Vaxart, Inc.
For the period ended May 19, 2026. Filed May 19, 2026.
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May 19, 2026 · Filed May 19, 2026
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Contents
EX-99.1 · Driving Clinical and Operational Progress
Driving Clinical and Operational Progress
We are strategically focusing our clinical development on areas where our Vector-Adjuvant-Antigen Standardized Technology (VAAST) platform can offer meaningful differentiation in areas that we believe have the potential to drive the greatest patient impact and commercial opportunity. The Board has prudently and deliberately positioned the Company with several potential catalysts for value creation.
| ● | COVID-19 – Platform Validation through Head-to-Head Comparison: Our Phase 2b COVID-19 trial, conducted in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA), is a cornerstone of our strategic roadmap. This trial is designed as a direct head-to-head evaluation of our oral pill vaccine candidate against a commercially available mRNA injectable booster. We believe this study has the potential to validate our technology and help redefine how vaccines are delivered. |
The trial is fully enrolled with approximately 5,400 total participants across a 400-person sentinel cohort and an approximately 5,000-participant main cohort. We are working toward the release of 12-month safety data from the sentinel cohort in the second quarter of 2026. While this sentinel data is not powered for statistical significance on efficacy, it will provide critical directional insights ahead of the primary efficacy and safety readout from the 5,000-participant main cohort, which is currently anticipated in early 2027.
| ● | Norovirus – Advancing a Potential First-in-Class Solution: Our norovirus program represents a significant opportunity in an expanding market where no vaccine currently exists. We are actively evaluating how our next-generation bivalent product candidate performs against the most dominant and highly-contagious strains of norovirus, as well as other strains, while continuing to pursue partnership and external funding opportunities to support future clinical development activities and clinical trials. |
| ● | Influenza – Proving Differentiation Against Market Leaders: We are continuing to develop our seasonal and avian influenza programs, which continue to serve as important proof points for our platform’s ability to compete with market-leading injectables. We previously reported positive data from a Phase 2 challenge study showing that our oral H1 influenza vaccine candidate was at least as protective as an approved market-leading injectable vaccine in humans. More recently, our avian influenza vaccine was found to be 100% protective in a robust preclinical model. These promising results demonstrate the potential of our platform for influenza, and more generally for virus protection. We are continuing to evaluate the next steps for this program. |
These programs take time and resources, and our highly qualified Board and management team are pulling every lever to advance our programs as quickly as possible and transition toward a sustainable commercial model.
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