Core Insights - Vaxart has entered into an exclusive license agreement with Dynavax for its COVID-19 oral pill vaccine candidate, potentially generating up to $700 million in cumulative proceeds plus royalties [1][4][3] - The company has completed enrollment of approximately 5,400 participants in its COVID-19 Phase 2b trial, with topline data expected in late 2026 and data from a 400-person sentinel cohort anticipated in the first quarter of 2026 [1][9] - Vaxart reported positive data from its Phase 1 clinical trial for its second-generation oral norovirus vaccine, indicating improved protection against infection [1][3] COVID-19 Vaccine Developments - The exclusive agreement with Dynavax includes a $25 million upfront license fee and a $5 million equity investment, with additional potential payments of $50 million and up to $195 million in regulatory milestone payments [4] - Vaxart retains operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase 2b clinical trial [4] - The company has received $125.9 million in cash payments associated with its COVID-19 vaccine program as of September 30, 2025 [9] Norovirus Vaccine Developments - Vaxart's second-generation oral pill norovirus vaccine constructs have shown significantly stronger antibody responses compared to first-generation constructs [3][9] - The company plans to publish complete results of the Phase 1 study in a peer-reviewed journal and is exploring partnership opportunities for its norovirus candidate [3][9] Financial Results for Q3 2025 - Vaxart reported revenue of $72.4 million for Q3 2025, a significant increase from $4.9 million in Q3 2024, primarily from government contracts [9][15] - Research and development expenses rose to $75.9 million in Q3 2025 from $15.1 million in Q3 2024, mainly due to increased clinical trial expenses [9][15] - The net loss for Q3 2025 was $8.1 million, an improvement from a net loss of $14.1 million in Q3 2024, with a net loss per share of $0.04 compared to $0.06 [9][15] Cash Position and Runway - As of September 30, 2025, Vaxart had cash, cash equivalents, and investments totaling $28.8 million, with a current runway extended into the second quarter of 2027 following the Dynavax agreement [1][9]

"We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025," said Steven Lo, Chief Executive Officer of Vaxart. "We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program." The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designe ...

Company Overview - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company aims to provide vaccines that can be administered in pill form, eliminating the need for refrigeration and reducing the risk of needle-stick injuries [6] Clinical Trial Progress - Vaxart has completed enrollment for its Phase 1 clinical trial of its second-generation oral norovirus vaccine constructs, which are being evaluated against first-generation constructs [2][3] - The Phase 1 trial is designed to assess safety and immune responses correlated with protection from norovirus, a leading cause of acute gastroenteritis globally [3] Future Development Plans - If the Phase 1 trial is successful, Vaxart plans to initiate a Phase 2 safety and immunogenicity study potentially starting in the second half of 2025, followed by an End of Phase 2 meeting with the FDA [5] - A Phase 3 trial could commence as early as 2026, contingent on successful outcomes and potential partnerships or funding [5] Safety Review - An independent Data and Safety Monitoring Board (DSMB) conducted an interim safety review and recommended that the study continue without modifications [4] Market Need - The development of Vaxart's oral norovirus vaccine is driven by a significant unmet public health need, as norovirus is a major cause of gastroenteritis worldwide [3]