Vaxart Highlights Progress of COVID-19, Norovirus and Influenza Programs

Core Insights - Vaxart is advancing its oral pill vaccine platform with significant developments in its COVID-19 and norovirus programs, aiming for key clinical milestones in the near future [2][3] COVID-19 Program Developments - An independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of the Phase 2b study after reviewing the 30-day safety data from the sentinel cohort [4] - The FDA is currently reviewing this safety data, and upon a favorable review, Vaxart plans to enroll approximately 10,000 participants for the next phase of the trial [5] - The primary efficacy analysis will occur 12 months post-vaccination for all participants [5] Norovirus Program Developments - Vaxart will initiate a Phase 1, open-label, dose-ranging clinical trial to evaluate its second-generation oral norovirus vaccine constructs against first-generation constructs, with topline data expected by mid-2025 [7][8] - If successful, a Phase 2 safety and immunogenicity study could begin as early as the second half of 2025, followed by a potential Phase 3 trial in 2026 [9] Influenza Program Developments - The company is advancing its avian influenza program, having created a new vaccine candidate to cover the latest clade 2.3.4.4b, with preclinical studies currently underway [10] Funding and Financial Outlook - Vaxart has received funding under Project NextGen, valued at up to $460.7 million, which will support its clinical and regulatory milestones into 2026 [6][11] - The company is exploring partnerships and non-dilutive funding options to extend its cash runway and maximize shareholder value [12] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines, including those for COVID-19, norovirus, and influenza, utilizing a proprietary delivery platform [13]