8-K: Vaxart, Dynavax Partner on Oral COVID-19 Vaccine

Vaxart and Dynavax Technologies Corporation have entered an exclusive worldwide license and collaboration agreement for Vaxart's investigational oral COVID-19 vaccine candidate.

Summary

• Vaxart, Inc. entered into an Exclusive License and Collaboration Agreement with Dynavax Technologies Corporation on November 4, 2025.
• Dynavax receives an exclusive, worldwide license to develop and commercialize Vaxart's investigational oral vaccine candidate for SARS-CoV-2, SARS coronavirus, MERS coronavirus, and other coronaviruses.
• Vaxart retains rights to its oral delivery platform and vaccine constructs for all indications other than the licensed coronavirus indications.
• Vaxart will continue to develop the Vaccine Candidate by conducting and completing its ongoing Phase 2b clinical trial and fulfilling obligations under its Project NextGen/BARDA award.
• Dynavax will pay Vaxart an upfront license fee of $25 million.
• Dynavax will purchase 11,111,111 shares of Vaxart's common stock at a price of $0.45 per share, for an aggregate purchase price of approximately $5 million.
• Following Vaxart's Phase 2b completion and a planned End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), Dynavax has the right, in its sole discretion, to elect to assume responsibility for continued development.
• If Dynavax elects to assume responsibility, it will pay Vaxart an additional fee of $50 million.
• Vaxart may also be entitled to receive up to $195 million in regulatory milestone payments, up to $425 million in net sales milestone payments, and tiered royalties at rates in the low-to-mid teens on net sales.
• The Phase 2b clinical trial has completed enrollment of approximately 5,400 participants, with topline data results expected in late 2026.

Sentiment

Score: 8

Explanation: The agreement provides significant non-dilutive upfront cash, a strategic equity investment, and a clear path for the oral COVID-19 vaccine candidate with a strong partner. While future payments are contingent, the potential upside is substantial, and the partnership validates Vaxart's platform. The phased approach by Dynavax mitigates some risk for them but still offers Vaxart a strong financial incentive.

Positives

• Secured an upfront license fee of $25 million from Dynavax, providing immediate capital.
• Received a $5 million equity investment from Dynavax, demonstrating partner confidence and providing additional capital.
• Potential for significant future payments, including an additional $50 million fee if Dynavax continues development, up to $195 million in regulatory milestones, and up to $425 million in net sales milestones.
• Entitlement to tiered royalties in the low-to-mid teens on net sales of licensed oral vaccines.
• Partnership with Dynavax, a commercial-stage biopharmaceutical company, provides late-stage expertise and potential for broader market access and commercialization.
• Vaxart retains full operational and financial responsibility for the oral COVID-19 vaccine program through Phase 2b completion, ensuring continued control over early development.
• The oral vaccine platform offers potential advantages like needle-free delivery, room-temperature stability, and mucosal immunity, which could improve patient acceptance and global distribution.

Negatives

• The License Agreement will terminate if Dynavax does not elect to assume responsibility for continued development after the Phase 2b trial and EOP2 meeting.
• Future milestone and royalty payments are contingent on Dynavax's election and successful clinical development, regulatory approval, and commercialization, which are subject to substantial risks and uncertainties.
• The equity investment involves selling 11,111,111 shares, which could lead to some dilution for existing shareholders.
• Topline data from the Phase 2b trial is not expected until late 2026, indicating a long development timeline before Dynavax's decision point.

Risks

• Uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates.
• Possibility of unfavorable new clinical data and further analyses of existing clinical data.
• Clinical trial data are subject to differing interpretations and assessments by regulatory authorities.
• Regulatory authorities may not be satisfied with the design of and results from the clinical studies.
• Decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of the oral COVID-19 vaccine candidate.
• Product candidates may not be approved by the FDA or non-U.S. regulatory authorities.
• Even if approved, the COVID-19 vaccine candidate may not achieve broad market acceptance.
• Uncertainty regarding the success of the collaboration with Dynavax.
• Uncertainty whether Dynavax will elect to assume responsibility for continued clinical development of the oral COVID-19 vaccine program.
• Competitive developments in the vaccine market.

Future Outlook

Vaxart will continue to lead and fund the development of its oral COVID-19 vaccine candidate through the completion of its ongoing Phase 2b clinical trial and a planned End-of-Phase 2 (EOP2) meeting with the FDA. Following this, Dynavax has the sole discretion to elect to assume responsibility for the continued clinical development and commercialization of the vaccine candidate. Topline data from the Phase 2b trial is expected in late 2026.

Management Comments

• "This collaboration exemplifies our disciplined approach to external innovation and long-term value creation. COVID-19 continues to cause significant levels of severe illness, hospitalization, and death each year. Vaxart's oral vaccine candidate represents what we believe is a differentiated and potentially transformative approach to improve protection, and reduce local and systemic adverse events with needle-free delivery." Ryan Spencer, Chief Executive Officer of Dynavax.
• "The agreement provides us with an exclusive license to a novel program while limiting our overall committed financial obligations. This gives Dynavax the opportunity to evaluate Phase 2b data before further committing to invest in late-stage development. This phased approach complements the strong growth trajectory of HEPLISAV-B and aligns with our commitment to building a diversified, sustainable vaccine portfolio." Ryan Spencer, Chief Executive Officer of Dynavax.
• "We are excited to partner with Dynavax. This agreement provides a clear and well-funded path forward for our oral vaccine platform in COVID-19." Steven Lo, Chief Executive Officer of Vaxart.
• "Dynavax's investment and late-stage expertise provide critical support for our technology. We are confident in our ability to complete the ongoing Phase 2b trial, and look forward to delivering a robust data package that could unlock the full potential of this collaboration and demonstrate the value of our oral vaccine platform." Steven Lo, Chief Executive Officer of Vaxart.

Industry Context

The collaboration addresses the long-term need for easily administered COVID-19 vaccine options, leveraging Vaxart's novel oral delivery platform which aims to induce mucosal immunity at respiratory tract entry points. This approach offers potential advantages over traditional injectable vaccines, such as needle-free administration, simplified distribution without cold chain requirements, and expanded accessibility, aligning with broader trends towards more convenient and globally distributable vaccine technologies. Dynavax, a commercial-stage company with an existing vaccine (HEPLISAV-B) and adjuvant (CpG 1018) in its portfolio, seeks to diversify its vaccine offerings and capitalize on the ongoing demand for COVID-19 protection.

Comparison to Industry Standards

• NA

Stakeholder Impact

• Shareholders: Potential for significant value creation through upfront payments, equity investment, and future milestones/royalties. The equity sale provides capital but also involves some dilution.
• Employees: Continued funding and strategic partnership support ongoing development efforts and job security related to the oral COVID-19 vaccine program.
• Customers/Public: Potential for a novel, easily administered oral COVID-19 vaccine that could improve accessibility, compliance, and public health outcomes, especially given its room-temperature stability and needle-free delivery.
• Creditors: Improved financial position through upfront payments and potential future revenues could enhance creditworthiness.

Next Steps

• Vaxart to continue developing the Vaccine Candidate by conducting and completing its ongoing Phase 2b clinical trial.
• Vaxart to perform obligations under its Project NextGen/BARDA award and related agreements.
• Vaxart to conduct additional development and manufacturing activities related to the Vaccine Candidate as agreed with Dynavax.
• Completion of the Phase 2b clinical trial and a planned End-of-Phase 2 (EOP2) meeting with the FDA.
• Dynavax to decide whether to elect to assume responsibility for the continued development of the Vaccine Candidate after Phase 2b data and EOP2 meeting.
• Closing of the Securities Purchase Agreement transactions expected on or about November 6, 2025.
• Topline data results from the Phase 2b clinical trial are expected in late 2026.
• The License Agreement and Purchase Agreement will be filed as exhibits to Vaxart's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025.

Key Dates

Recommendation

The agreement provides Vaxart with immediate capital ($30 million total from upfront fee and equity investment) and a clear, funded pathway for its oral COVID-19 vaccine candidate through Phase 2b. Partnering with Dynavax, a commercial-stage vaccine company, significantly de-risks future development and commercialization, offering substantial potential milestone payments (up to $620 million) and royalties. This strategic validation and financial injection are highly positive for a clinical-stage biotech, positioning the company for significant long-term growth if the vaccine progresses.

Keywords

Vaxart, Dynavax, COVID-19 vaccine, oral vaccine, license agreement, collaboration, biotechnology, clinical trial, Phase 2b, FDA, BARDA, Project NextGen, SARS-CoV-2, mucosal immunity, vaccine delivery platform, equity investment, biopharmaceutical