Vaxart's Q4 2024: Unpacking Contradictions in COVID-19 and Norovirus Programs Amid Regulatory and Funding Challenges

These are the key contradictions discussed in Vaxart's latest 2024Q4 earnings call, specifically including: COVID-19 Program Status and Regulatory Feedback, Norovirus Program Enrollment and Trial Design, Manufacturing Capacity and Production Timeline, and Partnership and Non-Dilutive Funding Options:



COVID-19 Program Update and Stop Work Order:
- Vaxart received a $460 million award to conduct a Phase 2b study comparing their COVID-19 vaccine candidate to an mRNA comparator.
- The study enrollment for the initial sentinel cohort was completed, and the independent data safety monitoring board recommended the study proceed without modifications.
- A stop work order was issued by the US Department of Health and Human Services, halting the planned 10,000 participant portion of the study for a period of up to 90 days.

Norovirus Program Progress:
- Vaxart initiated a Phase 1 trial evaluating second-generation oral norovirus vaccine constructs head-to-head against the first-generation constructs.
- The trial aims to measure safety and immune parameters, with top-line data expected as early as mid-2025.
- The progress is aligned with FDA recommendations and addresses the need for a vaccine against norovirus, which impacts approximately 20 million Americans annually.

Financial Performance and Cash Runway:
- Vaxart reported $28.7 million in revenue for 2024, compared to $7.4 million in 2023.
- The company ended 2024 with $51.7 million in cash, cash equivalents, and investments.
- Vaxart has implemented measures to reduce expenses and extend its cash runway into the fourth quarter of 2025, including a reduction in its workforce.

Avian Influenza and HPV Vaccine Programs:
- Vaxart has additional preclinical studies planned for its avian influenza and HPV vaccine programs.
- The company is conducting several preclinical studies to evaluate new constructs and prepare for clinical manufacturing.
- Updates on these programs are expected when the preclinical studies are complete.