Vaxart, Inc. Q4 FY2025 earnings call

Discussed the norovirus vaccine study in healthy lactating women showing safety, reactogenicity, and antibody responses in breast milk and serum. Mentioned phase one trial results of second-generation norovirus vaccine constructs with higher antibody responses. Plan to initiate next clinical trial of second-generation norovirus vaccine constructs in 2026. Also discussed financials with cash runway and ongoing efforts in seeking strategic partnerships.

Revenue for full year 2025 was $237.3 million, compared to $28.7 million for the full year 2024. Revenue in the full year 2025 and full year 2024 were primarily from government contracts related to the BARDA contracts awarded in June 2024, with 2025 also including revenue recognized from the DynaVax License and Collaboration Agreement signed in November 2025. Ended the fourth quarter with cash, cash equivalents, and investments of $63.8 million. Based on current plan, VaxArt expects cash runway into the second quarter of 2027.

Priorities for 2026 are to execute on data collection and analysis for the COVID-19 clinical trial and secure partnership/funding for the Norovirus program. Expect to share top line results from the 400-subject Sentinel cohort of the COVID-19 trial early in the second quarter of 2026 and data from the 5,000-subject KP2 cohort at the end of 2026.

Q: Concern about delay in 400-person Sentinel cohort data release from late first quarter to early second quarter and read-through to 5000-person data.

A: The 400-person cohort is a safety cohort designed to report primary safety endpoints and initial efficacy measures. Data release is in conjunction with BARDA. The 5000-person KP2 cohort data is expected in Q4 2026.

Q: Regulatory input on the endpoint constructs of the norovirus second-gen candidate in the next phase two study.

A: Had discussions with the FDA, and the phase two B study's primary endpoint is safety.