GeoVax Labs, Inc.

good afternoon and welcome everyone to the geovacs first quarter 2023 corporate update call my name is jack 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 mcgee 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. To ask a question, please press star 1 on your telephone keypad. As a reminder, this conference is being recorded. At this time, I am turning the call over to Gabby DeGravina of GC Capital.

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's race is 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.

Good afternoon, and thank you for participating in the GFX corporate update call. Since the start of 2023, we've expanded patient enrollment in support of the Godepton Phase 2 clinical trial and the two Phase 2 trials for GEO CMO4S1. Also, the third Phase 2 clinical program in support of CMO4S1, evaluating the vaccine as a booster among patients with chronic lymphocytic leukemia, has been viewed by the FDA and is expected to initiate soon. We also recently expanded our rights related to CMO4S1 to include Omicron variants, monkeypox, and smallpox, further differentiating our COVID-19 vaccine. While the clinical development progress and good depth in the CMO4S1 remain our priority, we are also focused on GEO-MVA, our vaccine against monkeypox and smallpox, as well as the implementation of the transformative MVA continuous cell line manufacturing process. Last year, we strengthened our balance sheet, adding $37 million during a very difficult investment environment, especially for the biotech industry. This has enabled us to expand our current clinical programs, including additional sites, while also adding near-term opportunities related to further development opportunities, including our MVA manufacturing process and expanding our oncology programs. We expect that our cash position will support our increased clinical program expansions and other initiatives through the remainder of this year. In the interim, we will evaluate opportunities to further strengthen our balance sheet, resulting from supportive stock activities, business development opportunities, and non-diluted opportunities related to government and NGO funding. 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 and funding for the current clinical trial from the FDA Orphan Drugs Clinical Trials Program. Our target population for the initial indication includes head and neck cancer patients who are receiving palliative care having failed other therapies and medical interventions. There are approximately 67,000 new cases of head and neck cancers annually in the U.S. and approximately 13,000 deaths annually resulting from head and neck cancers. This represents our initial targeted patient population. Worldwide, there are approximately 900,000 new cases of head and neck cancers annually and approximately 400,000 deaths. Patients suffering from advanced head and neck cancer represent a critical unmet medical need which we hope to The FDA funding the initial 10-patient portion of the clinical program underscores the recognition of this critical unmet medical need. Our focus is on completing the 10-patient study funded by the FDA. We anticipate completion of the initial 10-patient study yet this year, including our review of the results. 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 BLA filing. We're excited about the outlook and promise of Godeptin within advanced head and neck cancers, as well as other opportunities related to the expanded use and other indications. We foresee significant opportunity addressing various tumors as monotherapy, as well as the potential of combotherapy in conjunction with other therapies, such as immune checkpoint inhibitors. We also anticipate potential synergy with the Giavac's Mach 1 tumor-associated antigen approach. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use for which business development activities have already been initiated. We hold worldwide rights for the use of gadeptin, and all indications. The vast array of unmet medical needs within oncology represent significant opportunities for GiaVax to advance novel approaches addressing various cancer patient needs worldwide. Throughout 2023, we are participating in various oncology conferences, some of which we expect GADEPTIN presentations and with others, GADEPTIN partnering discussions. GEOCMO4S1, our next generation COVID-19 vaccine, differentiates from the current authorized COVID-19 vaccines in targeting both the antibody and cellular arms of the immune system, focusing on providing a more robust and durable protection than the current authorized vaccines. This is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current authorized vaccines and monoclonal antibodies are inadequate. Such populations include those with various blood cancers, renal disease, sickle cell anemia, HIV positive, autoimmune diseases such as lupus, and those on immune suppressive therapy. In general, patient groups with abated immune systems unable to respond adequately to approved mRNA vaccines are at such high risk. In the U.S., there are approximately 12 to 15 million individuals within this overall population, with over 200 million worldwide. There is a major critical need for next-generation COVID-19 vaccines to support such individuals, and we believe that CMO4S1 is the leading next-generation vaccine in clinical development. A recently published article in the New England Journal of Medicine highlights the critical need for vaccines to induce both antibodies and T cells for optimal protection against SARS-CoV-2 infections. CMO4S1 is specifically constructed to include the spike protein and the nucleocapsid protein and to induce a broader focused immune response specific to those proteins on the SARS-CoV-2 virus. Clinical evaluation demonstrated that CMO4S1 does in fact induce both strong antibody and T cell responses against both the spike and nucleocapsid proteins. The results of this clinical study were reported last year in the Lancet microbe publication of the Phase 1 data. The induction of T-cell immune responses is especially critical among those patient populations who have immune systems with depleted ability to mount effective antibody responses. New safety and immune response data from the Phase 2 trial were presented at the World Vaccine Congress in Washington, D.C. during April of 2023. highlighting the potential effectiveness of this vaccine in patients undergoing different types of treatment for hematologic cancer. Clinical testing of this vaccine continues to provide compelling data supporting development and ultimate use in the targeted patient populations. While the noise of COVID seems to have died down, SARS-CoV-2 continues to evolve with threatening variants of concern. It is well accepted that the current authorized vaccines are not sufficiently protective and that the durability is unsatisfactory. In fact, just a few weeks ago, the White House announced Project NextGen, a $5 billion initiative, the follow-on from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, particularly being interested in novel vaccine candidates in clinical trials or capable of entering clinical trials within the next nine months. We believe that CMO4S1 is the leading example of the desired next-generation vaccines. We have considerable interest both domestically and internationally in participating in our clinical development program. We believe that an opportunity for an expedited regulatory path will likely exist due to our focus on high-risk populations unserved by the current COVID-19 vaccines as well as the monoclonal antibody therapies. Also, we anticipate partnering and collaborations in support of worldwide commercialization and distribution. Our focus for the remainder of 2023 includes accelerating efforts in support of Gideptin and CMO4S1 Phase II clinical programs, advancing the Geovax MVA vaccine specific for monkeypox and smallpox into development, and further advancement of our program focused on improved MVA manufacturing processes. Presentations are expected at various scientific and medical conferences to update the progress on both gadeptin and CMO4S1. We anticipate reporting further preclinical information related to the use of the gadeptin technology used in conjunction with immune checkpoint inhibitors yet this year. Regarding GEO-MVA as a vaccine against monkeypox and smallpox, our intent is to be the first and primary U.S.-based supplier of an MVA-based vaccine to protect against mpox or monkeypox or smallpox, providing expanded supply and access worldwide, especially related to low- and middle-income countries, which have consistently experienced significant difficulty in the supply of many critical vaccine doses. We are advancing this initiative and look forward to reporting progress quarterly. Last year, 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 has reflected investor support and belief in the value and growth opportunities underway at Geovax. We continue to receive strong interest related to investment capital, which we'll evaluate but we're focused on execution towards our 2023 goals, strengthening shareholder value and achieving critical reporting milestones for our development programs. Now, I'd like to turn the presentation over to Mark Reynolds, Genovac's Chief Financial Officer, for a review of our recent results and financial status. Mark?