Vaxart, Inc. Q2 FY2024 earnings call

• Steven Lo joined in March, emphasized commitment to advancing science and execution. • Updates on COVID and norovirus programs, including BARDA-funded Phase 2b COVID trial and FDA dialog for norovirus. • James detailed Phase 2b COVID trial design (enrollment of ~10,000 adults, measuring efficacy, safety, etc.) and FDA discussions for norovirus. • Phil provided financial update: cash, cash equivalents, and investments of $62.6 million at end of Q2 2024, with $64.7 million received from BARDA post-quarter for COVID trial startup.

Revenue in the second quarter of 2024 was $6.4 million, primarily from work under the BARDA contract awarded in January 2024. Revenue in Q2 2023 was $1.4 million, primarily from the Gates Foundation grant. No detailed segmentation of product revenues by contribution % as there are no distinct product segments highlighted in terms of financial performance.

• Vaxart anticipates cash runway into 2026. • Proceeds from the $64.7 million BARDA payment will be used for COVID-19 Phase 2b clinical trial startup activities.

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

Q: For the Norovirus program, provide more color on additional details requested by the FDA and comparison of phase 2b trial design to prior phase 2 studies.

A: James Cummings stated FDA is reviewing norovirus data, no detailed info on FDA discussions, and details on phase 2b trial depend on ongoing discussions.

Q: What steps remain to initiate the phase 2b COVID study and additional info needed from FDA?

A: James Cummings said ongoing productive dialog with FDA, have addressed some comments, need to resolve remaining ones, manufacturing processes substantially complete, and key activities include trial site activation and subcontracting.

Q: Describe subject enrollment process for phase 2b COVID trial and challenges in recruiting 10,000 adults.

A: James Cummings said clinical trial management team will recruit, demographics to be representative of US population, with 25% at high risk of severe COVID-19.

Q: What was the $64.7 million payment for and milestones for COVID phase 2b study?

A: Phil Lee said it was for achieving a milestone in the ATI contract, remaining contract funding not tied to specific milestones but reimbursed for costs and fee as trial progresses.

Q: Elaboration on RSV being removed from pipeline.

A: Steven Lo said company reviews pipeline strategically, focusing on opportunities with near-term data generation, prioritizing COVID program due to BARDA funding.

Q: Steps for Vaxart's platform fitting into gov't vision for next-gen vaccines and pandemic preparedness.

A: Steven Lo said oral pill mucosal technology is key differentiator, aligned with gov't goals as seen in BARDA award.

Q: Whether norovirus vaccine is more robust against emerging strains and positioning vs HillVax.

A: Sean Tucker said HillVax data underscores need for mucosal response, Vaxart's candidates have serum and mucosal response, program focused on healthy adults, and IGA response allows cross reactivity.