Vaxart (VXRT) Q3 2024 earnings summary

Executive summary

• Advanced oral pill vaccine platform with lead programs in COVID-19, norovirus, and influenza, and a preclinical HPV therapeutic vaccine candidate; milestones achieved in COVID-19, norovirus, and HPV programs.

• Initiated enrollment of 400-participant sentinel cohort for Phase 2b COVID-19 oral vaccine trial, with completion expected in November 2024; next phase contingent on favorable safety review by FDA and DSMB.

• BARDA partnership supports COVID-19 phase II-B trial, with strong enrollment and robust demand for vaccines.

• Norovirus program received constructive FDA feedback; new constructs show improved potency in preclinical models.

• HPV vaccine constructs demonstrated promising preclinical efficacy in animal models and published preclinical data on mucosal vaccine technology for HPV-related cervical dysplasia.

Financial highlights

• Q3 2024 revenue was $4.9 million, up from $2.1 million in Q3 2023, mainly from BARDA contracts; nine-month revenue was $13.5 million, up from $4.1 million year-over-year.

• Net loss for Q3 2024 was $14.1 million ($0.06/share), improving from $17.4 million ($0.11/share) in Q3 2023; nine-month net loss was $55.0 million, down from $65.1 million year-over-year.

• Operating expenses for Q3 2024 were $19.4 million, down 3% year-over-year; R&D expenses were flat at $15.1 million, while G&A decreased 12% to $4.3 million.

• Ended Q3 2024 with $58.7 million in cash, cash equivalents, and investments.

• Cash used in operations for the nine months ended September 30, 2024, was $37.4 million, down from $56.9 million in the prior year period.

Outlook and guidance

• Plans to complete Sentinel cohort dosing for COVID-19 phase II-B trial soon, with full enrollment expected in about six months; expects to begin enrolling 10,000 participants in early 2025 pending safety review.

• Ongoing preclinical work on avian flu, seasonal flu, and HPV; strategic prioritization based on market and resource factors.

• Management expects existing funds to provide runway into 2026, with further capital needs dependent on business development, government funding, and potential partnerships.

• Significant future funding is expected from HHS BARDA contracts, but continued funding is subject to government decisions and contract milestones.

• Continues to advance norovirus program with new constructs and ongoing regulatory discussions.