BioVie receives $13.1M from Department of Defense for long-term COVID-19 trial

CARSON CITY, Nev. – BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, has received up to $13.1 million in grant funding from the U.S. Department of Defense (DOD) to fund Phase 2b bezisterim Clinical trials of an anti-inflammatory and insulin-sensitizing drug. The trial is designed to evaluate treatments for neurological symptoms associated with long-term COVID-19, a condition characterized by persistent symptoms after infection with COVID-19.

The grant, provided through the Peer-Reviewed Medical Research Program of the Congressionally Directed Medical Research Program, includes an initial $499,200 for the planning phase, with an option to fund $12.6 million in clinical trials after planning ends. The trial, expected to begin in early 2025, will assess the safety, tolerability and efficacy of bezisline in approximately 200 patients over a three-month treatment period.

Long-term COVID-19 affects more than 17 million adults in the United States, with symptoms such as fatigue, cognitive impairment, and sleep disturbances. The economic impact of this disease is enormous, costing an estimated $3.7 trillion due to reduced quality of life, reduced income, and increased medical costs. Currently, there are no proven treatments for long-term COVID-19.

Bezisterim's ability to penetrate the blood-brain barrier and modulate inflammation through activation of NF-kB makes it a promising candidate to address the root cause of long-term COVID-19 symptoms. The drug is also being studied for its potential in treating Alzheimer's and Parkinson's diseases.

BioVie President and CEO Cuong Do expressed optimism about the trial, noting that Bezisterim's mechanism of action is consistent with emerging evidence on the pathophysiology of long-term COVID-19. Dr. Michael Peluso, director of the long-term COVID-19 clinical trials program at the University of California, San Francisco, also welcomed the funding and the opportunity to further explore the drug's potential.

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The news, based on a press release statement from BioVie Inc., represents an important step in the search for effective treatments for long-term COVID-19 and related neurological diseases.

Investment Professional Insights

With BioVie Inc. (NASDAQ: BIVI) recently advancing its clinical trials with funding from the Department of Defense, investors are paying close attention to the company's financials and stock performance. BioVie has a market capitalization of $26.62 million, reflecting the company's size in the biopharma space, according to InvestingPro. Despite promising clinical development prospects, the company's financial metrics remain challenged. With an adjusted price-to-earnings ratio of -0.62 for the trailing 12 months to Q2 2024, BioVie is currently trading at negative earnings, consistent with InvestingPro's tip that analysts don't expect the company to be profitable this year.

Additionally, the stock has experienced a significant decline, with a 1-year price total return of -93.93% through 2024. This is confirmed by multiple InvestingPro tips that highlight significant price declines over the past year, including the past three and six months. These metrics suggest that while bezisterim's clinical potential is noteworthy, the market has reacted to concerns about BioVie's current financial health and future profitability.

Investors considering BioVie Inc. should note the company's favorable cash position, as it holds more cash than debt on its balance sheet, an InvestingPro Tip that may provide some comfort to the stock's recent performance. However, as another InvestingPro Tip points out, the lack of dividends may be a factor for those looking for income-generating investments.

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For those looking for a more comprehensive analysis, there are other InvestingPro tips available on the platform.To explore these insights and make more informed decisions, investors can use coupon codes PRONEWS24 Annual or biennial Pro and Pro+ subscriptions receive an additional 10% discount.

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