Vaxart, Inc. Q4 FY2024 earnings call

Key Messages

• Vaxart's mission is to transform global public health with next-generation oral pill vaccines.
• Progress in COVID-19 program: Completed enrollment of 400-participant sentinel cohort, DSMB recommended study proceed without modifications, but received a stop work order from HHS halting 10,000-participant portion for up to 90 days.
• Norovirus program: Initiated Phase 1 trial evaluating second-generation oral norovirus vaccine constructs head-to-head with first-generation; second-generation constructs show promise with higher potency in preclinical models; previous studies showed robust immunogenicity, favorable safety, and potential to protect via passive antibody transfer.
• Preclinical programs: Reviewing avian influenza and HPV vaccine programs; avian influenza program has preclinical data showing protection and new candidate for latest strain; HPV vaccine program has planned preclinical studies to characterize immune-stimulating activity.

In 2024, Vaxart's revenue was $28.7 million, compared to $7.4 million in 2023. The 2024 revenue was primarily from government contracts related to BARDA and non-cash royalty revenue from sales of Inavir in Japan. The absolute revenue in 2024 was $28.7 million, which was a significant increase from $7.4 million in 2023, and the revenue contribution from government contracts and Inavir royalties was the main driver.

Forward-Looking Statements

• Vaxart anticipates cash runway into the fourth quarter of 2025.
• Continues to explore strategies to extend cash runway through strategic partnerships, non-dilutive funding, and other cost reduction initiatives.

Risks

• Uncertainty inherent in clinical development and regulatory process.
• Stop work order related to the BARDA funded Project NextGen award from HHS, halting activities related to the planned 10,000-participant portion of the COVID-19 study for up to 90 days, which could impact the progress of the program.

Q: Regarding the new Phase 1 study for norovirus, is the second-generation product bivalent and whether the trial is enrolling young adults and older adults?

A: For the Phase 1 study, enrolling folks 18 to 49. The second-generation product is looking at GI.1 and GII.4, with minor changes to DNA backbone and antigen sequence for enhanced expression in intestinal epithelial cells.

Q: How does the DSMB's recommendation on the COVID-19 sentinel cohort data relate to FDA?

A: The data for the sentinel cohort was sent to the FDA at the same time it was sent to the DSMB.

Q: How does the stop work order impact manufacturing? Was product produced for the trial, and shelf life?

A: Vaxart has own GMP manufacturing facilities in the US. Routine monitoring of product stability shows shelf life is expected to last two years. Confident in adjusting to the stop work order as clarity is obtained