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spk00: Good afternoon and welcome everyone to the GeoVax second quarter 2024 corporate update call. My name is Alex and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, PhD Chief Scientific Officer, Kelly McKee and the MPH Chief Medical Officer, and John Sharkey. PhD Vice President Business Development. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gattaca of Precision HQ.
spk02: Thank you. Please note the following. Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether Geovax can develop and manufacture its product candidates with the desired characteristics in a timely manner, and such products will be safe for human use. Geovax's vaccines will effectively prevent targeted infections in humans. Geovax's product candidates will receive regulatory approvals necessary to be licensed and marketed. Geovax raises required capital to complete development of its products. There is development of competitive products that may be more effective or easier to use than GeoVax products. GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission. including those set forth at risk factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.
spk01: Thank you, Max. Good afternoon, and thank you for participating in the second quarter 2024 GeoVax Corporate Update Call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then your questions will be addressed. The second quarter included several major events in the development of GeoVax, led by the BARDA Project NextGen Award, valued at almost $400 million, supporting GEO CMO4S1, our next-generation COVID-19 vaccine, in a Phase IIb 10,000-patient trial, comparing our vaccine to an FDA-authorized mRNA vaccine. This program is already underway, with our having already initiated billings to BARDA as Mark will further discuss during the financial review. We are delighted to be partnered with Ellucent as our CRO for the Project NextGen trial, as Ellucent is our existing CRO supporting both our CMO4S1 and Gidepton clinical trials. In addition, during Q2, we conducted a comprehensive review of the Gidepton Phase 1B-2A trial in conjunction with the Gidepton Clinical Advisory Committee. deciding to proceed with the implementation of a Phase II trial, evaluating gadeptin in combination with an immune check inhibitor as therapy for patients with squamous cell head and neck cancer. Thus far, clinical evaluation of gadeptin therapy has demonstrated sufficient tumor stabilization or reduction activity to support plans to advance clinical development of gadeptin in such an expanded Phase II clinical trial. These two events and decisions represent significant milestones for GFX. Today, we'll discuss the progress, status, and plans related to CMO4S1 and Codeptin, as well as provide updates on our other programs, including our progress in the advanced MVA manufacturing process. Our goal is to successfully develop innovative cancer therapies and infectious disease vaccine, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization, and distribution. Last December, we announced the closure of enrollment for the phase A to B trial of Gideptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care who unfortunately die each year as a result of head and neck cancer. This represents 17,000 in the U.S. and over 400,000 individuals worldwide. Our goal is to obtain clinical evidence supporting advancement of this therapy, including in patients with earlier stage disease. You recall this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. The April comprehensive review of the results from the Phase 1 and the most recent Phase 1A and 2B trial of Godeptin concluded that Godeptin has demonstrated acceptable safety and efficacy to support continued development of a Phase 2 trial and first recurrence head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Godeptin therapy combined with an immune checkpoint inhibitor and screen the cell head and neck cancer. The company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection, with the trial activation anticipated during the first half of 2025. We believe that the GADEPTA mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology, and we are participating in various oncology and partnering conferences. We anticipate funding the Expanded Phase II trial through a combination of internal funding, potential partnering, and potential non-diluted funding resources. During the Q&A session, we welcome the opportunity to further discuss our plans for the Expanded Phase II trial. Our big news during Q2, however, was the announcement of the Barter Project NextGen award of almost $400 million, supporting CMO4S1, and a 10,000-patient comparative trial against an FDA-authorized mRNA vaccine. This announcement and award represent a highly significant event in the evolution of our company, which we believe represents a strong validation of our MVA technology and expertise. The vetting process was lengthy and rigorous, but we remained confident throughout and were delighted to be part of the Project NextGen vaccine program. Our aim with CMO4S1 is to provide a more practical, public health-friendly COVID-19 vaccine than that offered from the first-generation vaccines. We believe that this is achieved by stimulating a robust and durable immune response across multiple virus variants as a result of the induction of both the antibody and cellular arms of the immune system against multiple virus antigens. This distinction is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccine and monoclonal antibody therapies are typically inadequate. This represents the key differentiation between our vaccine and the first-generation approved vaccines. Our vaccine utilizes a proven, safe, and efficient delivery platform, Modified Vaccinia Anchor, or MVA, which does not replicate in mammalian cells. The safety of MVA has been well established and accepted by regulatory authorities worldwide, especially among patients with weakened immune systems as well as among pregnant women. That our vaccine platform, MVA, is also a standalone vaccine authorized for protection against mpox and smallpox is a unique feature with critically important clinical benefits. providing a significant differentiator for CMO4S1, especially as a preferred COVID-19 vaccine in regions endemic to MPOCs. A current example is within the Democratic Republic of the Congo, or DRC, where there is a threatening outbreak underway. Also, the CDC recently issued a warning of continued MPOC threats and risks within the U.S., We believe that CMO4S1 offers an immune profile optimal for more general use as a heterologous booster to current mRNA vaccines, providing a more robust, durable, and broadly functional immune response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccine. In fact, the HHS press release announcing our Project NextGen award specifically highlighted our award as providing the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider array of variants, and the potential for increased durability than that evidenced by the current authorized vaccines. The clinical data thus far from our current Phase II studies is supportive of this potential. Relative to CMO4S1, We anticipate partnering and collaborations in additional clinical and research efforts and in support of worldwide commercialization and distribution. Active initiatives are underway in these areas. As mentioned earlier, we're delighted to be partnered with Ellucent for this Phase IIb trial, and we recognize the VARTA funding provided to both GFX and Ellucent to ensure successful operational execution of this critically important study. As you recall, three Phase II clinical trials are underway with CMO4S1, two of which address the high-risk populations of immunocompromised patients. The other Phase II trial evaluates our vaccine as a heterologous booster among healthy adults following prior receipt of an mRNA vaccine. Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions of immunocompromised patients while also demonstrating the vaccine as a more robust, durable booster vaccine used in conjunction with mRNA vaccines. I won't delve further into these specific trials at this time, but we welcome any questions you may have during our Q&A session. With the announcement of our Project NextGen award last month and the progress in our other Phase II clinical studies, our activity related to partnering and collaborations has increased. We believe that CMO4S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide. During the remainder of 2024, we anticipate continued expanded discussions and advancing business development negotiations. In summary, we are focused on addressing opportunities that provide a basis for achieving leadership within differentiated patient areas and commercial markets. Our current clinical stage products, GADEPTIN and CMO4S1, are focused on patient populations currently underserved or unserved by existing therapies and or vaccines. GEO-MVA, our vaccine candidate against MPOCs and smallpox, is intended to disrupt the current monopoly in that important area, providing us a leadership as the first
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