Vaxart Q2 Earnings Call Highlights

Vaxart reported favorable 12-month safety data from its 400-person Phase II-B COVID-19 vaccine sentinel cohort, with no vaccine-related serious complications. The larger, roughly 5,000-participant cohort is fully enrolled, with top-line data expected in the first half of 2027, pending BARDA approval. BARDA provided $29 million to fund expanded safety, immunogenicity and efficacy analyses, including mucosal antibody testing, cellular biomarkers and genomic sequencing across the main study cohort. Vaxart ended Q2 2026 with $64 million in cash and short-term investments, enough to fund operations into Q2 2027 under its current plan. The company is still seeking a norovirus vaccine partner and has revised board leadership and committee structures following a shareholder cooperation agreement. Vaxart’s Phase II-B COVID-19 study is funded through the Biomedical Advanced Research and Development Authority’s, or BARDA’s, Project NextGen initiative. Chief Medical Officer Dr. James F. Cummings said the Sentinel cohort was designed primarily to evaluate safety before expansion into the larger study population. In the cohort, 201 participants received Vaxart’s oral COVID-19 vaccine candidate targeting the XBB variant, while 199 received an approved injectable mRNA vaccine comparator. According to Cummings, there were no vaccine-related serious health complications and no severe or long-lasting adverse events in either group over the 12-month period. The most commonly reported side effects among oral-vaccine recipients were mild-to-moderate fatigue, reported by 20.9% of participants; headache, reported by 18.9%; and loss of appetite, reported by about 10%. Fewer than 10% of oral-vaccine recipients reported other side effects, he said. Among mRNA vaccine recipients, more than 60% reported injection-site pain, while 40.2% reported injection-site tenderness. Other reported side effects included fatigue in 35.2% of participants, muscle pain in 33.2%, and headache in 28.6%. Cummings said between 10% and 15% of mRNA recipients reported joint pain, chills, nausea, diarrhea and arm swelling. There were 33 symptomatic COVID-19 cases in the oral-vaccine arm and 30 in the mRNA comparator arm. Each group recorded 12 asymptomatic cases. However, Cummings emphasized that the 400-person Sentinel cohort was not designed or powered to establish statistically significant differences in vaccine efficacy. The larger main cohort, which was vaccinated against the KP.2 variant and is fully enrolled, is intended to evaluate comparative safety and relative efficacy. Vaxart expects the complete data set, including the Sentinel and main cohorts, to be released in the first half of 2027, subject to BARDA approval of the timing and content of disclosures. Chief Executive Officer Steve Lo said a June contract modification with BARDA released dedicated funding for additional scientific analyses. Cummings said $29 million under the modification will support final study execution as well as expanded exploratory safety, immunogenicity and efficacy analyses. Those analyses include deeper sub-variant genomic sequencing and extended mucosal and.