• Revenue for 2024: $28.7 million, up from $7.4 million in 2023.
• Cash Equivalents and Investments: $51.7 million at the end of 2024.
• Cash Runway: Anticipated into the fourth quarter of 2025.
• Expense Reduction: Implemented measures including workforce reduction following BARDA stop work order.

• Warning! GuruFocus has detected 6 Warning Signs with VXRT.

Release Date: March 20, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Vaxart Inc (NASDAQ:VXRT) has developed a robust body of data across multiple clinical studies, demonstrating promising safety and immune response benefits of their oral vaccine platform.
• The company has initiated a Phase 1 trial for their second-generation oral Norovirus vaccine, which shows potential for improved potency over the first-generation constructs.
• Vaxart Inc (NASDAQ:VXRT) received a $460 million award to conduct a large-scale study comparing their COVID-19 vaccine candidate to an mRNA comparator, indicating significant external validation and support.
• The Norovirus vaccine program has shown promising efficacy in reducing infection rates and viral shedding, with a benign safety profile consistent with previous studies.
• The company is exploring strategic partnerships and non-dilutive funding options to extend their cash runway, demonstrating proactive financial management.

Negative Points

• A stop work order was issued for the BARDA-funded COVID-19 study, halting activities related to the planned 10,000 participant portion, creating uncertainty about the project's future.
• Vaxart Inc (NASDAQ:VXRT) had to implement expense reductions, including workforce reductions, due to the stop work order, indicating financial strain.
• There are no new updates on the 10,000 participant portion of the COVID-19 trial, leaving stakeholders in the dark about the project's progress.
• The company faces competition in the Norovirus vaccine market, with a competitor already in Phase 3 trials, potentially impacting market share.
• Vaxart Inc (NASDAQ:VXRT) ended 2024 with $51.7 million in cash equivalents and investments, which may not be sufficient to sustain operations without additional funding or partnerships.

Q & A Highlights

Q: Can you provide details on the new Phase 1 study for Norovirus, specifically whether the second-generation product is bivalent or monovalent, and the demographics of the trial participants? A: The Phase 1 study is enrolling participants aged 18 to 49. The second-generation product includes G11 and G24 constructs. Minor changes to the DNA backbone and antigen sequence have enhanced expression in intestinal epithelial cells, leading to greater immune responses in preclinical models. (James Cummings, Chief Medical Officer; Sean Tucker, Chief Scientific Officer)

Q: How might the greater immune response seen in animal data for the second-generation Norovirus vaccine translate to efficacy in humans? A: The expectation is that even a small increase in immune response in humans could significantly improve protective efficacy due to the exponential amplification of the signal. This is based on mathematical modeling of necessary antibodies in the intestinal space and serum. (Sean Tucker, Chief Scientific Officer)

Q: What immunogenicity measurements should be focused on for the Norovirus Phase 1 study, and how do they translate into protective efficacy? A: The study will measure serum Norovirus blocking antibody assay titers and fecal IgA, both of which correlated with protection in previous challenge studies. These are key indicators of efficacy. (Sean Tucker, Chief Scientific Officer)

Q: Has the FDA seen the data for the COVID-19 sentinel cohort, and what was their response? A: Yes, the data was sent to the FDA simultaneously with the DSMB. The DSMB recommended proceeding without modifications, underscoring the robust safety profile of the vaccine candidate. The FDA has reviewed the data, and there is no hold on moving the program forward. (James Cummings, Chief Medical Officer)

Q: How does the stop work order impact manufacturing for the COVID-19 trial, and what is the shelf life of the product? A: Vaxart maintains its own GMP manufacturing facilities in the U.S., allowing quick pivots in support of trials. The shelf life of the product is expected to last for two years, and the company is confident in adjusting to the stop work order as needed. (Ray Stapleton, Chief Technical Officer)

For the complete transcript of the earnings call, please refer to the full earnings call transcript.