Announcement • Jul 07
Vaxart Reports Topline 12-Month Safety Data from the 400-Participant Sentinel Safety Cohort of the Phase 2B Clinical Trial of Its Oral Pill Covid-19 Vaccine Vaxart reported topline data from the approximately 400-participant sentinel safety cohort of its Phase 2b clinical trial evaluating the Company’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. Participants in this safety cohort received Vaxart’s oral pill vaccine (201 participants dosed) or an approved mRNA vaccine (199 participants dosed) targeting the XBB strain of SARS-CoV-2, the virus that causes COVID-19. No vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher adverse events (AEs) were reported in either arm of the study. Data from the complete study, comprising the 400 dosed participants in the sentinel safety cohort and approximately 5,000 dosed participants in the main cohort, are currently anticipated in 2027. Participants in the main cohort received vaccines targeting the KP.2 viral strain prevalent at the time cohort dosing was initiated. Key topline 12-month results from the 400-participant sentinel safety cohort (201 oral vaccinees and 199 mRNA vaccinees) include: No vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher AEs were reported in either the oral pill vaccine or mRNA arms of the trial. The most common AEs in participants receiving the oral pill vaccine were malaise/fatigue (20.9%), headache (18.9%) and anorexia (10.0%). Fewer than 10% of participants experienced any other AE. The most common AEs in participants receiving the mRNA vaccine were injection site pain (60.3%), injection site tenderness (40.2%), malaise/fatigue (35.2%), myalgia/muscle pain (33.2%), and headache (28.6%). Arthralgia, chills, anorexia, nausea, diarrhea, and induration/swelling at the injection site were experienced by between 10-15% of participants. Fewer than 10% of participants experienced any other AE. With respect to the efficacy measure of symptomatic COVID, 33 participants in Vaxart’s oral pill vaccine arm and 30 participants in the injectable mRNA vaccine arm had symptomatic disease. Asymptomatic COVID cases were reported in 12 participants in the Vaxart oral pill arm and 12 in the mRNA vaccine arm. It should be noted that this 400-participant sentinel safety cohort was not powered to determine comparative efficacy between the two arms. Topline data from the complete study, comprising the 400 participants in the sentinel safety cohort and approximately 5,000 participants in the main cohort, are anticipated in 2027. The main cohort is designed and powered to support the planned statistical comparison of safety and relative efficacy outcomes between the two arms. Funding for this award was received under Project NextGen, an initiative by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) Consortium is valued at up to $344.8 million. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005. Live News • Jul 03
Vaxart Settles Proxy Contest and Reshapes Board With New Governance Initiatives Vaxart has settled a proxy contest by signing a cooperation agreement with a stockholder group, which will withdraw its director nominations while the company appoints a mutually agreed independent director and introduces new board committees and refreshed governance policies ahead of its 2026 annual meeting.
The company is adding Stockholder Engagement and Clinical and Regulatory Affairs Committees, updating director stock ownership and resignation policies, and rotating committee leadership, which collectively reshape how Vaxart’s board oversees its vaccine pipeline and interacts with investors.
Vaxart shares trade at about $0.64, with the stock up 75.6% year to date, reflecting a period of pronounced volatility and shifting sentiment around the company.
This governance reset reduces the distraction of a contentious proxy fight and puts more formal focus on investor dialogue and clinical oversight, but it also raises the bar on execution as the new structures and director begin influencing pipeline priorities and capital decisions. Announcement • Jul 02
Vaxart, Inc. Announces Board and Committee Changes Vaxart, Inc. announced a resolution to the proxy contest in connection with the Company's 2026 Annual Meeting of Stockholders. Vaxart, Inc. initiated a search for an additional independent director to be conducted within 90 days of the conclusion of the 2026 Annual Meeting. Pursuant to a cooperation agreement between the Company and stockholders Daniel P. Houle, Mark Silverberg, DDS, MD, Matthew M. Wallace, MD, Patrice Raffy, Marc Eustace Pereira and Third Quarter Nominees Pty Ltd., the Company will work with the Stockholder Group to identify a mutually agreeable candidate to be appointed to the Board. The Stockholder Group agreed under the cooperation agreement to withdraw the director nominations of Mr. Houle, Dr. Silverberg and Dr. Wallace in connection with the 2026 Annual Meeting. The cooperation agreement additionally provided for the formation of a Stockholder Engagement Committee and a Clinical and Regulatory Affairs Committee, Board committee refreshment, including the selection of new chairs for the Nominating and Governance and Compensation Committees, the adoption of director stock ownership and resignation policies, as well as certain customary standstill, voting, engagement and other provisions.