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SOUTH SAN FRANCISCO - Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company with a market capitalization of approximately $90 million and shares down nearly 49% over the past year, announced Wednesday that its second-generation oral pill norovirus vaccine candidates demonstrated significantly higher antibody responses compared to first-generation constructs in a Phase 1 clinical trial. According to InvestingPro analysis, the company maintains a favorable cash-to-debt position despite ongoing development costs.
The open-label trial involving 60 healthy volunteers showed the second-generation constructs produced a 141% increase in GI.1 norovirus blocking antibodies and a 94% increase in GII.4 norovirus blocking antibodies at the higher dose level, compared to first-generation constructs.
These increases were statistically significant despite the study not being specifically powered to demonstrate superiority. The vaccine candidates were reported as safe and well-tolerated across all dose groups with no vaccine-related serious adverse events.
"The significant increases in NBAA titers reported today give us high confidence that our second-generation constructs will provide even greater protection against infection," said Sean Tucker, Vaxart’s Founder and Chief Scientific Officer, in the press release.
Vaxart’s oral pill technology works by inducing expression of antigen proteins in intestinal cells. The second-generation technology, developed in 2023-2024, was designed to increase antigen protein expression levels and improve manufacturability.
The company indicated it plans to incorporate these results into discussions with potential partners. With partnership or other funding, Vaxart expects to conduct a Phase 2b safety and immunogenicity study potentially beginning in the second half of 2025, followed by an End of Phase 2 meeting with the FDA. InvestingPro data reveals the company’s current financial health score is rated as "FAIR," with analysts anticipating continued investment in research and development through 2025.
Currently, there is no approved vaccine against norovirus, which causes approximately 685 million infections globally each year, including 20 million in the United States, with an estimated economic burden of $60 billion worldwide. With analyst price targets ranging from $2 to $8 per share, investors seeking deeper insights can access comprehensive financial analysis and additional ProTips through InvestingPro’s detailed research reports.
In other recent news, Vaxart, Inc. has announced several developments aimed at maintaining its position on the Nasdaq stock exchange. The company is seeking shareholder approval for a reverse stock split, a move designed to meet Nasdaq’s minimum bid price requirements. This proposal has garnered support from proxy advisory firms Institutional Shareholder Services and Glass Lewis. Vaxart is also advancing its COVID-19 vaccine efforts with approval from the U.S. government’s Biomedical Advanced Research and Development Authority to expand its Phase 2b clinical trial, which will include 10,000 participants. This trial is part of a broader initiative funded by Project NextGen, potentially providing Vaxart with up to $460.7 million.
In addition, Vaxart has appointed Jeroen Grasman as its new Chief Financial Officer, effective May 19, 2025, succeeding Phillip Lee. Grasman brings over two decades of financial leadership experience in the biotech industry. The company has also implemented strategic cost reductions, including workforce cuts, to extend its cash runway into 2026. Vaxart’s President and CEO, Steven Lo, emphasized the importance of these measures for maintaining liquidity and access to institutional investors. The company continues to focus on its oral recombinant vaccine platform, developing candidates for diseases such as coronavirus, norovirus, influenza, and HPV.
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