SOUTH SAN FRANCISCO - Vaxart, Inc. (NASDAQ: NASDAQ:VXRT), a biotechnology company, announced today that it has been awarded up to $453 million by the U.S. government to fund a comparative study of its oral COVID-19 vaccine candidate. The study will evaluate the pill's efficacy against an FDA-approved mRNA vaccine.
The funding, provided by the Biomedical Advanced Research and Development Authority (BARDA), will support a Phase 2b trial, which is expected to begin enrollment by summer 2024. Approximately $65.7 million is available immediately for study start-up activities, with the remaining funds contingent upon certain milestones.
Vaxart's oral vaccine tablet, which has been manufactured under Good Manufacturing Practice (GMP) standards, is based on preclinical data suggesting increased potency compared to previous vaccine constructs. The upcoming trial will enroll around 10,000 adults in the U.S., with at least 25% being 65 years and older, to assess the vaccine's effectiveness for both symptomatic and asymptomatic COVID-19, as well as its overall safety profile.
Dr. James F. Cummings, Chief Medical Officer at Vaxart, expressed gratitude for the BARDA funding and optimism about the head-to-head trial with an mRNA vaccine. Previous studies indicated that Vaxart's vaccine candidates induced a broad immune response and were well-tolerated.
The Phase 2b study will measure the relative efficacy of the oral vaccine compared to the mRNA comparator, with primary analysis scheduled 12 months post-vaccination. An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety.
Vaxart's oral vaccines, which can be stored and shipped without refrigeration, aim to simplify vaccine administration and reduce the risk of needle-stick injury. The company has previously completed a Phase 2 trial of an oral COVID-19 vaccine and is also developing vaccines for other diseases, including norovirus and influenza.
This project is part of Project NextGen, a $5 billion initiative by the U.S. Department of Health and Human Services to develop new vaccines and therapeutics for COVID-19.
In other recent news, Vaxart Inc. has made significant strides in its vaccine development programs and reported Q1 2024 financial results. Positive results emerged from the Phase 1 clinical trial for a bivalent norovirus vaccine candidate, setting the stage for a mid-2024 FDA meeting to discuss the program's regulatory pathway. Concurrently, Vaxart is planning to launch a Phase 2b trial for its oral XBB COVID-19 vaccine candidate, pending additional funding and regulatory approval.
The company's Q1 revenue stood at $2.2 million, with cash and investments amounting to $36.7 million, projected to last until late 2024. In addition to these advancements, Vaxart has expanded its authorized shares from 250 million to 350 million and made amendments to its equity incentive and employee stock purchase plans. This move aims to provide greater flexibility for future corporate needs and incentivize the workforce.
Furthermore, Vaxart's stockholders ratified the appointment of WithumSmith+Brown, PC as the company's independent registered public accounting firm for the year ending December 31, 2024. These recent developments underscore Vaxart's ongoing efforts to advance its vaccine candidates and potentially facilitate future growth initiatives.
InvestingPro Insights
As Vaxart, Inc. (NASDAQ: VXRT) secures substantial funding for its oral COVID-19 vaccine candidate, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro data, Vaxart holds a market capitalization of $132.63 million, reflecting its position in the biotech sector. The company's Price to Book ratio, as of the last twelve months leading up to Q1 2024, stands at 2.4, suggesting how investors currently value the company's net assets.
Notably, Vaxart has experienced a striking 1174.75% year-over-year revenue growth in the last twelve months as of Q1 2024. This impressive growth indicates a significant increase in the company's sales, a metric that may intrigue investors considering the potential market for its oral vaccine. However, it's important to consider that analysts anticipate a sales decline in the current year, as highlighted by one of the InvestingPro Tips. Moreover, the company's gross profit margin is deeply negative at -660.08%, underscoring challenges in profitability as it continues to invest in research and development.
Another InvestingPro Tip worth mentioning is that Vaxart's liquid assets exceed its short-term obligations, providing the company with a buffer to fund its operations in the near term. This is a critical aspect for investors to consider, given that the company is not expected to be profitable this year and has been quickly burning through cash.
For those interested in delving deeper into Vaxart's financial analysis and obtaining more InvestingPro Tips, they can explore the dedicated page at https://www.investing.com/pro/VXRT. There are currently 7 additional tips available, which can be accessed with an exclusive offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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