GeoVax to present major milestones at BioFuture, an event for innovators.

$GOVX advances NextGen COVID-19 Vaccine Trials and Cancer Therapy, including important trials for immune-compromised patients.
PLACE: Lotte Hotel, NYC. TIME: 3:30 pm Thursday, October 5th.

Key Takeaways

  • GeoVax Labs has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1, a COVID-19 vaccine booster for patients who have previously received the Pfizer or Moderna mRNA vaccine, and believes it may offer more robust protection than current vaccines.
  • In addition to its COVID-19 initiatives, GeoVax is advancing its oncology program, recently presenting Phase 1/2 clinical trial data for its gene therapy candidate, Gedeptin®, at a joint conference of the American Association for Cancer Research and the American Head and Neck Society.
  • The technology platform used in their vaccines has been validated in numerous publications and conferences, including Nature, The Lancet, and the World Vaccine Congress, and is also the platform that supplies the U.S. and EU stockpile of small pox vaccines.

GeoVax Labs, Inc. ($GOVX), a biotechnology company focused on developing groundbreaking therapies and vaccines for cancers and numerous infectious diseases, is pleased to announce the achievement of significant milestones in its three ongoing clinical stage trials for COVID-19 vaccines and late-stage head and neck cancer treatment.

The company has successfully met the enrollment target for its Phase 2 clinical trial, which evaluates GEO-CM04S1 as a COVID-19 vaccine booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. This milestone is a testament to GeoVax's relentless pursuit of developing a next-generation COVID-19 vaccine that induces both antibody and T cell responses to parts of the virus less likely to mutate over time.

Chairman and CEO, David Dodd, expressed his gratitude to all those who played a part in reaching this crucial milestone. He firmly believes that GEO-CM04S1 may offer a more robust and durable degree of protection than the current authorized COVID-19 vaccines. It serves not only as a booster to the authorized mRNA vaccines but also is in a clinical trial as a primary vaccine for highly vulnerable immunocompromised patients.

In addition, GeoVax is making significant strides in its oncology program. The company recently presented Phase 1/2 clinical trial data for its gene therapy candidate, Gedeptin®, at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference.

GeoVax will present these milestones at BioFuture, an event for innovators, scheduled to take place at the Lotte Hotel in New York City at 3:30 pm on Thursday, October 5th. Investors receive complimentary registration for the event.

The company will also discuss the opportunities of the $5B Project NextGen Covid grants from the U.S. Government. This government funding boosts efforts to tackle the ongoing global health crisis through the development of more effective vaccines, manufacturing and research against future strains of COVID-19.

GeoVax continues to forge ahead with its mission of creating novel therapies and vaccines for some of the world's most threatening infectious diseases and cancers. The company's innovative approach, combined with their robust pipeline, promises exciting developments in the fight against these diseases. Visit the GeoVax website for more information about their ongoing projects and achievements.

For more details about the BioFuture event and registration, please visit the event website https://biofuture.com

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently, in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For additional information about GeoVax, visit our website: www.geovax.com. 

Forward-Looking Statements This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements primarily on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our results to differ may emerge from time to time, and it is impossible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Key Takeaways

  • GeoVax Labs has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1, a COVID-19 vaccine booster for patients who have previously received the Pfizer or Moderna mRNA vaccine, and believes it may offer more robust protection than current vaccines.
  • In addition to its COVID-19 initiatives, GeoVax is advancing its oncology program, recently presenting Phase 1/2 clinical trial data for its gene therapy candidate, Gedeptin®, at a joint conference of the American Association for Cancer Research and the American Head and Neck Society.
  • The technology platform used in their vaccines has been validated in numerous publications and conferences, including Nature, The Lancet, and the World Vaccine Congress, and is also the platform that supplies the U.S. and EU stockpile of small pox vaccines.
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In addition to the booster vaccine trial for which patient enrollment was just completed, GEO-CM04S1 is being evaluated in three other Phase 2 clin...
David Dodd — Chairman and CEO

Related Bios

David A. Dodd
Chairman, President & CEO
Mr. Dodd joined the GeoVax Board of Directors in March 2010 and was elected Chairman in January 2011. His executive management experience in the pharmaceutical and biotechnology industries spans more than 40 years. From September 2017 to June 2018, Mr. Dodd served as CEO, and as a member of the Board of Directors, of Medizone International, Inc., a medical device manufacturer. From April 2013 to July 2017, Mr. Dodd served as President and CEO, and as a member of the Board of Directors, of Aeterna Zentaris Inc., a drug development company. He was Chairman of the Board of Directors of Aeterna Zentaris, Inc. from May 2014 to May 2016, and continued to serve as a member of its Board of Directors until May 2018. From December 2007 to June 2009, Mr. Dodd was President, CEO and Chairman of BioReliance Corporation, a leading provider of biological safety and related testing services. From October 2006 to April 2009, he served as non-executive Chairman of Stem Cell Sciences Plc., where he oversaw the development and implementation of a strategic growth plan, implementation of an experienced executive team, and the sale of the company to Stem Cells, Inc. in April 2009. He is also the CEO of RiversEdge BioVentures, an investment and advisory firm focused on the life sciences and pharmaceuticals industries, which he founded in 2009.

During Mr. Dodd's six-year tenure as President, CEO and Director of Serologicals Corporation, the market value of that company increased from $85 million in June 2000 to an all-cash sale to Millipore Corporation in July 2006 for $1.5 billion. That successful transformation followed his five-year term as President and CEO of Solvay Pharmaceuticals, Inc. and as Chairman of its subsidiary Unimed Pharmaceuticals, Inc. Prior to that, Mr. Dodd held various senior management positions at Wyeth-Ayerst Laboratories, the Mead Johnson Laboratories Division at Bristol-Myers Squibb, and Abbott Laboratories.

He is a frequently invited speaker and panelist at business and economic development conferences, as well as various conferences focused on the life sciences and pharmaceutical industry. He is a recipient of the Oglethorpe Award for UK-US Business Relationships, the Georgia BIO Industry Growth Award, and the FastTech 50 Growth Company Award (2000-2006) while leading Serologicals Corporation.

Mr. Dodd holds Bachelor of Science and Master of Science degrees from Georgia State University and completed the Harvard Business School of Advanced Management Program.
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Mark W. Reynolds
Chief Financial Officer
Mr. Reynolds joined GeoVax on a part-time basis in October 2006 as Chief Financial Officer and Corporate Secretary, becoming a full-time employee in January 2010. From 2003 to 2006, before being named Chief Financial Officer of GeoVax, Mr. Reynolds provided financial and accounting services to the Company as an independent contractor. From 2004 to 2008, he served as Chief Financial Officer for HealthWatchSystems, Inc. a privately-held company in the consumer healthcare industry. From 2004 to 2006, he served as Chief Financial Officer for Duska Therapeutics, Inc., a publicly-held biotechnology company. From 1988 to 2002, Mr. Reynolds was first Controller and later Chief Financial Officer of CytRx Corporation, a publicly-held biopharmaceutical company. Mr. Reynolds began his career as an auditor with Arthur Andersen & Co. from 1985 to 1988. He is a certified public accountant and earned a master’s of accountancy degree from the University of Georgia.
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John W. Sharkey, Ph.D.
Head of Business Development
With 30+ years in the pharmaceutical and medical device industry, Dr. Sharkey possesses extensive experience in executive management, business development, pharmaceutical and medical device development, regulatory affairs, manufacturing and business operations covering multiple therapeutic segments.
As CEO of Largent Health, LLC, he managed the development and registration strategy of three 510(k) medical devices incorporating a proprietary antimicrobial technology, eventually leading to the registration and commercial launch of the 1st FDA cleared dental cavity cleanser with antimicrobial claims. He has also assisted several companies in their financing activities.
In 2010, Dr. Sharkey founded Cogas Consulting, LLC, a boutique consultancy providing executive management, technical development, regulatory and business development services to small and mid-size pharma and medical device companies. He has also assisted several companies in their financing activities.

Prior to the above, he held senior positions within both Novartis and Shionogi and was the lead on, or a critical contributor to, several notable partnering transactions including Novartis’ licensing of Lucentis®, Focalin® and Focalin® XR and Shionogi’s license for Osphena®.
Dr. Sharkey holds a Ph.D. in Chemistry from the University of Buffalo and a B.S. in Chemistry from the State University of New York at Oneonta.
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