GeoVax awarded $367M BARDA contract for COVID-19 vaccine trial

ATLANTA - GeoVax Labs, Inc. (NASDAQ:GOVX), a biotechnology firm specializing in vaccines and immunotherapies for infectious diseases and cancer, has secured a substantial contract from the Biomedical Advanced Research and Development Authority (BARDA) for a Phase 2b clinical trial of its COVID-19 vaccine candidate, GEO-CM04S1.

The company, in partnership with global clinical research organization Allucent, will conduct a 10,000-participant study to assess the efficacy, safety, and immunogenicity of GEO-CM04S1 compared to an existing FDA-approved mRNA COVID-19 vaccine. BARDA's funding, which is part of a $5 billion HHS initiative called Project NextGen, aims to develop vaccines offering broader and more durable protection against COVID-19, including emerging variants.

GeoVax's direct award is approximately $24.3 million, potentially increasing to $45 million, to support clinical trial activities and manufacturing of clinical materials. The combined awards to GeoVax and Allucent for this clinical evaluation total around $367-388 million.

This initiative is a response to the waning immunity observed with first-generation COVID-19 vaccines and the evolving resistance of the SARS-CoV-2 virus. GeoVax's vaccine candidate is designed to provide broader protection against variants of concern and a longer duration of immunity.

GeoVax has also reported progress in other areas, including positive initial findings from a Phase 2 trial of GEO-CM04S1 as a booster in adults previously vaccinated with Pfizer (NYSE:PFE) or Moderna (NASDAQ:MRNA). Additionally, the company has completed patient enrollment for a Phase 1/2 study of Gedeptin in advanced head and neck cancer and has achieved a key manufacturing milestone for Phase 3 and commercial production of its vaccines.

GeoVax's CEO, David Dodd, expressed optimism about the company's progress and the potential of GEO-CM04S1 to offer improved clinical protection against COVID-19. The company anticipates a catalyst-rich second half of 2024 with further trial progress and data readouts.

The information in this article is based on a press release statement from GeoVax.

In other recent news, GeoVax Labs has made substantial strides in its COVID-19 vaccine development program. The biotech firm's collaboration with Allucent is advancing its dual-antigen vaccine candidate, GEO-CM04S1, into a Phase 2b clinical trial, a development that has led H.C. Wainwright to maintain its Buy rating for GeoVax.

The Biomedical Advanced Research and Development Authority (BARDA) has also awarded GeoVax approximately $24.3 million to conduct a Phase 2b clinical trial of GEO-CM04S1.

In addition to these developments, GeoVax has announced a $1.3 million direct offering, selling over 800,000 shares of common stock to an institutional investor. Despite a reported net loss of $5.9 million for the first quarter, the company is optimistic about its potential to generate substantial revenue.

Furthermore, GeoVax is making progress on its Gedeptin therapy for advanced head and neck cancer and is in discussions with the FDA for an expedited path for this therapy.

InvestingPro Insights

GeoVax Labs, Inc. (NASDAQ:GOVX) has recently captured the attention of the biotech community with its significant contract from BARDA for the advancement of its COVID-19 vaccine candidate. As investors evaluate the company's prospects, certain financial metrics and analyst insights provide a deeper understanding of GeoVax's position in the market.

InvestingPro data underscores the financial landscape of GeoVax, with a notably small market capitalization of $7.26 million. This figure reflects the company's current valuation and can be a critical factor for investors gauging the potential growth and risk associated with the stock. Additionally, the company's Price / Book ratio, as of the last twelve months leading into Q1 2024, stands at an elevated 133.69, suggesting a premium valuation compared to its book value.

An InvestingPro Tip highlights that GeoVax holds more cash than debt on its balance sheet, which is a positive sign for financial stability and operational flexibility, especially as the company navigates the capital-intensive process of clinical trials. Conversely, the company is rapidly consuming cash, which is a point of concern considering the extensive funding required for research and development in the biotech industry.

Investors should note the high price volatility of GeoVax's stock, as evidenced by the recent 78.26% price total return over the last month. This volatility is not uncommon in the biotech sector, where stock prices can be significantly influenced by clinical trial outcomes, regulatory news, and market sentiment.

For those interested in a comprehensive analysis of GeoVax and additional insights, InvestingPro offers a range of tips, including observations on the company's cash burn rate, stock performance over various time frames, and valuation metrics. There are 15 additional InvestingPro Tips available, which can be accessed by visiting https://www.investing.com/pro/GOVX. Investors looking to leverage these insights can use the coupon code PRONEWS24 to receive up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.

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