David Dodd
Analyst · Maxim Group. Please go ahead
Thank you, Scott. Good morning and thank you for participating in this inaugural GeoVax's quarterly update call. During the third quarter 2020, GeoVax capitalized the company and achieved a NASDAQ listed, securing the resources in support of accelerating our development programs towards clinical development, hopefully, leading to eventual prevented 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 opportunity to GeoVax staff. We look forward to your continued commitment and support as we advanced our programs as well as value developments for shareholder, 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 of this pandemic has resulted in the development of four vaccine candidates that are either already begun or will soon begin animal testing for which we are seeking federal funding support to more rapidly accelerate our program through animal testing, selection of the lead candidate, manufacturing scale up and two critical human testing. The recent NIH license illustrates our confidence and that it confirms GeoVax access to use of critical NIH patents and materials and 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 and 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 they existed the established relationships between the Federal government and specific vaccine developers. Because those vaccine technologies are largely unproven, major questions exist regarding the safety, efficacy and durability, as well as the eventual public acceptance based on their performance profiles. Not the least of which is that a feasible distribution of populations across the world's various environments. RNA and DNA vaccine, such as those from Moderna, Pfizer and the Inovio, only allow for specific genetic fragments, meaning that they could 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 simply 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 degree 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 core COVID-19 vaccine candidates in animal testing with the intent of selecting our lead candidate for proceeding with 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 or potentially stronger and broader immune response without presenting an increased infectious risk to the vaccinated patient. The same GeoVax's 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 agents such as an immune checkpoint inhibitor, resulting in regression of tumor growth and development. Starting with the MUC1 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 or MUC1 is highly expressed in many different solid tumors. We constructed an MVA-VLP, MUC1 TAA vaccine, combining it with a checkpoint inhibitor or CPI, testing 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 preventive evaluation, again using humanized mice and a human tumor the GeoVax MVA-VLP MUC1 vaccine plus a MUC1 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. This result 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 immunotherapy. 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-dilutive 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-dilutive capital development opportunities as the product advanced post development completion of regulatory registration. To date, our developments in the areas of hemorrhagic fever virus vaccine such as Lassa, Marburg and Sudan and our malaria vaccine continue to advance towards completion of animal testing via non-dilutive funding as we similarly have seen with our Ebola and Zika virus vaccine program. 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 a 100% protection and 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 may remains on 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 vaccine. Our development programs are all focused on areas of major medical needs representing significant commercial opportunity. 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 GeoVax technology and approach has the potential to deliver single dose, safe, highly efficacious durable vaccines while also providing a new advanced within cancer therapies. The commercial opportunities are significant and we're focused on advancing in the clinical development as soon as possible. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax's Chief Financial Officer for a review of our recent results and financial status. Mark?