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Vaxart, Inc. (NASDAQ:VXRT), a biotechnology company specializing in the development of oral recombinant vaccines with a market capitalization of approximately $159 million, announced on Monday an amendment to its funding agreement with Advanced Technology International, which is backed by the Biomedical Advanced Research and Development Authority (BARDA). According to InvestingPro data, the company maintains a relatively strong balance sheet with more cash than debt, though it faces challenges with cash burn rates. The modification, dated February 7, 2025, significantly increases the financial support for the ongoing Phase 2b clinical trial of the company’s oral COVID-19 vaccine candidate.
This latest modification adds approximately $105.9 million to the project, bringing the total available funding to around $240.1 million. The trial aims to evaluate the efficacy and safety of Vaxart’s oral pill vaccine, comparing it against an mRNA vaccine that has received U.S. Food and Drug Administration approval.
Vaxart has completed enrollment for the initial part of the study, which involved around 400 participants and focused on the company’s oral pill XBB vaccine candidate. An independent data safety monitoring board has recommended the study continue without changes after a preliminary 30-day safety assessment.
The next phase of the trial will test the company’s KP.2 oral vaccine candidate against an mRNA vaccine targeting the same variant, with a planned enrollment of 10,000 participants. Vaxart is currently awaiting BARDA’s approval to start dosing in this portion of the trial.
The SEC filing by Vaxart provides a detailed account of the funding increase and trial plans, ensuring transparency in its reporting. However, the company also cautions that forward-looking statements related to clinical development and regulatory plans, as well as the anticipated outcomes and timings, involve risks and uncertainties that could cause actual results to differ.
The financial and strategic implications of this expanded funding and trial are significant for Vaxart, as it continues to advance its oral vaccine technology. This development marks a substantial step forward in the company’s efforts to provide an alternative to injectable vaccines in the fight against COVID-19. Based on InvestingPro analysis, the company appears undervalued compared to its Fair Value, though analysts have recently revised their earnings expectations downward. With revenue growth forecast at 166% for FY2024, investors seeking detailed insights can access comprehensive analysis and additional ProTips through InvestingPro’s detailed research report, available among its coverage of 1,400+ US equities.
In other recent news, Vaxart, Inc. has seen significant developments in its operations. The company has appointed Kevin Finney, a seasoned healthcare executive, to its Board of Directors, replacing Robert A. Yedid. The company has also advanced its Phase 2b COVID-19 vaccine trial, following a recommendation from an independent Data and Safety Monitoring Board. Vaxart has been granted an extension until June 30, 2025, to regain Nasdaq compliance by lifting its stock price to at least $1.00 for 10 consecutive business days.
Furthermore, Vaxart has secured an additional $4.6 million for the Phase 2b trial of its oral COVID-19 vaccine candidate, boosting the total funding to approximately $460.7 million. In terms of financial growth, the company reported an increase in revenue to $4.9 million for the third quarter of 2024, up from $2.1 million in the same period the previous year.
These recent developments reflect Vaxart’s strategic execution in its mission to develop oral vaccines. As the company continues to make strides in its vaccine programs, it remains committed to meeting key clinical and regulatory milestones.
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