GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax third quarter 2024 corporate update call. My name is Michelle and I'll 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, MD, MPH, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. At this time, all participants are in 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'm turning the call over to Max Gattaca of PrecisionAQ.

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 weather. Geovax can develop and manufacture its product candidates with 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's 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.

It is a pleasure to welcome everyone to the third 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 third quarter included several major events in the development of GFX, led by the Barter Project Next Gen Award, valued at almost $400 million, being announced during mid-June. This program is already underway with confirmation that all study sites have been selected, as well as our ongoing billings to barter. Mark will further discuss this during the financial review. We're delighted to have been paired by BARDA with Ellucent as our CRO for the project next-gen trial, as Ellucent is our existing CRO supporting our ongoing CMO for S1 and recently completed GADEPTIN clinical trials. In addition, during quarter three, we announced plans to conduct a phase two trial of GADEPTIN in combination with immune checkpoint inhibitor among patients with locally recurrent head and neck squamous cell carcinomas following primary therapy and for whom resection with curative intent is planned. Thus far, clinical evaluation of godeptin therapy has demonstrated an acceptable safety profile and sufficient tumor stabilization or reduction activity to support plans to advance clinical development of godeptin in such an expanded Phase II clinical trial. Relative to GOMVA, our vaccine candidate against MPOX and smallpox, We've continued to advance the program this past quarter from having the CGMP production of a master seed virus to establishing the working seed virus and currently having production of the first CGMP clinical substance batch underway with release anticipated by year end. In addition, we're moving forward with our advanced MVA manufacturing process with preparation of our AGE1 master cell bank being initiated. These activities represent significant progress and milestones for GFX. Our goal is to successfully develop innovative cancer therapies and infectious disease vaccines, 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. In late July, we announced plans to initiate a Phase II trial with cadeptin in combination with an immune checkpoint inhibitor for treatment of previously treated patients with recurrent head and neck cancer. The primary goal of this trial will be to demonstrate a pathological response with neoadjuvant cadeptin therapy combined with an immune checkpoint inhibitor in previously treated patients with recurrent squamous cell head and neck cancer in whom surgery with curative intent is planned. The company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection, with the trial activation anticipated during 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 are encouraged by the clinical results we've seen thus far, and we're even more excited about trial activation as soon as possible. Our big news recently was the announcement of the BARDA Project NextGen Award of almost $400 million, supporting GOCMO4S1 in a 10,000 patient comparative trial against an FDA authorized mRNA vaccine. This represents a highly significant event in the evolution of our company, which we believe represents a validation of our NVA technology and expertise. The vetting process was lengthy and rigorous, but we remained confident throughout, and we're delighted to be part of the Project NextGen vaccine program. Let me note that our vaccine selection represents one of only six vaccines awarded under Project NextGen. Already, all participating sites have been identified, selected by Ellucian, and manufacturing activities are proceeding in support of the study start during 2025. Our aim with CMO4S1 is to provide a more practical, public health-friendly COVID-19 vaccine than that offered from the first-generation approved vaccine. 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 vaccines are often inadequate. This represents the key differentiation between our vaccine and the first generation authorized vaccines. Our vaccine utilizes a proven safe and efficient delivery platform, modified vaccinia agra 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, such as among pregnant women. That our vaccine platform, MVA, is also a standalone vaccine authorized for protection against MPOCs and smallpox is a unique feature with critically important clinical benefits, providing a significant differentiator for CMO4S1. especially when considered as a potential COVID-19 vaccine in regions endemic to MPOCs. A current example is within the Democratic Republic of the Congo, or the DRC, where there is a threatening outbreak underway. Also, the CDC recently issued a warning of continued MPOCs threats and risks within the U.S. In addition to its benefits in immunocompromised individuals and protecting from severe COVID-19, We believe that CMO4S1 has potential for more general use as a heterologous booster to current mRNA vaccines, providing a durable and broadly functional immune response against emerging variants. The intriguing possibility is that GeoCMO4S1 could, by virtue of this immune profile, reduce the need for continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. 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 variety of variants and the potential for increased durability than that evidenced by the current authorized vaccines. The current data thus far from our existing phase two studies is supportive of that potential. Relative to CMO4S1, we anticipate partnering collaborations and additional clinical research efforts and in support of worldwide commercialization distribution. Active initiatives are underway in these areas. Three phase two clinical trials are underway with CMO4S1, two of which address populations of immunocompromised patients at high risk for developing severe COVID-19. The other phase two 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 and the progress in our other Phase II clinical studies, our activities related to partnering and collaborations with GEO CMO4S1 have increased. We believe that GEO CMO4S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide. In August, the WHO declared MPOCS as a public health emergency of international concern, highlighting the critical medical threat posed by this highly virulent virus. GFX is well positioned and actively progressing GOMVA, our vaccine against MPOCS and smallpox, intended to disrupt the current global monopoly in that important area. Moreover, we believe that our efforts will establish GeoVax as the first U.S.-based supplier of such a vaccine. This may also provide GeoVax our initial step into revenue generation due to significant governmental interest in U.S.-based supply chains versus over-dependence on non-U.S. suppliers. The strong sentiment in favor of such onsourcing initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders such as the White House, BARDA, WHO, the African CDC, and others regarding our progress towards having a CGMP clinical batch produced and manufacturing capabilities advancing. WHO has clearly stated the expectation of continued expanded migration of the mpox virus reflected in recent reports of multiple cases in the UK. The need for expanded Mpox vaccine supply is a priority for WHO and other public health agencies globally. Finally, we anticipate providing continued updates related to our advanced MVA manufacturing process, targeted to enable GeoVax to efficiently produce and distribute MVA-based vaccines in response to real-time market needs. We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. From a commercial perspective, these medical need opportunities represent a tremendous estimated annual U.S. revenue potential. I'll underscore that this isn't a sales forecast, but rather a reflection of the significance of the need to address these critically important areas of health care, both clinically and commercially. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GFX, our shareholders and their stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer, for a review of our recent results and financial stats. Mark?