Release Date: November 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vaxart Inc (VXRT, Financial) has achieved several milestones in advancing its oral pill vaccine platform, particularly in its COVID-19 program.
- The company has received significant funding from BARDA, with a project valued at up to $456 million, indicating strong governmental support.
- Vaxart Inc (VXRT) has promising data from its Norovirus program, with constructive feedback from the FDA and presentations at major conferences.
- The company has a robust pipeline with potential multibillion-dollar market opportunities, including COVID-19, Norovirus, and HPV programs.
- Financially, Vaxart Inc (VXRT) reported increased revenue in Q3 2024 compared to the previous year and anticipates a cash runway into 2026.
Negative Points
- The FDA has requested new clinical data for the Norovirus program, which may delay progress.
- The COVID-19 phase two B study is still in early stages, with full enrollment expected to take about six months.
- There is uncertainty regarding the impact of new COVID-19 variants on the efficacy of Vaxart Inc (VXRT)'s vaccine candidates.
- The company has not provided specific timelines for IND filings for its next-generation Norovirus constructs.
- Vaxart Inc (VXRT) faces challenges in developing a Norovirus vaccine for infants, requiring creative approaches and further data.
Q & A Highlights
Q: Can you provide an update on the COVID-19 Phase 2 study, specifically regarding the interest level from investigators and enrollment progress?
A: Stephen Lowe, CEO: We are pleased with the enrollment progress for the 400 participants in the sentinel study. There is strong interest, and we are on track with our projections. We hope to announce an update soon when we reach the 400 participants mark.
Q: Are you planning an interim analysis for the Phase 2B COVID-19 study?
A: Dr. Sean Tucker, Chief Scientific Officer: We are considering an interim analysis to evaluate safety and efficacy signals. However, our focus is on completing the full study through the 12-month visit post-vaccination for all participants.
Q: Can you provide more details on the feedback from the FDA regarding the Norovirus program and the required new clinical data?
A: Dr. Sean Tucker, Chief Scientific Officer: We received constructive feedback from the FDA, which provided clarity on the requirements for a successful end-of-phase-two meeting. We are not discussing specific details at this time but feel confident about the path forward.
Q: What are the expectations for the DSMB 30-day safety analysis in the COVID-19 trial?
A: Dr. Sean Tucker, Chief Scientific Officer: We expect no safety concerns from the DSMB review, allowing us to continue enrollment. We are collecting saliva, nasal swabs, and PBMCs to analyze mucosal and systemic immune responses.
Q: Regarding the Norovirus program, what are the next logical steps?
A: Dr. Sean Tucker, Chief Scientific Officer: Our goal is to have an end-of-phase-two meeting with the FDA to discuss phase three and licensure requirements. We need to add more data to our package and will proceed thoughtfully to build a compelling case for the FDA.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
