Summary of Vaxart Neurovirus Phase One Top Line Results Conference Call Company Overview - **Company**: Vaxart - **Focus**: Development of an oral pill vaccine for norovirus Key Industry Insights - **Norovirus Impact**: - Leading cause of acute gastroenteritis (AGE) globally - Approximately 685 million norovirus infections worldwide annually, with 20 million in the U.S. - Responsible for nearly 20% of diarrheal diseases globally - Economic burden estimated at $60 billion worldwide and $10 billion in the U.S. [5][6] - **Market Opportunity**: - Potential U.S. market size for a safe and effective norovirus vaccine is in the multibillion-dollar range - Target populations include elderly, immunocompromised individuals, healthcare professionals, and travelers [6][8] Core Findings from Phase One Clinical Trial - **Positive Results**: - Significant increase in norovirus blocking antibodies in both high and low dose cohorts of the new generation constructs - High dose cohort showed a statistically significant increase in antibodies [3][4] - **Immunogenicity Data**: - 141% increase in G11 NbAA titers in the high dose cohort (from 2.2 to 5.4) - 84% increase in G24 NbAA titers in the high dose cohort (from 1.9 to 3.5) [11] - **Safety Profile**: - All vaccine candidates were well tolerated with no serious adverse events reported [12][49] Future Development Plans - **Next Steps**: - Plans for a Phase 2b safety and immunogenicity study, potentially starting in the second half of 2025, followed by a Phase III trial in 2026 [14][15] - **Partnership Discussions**: - Ongoing discussions with various potential partners, including large multinational companies and regional players [52][53] - Interest in licensing the norovirus vaccine asset and potential collaborations on other vaccine programs [55] Additional Considerations - **Vaccine Characteristics**: - The vaccine must provide durable immune responses, be safe, easy to administer, and stable without complex cold chain logistics [7][8] - **Comparative Analysis**: - The new constructs are expected to show better performance compared to previous generation products, with ongoing studies to validate these findings [10][30] - **Scientific Rationale**: - The Phase one trial aimed to validate the superior immunogenicity of the new generation constructs using a proprietary norovirus blocking antibody assay [10][20] - **Upcoming Presentations**: - Plans to present complete data at relevant medical conferences, including the Khaleesi virus conference and the World Vaccine Congress in Europe [46] This summary encapsulates the critical insights and future directions for Vaxart's norovirus vaccine development, highlighting the significant public health need and market potential for effective vaccination against norovirus.

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $20.9 million, a significant increase from $2.2 million in Q1 2024, primarily driven by the BARDA contract awarded in June 2024 [22][23] - The company ended Q1 2025 with cash, cash equivalents, and investments totaling $41.9 million, with an expected cash runway into Q1 2026 [23] Business Line Data and Key Metrics Changes - The COVID-19 vaccine program has resumed activities following the lifting of the stop work order, with patient screening underway and dosing expected to start in Q2 2025 [5][12] - Enrollment in the Phase 1 trial for the norovirus vaccine was completed quickly, with top-line data expected in mid-2025 [8][15] Market Data and Key Metrics Changes - The company is actively pursuing strategic partnerships to enhance funding and support for its clinical programs, particularly in the norovirus and avian flu vaccine markets [17][19] Company Strategy and Development Direction - The company emphasizes the importance of vaccines in public health and aims to innovate oral pill vaccines that can provide effective and durable protection against infections [9][19] - A reverse stock split is being considered as a measure to maintain NASDAQ listing compliance, with management acknowledging the need for a strategic approach to regain investor confidence [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the COVID-19 program's potential and the importance of timely communication with stakeholders, despite contractual limitations [5][6] - The company is navigating challenges in the biotech environment and has made workforce reductions to streamline costs and maximize future opportunities [10][23] Other Important Information - The CFO, Phil Lee, announced his resignation for personal reasons, with Jerome Grossman set to take over [10][11] - The avian flu vaccine program has shown promising preclinical results, with plans to advance to clinical trials [19][20] Q&A Session All Questions and Answers Question: What are the gating factors to start patient dosing in the COVID-19 program? - Management indicated that the stop work order lifting allowed for immediate discussions with BARDA, and patient screening is currently underway, with dosing expected to start soon [37][39] Question: What does a positive outcome look like for the Phase 1 norovirus study? - Success is defined as the new constructs trending better than the old constructs on key immunogenicity endpoints, although statistical significance may not be achievable due to the study size [41][42] Question: What impact did the stop work order have on the expected timeline for the COVID-19 study? - The stop work order had a minor impact, but the company is now reactivating study sites and screening participants, with a projected six-month enrollment period once dosing begins [60][62] Question: Are there ongoing discussions for partnerships related to the norovirus program? - Management confirmed active discussions with a range of companies, with expectations that these will accelerate following the release of top-line results [65][66]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $20.9 million, a significant increase from $2.2 million in Q1 2024, primarily driven by the BARDA contract awarded in June 2024 [19][20] - The company ended Q1 2025 with cash, cash equivalents, and investments totaling $41.9 million, with an expected cash runway into Q1 2026 [20] Business Line Data and Key Metrics Changes - The COVID-19 vaccine program is progressing with the lifting of the stop work order, allowing for the initiation of patient dosing in the Phase 2b trial [4][10] - Enrollment in the Phase 1 trial for the norovirus vaccine was completed quickly, with top-line data expected in mid-2025 [6][12] Market Data and Key Metrics Changes - The company is actively pursuing strategic partnerships to enhance funding and support for its clinical programs, particularly in the norovirus and avian flu vaccine markets [6][17][64] Company Strategy and Development Direction - The company emphasizes the importance of vaccines in public health and aims to innovate oral pill vaccines that can provide effective and durable protection against infections [7][12] - A reverse stock split is being considered as a measure to maintain NASDAQ listing compliance, reflecting the company's focus on regaining investor confidence and market visibility [24][25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges in the biotech environment and has made workforce reductions to streamline costs and maximize future opportunities [8] - The lifting of the stop work order for the COVID-19 trial is seen as a positive development, reinforcing the need for novel vaccine technologies [29][30] Other Important Information - The resignation of the CFO, Phil Lee, was announced, with Jerome Grossman set to take over, bringing over 20 years of biotech experience [8][9][21] - The company is committed to transparent communication with shareholders while adhering to contractual obligations with BARDA and HHS [4][5] Q&A Session Summary Question: What are the gating factors to start patient dosing in the COVID-19 program? - Management indicated that the stop work order lifting allowed for the resumption of activities, with patient dosing expected to start in Q2 2025 [32][34] Question: What does a positive outcome look like for the Phase 1 norovirus study? - Success is defined as the new constructs trending better than the old constructs on key immunogenicity endpoints, although statistical significance may not be achievable due to the study size [37][38] Question: What are the implications of the recent DSMB review for the norovirus trial? - The review focused on safety, ensuring a clean safety profile to proceed with the protocol as designed [52] Question: How is the company planning to handle the results from the Sentinel cohort? - Management intends to engage with BARDA for potential interim analysis, with the study concluding in December [48] Question: What is the company's strategy regarding partnerships for the norovirus program? - The company is in discussions with various potential partners, with expectations that interest will accelerate following the release of top-line results [64]