GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax fourth quarter year-end 2021 corporate update call. I am Chuck with Coors Call and will facilitate today's call. With me are David Dodd, Chairman and CEO, Mr. Mark Reynolds, Chief Financial Officer, Mark Newman, PhD, Chief Scientific Officer, and John Sharkey, PhD and Head of Business Development. All participants will be in a listen-only mode should you need assistance Please signal a conference specialist by pressing the star key, followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. And to withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Jules Abraham of CORE-IR, who will provide a forward-looking statement regarding the call and the information herein. Please go ahead, sir.

Thank you, Chuck. Good afternoon, everyone. 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 GLS can develop and manufacture its vaccines with the desired characteristics in a timely manner, whether Geovax's vaccines will be safe for human use, whether Geovax's vaccines will effectively prevent targeted infections in humans, whether Geovax's vaccines will receive regulatory approvals necessary to be licensed and marketed, whether Geovax raises required capital to complete vaccine development, and there is development of competitive products that may be more effective or easier to use than Geovax's products. whether 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. With that, it's now my pleasure To introduce the Chairman and CEO of U of X, David Dodd. David.

Thank you, Jules. Good afternoon, and thank you for participating in the 2021 fourth quarter year-end update call. We're pleased to have this opportunity to review our successful acceleration to phase two clinical development within COVID-19 and immuno-oncology while we continue to secure critical resources in support of GEOVAC's growth and development while advancing our IND-enabling programs. Over the past year, we utilized our balance sheet to catapult into Phase II clinical development through the strategic in-licensing of both GEO CMO4S1 and GADEPTIN. CMO4S1, which we in-licensed exclusive global rights from City of Hope National Medical Center, is a next generation COVID-19 vaccine targeting both antibody and cellular immunity with the goal of providing more robust and durable protection than the current authorized vaccines. Gideptin is a cancer immunotherapy, which we analyze since exclusive global rights from PMP Therapeutics and the University of Alabama, Birmingham, currently being evaluated among patients suffering from advanced head and neck cancers that has received orphan drug status from the FDA. In addition, we're advancing encouraging internal programs on the path to IND filings. In January, we issued a 2021 milestone report addressing the goals we established and communicated early last year. Entering 2021, we built a strong balance sheet supporting both strategic transactions and an organization with the expertise to accelerate our growth and development. We successfully executed our plans, propelling our status into phase two clinical development within both COVID-19 and immuno-oncology. In addition, we advanced our internal programs within COVID-19 and immuno-oncology, as well as reported encouraging results in support of our hemorrhagic fever virus vaccine program. This included a scientific presentation at the 2021 World Vaccine and Immunotherapy Congress in early December. validating our COVID-19 vaccine approach of a multi-antigenic vaccine eliciting strong antibody and cellular immune responses, potentially providing more robust and durable protection beyond the current authorized vaccines, which are primarily designed to induce neutralizing antibodies. In fact, in a well-validated lethal challenge transgenic mouse model, our CMO2 candidate, which is the first step towards a universal coronavirus vaccine, provided complete protection following a single dose, even in the absence of measurable neutralizing antibodies. To our knowledge, these results are unprecedented. I'll note that both our phase two COVID-19 vaccine, CM04S1, and our CM02, both are multi-antigenic COVID-19 vaccines designed to strongly elicit both antibody and cellular immune responses. At that same scientific congress, We also reported further encouraging results in support of our Marburg and Sudan vaccines. During this year, we anticipate reporting milestones and progress related to both our clinical and IND enabling programs. So let's move into further discussion related to our exciting programs and activities underway at GFS. As we enter this year, we further strengthened our balance sheet while focusing on the acceleration of our CM04S1 in Gidepton Phase II programs in completing the IND enabling activities in support of our CMO2 vaccine for COVID-19, our Mach 1 vaccine in immune oncology, and our hemorrhagic fever virus vaccines, the latter of which are supported via non-diluted funding and activities. In addition, we have further enhanced our resources and expertise in support of successfully executing upon our 2022 and beyond plans for growth and development of the company. Our priority focus this year is to accelerate the recruitment and enrollment of our three Phase II programs. This includes our multi-site clinical trial in support of GADEPTIN and our two clinical trials in support of CM-04S1. Since our recent GADEPTIN announcement, we have confirmed two additional clinical sites in the assignment of CatoSMS as our CRO partner responsible for leading the expansion and acceleration of the Cadeptan Clinical Program. Our goal is to complete patient enrollment towards the end of 2022 or early 2023, followed by completion of patient evaluations by the end of 2023. Should the results be supportive, a BLA filing will likely shortly happen thereafter. In parallel with the ongoing clinical program, we're also engaged with a CDMO to prepare for commercial manufacture. We are confident that the Godeptin Phase II program will be successfully managed by CatoSMS and our clinical operations team with this possible expansion of further additional clinical sites soon. We're highly excited about the outlook and promise of Godeptin within advanced head and neck cancer, where it has received orphan drug designation from the FDA and has previously provided encouraging potential for such patients. In addition, there are promising opportunities relative to expanded use of cadeptin and other indications, as well as the GDEP technology in conjunction with other therapies and potential synergy with our MVA-VLP, tumor-associated antigen approach. We're looking forward to providing milestone updates throughout this year about the progress of our cadeptin program. In November of last year, we announced exclusive worldwide license of a phase two COVID-19 vaccine from City of Hope National Medical Center. This exciting vaccine is now referred to as GEO CM04S1, which I typically refer to as CM04S1. CM04S1 utilizes synthetic modified vaccinia anchor or MVA technology similar to our other vaccine programs under development at GeoVax. This transaction literally propelled us into a critical stage of clinical development. CM04S1 works by inducing immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies against SARS-CoV-2 that can block the virus from entering healthy cells while the immune system can also grow new disease-fighting T cells that can recognize and destroy infected cells. The vaccine includes both SARS-CoV-2 spike and nuclear capsid proteins. By inserting these proteins, the MVA delivery vehicle is able to drive the expression of both proteins within the body of the vaccine recipient, inducing immune responses. The role of the S protein is to elicit a neutralizing antibody response against the initial infection, while the M protein elicits a T cell response to directly attack virus-infected cells, reduce viral replication, and reduce severity and clearance. Thus, the vaccine is designed to induce both neutralizing antibodies and T cell responses specific for the S protein and the M protein. 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. Our goal is to provide a vaccine that gets ahead of the variants versus having to chase the variants, which if successful, will reduce reliance on the repeated administration of booster doses of existing vaccines. Frankly, we believe that such a multi-punch approach has the potential for providing more robust and durable immune response and protection than the current authorized vaccines. We also believe that various high-risk populations such as immune compromised individuals will greatly benefit from such a two-prong approach. CMO4S1 is currently being evaluated in two phase two clinical trials. One trial is the first comparative trial of an investigative COVID-19 vaccine with the current FDA approved Pfizer vaccine and people that have received or are undergoing specific blood cancer therapies associated with transplantation or CAR T therapy that suppress or severely reduce preexisting immunity to COVID-19 vaccine. Multiple clinical trials have demonstrated that such patients fail to respond optimally to the current generation vaccine. And we believe that CM04S1 will prove to be more potent because it is multi-antigenic and delivered using the MVA vector. We believe this will differentiate CM04S1 from the other vaccines by providing both a strong antibody response and a sustained T cell response in these patients who are still at high risk due to their immunocompromised status of severe COVID-19. The other trial currently underway is evaluating CMO4S1 as a booster for healthy patients who have previously received either the Pfizer or Moderna mRNA vaccines. We believe that providing a heterologous booster rather than a third or fourth shot of the same vaccine may provide more robust and durable immune response and protection. Heterologous prime boost immunizations are well studied in other fields, such as HIV. and are being evaluated in multiple countries using different COVID vaccines. We are working with Cato, SMS, and Pharmalon following their recent merger to oversee the acceleration and management of these two exciting clinical programs, working in conjunction with our internal clinical operations team. Finally, the ongoing GFX effort to develop a manufacturing process based on a continuously growing avian cell line to increase production consistency and capacity will mesh with the clinical development activities and full development schedule associated with the CM04S1 and the CMO2 vaccines. The potential benefits of this transaction to the G of X program are highly significant and timely. Now, I'd like to turn the presentation over to Mark Reynolds, G of X Chief Financial Officer, for a review of our recent results and financial statements. Mark?