Vaxart completes enrollment for oral norovirus vaccine trial

SOUTH SAN FRANCISCO – Vaxart, Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company with a market capitalization of approximately $97 million, has announced the completion of enrollment for its Phase 1 clinical trial, which is evaluating the company’s second-generation oral norovirus vaccine candidates. According to InvestingPro data, the company’s stock has shown significant momentum with a 24% return over the past week, despite trading at $0.43. This development marks a step forward in Vaxart’s efforts to address the significant global health challenge posed by norovirus, a leading cause of acute gastroenteritis.

The trial is designed as an open-label, dose-ranging study to compare the second-generation vaccine constructs directly with the first-generation versions. The primary focus of the study is to assess safety and to measure immune responses that have been correlated with protection in previous norovirus challenge studies. While the company maintains more cash than debt on its balance sheet, InvestingPro analysis reveals rapid cash burn and weak gross profit margins, factors that could impact the trial’s progression. Discover 10+ additional key insights about Vaxart’s financial health with an InvestingPro subscription. An independent Data and Safety Monitoring Board (DSMB) has already reviewed interim safety data and recommended the study’s continuation without any changes.

Vaxart’s CEO, Steven Lo, expressed optimism about the potential of the second-generation vaccines, which the company believes may offer enhanced potency compared to the first-generation constructs. The company anticipates sharing topline data from the trial in mid-2025.

Success in the Phase 1 trial, coupled with securing a partnership or additional funding, could pave the way for a Phase 2 safety and immunogenicity study. This next phase could potentially commence in the latter half of 2025, followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). If these stages are achieved, a Phase 3 trial could begin as early as 2026.

Vaxart’s vaccine candidates are based on its proprietary oral delivery platform, which offers the convenience of pill-based administration and eliminates the need for refrigeration and the risk of needle-stick injuries. The company’s pipeline includes oral vaccines for various diseases, including coronavirus, influenza, and human papillomavirus (HPV), alongside the norovirus candidate.

While Vaxart’s press release contains forward-looking statements regarding the development and potential of its vaccine candidates, these statements are subject to risks and uncertainties that could cause actual results to differ materially. The company’s future plans are contingent upon various factors, including clinical trial outcomes, regulatory reviews, market acceptance, and maintaining necessary intellectual property protection. Notably, analyst price targets range from $2 to $8, suggesting significant potential upside, though InvestingPro indicates the company is not expected to be profitable this year. With the next earnings report due on May 20, 2025, investors can access comprehensive analysis and valuation metrics through InvestingPro’s detailed Research Report, available alongside 1,400+ other US stocks.

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 notable discrepancy between earnings per share (EPS) and revenue expectations. The company’s EPS was reported at -$0.33, significantly missing the forecasted -$0.10, while revenue reached $28.7 million, surpassing the anticipated $20.77 million. Despite the EPS miss, the revenue beat indicates strong sales performance, primarily driven by government contracts and non-cash royalty revenue. Additionally, Vaxart has resumed its BARDA-funded clinical trial activities after receiving authorization to proceed, lifting a previous stop work order. This authorization allows Vaxart to prepare for a 10,000 participant trial, marking a significant step forward in its trial operations. The company maintains a cash runway into the fourth quarter of 2025 and continues its focus on advancing its norovirus and other vaccine programs. Vaxart’s strategic efforts include exploring partnership and non-dilutive funding options to extend its cash runway. The company’s recent developments have been closely monitored by investors, as Vaxart navigates financial challenges and regulatory processes.

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