11/6/2020

speaker
Cole
Conference Call Operator and Facilitator, Course Call

Good morning and welcome to the GeoVax Third Quarter 2020 Corporate Update Call. I am Cole with Course Call and will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, and Mark Newman, PhD, Chief Scientific Officer. All participants will be in 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 Scott Gordon of Core IR, who will provide a forelooking statement regarding this call and information herein. Please go ahead.

speaker
Scott Gordon
Managing Director, Core IR

Thank you, Cole. And thank you, everyone, for joining the call. 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 G of X 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. 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 is not intended to do so. More information about these factors is contained in GeoVax's filing, 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. David, please go ahead.

speaker
David Dodd
Chairman and Chief Executive Officer

Thank you, Scott. Good morning, and thank you for participating in this inaugural GeoVax quarterly update call. During third quarter 2020, GeoVax capitalized the company and achieved a NASDAQ listing, securing the resources in support of accelerating our development programs towards clinical development, hopefully leading to eventual preventive vaccines and meaningful cancer immunotherapies. We are focused on delivering meaningful results and value milestones over the next six to 12 months. This would not have been possible without the support and commitment of our existing investors and more recent new shareholders, as well as our dedicated, highly capable staff and our excellent external support resource teams. Thank you to all of those individuals, and we hope that our efforts will provide improved health for people worldwide while delivering attractive financial returns to our investors and career development opportunities to GeoVax staff. We look forward to your continued commitment and support as we advance our programs as well as value developments for shareholders, stakeholders, and public health worldwide. Throughout 2020, GeoVax has been highly focused on what many are calling the scourge of the century, now known as COVID-19. Our response to this pandemic has resulted in the development of four vaccine candidates that have either already begun or will soon begin animal testing and for which we are seeking federal funding support to more rapidly accelerate our program through animal testing, selection of a lead candidate, manufacturing scale-up, and into critical human testing. The recent NIH license illustrates our confidence in that it confirms GFacts' access to and use of critical NIH patents and materials in support of product development, clinical development, and continued progress through FDA registration, manufacturing, and commercialization. Despite there being vaccines that have entered clinical testing constructed using different approaches and different vector platforms than ours, there is increasing evidence that alternative vaccine approaches, including vaccines for various cohort populations, will be necessary to successfully address COVID-19 and related coronaviruses. Most of all, the desired attributes of such vaccines, reflecting high efficacy of 75% or greater, single-dose administration, extensive safety validation, durability, and minimal refrigeration appear to remain elusive when considering the current first-tier candidates. This is where we believe that the GeoVax approach can make a meaningful difference, potentially delivering on most, if not all, of these targeted attributes. With over 250 COVID-19 vaccines at various stages of development, critical challenges remain as to the timing of public use and distribution, attributes of the various vaccines, and long-term preparation readiness for potential future pandemic challenges. The initial COVID-19 vaccines and clinical trials being funded by BARDA under Operation Warp Speed are primarily focused on vaccine technologies where there existed established relationships between the federal government and specific vaccine developers. Because those vaccine technologies are largely unproven, major questions exist regarding their safety, efficacy, and durability, as well as the eventual public acceptance based on their performance profiles, not the least of which is that of feasible distribution to populations across the world's various environments. RNA and DNA vaccines, such as those from Moderna, Pfizer, and Inovio, only allow for specific genetic fragments, meaning that they potentially result in a tight, narrow focus, such as the COVID-19 virus S protein, as the target for preventive success. Adenovirus-based vaccines, such as the AstraZeneca and J&J platforms, similarly do not target a broader base approach and typically require multiple dosing, and additional components or adjuvants to achieve meaningful efficacy. Finally, there remains the challenge of feasible distribution to the public of various environments and localities. This critical issue presents a major challenge, especially when extreme frozen refrigeration such as minus 70 or minus 80 degrees Celsius is required with most of these technologies. The GeoVax approach enables insertion of multiple antigen fragments, potentially allowing broader spectrum virus prevention. As such, we have our four COVID-19 vaccine candidates in animal testing with the intent of selecting our lead candidate for proceeding to human testing. Using our approach, the inclusion of COVID-19 proteins support the virus-like particle or VLP formation, becoming targets for the cellular immune response. thereby increasing the overall immune response since the VLPs closely mimic what might be seen within a recovered patient. As a result, we anticipate a potentially stronger and broader immune response without presenting an increased infectious risk to the vaccinated patient. The same GeoVax approach used in constructing our infectious disease vaccines has shown excellent progress in cancer in both therapeutic and preventive animal models. Our cancer immunotherapy concept is to combine a tumor-associated antigen vaccine with a potent anti-tumor agent such as an immune checkpoint inhibitor, resulting in regression of tumor growth and development. Starting with the Mach 1 tumor-associated antigen, or TAA, we have identified additional TAAs which we intend to incorporate into such an approach depending on the targeted tumor type. As an example, since the Mucin-1 TAA of Mach 1 is highly expressed in many different solid tumors, we constructed an MVA-VLP Mach 1 TAA vaccine, combining it with a checkpoint inhibitor, or CPI, testing it in a humanized mouse model against a human tumor. The result of this combination was a 57% difference in tumor growth. within the cohort that received the vaccine CPI combination versus the cohort that didn't receive such therapy. Also, the GeoVax combo therapy was superior to that of either the vaccine or the CPI alone. In a preventive evaluation, again using humanized mice and a human tumor, the GeoVax MVA VLT Mach 1 vaccine plus a Mach One Peptide provided 100% prevention of tumor development versus 100% development of the tumor in the cohort that didn't receive the GeoVax vaccine peptide combination. These results have encouraged us to proceed as quickly as possible towards initiating a clinical development program. We believe that the GeoVax MVA-VLP combination approach provides an exciting and promising basis for novel efficacious cancer immunotherapies. While our primary focus is on accelerating our COVID-19 vaccine and immuno-oncology programs, GeoVax has several programs advancing that are supported by non-diluted funding that address compelling areas of medical need and significant commercial opportunities. In addition, several of these programs target medical areas within the FDA priority review voucher program. These present significant non-diluted capital development opportunities as the product advances towards development completion and regulatory registration. To date, our developments in the areas of hemorrhagic fever virus vaccines, such as Lassa, Marburg, and Sudan, and our malaria vaccine continue to advance towards completion of animal testing via non-diluted funding, as we similarly have seen with our Ebola and Zika virus vaccine programs. Let me again note and underscore that all six of these vaccine programs target medical areas within the priority review program. Currently, our Ebola vaccine has completed non-human primate testing, demonstrating 100% protection in a single dose with no adjuvants, ready to advance into human testing. The Lassa vaccine is being supported by the U.S. Army and is now in animal testing funded through non-human primates and preparation of the CGMP material for clinical development. We expect results of the animal testing of the Lassa vaccine either late this year or early next year. Both the Marburg and Sudan vaccines, having previously demonstrated 100% protection in rodent models, are being tested via the NIH preclinical services program through non-human primates at no cost to GeoVax. We expect results of the animal testing beginning first quarter of 2021. Our malaria vaccine candidates have recently entered animal testing with the results expected yet this year. And our Zika virus vaccine, for which a major health need remains in the southern hemisphere, meaning South America and parts of Africa, is ready to proceed into clinical development, having demonstrated excellent preclinical results. Most notably, that our Zika virus vaccine avoids the risk of antibody-dependent enhancement. Our development programs are all focused on areas of major medical needs representing significant commercial opportunities. Ultimately, the commercial value of these opportunities will be dependent on numerous parameters, starting with the eventual success of our development. Beyond that obvious hurdle, we believe that the GFX technology and approach has the potential to deliver single-dose, safe, highly efficacious durable vaccines while also providing a new advance within cancer therapies. The commercial opportunities are significant and we're focused on advancing into clinical development as soon as possible. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer for a review of our recent results in financial status. Mark.

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