Vaxart gets nod to expand COVID-19 pill vaccine trial

Published 15/05/2025, 13:06
Vaxart gets nod to expand COVID-19 pill vaccine trial

SOUTH SAN FRANCISCO – Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company with a current market capitalization of $91 million, has received authorization from the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) to begin dosing participants in a significant segment of its Phase 2b clinical trial for an oral COVID-19 vaccine. The trial will now include 10,000 individuals, with the first patient expected to be dosed in the second quarter of 2025. According to InvestingPro analysis, the company maintains a favorable cash position relative to its debt, though it’s currently experiencing rapid cash burn.

The study, which is a double-blind, multi-center, randomized, comparator-controlled trial, aims to evaluate the efficacy, safety, and immune response of Vaxart’s oral vaccine candidate in comparison to an approved mRNA COVID-19 vaccine in previously vaccinated adults. While the company’s stock has seen a strong return over the past month, InvestingPro data indicates significant volatility, with the share price currently trading below its Fair Value.

Funding for this trial comes from Project NextGen, a BARDA and National Institute of Allergy and Infectious Diseases (NIAID) initiative with a budget of $5 billion. The project’s goal is to accelerate the development of innovative COVID-19 vaccines and treatments. Vaxart’s award through the Rapid Response Partnership Vehicle (RRPV) Consortium could total up to $460.7 million.

Vaxart is a biotechnology firm focused on creating oral recombinant vaccines using its proprietary delivery platform. The company’s vaccines are formulated as pills, which can be distributed without the need for refrigeration and avoid needle-stick injuries. Vaxart’s pipeline includes vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV). With revenue of $47.4 million in the last twelve months and an overall Financial Health score of "FAIR" from InvestingPro, investors can access detailed analysis and 10+ additional ProTips through the comprehensive Pro Research Report.

This advancement in Vaxart’s clinical program is supported by federal funds from the U.S. Department of Health and Human Services (HHS), specifically from the Administration for Strategic Preparedness and Response (ASPR) and BARDA, under an Other Transaction agreement.

The information in this article is based on a press release statement from Vaxart, Inc.

In other recent news, Vaxart Inc. reported its fourth-quarter 2024 earnings, revealing a significant miss on earnings per share (EPS) but a notable beat on revenue. The EPS was -$0.33, falling short of the forecasted -$0.10, while revenue reached $28.7 million, surpassing expectations of $20.77 million. In another development, Vaxart has urged stockholders to approve a reverse stock split proposal aimed at maintaining its listing on the Nasdaq exchange. The company recently completed enrollment for a Phase 1 clinical trial of its second-generation oral norovirus vaccine candidates, with topline data expected in mid-2025. Additionally, Vaxart resumed a government-funded clinical trial after lifting a stop work order from the Biomedical Advanced Research and Development Authority (BARDA). The company has also appointed Jeroen Grasman as its new Chief Financial Officer, effective May 19, 2025. Grasman brings over two decades of financial leadership experience in the biotech industry. These developments reflect Vaxart’s ongoing efforts to advance its vaccine programs and address financial challenges.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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