GeoVax Labs, Inc.

Good afternoon and welcome everyone to the Geovax fourth quarter, full year 2022 corporate update call. My name is Diego and I will facilitate today's call. With me today are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, Chief Scientific Officer, Dr. Kelly McD, Chief Medical Officer, and Dr. John Sharkey, 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. Please note this conference is being recorded. I will now turn the conference over to our host, Gabby DeGravina of CG Capital. Thank you. You may begin.

Thank you. Please note the following. Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Segurities 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 vaccines with the desired characteristics in a timely manner, Geovax's vaccines will be safe for human use, Geovax's vaccines will effectively prevent targeted infections in humans, Geovax's vaccines will receive regulatory approvals necessary to be licensed and marketed. Geovax raises required capital to complete vaccine development. There's 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.

Good afternoon, and thank you for participating in the Geovax Corporate Update Call. Fourth quarter 2022 represented continued progress for Geovax as we advanced the Phase II clinical programs in support of Godeptin, our promising cancer therapy for patients with advanced head and neck cancers, and GEO-CMO4-S1, our next-generation COVID-19 vaccine, focused on the unmet needs of immunocompromised patients. We also continued to progress our overall development stage programs. This includes our GeoVax Mach 1 immunotherapy, currently in IND supportive studies. Also, the preclinical studies evaluating GADEPTIN in conjunction with immune checkpoint inhibitors continue to be encouraging with relevant data expected this year. Throughout 2022, we strengthened our balance sheet during a very difficult investment environment, especially for the biotech industry. As a result of our successful financings last year, We've expanded our current clinical programs to include additional sites while also adding near-term opportunities related to our manufacturing processes and the additional oncology programs. Recently, we announced the expansion of our Cadeptin Phase II clinical program with the activation of patient enrollment in the two additional sites at Emory University and Thomas Jefferson University. For our COVID-19 vaccine program, we implemented a novel Mobile Clinical Research Facility in Claremont, California, to support our Phase 2 COVID-19 vaccine booster trial. Additionally, multiple sites are in the process of joining our Phase 2 COVID-19 trial among immunocompromised patients, including some potential sites outside the U.S. There is significant interest in participating in the evaluation of our novel COVID-19 vaccine targeting the high-risk immunocompromised patient populations. During the fourth quarter, we also announced the acquisition of the rights from the NIH allowing Geovax to develop and commercialize their MVA as a vaccine against monkeypox or mpox and smallpox. Our intent is to be the first and primary U.S.-based supplier of a Geovax MVA vaccine against mpox and smallpox, resulting in expanded supply and access worldwide. especially related to low- and middle-income countries, which have consistently experienced significant difficulty in supply of many critical vaccines and therapies. Finally, we recently announced our successful progress towards becoming the first vaccine supplier using an avian cell line-based manufacturing process, significantly expanding the yield and capacity of MVA-based vaccines. This will allow us to reduce supply chain risk associated with the use of chicken eggs and to provide the means to greatly expand production cost scale to address potential global needs, again, especially related to lower-cost alternatives for supply to the low- and middle-income countries. Our mission is to provide immunotherapies and vaccines that improve lives worldwide, preventing or treating some of the world's most challenging cancers and infectious diseases. Our business strategy of partnering and collaborations is anticipated to allow us to provide worldwide access to our products while providing optimal value to our stakeholders. We believe that Gidepton, CMO4S1, and our other initiatives provide significant value expansion opportunities for the company, our shareholder, and stakeholders while providing compelling career development opportunities for the members of our teams. As a reminder, Godeptin is a cancer therapy currently in an expanded multi-site evaluation among patients suffering from advanced head and neck cancers. The product has received orphan drug designation from the FDA and funding for the current clinical trial is from the FDA Orphan Drugs Clinical Trials Program. Our focus is on completing the initial 10-patient study funded by the FDA. We will review those results with the FDA along with our recommendations for an expanded program, while also discussing with the FDA the potential for an expedited biologics license application filing. We're excited about the outlook and promise of Godeptin within advanced head and neck cancers, as well as other opportunities and indications relative to the expanded use of Godeptin. This includes the potential application of the underlying technology in conjunction with other therapies, such as immune checkpoint inhibitors, and potential synergy with our internally developed Giovax MOC1 tumor-associated antigen approach. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use for which business development activities have been initiated. The vast array of unmet medical needs within oncology represents significant opportunities for Giovax to advance novel approaches such as that of cadeptin therapy against multiple tumors, Godeptin in conjunction with immune checkpoint inhibitors, and the G of X Mach 1 cancer immunotherapy approach, addressing various cancer patient needs worldwide. As previously mentioned, we hold worldwide rights for the use of Godeptin and the G of X tumor-associated antigen technologies in all indications. Our plans include the successful development of commercialization globally in conjunction with collaborators and partners. GEOCMO4S1, which we refer to as CMO4S1, is in phase two clinical development as a COVID-19 vaccine, targeting both the antibody and cellular arms of the immune system. The goal is to provide a more robust and durable protection than the currently authorized vaccines, especially for immunocompromised individuals. This vaccine holds promise over the current authorized vaccines from several critical areas of differentiation and value to various patients. CMO4S1 is being developed to address those patient populations of immunocompromised individuals currently inadequately served by the authorized vaccines and the various monoclonal antibody therapies. A recent article in the New England Journal of Medicine addressed the critical need to address both antibodies and T cells relative to protection against SARS-CoV-2 infection and COVID-19. CM-04S1 is specifically constructed to include a broader focus on the SARS-CoV-2 virus, including both the spike protein and the nucleocapsid protein, resulting in strong humoral and cellular immune responses. As a result, it induces strong antibody and T-cell responses. Such immune responses were validated and reported last year in the Lancet Microbe publication of the Phase I data. Addressing the cellular immune responses via inclusion of the nucleotapsid protein is especially critical among those patient populations who have immune systems with a bladed ability to mount a response to antibody stimulation. This includes patient populations with various blood cancers, HIV, sickle cell anemia, kidney disease, autoimmune disease, and others with various comorbidities. We estimate at least 15 million such individuals in the US alone and over 200 million patients worldwide. We believe that CMO4S1 has the potential to address a critical worldwide medical need and commercial opportunity. We also believe that an opportunity for an expedited regulatory path may exist for such a development program. With CMO4S1, we also anticipate partnering and collaborations to occur for worldwide distribution providing a novel vaccine in support of patients with such compromised immune systems. Regarding 2023 milestones, our focus this year includes accelerating efforts in support of the GADEPTIN and CMO4S1 Phase II clinical programs, moving the GFX-MVA vaccine related to mpox and smallpox in its development, and advancing our MVA manufacturing process into operational validation. During the first half, we anticipate reporting initial clinical results of the safety lead-in for the CMO4S1 immunocompromised trial. Presentations are scheduled for the World Vaccine Congress in early April, the Vaccine Summit 2023 in late May, as well as the ISAC site flow cytometry international meeting in late May. In addition to the recently reported site expansion of the gadeptin study, We anticipate reviewing initial data later this year. Also this year, we anticipate reporting further preclinical information related to the use of the Codeptin technology used in conjunction with immune checkpoint inhibitors. Furthermore, we intend to provide updates relative to IND supportive studies of our advancing G of X Mark 1 tumor-associated antigen therapy. In early June, our team will be actively participating in ASCO 2023. During 2022, we strengthened our balance sheet, adding $37 million during a time when many biotech firms were furloughing programs and or people. We feel that our capital development success reflects investor support and belief in the value and growth opportunities underway at GeoVax. We continue to receive strong interest related to capital investment development, which we'll evaluate, but we're focused on execution towards our 2023 goals strengthening shareholder value, and achieving critical reporting milestones for our current development programs. Now, I'd like to turn the presentation over to Mark Ramos, GIAVAC's Chief Financial Officer, for a review of our recent results and financial status. Mark?