11/11/2021

speaker
Rocco
Chorus Call Facilitator

and welcome everyone to the geovacs third quarter 2021 corporate update call i am rocco with chorus call and will facilitate today's call with me are david dodd chairman and ceo mark reynolds chief financial officer mark newman phd chief scientific officer john sharkey phd head business development and don diamond phd professor department of hematology and hematopoietic cell transplantation, City of Hope. All participants will be in 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. 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 Jules Abraham of CORE-IR, who will provide a forward-looking statement regarding this call and information herein.

speaker
Jules Abraham
CORE-IR Representative

Jules Abraham Thank you, Rocco, 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 amounts of 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. It's now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. David.

speaker
David Dodd
Chairman and CEO, GeoVax

Thank you. Good afternoon. Thank you, everyone, for participating in the 2021 Third Quarter Update Call. We're pleased to have this opportunity to review and discuss our continued progress in accelerating our priority development programs towards clinical development and continuing to secure significant resources in support of GFX growth and development. We remain focused on delivering meaningful results and value milestones over the next 12 to 18 months, focused on our priority programs related to COVID-19 and immuno-oncology, developing increased value for shareholders, stakeholders, and public health worldwide. Over the past year, we strengthened our cash position while advancing towards important data milestones related to several of our programs. We remain pleased with the progress and outlook for Geovax. Over the past few weeks, we've announced the successful entry of clinical development within both immuno-oncology and COVID-19 vaccine developments. These successful milestones are consistent with our goal of accelerating clinical stage status within each of these strategic areas while providing a strong foundation for further developments of novel differentiated products within these critical medical areas. Since our recent Godeptan announcement, we've confirmed two additional clinical sites that initiated the IND transfer to our responsibility. Further expansion and acceleration of the Godeptin trial is underway. We're most excited about the outlook and promise of Godeptin within head and neck cancer, where it has received orphan drug designation from the FDA. In addition, there's promising opportunities relative to expanded use of the GDEP technology in conjunction with other therapies and in conjunction with our MVA-VLP tumor-associated antigen approach. Regarding the licensing of the Phase 2 COH04S1 vaccine program relative to COVID-19 and the expanded opportunities we expect in conjunction with our CMO2 program, we'll discuss those opportunities later in the call. In addition to the significant milestones achieved relative to gadeptin and O4S1, our programs related to hemorrhagic fever virus vaccines continue to successfully progress via non-diluted funding and support from the federal government. This is well addressed in our press release, noting the continued progress of these programs, especially through the suite of preclinical services from NIAID, for which Geovax's Sudan and Marburg vaccine candidates are being tested for immunogenicity and efficacy in the benchmark non-human primate model. Our vaccine against Lassa fever virus is in preclinical studies with funding support from the U.S. Department of Defense. We believe that our portfolio of hemorrhagic fever virus vaccines potentially offer a valuable addition to preventing these highly dangerous and threatening viral challenges. We look forward to continued reporting on the progress of these programs. Tuesday afternoon of this week, we announced the completion of an exclusive license pertaining to the COH04S1 vaccine, a phase two COVID-19 vaccine from City of Hope. a world-recognized research institution and NCI-designated comprehensive cancer center. The phase two clinical trial currently enrolling patients is the only one of its kind to prospectively study the safety and effectiveness of an investigational COVID-19 vaccine in blood cancer patients who have received a bone marrow transplant or CAR T therapy. O4-S1 utilizes modified vaccinia-ancra, or MVA technology, similar to our programs underway at Geovax. We anticipate significant synergy with and complement to our program, but this transaction propels us into a critical stage of clinical development. Created from a synthetic MVA, O4-S1 works by inducing immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies against the virus that can block the virus from entering healthy cells. With O4S1, the immune system can also grow new disease-fighting T cells that can recognize and destroy infected cells. This product has already been tested for safety and potency in healthy volunteers and induces strong T cell responses. O4S1 is Also, the only COVID-19 vaccine to advance the phase two trials in cancer patients that includes both SARS-CoV-2 spike and nucleocapsid or the N protein. By inserting these proteins into the MBA delivery vehicle, the MBA is able to drive the expression of both proteins within the body of the vaccine recipient, spurring immunity against the virus. Giving O4-S1 after CAR T therapy may work better in reducing the chances of contracting COVID-19 or developing a severe form of COVID-19 in patients with blood cancer compared to the current vaccine options. This trial is also the first comparative study of an investigational COVID-19 vaccine with the FDA-approved Pfizer BioNTech vaccine in people receiving immunosuppressive therapy. For patients who are likely to have difficulty mounting an antibody response due to extended B-cell aplasia post-therapy, the T-cell response to vaccine will be critical. But now in order to delve deeper into O4S1 and this transaction, it's my pleasure to introduce Dr. John Sharkey, head of business development at Geovax. John?

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