine candidates through clinical trials, enabling manufacturing activities in support of our product development efforts, acquiring and developing our technology and vaccine candidates, organizing and staffing our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such activities.
−Removed: As an organization, we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization or arrange for a third party to conduct these activities on our behalf.
+Added: As an organization, we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization or arrange for a third party to conduct certain of these activities on our behalf.
Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history.
−Removed: Our current vaccine candidate pipeline includes two clinical and three preclinical programs.
We may encounter unforeseen expenses, difficulties, complications, delays, changes in the regulatory environment, and other known or unknown factors in achieving our business objectives, including with respect to our vaccine candidates.
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If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
−Removed: As of December 31, 2024, we had cash, cash equivalents and investments of $3,134.7 billion.
+Added: As of December 31, 2025, we had cash, cash equivalents and investments of $2,442.6 million.
We believe our existing cash, cash equivalents and investments will fund our current operating plans through at least 12 months from the filing date of this Annual Report on Form 10-K.
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We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements or any combination of these approaches.
−Removed: Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, including higher inflation rates and changes in interest rates and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, including the trading price of common stock, resulting from civil and political unrest in certain countries and regions.
+Added: Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, including higher inflation rates, changes in interest rates and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, including the trading price of common stock, resulting from civil and political unrest in certain countries and regions.
Our future capital requirements will depend on many factors, including:
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Food and Drug Administration (“FDA”) and comparable foreign regulatory authorities, which may require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application;
−Removed: • the costs of establishing additional manufacturing capacity to meet potential incremental supply requirements following the initial commercial launch of VAX-31 if approved;
+Added: • the costs of establishing additional manufacturing capacity to meet potential incremental supply requirements following the initial commercial launches of VAX-31 in the adult population and VAX-31 or VAX-24 in the pediatric population, if approved;
• our ability to set an acceptable price for our product candidates and obtain coverage and adequate reimbursement from third-party payors;
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We could be required to seek collaborators for our vaccine candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, or relinquish or license on unfavorable terms our rights to our vaccine candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.
−Removed: In addition, in February 2025, the National Institutes of Health (“NIH”) announced that it would cap indirect costs for grants at 15%.
−Removed: If we cannot find
−Removed: additional funds to cover the gap created by the new funding gap, we may need to change or terminate our vaccine development program for VAX-GI, which is currently funded in part by grants obtained from the NIH and administered by the University of Maryland, Baltimore.
Due to the significant resources required for the development of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates.
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Our decisions concerning the allocation of research, development, management and financial resources toward particular vaccine candidates may not lead to the development of any viable commercial vaccines and may divert resources away from better opportunities.
−Removed: For example, although we allocated resources for the development of VAX-24 in the adult population through a Phase 1/2 program, we made the determination to suspend further development of VAX-24 for the adult indication because we have chosen to advance exclusively VAX-31 for an adult Phase 3 program following the positive results of the VAX-31 adult Phase 1/2 study.
+Added: For example, although we allocated resources for the development of VAX-24 in the adult population through a Phase 1/2 program, we made the determination to suspend further development of VAX-24 for the adult indication because we chose to advance exclusively VAX-31 for an adult Phase 3 program following the positive results of the VAX-31 adult Phase 1/2 study.
+Added: Additionally, in August 2025, we announced that as part of our continued focus on strategic capital deployment and in order to prioritize our resources towards our PCV franchise, we had paused the advancement, beyond preclinical development, of VAX-GI while remaining confident in its potential and preserving the option to advance the program in the future.
+Added: We also discontinued further development of VAX-PG, a vaccine candidate we were developing for periodontal disease, which demonstrated an acceptable safety profile but not sufficient efficacy signals to warrant further investment.
Similarly, our potential decisions to delay, terminate, license or collaborate with third parties in respect of certain vaccine candidates may subsequently also prove to be less than optimal and could cause us to miss valuable opportunities.
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Our approach to the discovery and development of our vaccine candidates is based on novel technologies that are unproven, which may expose us to unforeseen risks, require us to modify processes, and make it difficult to predict the time and cost of vaccine candidate development and the timing to apply for and obtain regulatory approvals.
−Removed: We are developing a pipeline of vaccine candidates utilizing our cell-free protein synthesis platform, which is comprised of the XpressCF TM platform exclusively licensed from Sutro Biopharma, Inc.
+Added: We are developing a pipeline of vaccine candidates utilizing our cell-free protein synthesis platform, which is comprised of the XpressCF ® platform exclusively licensed from Sutro Biopharma, Inc.
(“Sutro Biopharma”) and our proprietary know-how for vaccine applications against infectious disease.
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Over the course of the development and manufacturing of VAX-24, we previously encountered process-related matters that required us to make adjustments to our processes.
−Removed: For example, we encountered such process-related matters during our drug substance manufacturing campaign for VAX-24 at Lonza, Ltd.
+Added: For example, in 2020 we encountered such process-related matters during our drug substance manufacturing campaign for VAX-24 at Lonza, Ltd.
The cumulative impact of the time required to make adjustments to our processes led to a delay of our drug substance manufacturing campaign due to scheduling conflicts and capacity constraints at Lonza.
There can be no assurance that we or Lonza will be able to successfully manufacture drug substances in a timely manner in the future, or at all.
−Removed: Such process changes and manufacturing delays have caused a change in our Investigational New Drug (“IND”) application timelines in the past and future changes or delays could impact future timelines for VAX-31, VAX-24 or for our other product candidates.
−Removed: In addition, if we encounter similar manufacturing issues after product approval, it will
−Removed: require inspection and approval of the new manufacturing site and submission of a Biologics License Application (“BLA”) supplement, which may further impede or delay commercialization.
+Added: Such process changes and manufacturing delays have caused a change in our Investigational New Drug (“IND”) application timelines in the past and future changes or delays could impact future timelines for
+Added: VAX-31, VAX-24 or for our other product candidates.
+Added: In addition, if we encounter similar manufacturing issues after product approval, it will require inspection and approval of the new manufacturing site and submission of a Biologics License Application (“BLA”) supplement, which may further impede or delay commercialization.
In addition, the preclinical and clinical trial requirements of the FDA, European Medicines Agency (“EMA”) and other regulatory agencies and the criteria these regulators use to determine the safety and immunogenicity or efficacy of a vaccine candidate are determined according to the type, complexity, novelty and intended use and market of the potential products, taking into consideration the benefits and risks for the intended population who will receive the vaccine, as well as the disease(s) to be prevented .
Regulatory agencies also evaluate a sponsor’s data to determine whether the manufacturing and facility information assure product quality and consistency .
−Removed: Approvals by the FDA and EMA for existing pneumococcal vaccines, such as Pfizer Inc.'s (“Pfizer”) Prevnar 13 ® (“PCV13”) and Prevnar 20 ® (“PCV20”), and Merck & Co., Inc.'s (“Merck”) VAXNEUVANCE TM (“PCV15”), Capvaxive TM (“PCV21”) and Pneumovax ® 23 (“PPSV23”), may not be indicative of what these regulators may require for approval of our vaccine candidates.
−Removed: For example, the FDA may challenge our VAX-31 Phase 3 Chemistry, Manufacturing and Controls (“CMC”) strategy, which could cause significant delays or unanticipated costs.
+Added: Approvals by the FDA and EMA for existing pneumococcal vaccines, such as Pfizer Inc.'s (“Pfizer”) Prevnar 13 ® (“PCV13”) and Prevnar 20 ® (“PCV20”), and Merck & Co., Inc.'s (“Merck”) VAXNEUVANCE TM (“PCV15”), Capvaxive ® (“PCV21”) and Pneumovax ® 23 (“PPSV23”), may not be indicative of what these regulators may require for approval of our vaccine candidates.
+Added: For example, in the adult population, these existing pneumococcal vaccines were previously approved based on the establishment of non-inferiority of OPA responses relative to the then current standard of care vaccine(s), on a strain-by-strain basis, where non-inferiority was defined as greater than or equal to 0.50 of the lower limit of the two-sided 95% confidence interval of the OPA geometric mean titer ratio.
+Added: Following discussions with the FDA, the non-inferiority standard in our VAX-31 adult OPUS-1 Phase 3 pivotal, noninferiority trial is set at 0.667.
+Added: The FDA may challenge our VAX-31 Phase 3 Chemistry, Manufacturing and Controls (“CMC”) strategy, which could cause significant delays or unanticipated costs.
Additionally, novel aspects of our vaccine candidates and manufacturing processes may create further challenges in obtaining regulatory approval.
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Moreover, our vaccine candidates may not perform successfully in clinical trials.
−Removed: In addition, leadership of the FDA’s Center for Biologic Evaluation and Research, which oversees vaccine development, is supportive of novel approaches to vaccine development.
−Removed: If that leadership changes, we may face additional hurdles to development or may have to change our approach to meet regulatory expectations.
+Added: Evolving regulatory approaches to vaccine approval decisions may present additional hurdles to development that would necessitate a change to our approach to meet regulatory expectations.
Our vaccine candidates are in clinical or preclinical stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability.
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Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for and successfully commercializing our vaccine candidates, either alone or with third parties, and we cannot guarantee that we will ever obtain regulatory approval for any of our vaccine candidates.
−Removed: We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA.
−Removed: None of our vaccine candidates have been the subject of late-stage or pivotal clinical trials, and we may never be able to obtain marketing approval for any of our product candidates.
+Added: We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA, and we may never be able to obtain marketing approval for any of our product candidates.
Before obtaining regulatory approval for the commercial distribution of our vaccine candidates, we must conduct extensive preclinical studies and clinical trials to demonstrate the safety and immunogenicity or efficacy of our vaccine candidates.
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• varying interpretations of our data by the FDA and comparable foreign regulatory authorities.
−Removed: In addition, changes to the standard-of-care or the approval standards for new vaccines could change the threshold for achievement of non-inferiority using the established surrogate immune endpoints that our PCVs will need to meet in our clinical trials.
+Added: In addition, changes to the standard-of-care or the approval standards for new vaccines have, and could again in the future, change the threshold for achievement of non-inferiority using the established surrogate immune endpoints that our PCVs will need to meet in our clinical trials.
Our inability to complete development of or commercialize our vaccine candidates, or significant delays in doing so due to one or more of these factors, could have a material and adverse effect on our business, financial condition, results of operations and prospects.
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This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our vaccine candidates.
−Removed: Our business is highly dependent on the success of our PCV candidates, VAX-31 and VAX-24, both of which are in clinical development.
−Removed: If we are unable to successfully develop, obtain approval for and effectively commercialize VAX-31 or VAX-24, our business would be significantly harmed.
−Removed: Our business and future success depends on our ability to successfully develop, obtain regulatory approval of, and then commercialize our PCV candidates, which include VAX-31, our 31-valent clinical PCV candidate in development for both the adult and pediatric populations, and VAX-24, our 24-valent clinical PCV candidate in development for the pediatric population.
−Removed: Although VAX-31 has produced positive topline results in a Phase 1/2 clinical study in adults, it may not demonstrate the same results in future adult pivotal Phase 3 studies needed to obtain marketing approval from the FDA or comparable foreign regulatory authorities or in infant clinical studies.
−Removed: In addition, past VAX-24 results in adults may not be indicative of future results in infant clinical trials.
+Added: Our business is highly dependent on the success of our PCV candidates.
+Added: If we are unable to successfully develop, obtain approval for and effectively commercialize our PCV candidates, our business would be significantly harmed.
+Added: Our business and future success depends on our ability to successfully develop, obtain regulatory approval of, and then commercialize our PCV candidates, which include VAX-31, our 31-valent clinical PCV candidate in development for both the adult and pediatric populations, VAX-24, our 24-valent clinical PCV candidate in development for the pediatric population, and VAX-XL, our third-generation PCV candidate designed to provide the broadest coverage of any PCV currently in development.
+Added: Although VAX-31 has produced positive topline results in a Phase 1/2 clinical study in adults, it may not demonstrate the same results in the adult pivotal Phase 3 study needed to obtain marketing approval from the FDA or comparable foreign regulatory authorities or in infant clinical studies.
VAX-31 and VAX-24 will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient clinical and commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales.
−Removed: We cannot provide any assurance that we will be able to successfully advance VAX-31 and VAX-24 through the development process.
+Added: We cannot provide any assurance that we will be able to successfully advance our PCV candidates through the development process.
The clinical and commercial success of VAX-31, VAX-24, and future vaccine candidates will depend on a number of factors, including the following:
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• any changes to the required threshold for the achievement of non-inferiority using established surrogate immune endpoints that our PCVs will need to meet in our clinical trials;
−Removed: • our ability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities the safety and immunogenicity or efficacy and acceptable risk to benefit profile of VAX-31, VAX-24 and any future vaccine candidates;
−Removed: • the pace and prevalence of serotype replacement following the introduction of VAX-31, VAX-24 or other vaccines targeting pneumococcal disease;
+Added: • our ability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities the safety and immunogenicity or efficacy and acceptable risk to benefit profile of our PCV candidates and any future vaccine candidates;
+Added: • the pace and prevalence of serotype replacement following the introduction of our PCV candidates or other vaccines targeting pneumococcal disease;
• any vaccine-vaccine interference studies that may be required, particularly with the standard-of-care pediatric vaccine regimen;
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• achieving, maintaining and, where applicable, ensuring that our third-party contractors achieve and maintain compliance with our contractual obligations and with all regulatory requirements applicable to our lead vaccine candidates or any future vaccine candidates or approved products, if any;
−Removed: • obtaining and maintaining an Advisory Committee on Immunization Practices (“ACIP”) preferred recommendation or comparable foreign regulatory authority’s recommendation of our vaccine candidates and the willingness of physicians, operators of clinics and patients to utilize or adopt any of our future vaccine candidates to prevent or treat age-associated diseases;
+Added: • obtaining and maintaining Advisory Committee on Immunization Practices (“ACIP”), comparable foreign regulatory authority, professional society, or other clinical recommendation of our vaccine candidates and the willingness of physicians, operators of clinics, and patients to utilize or adopt any of our future vaccine candidates to prevent or treat age-associated diseases;
• our ability to successfully develop a commercial strategy and thereafter commercialize our vaccine candidates or any future vaccine candidates in the United States and internationally, if approved for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others;
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Pfizer implemented a similar approach to the development of its 20-valent PCV vaccine candidate, PCV20, which was approved by the FDA in June 2021 for use in adults and in April 2023 for use in infants and children.
−Removed: Pfizer announced in July 2024 and October 2024 that it is developing a 25-valent PCV candidate that is currently in adult and pediatric Phase 2 clinical trials.
−Removed: Pfizer also announced in October 2024 that it is working on a 30-plus valent PCV candidate that is in preclinical development.
+Added: Pfizer announced in 2024 that it is developing a 25-valent PCV candidate ("PCV25") that is currently in adult and pediatric Phase 2 clinical trials, and that it is working on a 30-plus valent PCV candidate that is in preclinical development.
+Added: Pfizer announced in November 2025 that it plans to initiate adult and pediatric pivotal trials evaluating PCV25 in 2026.
Merck received approval for PCV15, its 15-valent PCV, in July 2021 for use in adults and in June 2022 for use in infants and children.
Merck announced in June 2024 that PCV21, its 21-valent PCV, received approval from the FDA for use in adults.
−Removed: In addition, Sanofi and SK Chemicals have partnered to develop a 21-valent PCV and, in June 2023, announced positive results from their Phase 2 clinical trials in infants.
−Removed: In December 2024, Sanofi and SK Chemicals announced the initiation of a global pediatric Phase 3 clinical study of their 21-valent PCV candidate, as well as an expanded agreement to develop, license and commercialize "next-generation" PCVs for both pediatric and adult populations.
−Removed: GSK, which previously acquired Affinivax, is developing a 24-valent affinity-bound pneumococcal vaccine for infants, which is currently in a pediatric Phase 2 clinical trial with data anticipated in 2026 or later.
−Removed: In October 2024, GSK announced they have ceased the development of their 24-valent program in adults in favor of a preclinical 30-plus valent candidate.
+Added: In September 2025, Merck announced positive results from its Phase 3 study evaluating PCV21 in children aged 2–17 with increased risk for pneumococcal disease.
+Added: Merck is also advancing additional next-generation PCV candidates through multiple early-phase clinical studies evaluating different formulations.
+Added: In addition, Sanofi and SK bioscience have partnered to develop a 21-valent PCV and, in June 2023, announced positive results from their Phase 2 clinical trials in infants.
+Added: In December 2024, Sanofi and SK bioscience announced the initiation of a global pediatric Phase 3 clinical program of their 21-valent PCV candidate, as well as an expanded agreement to develop, license and commercialize "next-generation" PCVs for both pediatric and adult populations.
+Added: In February 2026, SK bioscience announced that it expected topline results from this Phase 3 study to be available in 2027, and that a next-generation PCV candidate, also co-developed with Sanofi, was in preclinical development with clinical trial entry expected in 2026.
+Added: GSK, which previously acquired Affinivax, was previously developing a 24‑valent affinity‑bound pneumococcal vaccine candidate in adults and infants.
+Added: In October 2024, GSK announced the termination of their adult 24-valent program in favor of a preclinical 30-plus valent candidate.
+Added: In October 2025, GSK announced the initiation of a Phase 1 study in Australia evaluating its 30-plus valent candidate in adults.
+Added: In the fourth quarter of 2025, GSK removed its pediatric 24-valent candidate, which had previously advanced into a Phase 2 clinical trial program, from its publicly disclosed pipeline.
Many of our competitors have established distribution channels for the commercialization of their vaccine products, whereas we have no such established channels or capabilities.
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While we are designing and developing a manufacturing process that we believe can scale to address clinical and commercial vaccine supply, we do not own or operate any manufacturing facilities.
−Removed: We rely on contract manufacturing organizations (“CMOs”), including our strategic partnership with our contract manufacturer, Lonza, to access resources to facilitate the development and, if approved, commercialization of VAX-31 or VAX-24 and our other vaccine candidates.
+Added: We rely on contract manufacturing organizations (“CMOs”) to access resources to facilitate the development and, if approved, commercialization of VAX-31 or VAX-24 and our other vaccine candidates.
Advancing our vaccine candidates may create significant challenges for our CMOs, including:
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Because no product manufactured on a cell-free manufacturing platform has been approved in the United States, there is no manufacturing facility that has demonstrated the ability to comply with FDA requirements, and, therefore, the timeframe for demonstrating compliance to the FDA’s satisfaction is uncertain.
+Added: Personnel changes at regulatory agencies could impact or delay the timing of pre-approval inspections or the issuance of required authorizations.
Delays in establishing our manufacturing process and ensuring the facilities we utilize for manufacturing comply with cGMP or disruptions in our manufacturing processes, implementation of novel technologies or scale-up activities, may delay or disrupt our development efforts.
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• receiving the U.S.
−Removed: Centers for Disease Control and Prevention (“CDC”) and ACIP recommendations for use, as well as recommendations of comparable foreign regulatory and advisory bodies;
+Added: Centers for Disease Control and Prevention (“CDC”), ACIP, comparable foreign regulatory authority, professional society, or other clinical recommendation for use;
• prevalence and severity of the disease targets for which our vaccine candidates are approved;
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• the effectiveness of our sales and marketing efforts.
−Removed: In the United States, the CDC and ACIP develop vaccine recommendations for both children and adults, as do similar agencies around the world.
+Added: In the United States, the CDC and ACIP develop vaccine recommendations for both children and adults, as do professional societies and similar agencies around the world.
To develop its recommendations, the ACIP forms working groups that gather, analyze and prepare scientific information.
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New pediatric vaccines that receive an ACIP preferred recommendation are almost universally adopted, and adult vaccines that receive a preferred recommendation are widely adopted.
−Removed: For example, in 2014, the ACIP voted to recommend PCV13 for routine use to help protect adults aged 65 years and older against pneumococcal disease, which caused PCV13 to become the standard-of-care along with continued use of PPSV23.
−Removed: The ACIP can also modify its preferred recommendation.
−Removed: For instance, in June 2019, the ACIP voted to revise the pneumococcal vaccination guidelines and recommend PCV13 for adults 65 and older based on the shared clinical decision making of the provider and patient, rather than a preferred use recommendation, which means the decision to vaccinate should be made at the individual level between health care providers and their patients.
−Removed: In October 2021, the ACIP voted to recommend the use of either PCV20, or PCV15 with PPSV23, for routine use in adults aged 65 years and older as well as for those between the ages of 19 and 64 years with certain underlying medical conditions or other risk factors who had not previously received a PCV or whose previous vaccination history was unknown.
−Removed: In June 2022, the ACIP voted to recommend that PCV15 may be used as an option to the then recommended PCV13 for children aged under 19 years according to then recommended PCV13 dosing and schedules.
−Removed: In June 2023, the ACIP voted to recommend the use of PCV20 as an option to PCV15 for routine use in children under the age of two, and as a “catch up” vaccination for healthy children between the ages of 24 and 59 months with incomplete PCV vaccination status and children between the ages of 24 and 71 months with certain underlying conditions and an incomplete PCV vaccination status.
−Removed: Further, the ACIP voted to recommend that children between the ages of two and 18 years with any risk condition who have received all recommended PCV doses before the age of six do not need additional doses if they have received at least one dose of PCV20.
−Removed: If children between the ages of two and 18 years with any risk condition received PCV13 or PCV15, but not PCV20, the ACIP recommend that they should receive a dose of PCV20 or PPSV23.
−Removed: The ACIP also voted to recommend that children between the ages of six and 18 years with any risk condition who have not received any dose of PCV13, PCV15 or PCV20 should receive a single dose of PCV15 or PCV20.
−Removed: When PCV15 is used in this instance, the ACIP recommended that it should be followed by a dose of PPSV23 at least eight weeks later if not previously given.
−Removed: In June 2023, the ACIP also recommended shared clinical decision-making regarding PCV20 use for adults aged 65 years and older who have completed the recommended vaccine series with both PCV13 and PPSV23.
−Removed: In June 2024, the ACIP voted to recommend PCV21 as an option to either PCV20, or PCV15 with PPSV23 for (i) adults aged 65 years and older who have not previously received a PCV or whose previous vaccination history is unknown, (ii) adults between the ages of 19 and 64 with certain underlying medical conditions or other risk factors who have not previously received a PCV or whose previous vaccination history is unknown and (iii) adults aged 19 years and older who have received PCV13 but not all recommended doses of PPSV23.
−Removed: Additionally, the ACIP recommended shared clinical decision-making regarding a supplemental dose of PCV21 for adults aged 65 and older who have completed their vaccine series with both PCV13 and PPSV23.
−Removed: In October 2024, the ACIP voted to recommend lowering the age-based pneumococcal vaccination guidelines for pneumococcal vaccination in adults from 65 years and older to 50 years and older.
−Removed: In line with this recommendation, the ACIP voted to recommend either a dose of PCV20 or PCV21, or PCV15 with PPSV23, for (i) adults aged 50 and older who have not previously received a PCV or whose previous vaccination history is unknown and (ii) adults between the ages of 19 and 49 with certain underlying medical conditions or other risk factors who have not previously received a PCV or whose previous vaccination history is unknown.
−Removed: The membership of the ACIP is influenced by the Department of Health and Human Services (“HHS”).
−Removed: Changes in the ACIP representation could impact the viability of new vaccines receiving a positive recommendation, particularly if there is a change in the federal government’s posture towards vaccines.
−Removed: If our vaccine candidates are approved but fail to receive CDC and ACIP recommendations, or recommendations of other comparable foreign regulatory and advisory bodies, or achieve market acceptance among physicians, healthcare providers, patients, third-party payors or others in the medical community, we will not be able to generate significant revenue.
+Added: Recent changes to federal vaccine policy have introduced new uncertainties regarding the regulatory, legal, and reimbursement landscape for vaccines in the United States.
+Added: Such changes have resulted in the American Academy of Pediatrics and other recommending bodies or organizations to generate their own recommended pediatric vaccine schedule.
+Added: We may need to engage with additional professional societies or organizations to secure access for both adults and infants.
+Added: The ACIP's composition and decisions could influence the pathway for new vaccines to receive a positive recommendation or the impact of a positive recommendation.
+Added: If our vaccine candidates are approved but fail to receive CDC, ACIP, comparable foreign authority, professional society, or other clinical recommendations, or fail to achieve market acceptance among physicians, healthcare providers, patients, third-party payors or others in the medical community, we will not be able to generate significant revenue.
Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.
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The success of our business depends in large part upon our ability to identify, develop and commercialize products based on our cell-free protein synthesis platform.
−Removed: We intend to pursue clinical development of additional vaccine candidates beyond VAX-31 and VAX-24 for IPD, including VAX-A1 for Group A Streptococcus (“Group A Strep”), VAX-PG for periodontitis and VAX-GI for dysentery and shigellosis.
+Added: In addition to our PCV franchise, our pipeline includes preclinical vaccine
+Added: candidates VAX-A1 for Group A Streptococcus (“Group A Strep”) and VAX-GI for dysentery and shigellosis.
Our research programs may fail to identify potential vaccine candidates for clinical development for a number of reasons or we may focus our efforts and resources on potential programs or vaccine candidates that ultimately prove to be successful in a smaller subset of patients than expected or completely unsuccessful.
In addition, we cannot provide any assurance that we will be able to successfully advance any of our existing or future vaccine candidates through the development process.
+Added: For example, we announced in August 2025 that preclinical data for VAX-PG demonstrated an acceptable safety profile
+Added: but not sufficient efficacy signals to support further investment, and we therefore discontinued further development of that
Our potential vaccine candidates may be shown to have harmful side effects, cause allergic reactions, or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval.
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In addition, we believe current PCVs do not provide adequate coverage of the strains currently causing pneumococcal disease or those that previously caused pneumococcal disease.
−Removed: There has been a decrease in the incidence of disease attributable to the strains covered by existing vaccines but an increase in incidence attributable to non-covered strains that now cause most residual disease.
+Added: There has been a decrease in the incidence of disease attributable to the strains covered by existing vaccines but an increase in incidence attributable
+Added: to non-covered strains that now cause most residual disease.
Such change is driven by the void created when strains are taken out of circulation after widespread vaccination, which is a phenomenon known as serotype replacement.
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In addition, because VAX-31 and VAX-24 are our most advanced vaccine candidates, and because our other vaccine candidates are also based on our cell-free protein synthesis platform, if VAX-31 or VAX-24 encounter safety or immunogenicity problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed.
−Removed: We currently rely on third-party manufacturing and supply partners, including Lonza and Sutro Biopharma, to supply raw materials and components for, and the manufacture of, our preclinical and clinical supplies as well as our vaccine candidates.
+Added: We currently rely on third-party manufacturing and supply partners to supply raw materials and components for, and the manufacture of, our preclinical and clinical supplies as well as our vaccine candidates.
Our inability to procure necessary raw materials or to have sufficient quantities of preclinical and clinical supplies or the inability to have our vaccine candidates manufactured, including delays or interruptions at our third-party manufacturers, or our failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
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Over the course of the development and manufacturing of VAX-24, we previously encountered process-related matters that required us to make adjustments to our processes.
−Removed: For example, we encountered such process-related matters during our drug substance manufacturing campaign for VAX-24 at Lonza.
+Added: For example, in 2020 we encountered such process-related matters during our drug substance manufacturing campaign for VAX-24 at Lonza.
The cumulative impact of the time required to make adjustments to our processes led to a delay of our drug substance manufacturing campaign due to scheduling conflicts and capacity constraints at Lonza.
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Such process changes and manufacturing delays have caused a change in our IND timelines in the past and future changes or delays could impact future timelines for VAX-31, VAX-24, or for our other product candidates.
−Removed: Since we utilize a third-party manufacturer, we are also subject to Lonza’s scheduling commitments for its other clients.
+Added: Since we utilize third-party manufacturers, we are also subject to their scheduling commitments for their other clients.
Scheduling conflicts with Lonza’s other clients have contributed to manufacturing delays in the past, and there is no guarantee that future scheduling conflicts or related capacity constraints will not affect our manufacturing campaigns and related timelines.
−Removed: Certain aspects of our manufacturing process for our clinical trial product materials and supplies have also been adversely affected by macroeconomic factors in the past and may in the future be adversely
−Removed: affected by these and numerous other factors, including earthquakes and other natural or man-made disasters, equipment failures, labor shortages, health epidemics, power failures and tariffs.
+Added: Certain aspects of our manufacturing process for our clinical trial product materials and supplies have also been adversely affected by macroeconomic factors in the past and may in the future be adversely affected by these and numerous other factors, including earthquakes and other natural or man-made disasters, economic downturns, equipment failures, labor shortages, health epidemics, power failures and significant changes in trade policies.
The manufacturing process for a vaccine candidate is subject to FDA or comparable foreign regulatory authority review.
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Moreover, we do not control the manufacturing process at our contract manufacturers and are completely dependent on them for compliance with current regulatory requirements.
−Removed: In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves or enter into an agreement with another third party, which we may not be able to do on reasonable terms, if at all.
−Removed: In some cases, the technical skills, raw materials or technology required to manufacture our vaccine candidates may be unique or proprietary to the original manufacturer or supplier, and we may have difficulty applying such skills or technology or sourcing such raw materials ourselves, or in transferring such skills, technology or raw materials to another third party, or such transfer may be subject to certain consent obligations and payment terms to Lonza.
+Added: In the event that any of our manufacturers fail to comply with such requirements or to perform their obligations in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves or enter into an agreement with another third party, which we may not be able to do on reasonable terms, if at all.
+Added: In some cases, the technical skills, raw materials or technology required to manufacture our vaccine candidates may be unique or proprietary to the original manufacturer or supplier, and we may have difficulty applying such skills or technology or sourcing such raw materials ourselves, or in transferring such skills, technology or raw materials to another third party, or such transfer may be subject to certain consent obligations and payment terms to the original
+Added: manufacturer.
These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to enable us, or to have another third party, manufacture our vaccine candidates.
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The delays associated with the verification of a new manufacturer could negatively affect our ability to develop vaccine candidates in a timely manner or within budget.
−Removed: We expect to continue to rely on third-party manufacturers and suppliers, including Lonza, if we receive regulatory approval for any PCV or any other vaccine candidates.
−Removed: For example, in October 2023, we entered into a pre-commercial services and commercial manufacturing supply agreement (the “Commercial Manufacturing and Supply Agreement”) with Lonza, pursuant to which Lonza will (i) construct and build out a dedicated suite (“Suite”) at Lonza’s facilities in Visp, Switzerland to manufacture certain key components (including drug substance) for our proprietary PCV franchise and any other products or intermediates we may choose (collectively, the “Products”), and (ii) maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us, including conducting related quality control and quality assurance operations.
−Removed: Pursuant to the Commercial Manufacturing and Supply Agreement, Lonza will be a preferred, non-exclusive, supplier of the Products to us, and we retain the right to procure the Products from one or more alternate and/or backup manufacturers of the Products (including at our own facilities).
+Added: We expect to continue to rely on third-party manufacturers and suppliers if we receive regulatory approval for any PCV or any other vaccine candidates.
+Added: For example, in October 2023, we entered into a pre-commercial services and commercial manufacturing supply agreement (the “Lonza Commercial Manufacturing and Supply Agreement”) with Lonza, pursuant to which Lonza will (i) construct and build out a dedicated suite (“Suite”) at Lonza’s facilities in Visp, Switzerland to manufacture certain key components (including drug substance) for our proprietary PCV franchise and any other products or intermediates we may choose (collectively, the “Products”), and (ii) maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us, including conducting related quality control and quality assurance operations.
+Added: In September 2025, we also entered into a master services agreement with Patheon Manufacturing Services LLC, part of Thermo Fisher Scientific (collectively, “Thermo Fisher”), pursuant to which Thermo Fisher will commercially manufacture and supply drug product for our PCV candidates, if approved (the “Thermo Fisher Commercial Manufacturing and Supply Agreement”).
To the extent that we have existing, or enter into future, manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance.
−Removed: In December 2019, we exercised our right to require Sutro Biopharma to establish a second supplier for extract and custom reagents to support our anticipated clinical and commercial needs.
−Removed: In December 2022, we entered into an option grant agreement with Sutro Biopharma (the “Option Agreement”).
−Removed: Pursuant to the Option Agreement, we acquired from Sutro Biopharma (i) authorization to enter into an agreement with an independent alternate CMO to directly source Sutro Biopharma’s cell-free extract, allowing us to have direct oversight over financial and operational aspects of the relationship with the CMO;
−Removed: and (ii) a right, but not an obligation, to obtain certain exclusive rights to internally manufacture and/or source extract from certain CMOs and the right to independently develop and make improvements to extract (including the right to make improvements to the extract manufacturing process as well as cell lines) for use in connection with the exploitation of certain vaccine compositions (the “Option”).
−Removed: We and Sutro Biopharma agreed to negotiate the terms and conditions of a form definitive agreement to be entered into in the event we exercise the Option, which would include the terms and conditions set forth in an executed term sheet between us (the “Term Sheet”) and such terms that were necessary to give effect to each of the terms and conditions set forth in the Term Sheet (the “Form Definitive Agreement”).
−Removed: On September 28, 2023, we and Sutro Biopharma mutually agreed in writing upon the Form Definitive Agreement to become effective in the event that we exercise the Option.
−Removed: In November 2023, we exercised the Option and entered into a manufacturing rights agreement (the “Manufacturing Rights Agreement”) with Sutro Biopharma to obtain control over the development and manufacture of cell-free extract.
−Removed: Pursuant to the Manufacturing Rights Agreement, we obtained exclusive rights to independently, or through certain third parties, develop, improve and manufacture cell-free extract for use in connection with our vaccine candidates.
−Removed: If Sutro Biopharma, the independent alternate CMO or the designated third parties are unable to provide a sufficient supply of cell-free extract, our third-party manufacturers may be delayed in their production of intermediate components, which may lead to delays of our drug substance manufacturing campaigns.
+Added: In November 2023, we entered into a manufacturing rights agreement (the “Manufacturing Rights Agreement”) with Sutro Biopharma pursuant to which we obtained exclusive rights to independently, or through certain third parties, develop, improve and manufacture cell-free extract for use in connection with our vaccine candidates.
+Added: If the independent alternate CMO or the designated third parties are unable to provide a sufficient supply of cell-free extract, our third-party manufacturers may be delayed in their production of intermediate components, which may lead to delays of our drug substance manufacturing campaigns.
If we are unable to obtain additional or maintain third-party manufacturing for vaccine candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our vaccine candidates successfully.
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Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
−Removed: In such an event, our clinical trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our vaccine candidates.
+Added: In such an event, our clinical trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order
+Added: us to cease further development of or deny approval of our vaccine candidates.
Such side effects could also affect trial recruitment or the ability of enrolled subjects to complete the clinical trial or result in potential product liability claims.
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Moreover, our success will depend upon physicians prescribing, and their patients being willing to receive, our vaccine candidates in lieu of, or in addition to, existing, more familiar vaccines for which greater clinical data may be available.
−Removed: Changes at the HHS could alter regulators' postures, or the public’s views, toward vaccines.
−Removed: For example, the HHS could disband the ACIP or fill the committee with membership that has a skeptical view of vaccines, change legal protections for vaccine manufacturers, and work with state governments as well as the Centers for Medicare & Medicaid Services (“CMS”) to remove requirements or reimbursement for childhood vaccines.
Increases in negative perceptions of vaccines or the technologies that we rely on by regulators may result in the FDA not approving our products or, if approved, fewer physicians prescribing our products.
−Removed: It also may reduce the willingness of patients to utilize our products or participate in clinical trials for our vaccine candidates.
We may not be able to file IND applications to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
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as a result of a new safety finding that presents unreasonable risk to clinical trial participants;
−Removed: a negative finding from an inspection of our clinical study operations or study sites;
+Added: a negative finding from an inspection of
+Added: our clinical study operations or study sites;
developments on trials conducted by competitors for related technology that raise FDA concerns about risk to patients of the technology broadly;
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• delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our vaccine candidates for use in clinical studies or the inability to do any of the foregoing.
−Removed: For example, based on the positive topline results from the VAX-24 Phase 1/2 proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age, the FDA supported the initiation of a pediatric study in infants.
−Removed: This study could uncover risks in this study population that could have potentially been discovered during a child and/or toddler study, which could then delay or stop the completion of clinical development.
Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue.
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• the risks and disruptions related to patient and physician investigator recruitment and retention and study site initiation and clinical trial activities.
−Removed: Based on our VAX-24 End-of-Phase 2 meeting with the FDA in October 2023, we believe there was agreement with the FDA on the clinical design of the then planned VAX-24 adult Phase 3 program, including the approximate overall number of subjects, the primary and secondary endpoints for the pivotal, non-inferiority study as well as confirmation that immunogenicity analyses would have been sufficient to support licensure and an efficacy study therefore would not have been required.
−Removed: Following the topline results of the VAX-31 Phase 1/2 study in adults 50 and older, we selected VAX-31 to exclusively advance to an adult Phase 3 program.
−Removed: We plan to hold an End-of-Phase 2 meeting for the VAX-31 adult program in advance of commencing a Phase 3 program.
−Removed: However, we believe the FDA position related to the previously discussed VAX-24 adult Phase 3 program will also apply to the VAX-31 adult Phase 3 program.
+Added: Based on our VAX-31 End-of-Phase 2 meeting with the FDA, we believe there is confirmation that the planned immunogenicity analyses are sufficient to support licensure and an efficacy study is therefore not required.
In the event that we are required to conduct any field efficacy studies for VAX-31 or any of our other product candidates, enrollment of a sufficient number of subjects may require additional time and resources given widespread vaccination rates in the United States, particularly in the pediatric population.
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Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.
+Added: Additionally, disclosure of interim topline or preliminary data by us or by our competitors has and may continue to result in volatility in the price of our common stock.
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 and our company in general.
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We have in the past and may in the future seek BTD or Fast Track designation for some of our vaccine candidates.
−Removed: For instance, in August 2022 we announced that the FDA granted Fast Track designation to VAX-24 in adults ages 18 and older and, in January 2023, we announced that the FDA granted a BTD for VAX-24 for the prevention of IPD in adults.
+Added: For instance, in August 2022 we announced that the FDA granted Fast Track designation to VAX-24 in adults ages 18 and older, in January 2023 we announced that the FDA granted a BTD for VAX-24 for the prevention of IPD in adults, in November 2024 we announced that the FDA granted a BTD for VAX-31 for the prevention of IPD in adults, and in August 2025 we announced that the FDA extended the BTD for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae in adults.
A sponsor may seek FDA designation of its vaccine candidate as a breakthrough therapy if the vaccine candidate is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
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The FDA has broad discretion whether or not to grant this designation, so 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.
−Removed: Even when we obtain Fast Track designation for one or more of our vaccine candidates, we may not experience a faster development process, review or approval compared to non-expedited FDA review procedures.
+Added: Even if we obtain Fast Track designation for one or more of our vaccine candidates, we may not experience a faster development process, review or approval compared to non-expedited FDA review procedures.
In addition, the FDA may withdraw Fast Track designation from any of our vaccine candidates that may receive the designation in the future, if it believes that the designation is no longer supported.
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We currently have no sales, marketing or distribution capabilities and as an organization have no experience in marketing products.
−Removed: If we develop an in-house marketing organization and sales force, we will require significant capital expenditures, management resources and time, and we will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.
+Added: If we develop an in-house marketing organization and sales force, we will require significant expenses, management resources and time, and we will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.
If we are unable or decide not to establish internal sales, marketing and distribution capabilities, we will pursue collaborative arrangements regarding the sales and marketing of our products;
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If we are not successful in commercializing our products or any future products, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.
−Removed: A variety of risks associated with potentially conducting research and clinical trials abroad and marketing our vaccine candidates internationally could materially adversely affect our business.
+Added: A variety of risks associated with our current and potential international operations and collaborations could materially adversely affect our business.
As we pursue approval and commercialization for our vaccine candidates overseas and conduct CMC and other operations overseas, we will be subject to additional risks related to operating in foreign countries, including, but not limited to:
• differing regulatory requirements in foreign countries;
−Removed: • tariffs (including tariffs that have been or may in the future be imposed by the U.S.
−Removed: and other countries), trade barriers (including further legislation or actions taken by the U.S.
−Removed: or other countries that restrict trade), trade protection measures, price and exchange controls and other regulatory requirements, as well as protectionist or retaliatory measures taken by the U.S.
−Removed: and other countries;
+Added: • significant changes in trade policies, price and exchange controls and other regulatory requirements;
• increased difficulties in managing the logistics and transportation of storing and shipping vaccine candidates abroad;
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• business interruptions resulting from geopolitical actions, including war and terrorism.
+Added: For example, our agreements with Lonza are denominated in Swiss Franc (“CHF”).
+Added: Fluctuations in the exchange rate for CHF may increase our costs and affect our operating results.
These and other risks associated with our international operations and our collaborations with Lonza, based in Switzerland, may materially adversely affect our ability to attain or maintain profitable operations.
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Our future financial performance and our ability to commercialize our vaccine candidates will depend, in part, on our ability to effectively manage our growth.
−Removed: Our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
+Added: Our management may also have to divert a disproportionate amount of its
+Added: attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our vaccine candidates and, accordingly, may not achieve our research, development, manufacturing and commercialization goals.
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For example, even if the FDA grants marketing approval of a vaccine candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the vaccine candidate in those countries.
−Removed: Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one
−Removed: jurisdiction may not be accepted by regulatory authorities in other jurisdictions.
+Added: Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.
In many jurisdictions outside the United States, a vaccine candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.
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Such decline could adversely affect our revenue over time.
−Removed: If our information technology systems or those of the third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to significant fines or other liability;
+Added: If our information technology systems or those of the third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including, but not limited to, significant fines
+Added: or other liability;
regulatory investigations or actions;
disruptions of our development programs or business operations;
−Removed: harms to our reputation, and other adverse consequences.
+Added: harms to our reputation;
+Added: and other adverse consequences.
In the ordinary course of our business, we and the third parties upon which we rely collect, receive, use, retain, safeguard, disclose, share, transfer, make accessible, dispose of, transmit or otherwise process proprietary, confidential and sensitive information, including personal data (including, key-coded data, health information, data we collect about trial participants in connection with clinical trials and other special categories of personal data), intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other parties, and other sensitive third-party data (collectively, “Sensitive Information”).
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While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.
−Removed: In addition, supply-chain attacks have increased in frequency and
−Removed: severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.
+Added: In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.
Cyberattacks and cybersecurity incidents, system outages, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our Sensitive Information and our information technology systems, and those of the third parties upon which we rely.
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additional reporting requirements and/or oversight;
−Removed: restrictions on
−Removed: processing data (including personal data);
+Added: restrictions on processing data (including personal data);
litigation (including class claims);
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We cannot be sure that our insurance coverage, if any, will be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation, fines, penalties, business loss, data loss, regulatory actions or other materially adverse impacts arising out of our processing activities, privacy and security practices, or security breaches we may experience.
−Removed: The successful assertion of one or more large claims against use that exceeds our available insurance coverage, or results in changes to our insurance policies (including premium increases or the imposition of large excess or deductible or co-insurance requirements), could result in substantial cost increase or prevent us from obtaining insurance on acceptable terms.
+Added: The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes to our insurance policies (including premium increases or the imposition of large excess or deductible or co-insurance requirements), could result in substantial cost increase or prevent us from obtaining insurance on acceptable terms.
Additionally, our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.
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Any such cybersecurity incidents related to our use of AI applications could adversely affect our business and reputation.
−Removed: AI also presents emerging ethical issues, and if our use of AI becomes controversial, we may experience brand or reputational harm, competitive harm, regulatory scrutiny or legal liability.
+Added: AI also presents emerging ethical issues, and if our use of
+Added: AI becomes controversial, we may experience brand or reputational harm, competitive harm, regulatory scrutiny or legal liability.
In addition, use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations.
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In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
−Removed: These laws and
−Removed: regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
+Added: These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
Such misconduct also could involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, creating fraudulent data in our preclinical studies or clinical trials or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation.
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Changes in tax laws or tax rulings could affect our financial position.
−Removed: In December 2017, the Tax Cuts and Jobs Act (“Tax Act”) was signed into law.
−Removed: The Tax Act, among other things, contains significant changes to corporate taxation, including (i) changes to the expensing of research and development expenses for tax years beginning after December 31, 2021, (ii) reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, (iii) limitation of the tax deduction for interest expense to 30% of adjusted earnings (with certain exceptions, including for certain small businesses), (iv) limitation of the deduction for post-2017 net operating losses (“NOL”) to 80% of current-year taxable income and elimination of net operating loss carrybacks for post-2017 NOLs, (v) immediate deductions for certain new investments instead of deductions for depreciation expense over time and (vi) modifying or repealing many business deductions and credits (including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rare diseases or conditions generally referred to as “orphan drugs”).
−Removed: Effective January 1, 2022, we are also subject to mandatory capitalization of Section 174 research and development expenditures.
−Removed: The capitalized expenses are subject to amortization over five and fifteen years for expenses incurred within the U.S.
−Removed: and outside of U.S., respectively.
−Removed: The Infrastructure Investment and Jobs Act was signed on November 15, 2021, and it contained several tax provisions, including changes to the Employee Retention Tax Credit and changes to excise taxes.
−Removed: These provisions do not have a material impact to our current tax provision.
−Removed: In accordance with the 2017 Tax Act, research and experimental (“R&E”) expenses under Internal Revenue Code Section 174 are required to be capitalized beginning in 2022.
−Removed: R&E expenses are required to be amortized over a period of five years for domestic expenses and 15 years for foreign expenses.
−Removed: We have capitalized research and experimental expenditures in our current tax provision as a result.
−Removed: The IRA of 2022 specifically introduces the topic of corporate alternative minimum tax on adjusted financial statement income on applicable corporations for taxable years beginning after December 31, 2022.
−Removed: There is no impact to our current tax provision.
−Removed: The American Rescue Plan Act was signed on March 11, 2021.
−Removed: One of the provisions of the Act included expanding the definition of covered employees subject to IRC 162(m) to include an additional top five highest compensated employees beyond the CEO, CFO and three highest paid officers currently covered under IRC 162(m).
−Removed: This expanded provision is applicable for tax years beginning after December 31, 2026.
−Removed: We do not believe that this update to IRC 162(m) would have a material impact on our income tax provision currently and will continue to monitor this provision.
+Added: On July 4, 2025, the One Big Beautiful Bill Act ("OBBBA") was signed into law in the United States, and contains a wide range of tax reform provisions, including extending and modifying certain key Tax Act provisions, such as 100% bonus depreciation and the business interest expense limitation.
+Added: Additionally, the OBBBA repealed mandatory capitalization and amortization of domestic R&D expenses, reverting to the immediate expensing of R&D expenditures for tax years beginning in 2025.
+Added: Further, the OBBBA provided for an election to deduct the remaining unamortized domestic R&D expense as of December 31, 2024, either entirely in 2025 or over two years, in 2025 and 2026.
+Added: The American Rescue Plan Act (“ARPA”) was signed on March 11, 2021.
+Added: One of the provisions of the ARPA included a modification to the provision limiting the deductibility of executive compensation expense, expanding the definition of covered employees to include the top five highest compensated employees beyond the CEO, CFO and three highest paid officers.
+Added: The provision was further modified by the OBBBA, which made the provision applicable to publicly traded companies and all members of their controlled group (as opposed to members of the affiliated group, as prescribed under prior law).
+Added: All changes are effective for tax years beginning after December 31, 2025.
+Added: While we do not believe that these modifications will have a material impact on our income tax provision currently, we will continue to monitor this provision.
We are unable to predict what tax changes may be enacted in the future or what effect such changes would have on our business, but such changes could affect our effective tax rate and could have an adverse effect on our overall tax position in the future, along with increasing the complexity, burden, and cost of tax compliance.
−Removed: Our ability to utilize our NOL carryforwards and certain other tax attributes may be limited.
+Added: Our ability to utilize our net operating loss ("NOL") carryforwards and certain other tax attributes may be limited.
We have incurred substantial losses since inception and do not expect to become profitable in the near future, if ever.
As of December 31, 2025, we had federal and state NOL carryforwards of $796.1 million and $1,907.7 million, respectively.
−Removed: The federal and state loss carryforwards, except the federal loss carryforward arising in tax years beginning after December 31, 2017, begin to expire in 2034 unless previously utilized.
+Added: federal and state loss carryforwards, except the federal loss carryforward arising in tax years beginning after December 31, 2017, begin to expire in 2034 unless previously utilized.
Federal NOLs arising in tax years beginning after December 31, 2017 have an indefinite carryforward period and do not expire.
As of December 31, 2025, we also had federal and state research credit carryforwards of $40.3 million and $12.3 million, respectively.
−Removed: The federal research and development tax
−Removed: credit carryforwards expire beginning in 2039 unless previously utilized, and the state research and development tax credits can be carried forward indefinitely.
−Removed: In general, under Sections 382 and 383 of the U.S.
−Removed: Internal Revenue Code of 1986, as amended, a corporation that undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a rolling three-year period) is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income.
+Added: The federal research and development tax credit carryforwards expire beginning in 2039 unless previously utilized, and the state research and development tax credits can be carried forward indefinitely.
+Added: In general, a corporation that undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a rolling three-year period) is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income.
We have experienced ownership changes in the past.
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These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our behalf.
−Removed: If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our vaccine candidates.
−Removed: As a result, our financial results and the
−Removed: commercial prospects for our vaccine candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
+Added: If these third parties do not successfully carry out their contractual duties or
+Added: obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our vaccine candidates.
+Added: As a result, our financial results and the commercial prospects for our vaccine candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
If any of our relationships with trial sites or any CRO that we may use in the future terminate, we may not be able to enter into arrangements with alternative trial sites or CROs or do so on commercially reasonable terms.
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As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
−Removed: We rely on third parties, including Sutro Biopharma and Lonza, to supply raw materials and manufacture our preclinical and clinical product supplies of our vaccine candidates, and expect to rely on third parties to supply raw materials and produce and process our vaccine candidates, if approved.
+Added: We rely on third parties to supply raw materials and manufacture our preclinical and clinical product supplies of our vaccine candidates, and expect to rely on third parties to supply raw materials and produce and process our vaccine candidates, if approved.
The loss of these suppliers or their failure to comply with applicable regulatory requirements or provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
We do not have the infrastructure or capability internally to manufacture supplies for our vaccine candidates or the materials necessary to produce our vaccine candidates for use in the conduct of our preclinical studies or clinical trials, and we lack the internal resources and the capability to manufacture any of our vaccine candidates on a preclinical, clinical or commercial scale.
−Removed: We have entered into an agreement with Sutro Biopharma to supply us with extract and custom reagents for use in manufacturing non-clinical and certain clinical supply of vaccine compositions.
−Removed: Pursuant to the Manufacturing Rights Agreement, we obtained exclusive rights to independently, or through certain third parties, develop, improve and manufacture cell-free extract for use in connection with our vaccine candidates.
−Removed: We have engaged Lonza to perform manufacturing process development and clinical manufacture and supply of components for VAX-31 and VAX-24, including the manufacture of polysaccharide antigens, our proprietary eCRM protein carrier and conjugated drug substances.
−Removed: In addition, Lonza is currently in the process of manufacturing certain components of our vaccine candidates on a clinical scale.
−Removed: In October 2023, we and Lonza entered into the Commercial Manufacturing and Supply Agreement pursuant to which Lonza will (i) construct and build out a Suite at Lonza’s facilities in Visp, Switzerland to manufacture the Products, and (ii) maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us.
−Removed: Pursuant to the Commercial Manufacturing and Supply Agreement, Lonza will be a preferred, non-exclusive, supplier of the Products to us, and we retain the right to procure the Products from one or more alternate and/or backup manufacturers of the Products (including at our own facilities).
−Removed: Our agreements with Lonza are denominated in Swiss Francs (“CHF”).
−Removed: Fluctuations in the exchange rate for CHF may increase our costs and affect our operating results.
+Added: Pursuant to the Manufacturing Rights Agreement with Sutro Biopharma, we obtained exclusive rights to independently, or through certain third parties, develop, improve and manufacture cell-free extract for use in connection with our vaccine candidates.
+Added: We have engaged Lonza to perform manufacturing process development and clinical manufacture and supply of components for our PCV candidates.
+Added: Lonza is currently in the process of manufacturing certain components of our vaccine candidates on a clinical scale.
+Added: In addition, we entered into the Lonza Commercial Manufacturing and Supply Agreement pursuant to which Lonza will (i) construct and build out a Suite at Lonza’s facilities in Visp, Switzerland to manufacture the Products, and (ii) maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us.
+Added: In September 2025, we also entered into the Thermo Fisher Commercial Manufacturing and Supply Agreement, pursuant to which Thermo Fisher will commercially manufacture and supply drug product for our PCV candidates, if approved.
We have not yet caused our vaccine candidates to be manufactured on a commercial scale and may not be able to achieve commercial scale manufacturing and may be unable to create an inventory of mass-produced product to satisfy demands for any of our vaccine candidates.
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• Our third-party suppliers and manufacturers might be unable to timely formulate and manufacture or supply raw materials for our vaccine candidates or produce the quantity and quality required to meet our clinical and commercial needs, if any.
−Removed: For example, if Sutro Biopharma, the independent alternate CMO or the designated third parties under the Manufacturing Rights Agreement are unable to provide a sufficient supply of cell-free extract, our third-party manufacturers may be delayed in their production of intermediate components, which may lead to delays of our drug substance manufacturing campaigns.
+Added: For example, if the independent alternate CMO or the designated third parties under the Manufacturing Rights Agreement are unable to provide a sufficient supply of cell-free extract, our third-party manufacturers may be delayed in their production of intermediate components, which may lead to delays of our drug substance manufacturing campaigns.
Additionally, if Lonza is unable to identify a timely or manageable solution for handling cell-free extract during our clinical studies, such studies may be delayed, and we will incur additional costs;
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In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.
−Removed: The development of our product candidates also may be delayed by other events beyond our control.
−Removed: For example, U.S.
−Removed: government actions to limit federal agency budgets or personnel, may result in reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our vaccine candidates.
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We believe our previously reported topline results for VAX-31 support clinical non-inferiority to PCV20, but there can be no assurance that this approach in pivotal studies will be sufficient for regulatory approval.
+Added: The FDA has recently indicated consideration of additional evidentiary standards for certain vaccine approvals, including potential requirements for expanded clinical trials, additional safety data, and additional post-marketing surveillance.
+Added: If applied, these changes may increase the time, cost, and complexity of developing and commercializing our vaccine candidates, and may delay or prevent the approval of new vaccines or updates to existing products.
We may seek Accelerated Approval from the FDA for our vaccine candidates and, if granted, the FDA may require us to perform post-marketing studies as a condition of approval to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoints.
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Raimondo , overturned long-standing precedent regarding the deference courts owe to agencies’ interpretation of ambiguous statutes in their rulemaking.
−Removed: While the impact of the Loper Bright decision on our business and regulatory strategy is unknown, the decision generally may, among other things, increase the frequency of challenges to decisions and rulemaking of health regulators, including FDA determinations of drug approval and market exclusivity and the CMS rules regarding reimbursement, and also impact the speed at which such health regulators make decisions and issue regulations.
+Added: While the impact of the Loper Bright decision on our business and regulatory strategy is unknown, the decision generally may, among other things, increase the frequency of challenges to decisions and rulemaking of health regulators, including FDA determinations of drug approval and market exclusivity and the Centers for Medicare & Medicaid Services ("CMS") rules regarding reimbursement, and also impact the speed at which such health regulators make decisions and issue regulations.
+Added: Changes to federal vaccine recommendations could lower utilization, change reimbursement for our products, and create access challenges because vaccine coverage requirements, including limits on cost-sharing, for nearly all insurers are linked to ACIP and CDC recommendations.These changes may affect the scope of liability protections under the National Vaccine Injury Compensation Program, insurance coverage and reimbursement for certain vaccines, and the requirements for state-level vaccine mandates.
+Added: Ongoing and potential reforms to the federal vaccine injury compensation system, as well as increased state-level divergence from federal recommendations, may further impact our business, operations, and financial condition.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.
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The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic.
−Removed: Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA and the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference product, and will not approve a biosimilar until 12 years after the date of first licensure .
+Added: Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA and the FDA will not accept an application for a biosimilar product based on the reference biological product until four years after the date of first licensure of the reference product, and will not approve a biosimilar until 12 years after the date of first licensure .
These periods of exclusivity can be extended by six months by obtaining pediatric exclusivity.
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In addition, there is a risk that any exclusivity period we receive for any of the vaccine candidates we develop that is approved in the United States as a biological product under a BLA could be shortened due to congressional action or otherwise, or that the FDA will not consider the subject vaccine candidates to be reference products for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated.
−Removed: The FDA has been approving biosimilar products as interchangeable without requiring switching studies, which has allowed biosimilars to be automatically substituted for the reference product upon approval.
+Added: In October 2025, the FDA announced that it will no longer require comparative efficacy studies to establish biosimilarity.
+Added: In addition, although it has not announced a formal policy, the FDA is no longer requiring switching studies for interchangeable products.
+Added: In addition, the FDA’s updated guidance no longer requires an interchangeability statement on labeling.
+Added: The FDA’s more expansive view of interchangeability may allow more biosimilars to be automatically substituted for the reference product upon approval.
Our relationships with customers, physicians and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, health information privacy and security laws and other healthcare laws and regulations.
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Healthcare providers, including physicians and third-party payors, in the United States and elsewhere will play a primary role in the recommendation and prescription of any vaccine candidates for which we obtain marketing approval.
−Removed: Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws.
+Added: Our current and future interactions and arrangements with healthcare professionals, principal investigators, consultants, customers, third-party payors, and patients subject us to various federal and state fraud and abuse laws and other healthcare laws.
These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our vaccine candidates, if approved.
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federal healthcare program, such as Medicare and Medicaid.
−Removed: A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
−Removed: federal civil and criminal false claims laws, including the civil False Claims Act, which can be enforced through civil whistleblower or qui tam actions, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the U.S.
−Removed: federal government, claims for payment or approval 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 U.S.
+Added: The term “remuneration” has been broadly interpreted to include anything of value.A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
+Added: federal civil and criminal false claims laws, including the civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment of government funds, including Medicare and Medicaid, that are false or fraudulent, or 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 U.S.
federal government.
−Removed: Pharmaceutical manufacturers can cause false claims to be presented to the U.S.
+Added: Actions under the civil False Claims Act may be brought by the federal government or as a qui tam or whistleblower action by a private individual in the name of the government.
+Added: Pharmaceutical manufacturers have been investigated and have reached substantial financial settlements under the civil False Claims Act for causing false claims to be presented to the U.S.
federal government by engaging in impermissible marketing practices, such as the off-label promotion of a product for an indication for which it has not received FDA approval.
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HITECH also created tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;
−Removed: • the Federal Food Drug or Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;
−Removed: Physician Payments Sunshine Act and its implementing regulations, which require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the CMS information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as information regarding ownership and investment interests held by the physicians described above and their immediate family members;
+Added: • the Federal Food Drug, and Cosmetic Act and its implementing regulations, which prohibit, among other things, the adulteration or misbranding of drugs, biologics and medical devices;
+Added: Physician Payments Sunshine Act and its implementing regulations, which require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the CMS information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners),
+Added: and teaching hospitals, as well as information regarding ownership and investment interests held by the physicians described above and their immediate family members;
• analogous U.S.
−Removed: state laws and regulations, including:
−Removed: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers;
+Added: state laws and regulations, including state anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs;
state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S.
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federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare.
−Removed: For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”), was passed, which substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S.
+Added: For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care
+Added: and Education Reconciliation Act of 2010 (collectively, the “ACA”), was passed, which substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S.
pharmaceutical industry.
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(v) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
−Removed: (vi) created a Medicare Part D coverage gap discount program;
−Removed: (vii) and established a
−Removed: Center for Medicare & Medicaid Innovation (“CMMI”) at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drugs.
+Added: (vi) created a Medicare Part D coverage gap discount program (now replaced by the IRA);
+Added: and (vii) established a Center for Medicare & Medicaid Innovation (“CMMI”) at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drugs.
There have been executive, judicial and Congressional efforts to repeal, substantially modify or invalidate some or all of the provisions of the ACA, some of which have been successful.
−Removed: For example, the Tax Act included a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, which is commonly referred to as the “individual mandate.” On June 17, 2021, the United States Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.
−Removed: More recently, a challenge to the ACA is advancing in federal courts.
+Added: For example, the Tax Act included a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, which is commonly referred to as the “individual mandate.” On June 17, 2021, the U.S.
+Added: Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.
Other legislative changes also have been proposed and adopted in the United States since the ACA was enacted.
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Further, in the United States, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug and biological product pricing, reduce the cost of prescription drugs and biological products under government payor programs and review the relationship between pricing and manufacturer patient programs.
−Removed: For example, the IRA, among other things, (i) enables the HHS to assert control over the prices of certain single-source drugs and biologics covered under Medicare, (ii) subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, (iii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and (iv) redesigns the funding and benefit structure of the Medicare Part D program, potentially increasing manufacturer liability while capping annual out-of-pocket drug expenses for Medicare beneficiaries.
+Added: For example, the IRA, among other things, (i) enables the Department of Health and Human Services (“HHS”) to assert control over the prices of certain single-source drugs and biologics covered under Medicare, (ii) subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, (iii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and (iv) redesigns the funding and benefit structure of the Medicare Part D program, potentially increasing manufacturer liability while capping annual out-of-pocket drug expenses for Medicare beneficiaries.
The IRA also eliminates patient cost sharing for FDA-approved adult vaccines that are recommended by the ACIP and covered under Medicare Part D, and mandates that all state Medicaid programs cover FDA-approved adult vaccines that are recommended by the ACIP and their administration without cost sharing.
−Removed: In addition, in January 2025, the HHS announced the list of 15 drugs that will be subject to the second round of price negotiations.
−Removed: The IRA is currently subject to legal challenges and it is unclear how the IRA will be effectuated or changed under the current U.S.
−Removed: administration.
+Added: In addition, in January 2026, the HHS announced the list of 15 drugs that will be subject to the third round of price negotiations.
+Added: The IRA is currently subject to legal challenges, and it is unclear how the IRA will be effectuated or changed in the future.
However, the IRA does not change either the CDC’s Vaccines for Children program (“VFC") or the provisions added in 2010 under the ACA.
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Further, many vaccines are excluded from Medicare Part B rebate requirements.
−Removed: Additional action has been taken to limit or change healthcare policies pursued by the Biden administration.
−Removed: For example, an executive order issued by former President Biden was recently rescinded, pursuant to which the CMMI created three drug pricing experiments, and it is unclear whether the CMMI will continue to pursue some or any of these models.
−Removed: Likewise, it remains unclear whether the current U.S.
−Removed: administration will continue an initiative announced by the Biden administration to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act.
−Removed: At the state level, legislatures and regulatory agencies have increasingly passed legislation and implemented regulations designed to control drug pricing, including restrictions on pricing or reimbursement at the state government level, limitations on discounts to patients, advance notices of price increases, marketing cost disclosure and transparency measures, and, in some cases, policies to encourage importation from other countries (subject to federal approval) and bulk purchasing.
+Added: Additional action has been taken to change healthcare policies.
+Added: For example, the federal government has shown substantial interest in taking a variety of measures aimed at lowering U.S.
+Added: prescription drug prices to align with the lowest prices available for the same drugs in comparable developed nations (so called “most favored nation” pricing), including through CMMI models.
+Added: At the state level, legislatures and regulatory agencies have increasingly passed legislation and implemented regulations designed to control drug pricing, including restrictions on pricing or reimbursement at the state government level, limitations on discounts to patients, advance notices of price increases, marketing cost disclosure and transparency
+Added: measures, and, in some cases, policies to encourage importation from other countries (subject to federal approval) and bulk purchasing.
+Added: The OBBBA will also reduce funds for Medicaid programs, which are administered by the states.
We expect that additional U.S.
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The adoption of cost containment measures or other healthcare reforms, and our associated compliance obligations, may prevent us from being able to generate revenue, attain profitability or commercialize any product candidates, if approved.
−Removed: Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
−Removed: The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels for critical departments, payment of user fees and reauthorization of user fee programs, ability to hire and retain key personnel involved in the review of sponsor applications, as well as statutory, regulatory and policy changes.
−Removed: In addition, funding of other government agencies that support research and development activities relevant to FDA review, such as research to understand new technologies or establish new standards, is subject to the political process, which is inherently fluid and unpredictable.
−Removed: If the federal government implements efforts to downsize critical departments involved in the review of sponsor applications;
−Removed: removes job elimination protections for federal workers necessary to these activities;
−Removed: limits certain communications;
−Removed: changes the user fee reauthorization process or fails to reauthorize user fee programs;
−Removed: or cuts teams critical to the FDA’s ability to conduct regular inspections, reviews, or other regulatory activities, the FDA’s ability to timely review our regulatory submissions could be affected.
−Removed: This, in turn, could delay the development and regulatory approval of new products and related services and have a material adverse effect on our business.
−Removed: We are increasingly subject to stringent and rapidly changing U.S.
−Removed: and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to privacy and data security.
+Added: The development, review and approval of our product candidates are subject to the operational capacity, processes and resource levels of regulatory authorities, which may fluctuate over time and could delay or adversely affect our business.
+Added: The ability of the FDA to review and approve new products can be affected by a variety of factors, including budget and funding levels for critical departments, payment of user fees and reauthorization of user fee programs, staffing levels, retention of key personnel, as well as statutory, regulatory and policy changes.
+Added: In addition, funding of other government agencies that support research and development activities relevant to FDA review, such as research to understand new technologies or establish new standards, may also fluctuate over time.
+Added: Changes in policies or actions that impact the funding, staffing, or operations of regulatory agencies, including changes to the user fee reauthorization process or a failure to reauthorize user fee programs in a timely manner, could lead to changes in review periods or response times.
+Added: This, in turn, could affect the development and regulatory timelines for approval of new products and related services and have a material adverse effect on our business.
+Added: We are subject to stringent and rapidly changing laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to privacy and data security.
The obligations and restrictions imposed by these requirements can lead to substantial related implementation costs.
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In the United States, federal, state, and local governments have enacted numerous data privacy and data security laws beyond HIPAA and other healthcare privacy laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws).
−Removed: For example, the CCPA imposes obligations on covered businesses, including but not limited to, providing specific disclosures in privacy notices and affording California residents certain rights related to their personal data.
+Added: For example, the CCPA imposes obligations on covered businesses, including, but not limited to, providing specific
+Added: disclosures in privacy notices and affording California residents certain rights related to their personal data.
In addition, the CPRA expanded the CCPA’s requirements, including by adding new rights allowing individuals to opt out of the sharing (as defined under the CCPA) of and correct their personal data and limit the use and disclosure of their sensitive personal data, as well as by establishing a new California Privacy Protection Agency to implement and enforce, alongside the California Attorney General, the CCPA.
−Removed: states have also recently enacted comprehensive data privacy laws—including Virginia, Connecticut, Utah, Colorado, Delaware, Indiana, Iowa, Kentucky, Montana, New Hampshire, New Jersey, Oregon, Tennessee, and Texas—and other local, state, and federal laws are currently under consideration.
+Added: states have also recently enacted comprehensive data privacy laws —including Virginia, Connecticut, Utah, Colorado, Delaware, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, New Hampshire, New Jersey, Nebraska, Oregon, Rhode Island, Tennessee, and Texas — and other local, state, and federal laws are currently under consideration.
Certain states also impose stricter requirements, such as conducting data privacy impact assessments, for processing certain personal data, including sensitive information.
These state laws allow for statutory fines for noncompliance.
−Removed: the CCPA allows for fines of up to $7,500 per intentional violation and allows for private litigants affected by certain data breaches to recover significant statutory damages.
+Added: For example, the CCPA allows for fines of up to $7,500 per intentional violation and allows for private litigants affected by certain data breaches to recover significant statutory damages.
While these states, like the CCPA, also exempt some data processed in the context of clinical trials, these developments further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon which we rely.
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Moreover, despite our efforts, our personnel or third parties upon which we rely may fail (or be perceived to have failed) to comply with such obligations, which could negatively impact our business operations and compliance posture.
−Removed: If we or the third parties on which we rely fail, or are perceived to have failed, to address or comply with data privacy and security obligations, we could face significant consequences.
+Added: If we or the third parties on which we rely fail, or are perceived to have failed, to address or
+Added: comply with data privacy and security obligations, we could face significant consequences.
These consequences may include, but are not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar);
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loss of customers;
−Removed: interruptions or
−Removed: stoppages in our business operations (including clinical trials);
+Added: interruptions or stoppages in our business operations (including clinical trials);
inability to process personal data or to operate in certain jurisdictions;
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We rely upon a combination of patents, trademarks, trade secret protection and confidentiality agreements to protect the intellectual property related to our vaccine development programs and vaccine candidates.
−Removed: Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to VAX-31, VAX-24 and any future vaccine candidates, as well as methods of making our vaccine candidates and components thereof.
+Added: Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our PCV candidates and any future vaccine candidates, as well as methods of making our vaccine candidates and components thereof.
We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our development programs and vaccine candidates.
The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.
−Removed: The patents and patent applications that we own or in-license may fail to result in issued patents with claims that protect VAX-31, VAX-24 or any future vaccine candidate in the United States or in other foreign countries.
+Added: The patents and patent applications that we own or in-license may fail to result in issued patents with claims that protect our PCV candidates or any future vaccine candidate in the United States or in other foreign countries.
There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application, or be used to invalidate a patent.
−Removed: Even if patents do successfully issue and even if such patents cover VAX-31, VAX-24 or any future vaccine candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable.
+Added: Even if patents do successfully issue and even if such patents cover our PCV candidates or any future vaccine candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable.
Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any vaccine candidates or companion diagnostic that we may develop.
Further, if we encounter delays in regulatory approvals, the period during which we could market a vaccine candidate under patent protection could be reduced.
−Removed: If the patent applications we hold or have in-licensed with respect to our development programs and vaccine candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for VAX-31, VAX-24 or any future vaccine candidate, it could dissuade companies from collaborating with us to develop vaccine candidates and threaten our ability to commercialize future vaccines.
+Added: If the patent applications we hold or have in-licensed with respect to our development programs and vaccine candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our PCV candidates or any future vaccine candidate, it could dissuade companies from collaborating with us to develop vaccine candidates and threaten our ability to commercialize future vaccines.
Any such outcome could have a materially adverse effect on our business.
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Patent and Trademark Office (“USPTO”) or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others.
−Removed: The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain.
+Added: The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the
+Added: outcome can be uncertain.
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
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The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad.
−Removed: Such challenges may
−Removed: result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
+Added: Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date.
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If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our vaccine candidates.
−Removed: We have licensed certain intellectual property rights related to the XpressCF TM platform, components of our PCV candidates, and methods of making components of VAX-31 or VAX-24 from Sutro Biopharma and University of Georgia Research Foundation, Inc.
+Added: We have licensed certain intellectual property rights related to the XpressCF ® platform, components of our PCV candidates, and methods of making components of our PCV candidates from Sutro Biopharma and University of Georgia Research Foundation, Inc.
We also license certain intellectual property rights related to a non-cross-reactive Group A Strep carbohydrate antigen and related methods of production from the Regents of the University of California.
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Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
−Removed: If we or our licensors fail to maintain the patents and patent applications covering VAX-31, VAX-24 or any future vaccine candidate, or the XpressCF TM platform, our competitors might be able to enter the market, which would have an adverse effect on our business.
−Removed: Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development, manufacturing and commercialization of VAX-31 or VAX-24 and any future vaccine candidate.
+Added: If we or our licensors fail to maintain the patents and patent applications covering our PCV candidates or any future vaccine candidate, or the XpressCF ® platform, our competitors might be able to enter the market, which would have an adverse effect on our business.
+Added: Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development, manufacturing and commercialization of our PCV candidates and any future vaccine candidate.
Our commercial success depends in part on our avoiding infringement and other violations of the patents and proprietary rights of third parties.
−Removed: There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation and administrative law proceedings, inter partes review and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions.
+Added: There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent
+Added: infringement lawsuits, interferences, derivation and administrative law proceedings, inter partes review and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions.
Numerous U.S.
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Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation.
−Removed: The outcome following legal assertions of invalidity and unenforceability is unpredictable.
+Added: outcome following legal assertions of invalidity and unenforceability is unpredictable.
We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution.
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We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.
−Removed: Our business could be harmed if in
−Removed: litigation the prevailing party does not offer us a license on commercially reasonable terms.
+Added: Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms.
Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.
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Risks Related to Ownership of Our Common Stock
−Removed: The price of our stock may be volatile, and the value of our common stock may decline.
−Removed: The market price of our common stock may be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume.
−Removed: In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, these factors include, but are not limited to:
+Added: The price of our stock has been and may continue to be volatile, and the value of our common stock has and may continue to decline, any of which could result in substantial losses for investors.
+Added: The market price of our common stock has been and may continue to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume.
+Added: addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, these factors include, but are not limited to:
• the commencement, enrollment or results of our planned or future preclinical studies or clinical trials of our vaccine candidates and those of our competitors;
−Removed: • regulatory or legal developments in the United States and abroad, including as a result of the change in the U.S.
−Removed: administration in 2025;
+Added: • regulatory, recommending body or legal developments in the United States and abroad;
• the success of competitive vaccines or technologies;
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• changes in the structure of healthcare payment systems, including coverage and adequate reimbursement for any approved vaccine;
−Removed: • general economic, political and market conditions, including high inflation rates, bank failures, changes in interest rates, government tapering policies and the conflicts in Ukraine and the Middle East, tariffs, and overall fluctuations in the financial markets in the United States and abroad;
+Added: • general economic, political and market conditions, including high inflation rates, bank failures, changes in interest rates, government tapering policies and the conflicts in Ukraine and the Middle East, significant changes in trade policies, and overall fluctuations in the financial markets in the United States and abroad;
• investors’ general perception of us and our business.
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Expectations relating to environmental, social and governance programs may impose additional costs and expose us to new risks.
−Removed: There is an increasing focus from certain investors and other key stakeholders concerning corporate responsibility, specifically related to environmental, social and governance (“ESG”) factors, and new ESG laws and regulations are expanding mandatory disclosure, reporting and diligence requirements.
−Removed: As a result, there is an increased emphasis on corporate responsibility ratings and a number of third parties provide reports on companies in order to measure and assess corporate responsibility performance.
+Added: The focus of certain investors and other key stakeholders concerning corporate responsibility, specifically related to environmental, social and governance (“ESG”) factors has been changing, and ESG laws and regulations regarding disclosure, reporting and diligence requirements continue to evolve.
+Added: Some parties have placed an increased emphasis on corporate responsibility ratings and a number of third parties provide reports on companies in order to measure and assess corporate responsibility performance.
In addition, the ESG factors by which companies’ corporate responsibility practices are assessed may change, which could result in greater expectations of us and cause us to undertake costly initiatives to satisfy such new criteria.
Alternatively, if we are unable to satisfy such new criteria, investors may conclude that our policies with respect to corporate responsibility are inadequate.
+Added: On the other hand, state attorneys general and other governmental authorities may take action against certain ESG policies or practices.
We risk damage to our brand and reputation if our corporate responsibility procedures or standards do not meet the standards set by various constituencies or comply with new laws and regulations or changes to legal or regulatory requirements concerning ESG.
−Removed: We may be required to make investments in matters related to ESG, which could be significant and adversely impact our results of operations.
−Removed: Furthermore, if our competitors’ corporate responsibility performance is perceived to be greater than ours, potential or current investors may elect to invest with our competitors instead.
+Added: We may be required to make investments to comply with various ESG and anti-ESG practices and regulations, which could be significant and adversely impact our results of operations.
+Added: Furthermore, if our competitors’ corporate responsibility
+Added: performance is perceived to be greater than ours, potential or current investors may elect to invest with our competitors instead.
In addition, if we communicate certain initiatives and goals regarding ESG matters, we could fail, or be perceived to fail, in our achievement of such initiatives or goals, or we could be criticized for the scope of such initiatives or goals.
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Our amended and restated bylaws provide that we are required to indemnify our directors and officers to the fullest extent permitted by Delaware law and may indemnify our other employees and agents.
−Removed: Our amended and restated bylaws also provide that, on satisfaction of certain conditions, we will advance expenses incurred by a director or officer in advance of the final disposition of any action or proceeding, and permit us to secure insurance on behalf of any officer, director,
−Removed: employee or other agent for any liability arising out of his or her actions in that capacity regardless of whether we would otherwise be permitted to indemnify him or her under the provisions of Delaware law.
+Added: Our amended and restated bylaws also provide that, on satisfaction of certain conditions, we will advance expenses incurred by a director or officer in advance of the final disposition of any action or proceeding, and permit us to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in that capacity regardless of whether we would otherwise be permitted to indemnify him or her under the provisions of Delaware law.
We have entered and expect to continue to enter into agreements to indemnify our directors and executive officers.
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We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements, including through the use of our “at-the-market” facility.
−Removed: To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will
−Removed: be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
+Added: To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
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Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
−Removed: The global credit and financial markets have experienced extreme volatility and disruptions in the past several years, including as a result worsening global economic conditions, including higher inflation rates and changes in interest rates, and civil and political unrest in certain countries and regions.
+Added: The global credit and financial markets have experienced extreme volatility and disruptions, including as a result worsening global economic conditions, including higher inflation rates and changes in interest rates, and civil and political unrest in certain countries and regions.
Such volatility and disruptions have caused and may continue to cause severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.
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If one or any of the financial institutions in which we hold our funds for working capital and operating expense needs were to fail, we cannot provide any assurances that such governmental agencies would take action to protect our uninsured deposits in a similar manner.
+Added: Significant changes and volatility in trade policies could materially affect our business, financial condition, liquidity and results of operations, and stock price.
+Added: International trade policies are subject to periodic revision and may change in response to economic, geopolitical or national security considerations.
+Added: government and certain foreign governments have recently announced new or increased tariffs on imported goods, and additional tariffs or increases in tariffs could be assessed in the future.
+Added: Pharmaceuticals have historically been exempt from tariffs and have, thus far, been exempt from recently imposed tariffs.
+Added: However, the government has recently launched an investigation under Section 232 of the Trade Expansion Act of 1962 to determine the effects on national security of imports of pharmaceuticals and pharmaceutical ingredients, and their derivative products.
+Added: This investigation is intended to cover both finished generic and branded drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients and key starting materials, and derivative products of those items.
+Added: It is possible that this investigation will result in the imposition of tariffs on a range of pharmaceutical products and ingredients, in ways that negatively impact certain aspects of our manufacturing process for our clinical trial product materials and supplies, the level of expenses related to our vaccine candidates or preclinical and clinical development programs, and our business.
+Added: We rely on third-party manufacturers with global operations, so our business may be impacted by tariffs.
+Added: We do not sell
+Added: any commercial products nor do we expect to do so in the immediate future, so we cannot pass on the increased costs from
+Added: the tariffs to customers.
+Added: Therefore, we will need to absorb any increased costs, which will put further financial strain on our
Our financial condition and results of operations may fluctuate from quarter to quarter and year to year, which makes them difficult to predict.
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We are currently in the process of hiring additional accounting and finance staff as we grow our business.
−Removed: If we are unable to hire the additional accounting
−Removed: and finance staff necessary to comply with these requirements, we may need to retain additional outside consultants.
+Added: If we are unable to hire the additional accounting and finance staff necessary to comply with these requirements, we may need to retain additional outside consultants.
If we or, if required, our auditors, are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
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We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
−Removed: We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
+Added: We believe that any
+Added: disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
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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.