GeoVax Labs, Inc.

Good afternoon and welcome everyone to the Geofax fourth quarter full year 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 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've turned 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 whether GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products are safe for human use, Geovax's vaccines will effectively prevent targeted infections in humans. Geovax's product candidates will receive regulatory approval 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 easy to use than Geovax's products. Geovax will be able to enter into favorable manufacturing and distribution agreements and other factors over which Geovax's 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 the 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.

Welcome to Fourth Quarter Full Year 2024 GEOVAX Corporate Update Call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions you may have. 2024 includes several major events of the development of GeoVax, led by the BARDA Project NextGen Award, valued at almost $400 million, being announced during mid-June in support of GEO CMO4S1, our next generation COVID-19 vaccine. This program is underway with confirmation of all study sites, Manufacturing and support of vaccine product is underway, and we continue our ongoing billings to BARDA. Relative to GEO-MVA, our vaccine candidate against MPOCs and smallpox, during Q4, we completed CGMP product and quality release of the clinical batch of GEO-MVA. We anticipate having the available vaccine for clinical evaluation in the second half of this year. We're pleased to state that we've produced sufficient amount of products to support the anticipated clinical evaluation, as well as additional product in support of potential additional clinical use in conjunction with various stakeholder discussions that we have underway. Relative to our plans for a phase two good depth in trial, the clinical operations plans are underway as we complete the necessary regulatory aspect and product manufacturing in support of the trial. In addition, we are moving forward with our advanced MVA manufacturing process, utilizing our AGE-1 master cell bank. This process is implemented, and we anticipate the ability to produce significantly more MVA-based vaccine material much faster, utilizing a flexible process to support local decentralized vaccine manufacturing, while reducing the manufacturing cost significantly. 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, distribution. Our priorities and anticipated milestones for 2025 remain focused on advancing GEO CMO4S1, especially relative to Project NextGen. We remain in close contact with BARDA in support of plans to initiate the trial later this year or in early 2026. There's a clear need to fill the gap reflected in the first-generation COVID-19 vaccine, and we believe that GEO CMO4S1 has the potential as well as expanded value to fill this gap relative to the 40-plus million Immunocompromised adults in the U.S. currently not served well by the authorized vaccines. Our vaccine uses 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. MVA is well-characterized, well-known, and accepted by regulatory authorities worldwide. There are essentially no outstanding questions pertaining to potential safety issues and uses within various critically important patient populations, which may not be the case for alternative vaccine technologies. Our vaccine platform, MVA, is also a standalone vaccine authorized for protection against MPOCs and smallpox. This is a unique feature with critically important clinical benefits, providing a significant differentiator for CM04S1, especially when considered as a potential COVID-19 vaccine in regions where mpox is endemic. Finally, in addition to its benefits to immunocompromised individuals, we believe that CM04S1 has the potential for broader use as a heterologous booster to current mRNA vaccines, providing a durable and broad immune response against emerging variants. The intriguing possibility is that CMO4S1 could, by virtue of this immune profile, reduce the need for the continuous vaccine reconfiguration that appears necessary with mRNA vaccines. In fact, the HHS press release announcing the project NextGen Award in support of CMO4S1 specifically highlighted that our vaccine holds the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider array of variants and the potential for increased durability. In other words, longer lasting than that evidenced by the current authorized vaccines. Most important, we believe, is the value to immunocompromised patient populations who are currently not served well by the first generation COVID-19 vaccine. Thus far, the clinical data from our phase two studies is supportive of these potential next generation benefits. Beyond the next gen trial, 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 the prior receipt of an mRNA vaccine. 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. Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions, if not hundreds of millions, on a global basis of immunocompromised patients while also demonstrating the vaccine as a more robust, durable booster vaccine used in conjunction with first-generation vaccines. In 2025, we anticipate multiple presentations of clinical results for CMO4S1 at various conferences, including the upcoming World Vaccine Congress, the European Hematology Association, the International Workshop on Chronic Leprosythic Leukemia, and the American Association of Immunologists, further underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. These presentations can also serve as important catalysts for strategic partnership discussions. With the announcement of our project NextGen Award and the progress in our Phase II clinical studies, our activities related to partnering and collaborations with CMO4S1 have understandably 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. Turning now to GeoMVA, our MPoS smallpox vaccine candidate. In August 2024, the WHO declared MPoS as a public health emergency of international concern, highlighting the critical global health threat posed by this highly virulent virus. As a result of the continued spread and contagious nature of the current MPoS variant, WHO has reiterated the global health emergency declaration in November of 2024 and even more recently on February the 27th of this year. Such a declaration of a global public health threat three times within six months underscores and emphasizes the significant global health threat posed by MPOC. GEOVAX is well-positioned and actively progressing GEO-NVA intended to disrupt the current global monopoly in this important and critical area. Moreover, we believe that our efforts will establish GeoVax as the first U.S.-based supplier of such a vaccine, potentially resulting in our initial step to revenue generation. Increasingly, there appears to be significant government interest in U.S.-based supply chains versus the current over-dependence on non-U.S. suppliers. The strong sentiment in favor of such on-shoring initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, such as the White House, congressional offices, BARDA, WHO, the Africa CDC, and others regarding our progress towards having CGMP clinical batch vaccine produced and available for clinical evaluation and potential use. WHO has clearly underscored a critical need for expanded impact vaccine supply as a priority for WHO and other public health agencies worldwide. 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. Our strategic focus on oncology, specifically related to gadeptin, remains a major priority for 2025, as well as the future of Geovax. We have high expectations for the potential broad utilization of Godeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. Last summer, we announced our plans to evaluate Godeptin in combination with an 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. Our clinical operations plans for this trial are being finalized along with the regulatory aspects and necessary product manufacturing in support of the Phase II study. We also look forward to the upcoming Godeptin presentation at the American Association of Cancer Research, or AACR. In addition, we're planning various animal validation studies, further building a compelling basis of the potential value of Godeptin addressing various solid tumors. We're confident we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. Now I'd like to turn the presentation over to Mark Reynolds, GFXP Financial Officer, for a review of our recent results and financial status. Mark?