GeoVax Labs, Inc.

Good afternoon, and welcome, everyone, to the Geovax Third Quarter 2022 Corporate Update Call. My name is Rob, and we'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. Please note that this event is being recorded, and at this time I'm turning the call over to Gabby DeGravina of CG 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 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 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 Geovax corporate update call. The third quarter represented continued progress for GFX as we advanced the phase two clinical programs in support of Godeptin, our cancer therapy for patients with advanced head and neck cancers, and GEOCMO4S1, our next generation COVID-19 vaccine. In addition, we continued to progress our preclinical development stage programs. We also further strengthened our ballot sheet during a very difficult investment environment, especially for the biotech industry. As a result of our successful financings this year, we are well-capitalized to complete our current Phase II clinical programs, including expansion of the GADEPTIN multi-site trial and expanding the CMO4 S1 COVID-19 vaccine trial among immunocompromised patients to additional sites. We are focused on accelerating our programs with anticipated initial data readouts over the next six to nine months. 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. Also, we recently initiated business development discussions towards partnering and collaborations to ensure worldwide access to our products and value to our stakeholders. Gedefin and CM04S1 provide significant value expansion opportunity for the company, our shareholders, and our stakeholders. 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 as well as the initial funding and support of the current clinical trial coming from the FDA Orphan Drugs Clinical Trials Program. Our focus is on accelerated and expanded patient enrollment now that additional Godeptin sites are on board. Our goal is to complete patient enrollment in 2023, followed by completion of patient evaluations before the end of 2024. In the interim, we expect to engage with the FDA regarding the results with the focus on clarifying the opportunity for an expedited biologics license application filing. We're excited about the outlook and promise of Godeflin within advanced head and neck cancers. In addition, there are promising opportunities relative to expanded use of gadeptin and other indications, as well as application of the underlying technology in conjunction with other therapies and potential synergy with our internally developed Mach 1 two-year associated antigen approach. We also anticipate expanded discussions related to partnering and collaborations related to gadeptin. CMO4S1 is our leading next generation COVID-19 vaccine currently in phase two clinical development, targeting both the antibody and cellular arms of the immune system with the goal of providing more robust and durable protection than the currently authorized vaccines. This vaccine holds promise over the current authorized vaccines from several critical areas of differentiation and value to various patient populations. Our focus is on accelerating the clinical development of each of these products, including the potential for expedited regulatory review. Meanwhile, we continue to advance other internal development programs in the path to IMD filing. We remain focused on accelerating efforts towards our milestones over the next 12 to 18 months in support of both the Godepin and the CMO4S1 COVID-19 vaccine program. We expect to report not only on the expansion of the Gidepton study to additional sites, but also initial clinical data, which we anticipate reporting during the first half of 2023. We also anticipate reporting initial clinical results in support of CMO for S1 during the first half of 2023. In addition, we will continue to provide updates related to the progress of our programs that are advancing the clinical status. Since January, we have added $37 million to our balance sheet, despite this year representing what many consider the most challenging year in over a decade for capital development within the biotech industry. Our successful financing supports efforts towards the completion of the current clinical programs. We continue to receive strong interest related to investment capital, which we'll evaluate, but we're focused on execution towards our 2022 and 2023 goals in building shareholder value. We're committed to the clinical development of CMO4S1 against COVID-19, specifically as an invaluable medical tool to address the continually emerging variants of concern, while also providing critically important value to those with compromised immune systems. CMO4S1 induces immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies that can block the virus entering healthy cells while also inducing the growth of new disease-fighting T cells that can recognize and destroy infected cells. This is an important distinction between CMO4S1 and the first-generation COVID-19 vaccines. Our vaccine includes both SARS-CoV-2 spike and nucleocapsid proteins as immunogens, differing from the current authorized vaccines, which only include the spike protein. By inserting both of these viral genes, the vaccine is able to drive the expression of both proteins within the body of the vaccine recipient. Again, this is an important distinction as CMO4 is specifically designed to induce an expanded immune response offering significant potential for improved levels of efficacy and differentiation within the field. This vaccine design was implemented specifically to induce an expanded immune response to better combat and clear infections regardless of the circulating SARS-CoV-2 variants. The vaccine is the first step in the worldwide goal to provide a vaccine that actually gets ahead of the variants versus having to chase the variants. Our approach of using the spike in nucleocapsid viral proteins was recently validated by multiple independent academic research groups and animal models using MVA and other vaccine platforms. Assuming continued success, this vaccine will likely reduce the requirement to continually adjust the vaccine and the reliance on the repeated administration of booster doses. This is what we mean in stating getting ahead of the variants versus chasing the variants. In July, analysis of data from the phase one study of CMO4S1 published in the peer-reviewed journal iScience showed that the vaccine, which is based on the same Wuhan strain as the first generation approved vaccines, induced potent and equivalent T cell cross-reactivity against Delta and Omicron variants. These findings suggest that T cell immunity simulated by CMO4S1 may constitute a critical line of defense to provide long-term protection against SARS-CoV-2 variants. We also believe that the multi-punch approach has the potential of providing a more robust and durable immune response and protection in various high-risk populations specifically immunocompromised individuals who will benefit from such a multi-pronged approach resulting in broader and more durable protection. The vaccine is currently being evaluated in two phase two clinical trials. One is a comparative study of our vaccine as the primary vaccine versus the current FDA approved Pfizer vaccine in individuals that have received or are undergoing specific blood cancer therapies associated with transplantation or CAR T therapy, which severely reduced preexisting immunity to COVID-19 vaccines. Clinical evidence indicates that such patients fail to respond optimally to the current generation vaccines. And we believe that CMO4S1 will prove to be more potent because it is multi-antigenic and delivered using the highly potent MVA viral vector. We believe this will differentiate CMO4S1 from the other vaccines by inducing strong and sustained antibody T cell responses in patients who are at severe risk of COVID disease due to their immunocompromised status. The other phase two trial underway is evaluating CMO4S1 as a booster for healthy patients who have previously received either the Pfizer or Moderna vaccines. We believe that providing a heterologicus booster rather than continued multiple shots of the same vaccine will induce more robust and durable immune responses and protection. Heterologicus prime boost immunizations are well studied in other fields such as HIV and are being evaluated in multiple countries using different COVID vaccines. Our goal is to provide a vaccine that ends the requirement of multiple boosters throughout a year. Finally, I want to reinforce the concept that our internal effort to develop an advanced MVA manufacturing process based on continuously growing avian cell lines to increase production consistency, capacity, and flexibility will mesh with the clinical development activities. In total, this represents the full development scope associated with the GFX coronavirus vaccines. Monkeypox cases continue to increase worldwide, with nations enacting procedures and policies in support of minimizing the health risk of their populations. There is also concern that more virulent and infectious forms of monkeypox might evolve, resulting in an increased spread of disease and deaths. The vaccine vector, Modified Vaccinia Ancora, or MVA, which is utilized in numerous GeoVax including our CMS04S1 COVID-19 vaccine is the primary vaccine used to prevent the global monkeypox threat. As you may know, MVA is currently stockpiled and utilized to protect against both monkeypox and smallpox. In August, our colleagues at City of Hope published results demonstrating that both CMO4S1 and the synthetic MVA used in the construct of CMO4S1 induced robust antibody and cellular immune responses against monkeypox that were durable for over six months post-vaccination. The authors concluded that CMO4S1 and synthetic MVA represent unique vaccine candidates to control the expanding global monkeypox outbreak. Geovax is evaluating development and regulatory pathways towards this opportunity as the need for expanding the MVA vaccine availability beyond the current limited single source provider is a global and increasing concern. In fact, just today, we've announced our securing the rights of the NIH MVA for use against monkeypox and smallpox. Now, I'd like to turn the presentation over to Mark Reynolds, GFAC's Chief Financial Officer, for a review of our recent results and financial status.