COVID-19 program enrollment timeline, norovirus program dose optimization, COVID-19 program gating factors and timeline, regulatory and political environment, and norovirus program partnership discussions are the key contradictions discussed in Vaxart's latest 2025Q1 earnings call.
COVID-19 Program and BARDA Collaboration:
-
successfully had the
stop work order lifted on the COVID-19 Phase 2b trial after productive dialogues with BARDA and HHS.
- The lifting of the order allows for the initiation of patient dosing in the second quarter of 2025, with plans to restart activities including patient screening and material shipment.
- The progress was driven by the collaborative effort and support from government partners, ensuring the study's results will have greater confidence.
Norovirus Vaccine Development:
- Vaxart completed enrollment in a
Phase 1 trial comparing second-generation norovirus constructs with first-generation ones, seeking improved protection and efficacy.
- The trial's results are expected by mid-2025, which could lead to strategic partnerships and additional clinical trials.
- The focus on second-generation constructs is aimed at optimizing vaccine candidates for superior protection against infections and symptoms.
Financial Performance and Cash Runway:
- Vaxart reported
revenue of
$20.9 million for Q1 2025, primarily from a BARDA contract awarded in June 2024.
- The company ended the quarter with
cash, cash equivalents, and investments of
$41.9 million and expects a cash runway into the first quarter of 2026.
- The financial performance was supported by government contracts, which primarily fund trial operations, and cost-reduction measures, including workforce reductions.
Leadership Changes and Strategic Hiring:
- Phillip Lee, CFO, announced his resignation, with Jeroen Grasman joining as the new CFO.
- Jeroen Grasman brings extensive experience in healthcare and finance, having previously held significant roles at companies like AltruBio, PACT Pharma, Intarcia Therapeutics, and Genentech.
- The appointment aims to support Vaxart's ongoing efforts to achieve upcoming milestones and maintain operational efficiency.
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