GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax First Quarter 2022 Corporate Update Call. I am Chuck with Course Call and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mr. Mark Reynolds, Chief Financial Officer, Mr. Mark Newman, Ph.D., Chief Scientific Officer, and Mr. John Sharkey, Ph.D., Head of Business Development. All participants will be in a listen-only mode. Should you need assistance, please signal conference specialists 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 1 on your telephone keypad. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Jules Abraham of Core IR, who will provide a forward-looking statement regarding this call and information herein. Please go ahead, sir.

Jules Abraham, Core IR Thank you, Chuck, and 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 GeoVax 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, there is development of competitive products that may be more effective or easier to use in 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 as risk factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

Thank you and good afternoon, everyone. And again, thank you for participating in the 2022 first quarter update call. First quarter marked a transformational period for GeoVax in that we achieved clinical stage development status within the two priority areas of COVID-19 vaccine development and cancer immunotherapy. In addition, we added strong expertise and experience to ensure our ability to expand and accelerate are clinical development programs and the requisite activities through regulatory registration, manufacturing, and distribution. Our mission is to provide products that prevent or treat some of the world's most challenging infectious diseases and cancers by leveraging technology and collaborations that allow us to successfully provide life-enhancing products in a safe, scientific, validated manner. Our pursuit is to deliver safe, affordable products to improve lives worldwide, delivering increased value to our shareholders and providing motivating career development opportunities to members of our team. We firmly believe that GeoVax can provide differentiated advanced vaccine and immunotherapies competing with and collaborating with other companies worldwide. We intend to successfully execute in this regard. We're pleased to have this opportunity to review our successful progress into phase two clinical development while securing critical resources in support of GeoVax's growth and development while also advancing our IND-enabling programs. The in-licensing of both GEO, CMO4S1, and Godeptin represented watershed events in the transformation of GeoVax as milestones towards potential significant value expansion of the company. 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. Gadeftin is a cancer immunotherapy which we in-licensed exclusive global rights from PMP Therapeutics and the University of Alabama Birmingham. are currently being evaluated among patients suffering from advanced head and neck cancers and has already received orphan drug designation from the FDA. In addition, we're advancing encouraging internal programs on the path to IND final. In January, we issued a 2021 milestone report addressing the goals we established and communicated early last year. That update outlined our successful 2021 performance in executing upon those goals bringing us to the phase two clinical status, enabling our progress related to our internal programs while strengthening the organization with the expertise to accelerate our growth and development. At the 2021 World Vaccine and Immunotherapy Congress last December, we reported results validating our COVID-19 vaccine approach of a multi-antigenic vaccine inducing strong antibody and cellular immune responses potentially providing more robust and durable protection beyond the current authorized vaccines. In fact, in a well-validated lethal challenge transgenic mouse model, our CM02 vaccine 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. For our knowledge, these results are unprecedented. I'll note that both our Phase 2 COVID-19 vaccine, CMO4S1, and our universal coronavirus vaccine candidate, CMO2, are each multi-antigenic COVID-19 vaccines, designed to strongly induce 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. Last week at the World Vaccine Congress, Dr. Newman further discussed the status of CM04S1 in our basis and support of our multi-antigen universal coronavirus vaccine. In January, we further strengthened our balance sheet and are currently well capitalized for at least a year. We anticipate further strengthening of our balance sheet during 2022, which will be addressed later by Mark Reynolds, our CFO. Our primary 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 Gdeptin and our two clinical trials in support of CMO4S1. Since acquiring the rights to Gdeptin, 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 Gdeptin clinical program. Our focus on accelerated and expanded patient enrollment is actively underway with the goal to complete patient enrollment towards the end of 2022 or early 2023, followed by completion of patient evaluations perhaps by the end of 2023. Should the results be supportive of BLL filing, we'll likely follow shortly thereafter. In parallel with the ongoing clinical program, we are also engaged with the CDMO to prepare for commercial manufacturing. We are confident that the Godeptin Phase II program will be successfully managed by CATL-SMS and our clinical operations team with possible expansion of further additional clinical sites. We're highly excited about the outlook and promise of Godeptin within advanced head and neck cancer where it has received orphan drug designation and has previously provided encouraging potential for such patients. In addition, there are promising opportunities relative to expanded use of gadeptin and other indications, as well as the GDEP technology in conjunction with other therapies and potential synergy with our own MVA-VLP tumor-associated antigen approach. We're looking forward to providing milestone updates throughout this year about the progress of our gadeptin program. Also during first quarter, we focused on the two phase two clinical trials in support of CMO4S1. This vaccine utilizes synthetic modified vaccinia anchor or MVA technology, similar to other vaccine programs under development at GeoVax. CMO4S1 induces 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 nucleocapsid 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 N protein elicits or induces 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 N protein. This vaccine design was implemented specifically to induce an expanded immune response to better combat and clear infection regardless of the circulating SARS-CoV-2 variants. This vaccine is the first step in the worldwide goal to provide a vaccine that gets ahead of the variants versus having to chase the variants. If successful, this vaccine will reduce reliance on the repeated administration of booster doses of existing vaccines. We believe that a multi-punch approach has the potential for providing a 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 benefit from such a two-prong approach. CMO4S1 is currently being evaluated in two Phase II clinical trials. One trial is the first comparative study of an investigative Investigational COVID-19 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 that suppress or severely reduce preexisting immunity to COVID-19 vaccines. Multiple clinical evidence has demonstrated and Val Dade that such patients fail to respond optimally to the current generation vaccine and we believe that CMO4S1 will prove to be the more potent vaccine because it is a multi-antigenic and delivered using the MVA vector. We believe this will differentiate CMO4S1 from the other vaccines by providing both a strong antibody response and a sustained and T-cell response in these patients who are still at high risk of severe COVID-19 due to their immunocompromised status. 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 or fifth shot of the same vaccine may provide more robust and durable immune response and protection. Heterologica's PrimeBoost 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 the now combined Cato, SMS, and Formilon to oversee the acceleration and management of these two exciting clinical programs working under the direction of 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 CM04S1 and CM02 vaccines. Now I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer, for a review of our recent results and financial status.