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Vaxart Announces Safety Data from COVID-19 Oral Vaccine Trial

Vaxart announced 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 or an approved mRNA vaccine targeting the XBB strain of SARS-CoV-2, the virus that causes COVID-19. No vaccine-related serious adverse events or sustained Grade 3 or higher adverse events 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. No vaccine-related serious adverse events 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, headache and anorexia. Fewer than 10% of participants experienced any other AE. The most common AEs in participants receiving the mRNA vaccine were injection site pain, injection site tenderness, malaise/fatigue, myalgia/muscle pain and headache. 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.

Vaxart Resolves Proxy Contest, Seeks Independent Director

Vaxart announced a resolution to the proxy contest in connection with the company's 2026 annual meeting of stockholders. Vaxart will initiate 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 Houle, Mark Silverberg, Matthew Wallace, Patrice Raffy, Marc Eustace Pereira and Q3 Nominees, the company will work with the stockholder group to identify a mutually agreeable candidate to be appointed to the board. The stockholder group has also agreed under the cooperation agreement to withdraw the director nominations of Houle, Silverberg and Wallace in connection with the 2026 annual meeting. The cooperation agreement additionally provides 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.

Vaxart Secures $29M Funding for Oral Vaccine Trial

Vaxart announced a contract modification releasing additional funding from the Biomedical Advanced Research and Development Authority to support its ongoing Phase 2b oral vaccine trial. Under the agreement, total available funding for the trial was adjusted to approximately $345M, reflecting a previously ordered enrollment reduction. The modification releases approximately $29M for trial completion and advanced data analysis, enabling Vaxart to report 12-month data from its 400-participant sentinel cohort in the coming weeks and 12-month data from its 5,085-participant main cohort in the first half of 2027. "This contract modification was a necessary step to unblinding and reporting the first set of data from our sentinel cohort and underscores our progress toward the completion and reporting of the full data set from this breakthrough study," said Steven Lo, CEO of Vaxart.