Vaxart Inc Stock Price, News & Analysis

Vaxart (NASDAQ: VXRT) has received BARDA approval to begin dosing in the 10,000-participant portion of its Phase 2b clinical trial for its oral pill COVID-19 vaccine candidate. The double-blind, multi-center study will compare the efficacy, safety, and immunogenicity of Vaxart's oral vaccine to an approved mRNA COVID-19 vaccine in previously vaccinated adults.

The company expects to dose the first patient in Q2 2025. The trial is funded through Project NextGen, a $5 billion BARDA and NIAID initiative, with Vaxart's project award valued at up to $460.7 million through the Rapid Response Partnership Vehicle (RRPV) Consortium.

Vaxart (VXRT) has published complete data from its Phase 2b challenge study of its first-generation oral pill norovirus vaccine candidate in Science Translational Medicine. The study, involving 165 healthy adults, met five of six primary endpoints, demonstrating safety, efficacy, and immunogenicity. Key results include a 30% relative reduction in norovirus infection compared to placebo (p=0.003) and a 21% reduction in norovirus gastroenteritis. The vaccine showed significant increases in serum IgA, IgG, and norovirus-blocking antibodies. Machine learning analyses identified functional blocking antibody and fecal IgA as correlates of protection, which will inform the development of Vaxart's second-generation vaccine candidate. The company initiated a Phase 1 trial comparing first- and second-generation candidates in March 2025, with previous positive results in elderly adults and lactating mothers showing promising outcomes.

Vaxart (NASDAQ: VXRT) reported its Q1 2025 financial results and provided key business updates. The company has begun screening for the 10,000-participant portion of its COVID-19 Phase 2b trial, with dosing expected in Q2 2025. The trial's stop work order was lifted, with potential funding of up to $460.7 million under Project NextGen. Vaxart completed enrollment for its Phase 1 norovirus vaccine trial, with topline data expected mid-2025.

Financial highlights include Q1 2025 revenue of $20.9 million (vs $2.2M in Q1 2024), cash position of $41.9 million, and a reduced net loss of $15.6 million ($0.07 per share). The company appointed Jeroen Grasman as new CFO effective May 19, 2025. In preclinical developments, Vaxart's new avian influenza vaccine showed 100% protection in ferret studies.

Vaxart (NASDAQ: VXRT) has appointed Jeroen Grasman as its new Chief Financial Officer, effective May 19, 2025. Grasman, who brings over 20 years of biotech financial leadership experience, succeeds Phillip Lee, who is stepping down for personal reasons. Lee will remain with the company as a non-executive employee through June 1, 2025, to ensure a smooth transition.

Grasman most recently served as CFO at AltruBio from 2021 to 2025, where he led finance and operations for global clinical studies. His previous roles include VP of Finance and Operations at PACT Pharma, VP of Finance at Intarcia Therapeutics, and a 10-year tenure at Genentech. He holds an MSc in Applied Mathematics from Groningen University and an MBA from Harvard Business School.

Vaxart (VXRT) is addressing stockholder questions regarding a proposed reverse stock split ahead of its Annual Meeting on May 21, 2025. The company is seeking stockholder approval to implement a reverse split ratio between 1-for-5 and 1-for-50 to regain Nasdaq compliance, as its current share price of $0.42 (as of May 9, 2025) falls below the required $1.00 minimum bid price.

The company emphasizes that the reverse split won't change stockholders' investment value or cause dilution, but will result in fewer shares at a higher price. Both leading proxy advisory firms, ISS and Glass Lewis, support the proposal. Management stresses that maintaining Nasdaq listing is crucial for market visibility, trading volume, and future financing opportunities to advance their clinical programs for COVID-19 and norovirus.

The board intends to select a ratio just high enough to resolve the Nasdaq deficiency, with no current plans to implement the maximum 1:50 ratio.

Vaxart (VXRT) CEO Steven Lo issued a letter to stockholders highlighting recent developments and urging support for a reverse stock split proposal. Key updates include: the lifting of a government stop work order on April 24, 2025, allowing continuation of their COVID-19 vaccine clinical trial and potential BARDA funding. The company has completed enrollment of 60 participants in their norovirus program, with topline data expected mid-2025. Vaxart implemented strategic cost reductions, including workforce cuts, extending cash runway into 2026. The company seeks stockholder approval for a potential reverse stock split at the May 21, 2025 annual meeting to maintain Nasdaq listing compliance ($1.00 minimum bid requirement). Leading proxy advisors ISS and Glass Lewis recommend voting "FOR" the proposal. Management emphasizes they will only implement the split if necessary to avoid delisting.

Vaxart (NASDAQ: VXRT) has scheduled its first quarter 2025 business update and financial results conference call for May 13, 2025, at 4:30 p.m. ET, following the market close. The company's senior management team will host the conference call, which will be accessible via webcast and telephone. Investors can participate using domestic line (877) 407-0832 or international line (201) 689-8433 with Conference ID 13753354. Investors may submit questions in advance to ir@vaxart.com by May 12, 2025. A replay of the webcast will be available on Vaxart's website after the event.

Vaxart (NASDAQ: VXRT) has announced its upcoming participation in the Citizens Life Sciences Conference, scheduled for May 7-8, 2025. The company's management team will deliver a presentation on Wednesday, May 7 at 1:00 PM ET.

The presentation will be accessible through a live webcast on Vaxart's official website (www.vaxart.com). For those unable to attend the live session, a replay will remain available for 30 days after the event.

Institutional investors interested in engaging with the management team during the conference can coordinate through their Citizens representative.

Vaxart has completed enrollment in its Phase 1 clinical trial comparing second-generation and first-generation oral norovirus vaccine constructs. The company expects to release topline data in mid-2025.

The open-label, dose-ranging study will evaluate safety and immune parameters that previously correlated with protection in a completed norovirus challenge study. A Data and Safety Monitoring Board has reviewed interim safety data and recommended continuing the study without modifications.

CEO Steven Lo emphasized the significant unmet need for a norovirus vaccine, expressing optimism about the potential increased potency of their second-generation constructs. Pending successful Phase 1 results and securing partnership or funding, Vaxart plans to:

• Launch Phase 2 safety and immunogenicity study in late 2025
• Hold End of Phase 2 meeting with FDA
• Potentially begin Phase 3 trials in 2026