Vaxart, Inc. Q3 FY2024 earnings call

• Steven Lo highlighted achievements in advancing the oral pill vaccine platform, including milestones in COVID, Norovirus, and HPV programs. The COVID program has started enrollment in a Phase 2b study with BARDA. The Norovirus program received constructive FDA feedback and has promising preclinical data. The HPV program has preclinical studies planned.
• James Cummings discussed the BARDA Phase 2b COVID trial, noting it will evaluate efficacy, safety, and immunogenicity.
• Sean Tucker provided updates on the Norovirus program, including feedback from FDA and preclinical data on HPV, and discussed constructs for Norovirus.
• Phil Lee discussed financial results for Q3 2024.

Revenue for the third quarter of 2024 was $4.9 million, compared to $2.1 million in the third quarter of 2023. Revenue in Q3 2024 was primarily from government contracts related to BARDA. Vaxart ended Q3 2024 with cash, cash equivalents and investments of $58.7 million and anticipates cash runway into 2026.

• Vaxart anticipates cash runway into 2026.
• Progressing with enrollment in the BARDA Phase 2b COVID trial and continuing work on Norovirus and HPV programs.

• Uncertainty inherent in the clinical development and regulatory process.
• Risks described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and other periodic reports filed with the SEC.

Q: On the COVID-19 Phase 2 study, interest level from investigators and enrollment progress versus projections, and interim analysis plans.

A: Steve Lo said enrollment is on track with 400 participants in the sentinel study, no issues with enrolling patients. Sean Tucker mentioned considering interim analysis for safety and efficacy signals but focusing on full study through 12-month visit.

Q: On Norovirus program, feedback from FDA and required new clinical data.

A: Sean Tucker said they got clear path forward from FDA to get to end of Phase 2 meeting but didn't discuss specific details.

Q: On COVID trial's DSMB 30-day safety analysis, study blind, and mucosal immunity endpoints.

A: Sean Tucker said DSMB will review 30-day safety data, study is blinded, and they're looking at systemic and mucosal immune induction.

Q: On Norovirus next-gen constructs and correlates with FDA.

A: Sean Tucker said next-gen constructs are more potent in antibody responses, learnings from FDA can help expedite next-generation candidates.

Q: On COVID enrollment impact from seasonality and infection rate.

A: Steve Lo said enrollment is on track with no slowdown, Sean Tucker mentioned COVID strains changing rapidly but their platform has cross-reactive mucosal IgA responses.

Q: On how quickly to start 10,000 participant phase of COVID trial.

A: Sean Tucker said after favorable review of 30-day safety data from DSMB and FDA, plan is to start enrollment in early 2025.

Q: On Norovirus program's most logical next step.

A: Sean Tucker said goal is end of Phase 2 meeting with FDA to discuss requirements for Phase 2 and licensure, need to add more data.

Q: Would Vaxart consider conducting trial outside US?

A: Steven Lo said open to collaboration with companies outside US for co-development and non-dilutive funding.

Q: Updates on earlier stage programs like seasonal flu, HPV, avian flu.

A: Sean Tucker said conducting preclinical work on avian flu, seasonal flu, and HPV, regularly review candidate pipeline based on various factors.