Vaxart Secures Additional Funding for Oral COVID-19 Vaccine Candidate

Just days ago, it seemed that Vaxart's oral COVID-19 vaccine candidate was poised to make significant strides in its development journey. Now, with the company's announcement of a modification to its Project Agreement, investors can expect even greater progress. The Biomedical Advanced Research and Development Authority (BARDA) has increased the total estimated ceiling for funding to approximately $460.7 million, a rise of about $4.6 million. This additional funding will significantly impact the timeline and completion of the Phase 2b comparative study, as well as the regulatory approval process for Vaxart's oral COVID vaccine candidate.

In an 8-K filing with the Securities and Exchange Commission dated December 20, 2024, Vaxart announced the modification to its Project Agreement. The additional funding will be allocated for two primary purposes: acquiring and distributing the mRNA comparator and other clinical materials to clinical sites involved in the trial, and supporting clinical trial site readiness for the main efficacy and safety phase of the study.

The increased funding for clinical trial site readiness can enhance the main efficacy and safety portion of the Trial in several ways. First, it can help clinical sites better prepare for the trial, ensuring they have the necessary resources, such as trained staff, adequate facilities, and proper equipment. This can lead to improved patient recruitment and retention, faster trial initiation and completion, and ultimately, better data quality and integrity.

The additional funding allocated for acquiring and distributing the mRNA comparator and other clinical materials will significantly impact the trial's efficiency and accuracy. It will ensure an adequate supply of the comparator vaccine, streamline distribution, and support clinical site preparation. This can help minimize delays, maintain the integrity of the study, and enhance the statistical power of the trial.

The increased funding could also have a significant impact on the regulatory approval process for Vaxart's oral COVID vaccine candidate. With the additional resources, Vaxart may be able to accelerate the trial timeline, enabling it to submit its regulatory application sooner. This could potentially lead to a faster regulatory review process. Additionally, the increased funding could help Vaxart invest more resources in building and maintaining strong relationships with regulatory authorities, ensuring compliance with all regulatory requirements and submitting well-received applications.

In conclusion, the additional funding for Vaxart's oral COVID-19 vaccine candidate, as outlined in the modification to its Project Agreement, can significantly enhance the timeline and completion of the Phase 2b comparative study, as well as the regulatory approval process. This increased funding can help Vaxart better prepare clinical sites, ensure adequate supply of clinical materials, and ultimately, bring its oral COVID vaccine candidate to market more quickly and efficiently.



Vaxart shares were up 15% in premarket trading Thursday, to $15. That brings the stock above the $14.50 price point at which it closed on Monday, following the announcement of the Project Agreement modification. At the time of writing, Vaxart's stock has gained 50% so far this year and 70% over the past 12 months. In a note on Wednesday, J.P. Morgan analyst Eric Joseph wrote that Vaxart expects to complete its submission of data on the manufacturing changes and receive an emergency-use authorization within “weeks.”