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Vaxart(VXRT) - 2025 Q1 - Earnings Call Transcript

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]