Vaxart Conference Call Summary Company Overview - **Company**: Vaxart - **Industry**: Biotechnology, specifically focusing on oral vaccine development Key Developments - **Acquisition**: Sanofi acquired Dynavax, Vaxart's partner, in February 2026, which is expected to enhance collaboration on the oral COVID-19 vaccine program [4][6] - **Cash Runway**: Vaxart has a cash runway extending into the second quarter of 2027, allowing for continued operations without immediate need for capital raising [4][20] - **Clinical Trials**: The company is prioritizing the execution of its Phase 2B COVID-19 trial, with expected top-line data from a 400-participant cohort in early Q2 2026 [5][28] Clinical Programs - **COVID-19 Vaccine**: - Collaboration with BARDA for funding the Phase 2B trial [8] - A $50 million milestone payment is contingent upon advancing to Phase 3 after Phase 2B results [9][28] - **Norovirus Program**: - The start of the Phase 2B trial is contingent on securing a strategic partnership or non-dilutive funding [11][12] - Positive results from a study on lactating mothers suggest potential for mucosal immunity transfer to infants [12][41] - **Avian Influenza**: - Completed primary analysis showing 100% protection in a ferret model, with plans to publish results in a peer-reviewed journal [33] Financial Management - **Cost Management**: - Recent lease termination expected to save over $1 million annually [31] - Headcount reduced from 105 in 2024 to 65 in 2025, allowing for consolidation of operations [74] - **Funding Strategy**: - Preference for non-dilutive funding through partnerships, but open to other financing options if necessary [21][50] Market Position and Strategy - **Competitive Advantage**: - Vaxart's oral vaccine platform addresses vaccine fatigue and needle hesitancy, positioning it uniquely in the market [25] - Global demand for effective immunization remains strong, with significant funding from international stakeholders [26] - **Partnership Discussions**: - Ongoing discussions with potential partners for various programs, including avian flu and norovirus [48][46] - Interest in the entire oral vaccine platform beyond traditional licensing [46] Regulatory and Compliance - **FDA Interactions**: - Vaxart maintains operational responsibility for the COVID-19 program until the completion of the Phase 2B trial [8] - The company is working closely with BARDA to finalize data release timelines, which have been delayed from Q1 to early Q2 2026 [17][81] Future Outlook - **Next Steps**: - If COVID-19 trial data is positive, Vaxart will submit a data package to the FDA for potential advancement to Phase 3 [28] - The company is exploring additional funding opportunities and partnerships to support ongoing and future clinical trials [14][16] Additional Insights - **Market Sentiment**: - The domestic vaccine environment is characterized by increased scrutiny, but Vaxart's unique delivery method may help re-engage the market [25] - **Operational Adjustments**: - Consolidation of facilities and reduction in manufacturing footprint to align with strategic goals and cost management [90] This summary encapsulates the key points discussed during the Vaxart conference call, highlighting the company's strategic direction, clinical programs, financial management, and market positioning.

Management View - Vaxart, Inc. has achieved significant milestones, including a partnership with Dynavax for its oral COVID-19 vaccine candidate [2] - The company has also published clinical study data for its oral norovirus vaccine, indicating progress in its vaccine development pipeline [2]

Financial Position and Funding - The company has incurred an accumulated deficit of $460.2 million as of December 31, 2025, and expects to continue incurring significant losses for the foreseeable future [175]. - The company has $63.8 million in cash, cash equivalents, and investments as of December 31, 2025, which is expected to fund operations into the second quarter of 2027 [176]. - The company may need to raise additional capital through various means, including equity and debt financing, to continue its operations and development programs [176]. - The company anticipates that funding for the COVID-19 vaccine candidate will come from the 2024 ATI-RRPV Contract, which has a total funding amount of approximately $316.0 million [182]. - The company may need to seek alternative funding sources if government funding under the 2024 ATI-RRPV Contract is discontinued, which could negatively impact revenues and cash flows [182]. Research and Development - The company anticipates significant increases in research and development expenses for its tablet vaccines, including those for norovirus, coronavirus, and HPV-related conditions [175]. - The company is developing oral vaccines administered by tablet, but the development of its norovirus and coronavirus vaccine candidates is still at an early stage [184]. - The company expects to require substantial additional capital to complete the development and commercialization of its tablet vaccine candidates for norovirus, coronavirus, influenza, and HPV [190]. - Clinical trials are expensive and time-consuming, with significant risks of failure at any stage, which could delay or prevent marketing approval for the tablet vaccine candidates [228]. - The company must conduct extensive and costly preclinical studies and clinical trials to demonstrate safety and efficacy, with uncertain outcomes that could materially harm business if unfavorable [298]. Regulatory Challenges - The regulatory pathway for coronavirus vaccines is evolving, presenting potential unforeseen challenges for the company [169]. - The company may face significant delays or failures in obtaining regulatory approvals, which could adversely affect its business and financial condition [186]. - The FDA may impose additional requirements for preclinical studies, potentially delaying the initiation of Phase 1 studies for HPV therapeutic vaccine candidates [228]. - The process of obtaining marketing approvals is expensive and can take many years, with substantial discretion given to regulatory authorities [259]. - Compliance with state and federal healthcare regulatory laws is critical, as violations could lead to substantial penalties and harm the company's operations [270]. Market Competition - The company faces significant competition from other biotechnology and pharmaceutical companies in the vaccine development space [169]. - The company faces intense competition from larger pharmaceutical companies and must demonstrate compelling advantages in efficacy, convenience, and safety to succeed in the market [242]. - The COVID-19 vaccine market is highly competitive, with Pfizer-BioNTech, Moderna, and Novavax having approved vaccines in the U.S. [253]. - The company anticipates facing intense competition as new vaccines enter the market and advanced technologies become available [250]. - The company faces significant competition in securing collaborations, which may affect its ability to fund product development and commercialization [334]. Manufacturing and Supply Chain - The company may face challenges in scaling up manufacturing capacity for its vaccine candidates, which could affect the number of doses produced [188]. - The company currently depends on single-source vendors for key components of its tablet vaccine candidates, which poses a risk to manufacturing and supply [327]. - The company relies on third-party contractors for clinical trials and manufacturing, which may lead to compliance issues or delays if they fail to meet obligations [301]. - The company’s ability to manufacture product candidates in sufficient quantities for commercialization is critical, and any issues in scaling up production could delay market entry [324]. - Delays in third-party contract manufacturing could adversely affect the company's ability to conduct clinical trials and commercialize product candidates [345]. Legal and Liability Risks - The company is subject to ongoing legal proceedings that may result in substantial costs and divert management's attention, adversely impacting business operations [217]. - The company faces significant product liability exposure related to its tablet vaccine candidates, which could lead to substantial liabilities and limit commercialization efforts [276]. - Product liability insurance coverage is currently up to $10 million per claim, but may not be adequate to cover all potential liabilities [277]. - The company could incur substantial expenses and face significant liabilities if involved in patent litigation or other legal proceedings [361]. - The company’s relationships with healthcare providers and third-party payors are subject to strict healthcare laws, which could expose it to legal and financial risks [335]. Strategic Partnerships and Collaborations - The company expects to enter into license and collaboration agreements, but reliance on partners may result in reduced revenues if they do not perform as expected [308]. - The company may seek collaborations for product development, but failure to establish these on commercially reasonable terms could alter its commercialization plans [333]. - The company acknowledges that favorable results in preclinical studies and early-stage clinical trials do not guarantee success in late-stage clinical trials, which may lead to delays or failures in product development [294]. - If the company fails to secure additional strategic partnerships for unpartnered product candidates, it may incur increased costs and risks associated with development, potentially leading to a higher cash burn rate [338]. - Strategic partnerships or acquisitions may not yield the expected benefits, and the company may encounter difficulties in integrating acquired businesses profitably [339]. Market Acceptance and Revenue Generation - The company faces risks related to market acceptance of its product candidates, which may not generate significant revenues if they do not gain meaningful acceptance in their intended markets [314]. - The company expects sales from its tablet vaccine candidates for coronavirus and norovirus to generate substantially all of its revenues for the foreseeable future [268]. - The company may face challenges in obtaining adequate reimbursement from third-party payers, which could negatively impact revenues and profitability [311]. - The company relies on adequate reimbursement and insurance coverage for its product candidates, and any limitations could restrict revenue generation [210]. - Seasonal fluctuations in influenza vaccine sales could lead to unpredictable royalty revenues and significant variations in operating results [289].

Financial Data and Key Metrics Changes - Revenue for the full year 2025 was $237.3 million, a significant increase from $28.7 million in 2024, primarily driven by government contracts and the Dynavax collaboration [20] - Cash equivalents and investments at the end of the fourth quarter were $63.8 million, with an expected cash runway into the second quarter of 2027 [20][21] Business Line Data and Key Metrics Changes - The partnership with Dynavax for the oral COVID-19 vaccine candidate includes a $25 million upfront payment and a $5 million equity investment, with potential future payments totaling up to $700 million [5][7] - The oral norovirus vaccine candidate has shown promising results in clinical studies, with significant increases in IgA levels in both serum and breast milk [14][15][16] Market Data and Key Metrics Changes - The collaboration with Dynavax, now a Sanofi company, is expected to enhance the company's market position in the vaccine space [6][7] - The ongoing phase 2B trial of the oral COVID-19 vaccine candidate is crucial for addressing the ongoing need for next-generation solutions in the context of COVID-19 [10][11] Company Strategy and Development Direction - The company is focused on managing financial resources effectively, pursuing strategic partnerships, and reducing operating costs to enhance cash runway [8][21] - Future priorities include executing data collection for the COVID-19 clinical trial and securing partnerships for the norovirus program [22] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the potential of both the COVID-19 and norovirus oral vaccine programs to provide public health benefits and create shareholder value [22] - The company is committed to realizing the value of its oral pill vaccine platform, which is seen as a disruptive technology in the vaccination landscape [22] Other Important Information - The company has entered into a lease termination agreement to reduce operating expenses, allowing for a more focused allocation of financial resources [5][8] - The results from the 400-participant sentinel cohort of the COVID-19 trial are expected to be reported in early Q2 2026, with the larger KP2 cohort data anticipated in Q4 2026 [11][22] Q&A Session Summary Question: Delay in 400-person sentinel cohort data - Management acknowledged a slight delay in reporting the 400-person sentinel cohort data, now expected in early Q2 instead of late Q1, due to interactions with BARDA [26][28] Question: Expectations for sentinel data and follow-up - The 400-person cohort will provide safety data, while the 5,000-person KP2 cohort will offer efficacy insights, with results expected in Q4 2026 [29][31] Question: Decision points after sentinel data - The decision-making process for next steps post-sentinel data will involve both BARDA and Dynavax, with Vaxart overseeing the Phase 2B trial [35][36] Question: Regulatory input on norovirus candidate - Discussions with the FDA regarding endpoints for the next phase 2 study of the norovirus candidate are ongoing, with a focus on safety and immunogenicity [42][43]

Financial Data and Key Metrics Changes - Revenue for the full year 2025 was $237.3 million, a significant increase from $28.7 million in 2024, primarily driven by government contracts and the Dynavax collaboration [35] - Cash equivalents and investments at the end of the fourth quarter were $63.8 million, with an expected cash runway into the second quarter of 2027 [36] Business Line Data and Key Metrics Changes - The partnership with Dynavax for the oral COVID-19 vaccine candidate includes a $25 million upfront payment and a $5 million equity investment, with potential future payments totaling up to $700 million [8][11] - The oral norovirus vaccine candidate has shown promising results in clinical studies, with significant increases in IgA levels in both serum and breast milk [24][28] Market Data and Key Metrics Changes - The partnership with Dynavax, now a Sanofi company, is expected to enhance collaboration and development efforts in the vaccine space [9] - The ongoing phase 2b trial of the oral COVID-19 vaccine candidate is crucial for assessing its efficacy compared to mRNA vaccines [14] Company Strategy and Development Direction - The company is focused on managing financial resources effectively, pursuing strategic partnerships, and reducing operating costs to extend cash runway [12][36] - Priorities for 2026 include executing data collection for the COVID-19 clinical trial and securing funding for the norovirus program [38][39] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the potential of the COVID-19 and norovirus oral vaccine programs to provide public health benefits and create shareholder value [37] - The company is committed to realizing the value of its oral pill vaccine platform, which is seen as a disruptive technology in addressing public health challenges [39] Other Important Information - The company has entered into a lease termination agreement to reduce operating expenses, allowing for better allocation of financial resources [13] - The results from the 400-participant sentinel cohort of the COVID-19 trial are expected to be reported in early Q2 2026, with further data from the 5,000-participant KP2 cohort anticipated in Q4 2026 [17][20] Q&A Session Summary Question: Delay in 400-person sentinel cohort data - Management acknowledged a slight delay in reporting the 400-person sentinel cohort data, now expected in early Q2 instead of late Q1, due to discussions with BARDA [44][46] Question: Next steps after sentinel data - Management explained that after the sentinel data is available, Dynavax will decide on further development based on the phase 2 data package submitted to the FDA [53][55] Question: Regulatory input on norovirus candidate - Management confirmed ongoing discussions with the FDA regarding the endpoints for the next phase 2 study of the norovirus vaccine [60][61]

Financial Data and Key Metrics Changes - Revenue for the full year 2025 was $237.3 million, a significant increase from $28.7 million in 2024, primarily driven by government contracts and the Dynavax collaboration [20] - Cash equivalents and investments at the end of the fourth quarter were $63.8 million, with an expected cash runway into the second quarter of 2027 [20][21] Business Line Data and Key Metrics Changes - The partnership with Dynavax for the oral COVID-19 vaccine candidate included a $25 million upfront payment and a $5 million equity investment, validating the oral vaccine platform [5][6] - The oral norovirus vaccine candidate showed promising results in a clinical study, with significant increases in IgA levels in both serum and breast milk [14][15][17] Market Data and Key Metrics Changes - The COVID-19 vaccine trial is currently in phase 2B, with a focus on comparing the oral vaccine's efficacy against an mRNA vaccine [9][10] - The need for next-generation solutions in COVID-19 vaccination remains critical as the pandemic continues to impact global health [11] Company Strategy and Development Direction - The company aims to manage financial resources effectively, pursuing strategic partnerships and reducing operating costs to focus on advancing lead programs [7][21] - The oral pill vaccine platform is viewed as a disruptive technology that could address public health challenges and changing vaccination preferences [24] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the potential of the COVID-19 and norovirus oral vaccine programs to provide public health benefits and create shareholder value [22] - The company plans to report top-line results from the COVID-19 trial's sentinel cohort in early Q2 2026 and from the KP2 cohort in Q4 2026 [23] Other Important Information - A lease termination agreement was entered into to reduce operating expenses, allowing for a more focused allocation of financial resources [5][8] - The company is exploring licensing or partnership opportunities for earlier-stage assets, including seasonal and pandemic flu candidates and the HPV program [24] Q&A Session Summary Question: Delay in 400-person sentinel cohort data - Management acknowledged a slight delay in reporting the 400-person sentinel cohort data, now expected in early Q2 instead of late Q1, due to interactions with BARDA [27][28] Question: Next steps after sentinel data - The decision points for next steps will involve both BARDA and Dynavax, with Vaxart overseeing the Phase 2B trial [36][37] Question: Immunogenicity data availability - Immunogenicity data will not be included in the Q2 update but will follow after the initial safety data [36][39] Question: Regulatory input on norovirus candidate - Discussions with the FDA have occurred regarding the primary endpoint of safety for the next phase 2 study of the norovirus candidate [42][43]

Financial Performance - Vaxart reported revenue of $237.3 million for the full year 2025, a significant increase from $28.7 million in 2024, primarily driven by government contracts and a collaboration agreement with Dynavax[8]. - Vaxart achieved a net income of $16.3 million for 2025, a turnaround from a net loss of $66.9 million in 2024, resulting in a net income per share of $0.07[9]. - Total assets increased to $186.1 million as of December 31, 2025, up from $166.4 million in 2024[17]. - Total liabilities decreased to $98.3 million in 2025 from $107.5 million in 2024, while stockholders' equity rose to $87.8 million[17]. Research and Development - Research and development expenses rose to $201.6 million in 2025, compared to $74.2 million in 2024, mainly due to increased clinical trial costs for the COVID-19 vaccine[9]. - Enrollment for the COVID-19 Phase 2b trial was completed with approximately 5,400 participants, including a sentinel cohort of 400, with safety data expected in early Q2 2026[8]. - Vaxart's norovirus vaccine program demonstrated significant increases in norovirus-specific antibodies in lactating women, indicating potential for passive immunity transfer to infants[4]. - The company plans to initiate its next norovirus clinical trial in 2026, pending partnership or funding[8]. Cash and Funding - The company has cash, cash equivalents, and investments totaling $63.8 million as of December 31, 2025, with an anticipated cash runway extending into the second quarter of 2027[8]. - Vaxart's collaboration with Dynavax is expected to provide a well-funded path forward for its COVID-19 vaccine program, highlighting the potential value of its mucosal vaccine platform[4].

Core Insights - Vaxart, Inc. announced positive clinical results for its oral norovirus vaccine candidate, demonstrating safety and immunogenicity in lactating women, with passive antibody transfer to infants via breast milk [1][2] - The company reported a significant increase in revenue for 2025, totaling $237.3 million, compared to $28.7 million in 2024, primarily due to government contracts and a collaboration with Dynavax [12][18] - Vaxart has a cash position of $63.8 million as of December 31, 2025, providing a runway into the second quarter of 2027 [1][12] COVID-19 Vaccine Developments - The COVID-19 program reached a strategic inflection point with a collaboration with Dynavax, which is expected to provide funding and enhance the recognition of Vaxart's mucosal vaccine platform [2] - The company completed enrollment of approximately 5,400 participants for its Phase 2b trial, with safety data from the sentinel cohort expected in early Q2 2026 and full trial data anticipated in Q4 2026 [5][2] Norovirus Vaccine Developments - Vaxart's oral bivalent norovirus vaccine demonstrated a significant increase in norovirus-specific antibodies in lactating women, providing clinical evidence of passive mucosal immunity to infants [5][2] - The company plans to initiate its next norovirus clinical trial in 2026, pending partnership or funding [6] Financial Results - For the full year 2025, Vaxart reported a net income of $16.3 million, a significant turnaround from a net loss of $66.9 million in 2024 [12][18] - Research and development expenses increased to $201.6 million in 2025 from $74.2 million in 2024, primarily due to clinical trial expenses for the COVID-19 vaccine [12][18] - General and administrative expenses decreased to $17.6 million in 2025 from $20.8 million in 2024, attributed to lower personnel costs and legal fees [12][18]

Summary of Vaxart's Presentation at Oppenheimer's 36th Annual Healthcare Conference Company Overview - **Company**: Vaxart - **Industry**: Biotechnology, specifically focusing on oral pill vaccines Core Points and Arguments 1. **Innovative Vaccine Platform**: Vaxart is pioneering a transformative approach to oral pill vaccines that generate both systemic and mucosal immunity, which is expected to revolutionize vaccine distribution and administration [2][3] 2. **Partnership with Dynavax**: A partnership with Dynavax was announced, which validates Vaxart's platform and extends its cash runway. This partnership includes a BARDA-funded COVID-19 vaccine and other vaccine opportunities [3][29] 3. **Pipeline Overview**: Vaxart has multiple vaccine programs, including: - A COVID-19 vaccine in Phase II testing, with top-line data expected soon [9][27] - A norovirus vaccine with promising data from previous studies [10][15] - An influenza vaccine with statistically significant results compared to existing vaccines [11][22] - A therapeutic HPV vaccine in preclinical development [12] 4. **Safety and Efficacy**: The oral pill vaccines have shown a safety profile comparable to placebo, with no injection site reactions. The mucosal immunity provided by the vaccine is seen as a potential advantage [5][6] 5. **Clinical Data**: - The COVID-19 vaccine study has enrolled 5,400 subjects, with a focus on safety and efficacy over a 12-month period [12][13] - The norovirus vaccine showed a 30% relative reduction in G11 and a 21% reduction in acute gastroenteritis in challenge studies [18] - The influenza vaccine demonstrated a 49% decrease in infection compared to placebo [22] 6. **Market Potential**: The norovirus represents a $10 billion annual economic burden in the U.S., highlighting the significant unmet need for effective vaccines [15][16] 7. **Future Milestones**: Vaxart is focused on completing its COVID-19 study and advancing its norovirus and influenza programs, with important milestones expected through 2027 [27][29] Additional Important Content 1. **Regulatory and Partnership Dynamics**: The acquisition of Dynavax by Sanofi is expected to enhance Vaxart's partnership dynamics, as Sanofi is a market leader in vaccines [30][36] 2. **Combination Vaccine Strategy**: Vaxart is exploring the potential for combination vaccines, which could allow for multiple strains or antigens to be included in a single oral pill [49][50] 3. **Expansion Opportunities**: The platform's ability to generate mucosal immunity positions Vaxart to explore vaccines for other pathogens that enter through mucosal surfaces, such as respiratory and gastrointestinal pathogens [47][48] This summary encapsulates the key points from Vaxart's presentation, highlighting the company's innovative approach, pipeline, and future opportunities in the biotechnology sector.

Oppenheimer 36th Annual Healthcare Life Sciences Conference The Pill That Moves The Needle® Forward Looking Statement * Sanofi announced on February 10, 2026, that it had completed its acquisition of Dynavax Technologies Corporation Vaxart Corporate Presentation | February 2026 3 February 25-26, 2026 This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart ...