- **COVID-19 Trial Resumes**: 10,000-participant Phase 2b study to begin dosing in Q2 2025, with enrollment expected in 5-6 months.
- **Norovirus Data Watch**: Phase 1 results in mid-2025 could enable Phase 2b trial with strategic partners.
- **Avian Flu Breakthrough**: 100% survival in preclinical model, advancing toward clinical studies.
- **Financial Stability**: $41.9 million cash balance, extended runway to Q1 2026 via cost-cutting and BARDA funding.
- **Listing Risk**: Reverse stock split proposal to avoid NASDAQ delisting, contingent on shareholder approval.

**【Management Opening Remarks】**
- CEO Steven Lo announced the lifting of the stop work order on the 10,000-participant portion of the COVID-19 Phase 2b trial, resuming patient screening and dosing in Q2 2025. The trial remains under the original $460.7 million BARDA contract.
- CFO Phillip Lee resigned for personal reasons, with Jeroen Grasman set to join as incoming CFO. The company implemented workforce reductions to extend cash runway into Q1 2026.
- Vaxart faces a potential reverse stock split to avoid NASDAQ delisting, contingent on shareholder approval at the May 21 annual meeting.

**【COVID-19 Clinical Program Update】**
- CMO James Cummings detailed the 10,000-participant trial comparing KP2 oral vaccine to mRNA comparator, with enrollment expected to take 5-6 months post-dosing initiation. The 400-participant sentinel cohort (XBB vs. mRNA comparator) is completing 12-month follow-up.
- The company anticipates Phase 2b safety and efficacy data in late 2025, with potential for mucosal immunity advantages over injected vaccines.

**【Norovirus Clinical Program Update】**
- Phase 1 open-label trial of second-generation norovirus vaccine completed enrollment of 60 participants, with top-line data expected in mid-2025. The study compares safety and immunogenicity against the first-generation construct.
- Positive Phase 1 results could lead to a Phase 2b trial in H2 2025, requiring strategic partnerships for further development.

**【Avian Flu Preclinical Program】**
- CSO Sean Tucker reported 100% survival in a ferret challenge model for the avian flu vaccine candidate, with plans to publish preclinical data in 2025. The VAAST platform enables rapid vaccine development against emerging pathogens.

**【Financial Highlights】**
- Q1 2025 revenue: $20.9 million (vs. $2.2 million in Q1 2024), driven by BARDA contract payments. Cash balance: $41.9 million, with cash runway extended to Q1 2026 through cost-cutting and non-dilutive funding pursuits.
- No ATM share sales since March 2025, with management emphasizing undervaluation and avoidance of dilutive financing.

**【Q&A Key Highlights】**
- **COVID-19 Enrollment Timeline**: 5-6 months for 10,000 participants, with 20 sites activated and 199 patients in screening.
- **Norovirus Phase 1 Success Criteria**: Improved immunogenicity trends (e.g., functional antibodies, fecal IgA) for second-generation construct.
- **Partnership Strategy**: Actively engaging with global and regional vaccine companies, with interest driven by oral delivery and second-generation data.
- **Reverse Stock Split Rationale**: Necessary to maintain NASDAQ listing and avoid OTC liquidity risks, with ratio to be determined post-approval.


Vaxart, Inc. (VXRT) Q1 2025 Earnings Call Transcript

- **Norovirus Innovation**: 2nd-gen constructs show 2x+ immune response in preclinical models; Phase 1 trial underway to validate dose-sparing potential.
- **COVID-19 Regulatory Risk**: 10,000-patient study halted; 400-patient sentinel cohort continues as company navigates HHS review.
- **Financial Resilience**: $51.7M cash balance post-Q1 layoffs; targeting Q4 2025 cash runway with strategic partnerships.

**【CEO Business Update】**
- **COVID-19 Program**: $460M BARDA-funded 10,000-patient head-to-head study paused due to HHS stop work order, impacting Phase 2b expansion. Sentinel cohort of 400 remains active. Company adjusting expenses to extend cash runway.
- **Norovirus Program**: Initiated Phase 1 trial comparing 2nd-gen (GI.1/GII.4) vs 1st-gen constructs. 2nd-gen shows higher antigen expression in preclinical models, targeting mid-2025 top-line data. No approved norovirus vaccines exist; $10B US economic burden.
- **Preclinical Pipeline**: Evaluating avian influenza (new clade 2.3.4.4b construct) and HPV programs. 19 clinical trials across 7 viruses demonstrate favorable safety profile.

**【CMO & CSO Norovirus Insights】**
- **Phase 1 Trial Design**: 60 participants (18-49yo) testing low/high doses of 2nd-gen vs 1st-gen. Key endpoints: serum NBAA titers and fecal IgA levels. Preclinical data shows 2nd-gen constructs induce stronger immune responses.
- **Clinical Validation**: 2024 Phase 2 challenge study showed vaccine reduced infection rates and viral shedding. Lactating mothers trial demonstrated passive infant protection via antibodies.
- **Publication Highlights**: Science Translational Medicine featured robust mucosal immunity in older adults and cross-reactive antibody responses post-vaccination.

**【CFO Financial Overview】**
- **2024 Revenue**: $28.7M (vs $7.4M in 2023), driven by BARDA contracts and Inavir royalties.
- **Cash Position**: $51.7M as of Q4 2024. Q1 2025 workforce reduction extended cash runway to Q4 2025. Exploring partnerships, non-dilutive funding, and cost optimization.
- **2025 Outlook**: Focus on advancing multiple programs with existing cash, pending external funding opportunities.

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