ATLANTA – GeoVax Labs, Inc. (NASDAQ:GOVX), a biotechnology company specializing in vaccines and immunotherapies, announced a partnership with Allucent to conduct a Phase 2b clinical trial of its next-generation COVID-19 vaccine candidate, GEO-CM04S1.
The study, involving 10,000 participants, is funded by the Biomedical Advanced Research and Development Authority (BARDA) through Project NextGen and will compare the effectiveness of GEO-CM04S1 to that of an approved COVID-19 vaccine.
The trial is a randomized, double-blind study designed to prevent symptomatic SARS-CoV-2 infection confirmed by PCR. According to David Dodd, president and CEO of GeoVax, this study represents an important step in the fight against COVID-19 and its variants. Mark A. Goldberg, MD, President and CEO of Allucent, also expressed excitement about the opportunity to implement the Phase 2b trial in collaboration with GeoVax.
GeoVax’s GEO-CM04S1 is based on the company’s MVA viral vector platform and encodes both the spike antigen and the nucleocapsid antigen of SARS-CoV-2. The vaccine aims to induce an immune-type reaction. The vaccine aims to induce a broad immune response and is currently being evaluated in three other Phase 2 trials targeting immunocompromised patients and as a booster for healthy adults previously vaccinated with mRNA vaccines.
Project NextGen is a $5 billion HHS initiative to develop new vaccines and therapies for COVID-19 that can offer broader and longer-lasting protection than first-generation vaccines. Federal funding for GeoVax and Allucent’s roles in the project is provided by separate contracts and agreements with BARDA.
GeoVax’s vaccine development is part of a broader portfolio that includes an oncology program and other infectious disease initiatives. Allucent, with more than 30 years of experience in drug development, brings its clinical expertise to the partnership.
The information in this article is based on a press release.
In other recent news, GeoVax Labs, Inc. has made significant strides in vaccine development. The biotech company has secured a substantial $24.3 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b clinical trial of its next-generation COVID-19 vaccine, GEO-CM04S1. The trial will enroll 10,000 participants to evaluate the vaccine’s efficacy, safety, and immunogenicity.
In addition to the COVID-19 vaccine trial, GeoVax is engaged in other important initiatives. The company announced a direct offering of $1.3 million and plans to sell more than 800,000 shares of its common stock to an institutional investor. Despite a net loss of $5.9 million for the first quarter, the company remains confident about its potential to generate substantial revenue.
GeoVax is also advancing its smallpox MVA and Mpox vaccine program and is in discussions with Emory and Oxford universities for a potential study in solid tumors. These recent developments highlight GeoVax’s ongoing commitment to addressing critical healthcare needs through the development of vaccines and therapeutics.
Insights from InvestingPro
As GeoVax Labs, Inc. (NASDAQ:GOVX) prepares to embark on a major Phase 2b clinical trial for its COVID-19 vaccine candidate, investors are closely monitoring the company’s financial health and market performance. The latest real-time data from InvestingPro reveals some critical aspects of GeoVax’s financial health.
With a market cap of just $5.56 million, the company is at the lower end of the biotech spectrum. Furthermore, the company’s price-to-book ratio of 93.87 for the trailing twelve months to Q1 2024 suggests a market valuation significantly higher than the company’s net asset value.
InvestingPro tips that GeoVax has more cash than debt on its balance sheet, which could be a positive sign for the company’s ability to fund its ongoing trials and operations. However, the company is rapidly burning through cash and is suffering from weak gross profit margins, as evidenced by a gross profit of -$22.33 million in the same period. GeoVax has been struggling with profitability, having not made a profit in the last twelve months.
The company’s share price has been volatile and has fallen significantly over the past year, with a one-year total return of 75.51%. Nonetheless, GeoVax has posted a strong return over the past month, up 15.8%, which may reflect the market’s optimistic view on the potential success of its vaccine candidate. Investors can keep an eye on these metrics and consider InvestingPro’s 12 additional recommendations available at https://www.investing.com/pro/GOVX for a more comprehensive analysis.
For those wishing to delve deeper into GeoVax’s financial data and market performance, InvestingPro offers a wide range of analyzes and insights. Use the coupon code PRONEWS24 to get an additional 10% discount on an annual or two-year subscription to Pro and Pro+ and gain access to insights that could help inform investment decisions at this critical stage of vaccine development.
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