$GOVX CEO Discusses Key Value Drivers, Including COVID Vaccine and Immuno-Oncology Milestones for 2021.

We made tremendous progress in 2020 to fundamentally improve the position of the company, including cleaning up our capital structure, securing long-term funding, signing critical licensing agreements, accelerating our programs towards clinical development, and achieving NASDAQ listing. We are excited about the numerous upcoming milestones with our developments, which should see several data read-outs over the next six to twelve months. Our focus is on advancing our priority programs related to COVID-19 and immuno-oncology, developing increased value for shareholders, stakeholders, and public health worldwide.

We are particularly excited about the recent signing of two license agreements with the National Institutes of Health (NIH), both of which underscore a commitment to and confidence in our unique vaccine development approach.

The initial agreement announced October 2020 grants GeoVax full access to and use of critical NIH patents of materials in support of COVID-19 vaccine product development, clinical development, and continued progress through FDA registration, manufacturing, and commercialization of a preventative vaccine for COVID-19.

The second license, signed in November 2020, supports the ongoing research and development of our other infectious disease vaccines and cancer immunotherapies.

With respect to our efforts in developing a preventative vaccine for COVID-19, in January 2021, we announced receipt of NIH funding in support of our COVID-19 vaccine development programs. There's increasing evidence that the COVID-19 virus will continue to evolve, requiring expanded virus variant coverage, otherwise requiring annual reconfigured vaccines, similar to what is necessary with annual influenza vaccination. We hope to change that paradigm, encompassing potential variants before they emerge versus chasing the evolving virus as will be likely required of various competitive technologies. In November 2020, the NIH issued a request for proposals for pan-coronavirus vaccine development programs. That is exactly what we are pursuing using our differentiated technology focused on developing a single-dose vaccine with minimal or no refrigeration required.

We are in the final stages of small-animal testing with our various COVID-19 vaccine candidates and we hope to report these data in the coming months. As a reminder, the primary advantage of our MVA-VLP platform is that it can incorporate a large genetic coding capacity, which allows us to include multiple genes for a given target. For COVID-19, our preventative vaccine constructs not only include the Spike, or S protein, but also the matrix and envelope proteins, M & E proteins, which serve as additional targets for cellular immune responses and should not be significantly impacted by variants that are evolving within the population. This ultimately facilitates our goal of developing a single-dose, universal, pan-coronavirus vaccine.

In other infectious diseases, we continue to make advances with our vaccine pipeline. The Lassa vaccine is now in animal testing through non-human primates, with results expected later this year. This program is being supported by the U.S. Army and will also fund the preparation of cGMP material for clinical development. 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 the results of the animal testing in 2021. Our malaria vaccine candidates have recently entered animal testing with the results expected later this year. Our Zika virus vaccine is ready to proceed into clinical development, having demonstrated excellent preclinical results, including avoiding the risk of antibody-dependent enhancement of infection against Dengue or other flaviviruses. Similarly, our Ebola virus vaccine is ready to proceed into clinical development, having demonstrated 100% protection from a single-dose without any adjuvants or booster necessary.

And finally, we continue to make progress with our efforts in cancer immunotherapy. We are working to advance our lead MUC1 candidate into the clinic in 2021. As a reminder, we are applying the same approach that we use in constructing our infectious disease vaccines to cancer. Our cancer immunotherapy concept is to combine a tumor-associated antigen vaccine with potent anti-tumor agents such as immune checkpoint inhibitors (ICI). Mucin-1 TAA or MUC1 is highly expressed in many different solid tumors and, in a humanized mouse model study, our MVA-VLP, MUC1 TAA vaccine construct combined with a checkpoint inhibitor resulted in a 57% difference in tumor growth between the cohort receiving our vaccine/ICI combination compared to a cohort that didn’t receive our combination treatment. In a preventive humanized mouse model, intended to reflect prevention of tumor recurrence, our 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. These highly promising results have encouraged our focus on advancing our cancer immunotherapy program into clinical development as soon as possible.

The commercial opportunity for all the above vaccines. 

In addition to major medical needs, our product development focus reflects significant commercial opportunities.

In summary, we continue to strengthen our IP portfolio, now having over 70 granted or pending patent applications spread over 20 patent families. We are confident that we have a strong IP position, providing an increasingly more competitive position. We have a compelling pipeline focused on major medical needs, providing significant commercial market opportunities with near-term value milestones. Included in our development portfolio are six indications that qualify for the FDA priority voucher program, most of which are continuing to advance with non-dilutive funding.