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Mar 31, 2024
Vaxart Q1 2024 Earnings Report
Vaxart reported first quarter 2024 financial results and provided a business update.
Key Takeaways
Vaxart announced positive topline results from its Phase 1 trial of an oral pill bivalent norovirus candidate focused on lactating mothers. They also anticipate initiating a Phase 2b study evaluating their XBB COVID-19 vaccine candidate as early as the second quarter of 2024.
Positive results from Phase 1 norovirus study in lactating mothers indicate the potential of Vaxart’s oral pill vaccine candidate to protect or reduce the effect of the disease in infants
Expects to initiate Phase 2b study evaluating Vaxart’s oral pill XBB COVID-19 vaccine against an approved mRNA vaccine comparator as early as the second quarter of 2024
Anticipates meeting with the FDA in mid-2024 to evaluate clinical data and discuss next steps for its norovirus program
Antibodies to norovirus rose on average 4.0 fold in response to the GI.1 virus strain and 6.0 fold in response to the GII.4 virus strain in the breastmilk of lactating mothers who received the Vaxart vaccine candidate in the high dose group.
Vaxart
Vaxart
Forward Guidance
Vaxart anticipates initiating the Phase 2b trial as early as the second quarter of 2024 and meeting with the FDA in mid-2024 to evaluate clinical data and discuss next steps for its norovirus program.
Positive Outlook
- Positive results from Phase 1 norovirus study
- Potential of oral pill vaccine to protect infants
- Initiating Phase 2b study for XBB COVID-19 vaccine
- Meeting with the FDA to evaluate norovirus program
- Recent preclinical data suggests COVID-19 XBB construct showed a more robust immunogenic response
Challenges Ahead
- Uncertainties inherent in research and development
- Risk of unfavorable new clinical data
- Clinical trial data are subject to differing interpretations
- Vaxart may not be able to obtain, maintain, and enforce necessary patent
- Vaxart's capital resources may be inadequate