ATLANTA - GeoVax Labs, Inc. (NASDAQ:GOVX), a biotech firm specializing in vaccines and immunotherapies, has announced a partnership with Allucent to carry out a Phase 2b clinical trial for 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 efficacy of GEO-CM04S1 against an approved COVID-19 vaccine.
The trial is a randomized, double-blinded study designed to prevent symptomatic, PCR-confirmed SARS-CoV-2 infection. It represents a significant step in the ongoing efforts to combat COVID-19 and its variants, according to David Dodd, Chairman & CEO of GeoVax. Mark A. Goldberg, M.D., Chairman and CEO of Allucent, also expressed enthusiasm for 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 for both the spike and nucleocapsid antigens of SARS-CoV-2. The vaccine aims to induce a broad immune response and is currently under evaluation 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 therapeutics for COVID-19, offering broader and longer-lasting protection than first-generation vaccines. The federal funds for GeoVax and Allucent's roles in the project are provided under separate contracts and agreements with BARDA.
GeoVax's vaccine development is part of a broader portfolio, including an oncology program and other infectious disease initiatives. Allucent, with over 30 years of drug development experience, brings its clinical expertise to the partnership.
The information for this article is based on a press release statement.
In other recent news, GeoVax Labs, Inc. has been making significant strides in its vaccine development efforts. The biotech company has been granted a substantial $24.3 million by 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 involve 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 notable ventures. The company has announced a $1.3 million direct offering and plans to sell over 800,000 shares of common stock to an institutional investor. Despite a net loss of $5.9 million for the first quarter, the company remains hopeful about its potential to generate substantial revenue.
GeoVax is also progressing with its MVA vaccine program against Smallpox and Mpox, and is in discussions with Emory and Oxford universities for a potential study on solid tumors. These recent developments underscore GeoVax's ongoing commitment to addressing critical healthcare needs through the development of vaccines and therapeutics.
InvestingPro Insights
As GeoVax Labs, Inc. (NASDAQ:GOVX) embarks on a significant 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 situation.
With a market capitalization of just $5.56 million, the company is on the smaller end of the biotech spectrum. Moreover, the company's Price / Book ratio, sitting at a high 93.87 as of the last twelve months leading up to Q1 2024, suggests a market valuation that is significantly higher than the company's net asset value.
InvestingPro Tips indicate that GeoVax holds 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 quickly burning through cash and suffers from weak gross profit margins, as evidenced by a gross profit of -$22.33 million over the same period. GeoVax has been facing challenges with profitability, not having turned a profit over the last twelve months.
The company's stock price has been volatile, experiencing a significant decline over the past year with a -75.51% one-year price total return. Despite this, GeoVax has shown a strong return over the last month, with a 15.8% increase, which could be a reflection of the market’s optimistic view of the potential success of their vaccine candidate. Investors may want to keep an eye on these metrics and consider the additional 12 InvestingPro Tips available at https://www.investing.com/pro/GOVX for a more comprehensive analysis.
For those looking to delve deeper into GeoVax's financials and market performance, InvestingPro offers a wealth of analytics and insights. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and gain access to the insights that could help inform investment decisions during this critical phase of vaccine development.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.