VXRT News & Events

Vaxart announced the publication in npj Vaccines of data from a double-blind, placebo-controlled Phase 1 trial evaluating a single-dose, oral bivalent vaccine candidate in post-partum, breastfeeding women. Topline safety and immunogenicity results in lactating women were initially reported in April 2024; the newly published study additionally shows vaccine-induced functional norovirus-specific antibodies in breastmilk and serum from vaccinated women, and norovirus-specific IgA in the stool of their breastfed infants. A positive correlation between levels of breast milk IgA and infant stool IgA was observed.

Dynavax Technologies (DVAX) and Vaxart (VXRT) announced that they have entered into an exclusive, worldwide license and collaboration agreement for Vaxart's investigational oral COVID-19 vaccine candidate. Vaxart's investigational oral vaccine candidate has a novel mechanism of action and delivery method relative to commercially available COVID-19 vaccines. The oral delivery approach is believed to induce mucosal immunity at respiratory tract entry points, potentially reducing infection, transmission and severity of disease. The oral vaccine delivery format has the potential to significantly improve patient acceptance, simplify distribution without cold chain requirements, and expand the accessibility and public health impact of COVID-19 vaccination. Under the terms of the agreement, Dynavax will pay Vaxart an upfront license fee of $25M and make a $5M equity investment in Vaxart and receive an exclusive, worldwide license to develop and commercialize oral COVID-19 vaccines based on Vaxart's delivery platform. Vaxart will retain full operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase 2b clinical trial and the subsequent End of Phase 2 meeting with the U.S. FDA. After receiving the data from the Phase 2b clinical trial, Dynavax has the right - but not the obligation - to elect whether to assume future clinical development of Vaxart's oral COVID-19 vaccine program. Dynavax has also agreed to make an additional payment to Vaxart should Dynavax elect to assume responsibility for the program.

Vaxart has withdrawn its reverse stock split proposal. "After careful consideration, we have decided to officially withdraw our reverse stock split proposal. Moving forward, we will continue to communicate frequently with our stockholders across multiple channels," said Steven Lo, Chief Executive Officer of Vaxart. "At the same time and more importantly, our team remains intensely focused on advancing the science behind our promising oral pill vaccine platform to create significant long-term value for all our stockholders."