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GeoVax Labs, Inc.
8/9/2023
Good day. My name is Jordan, and I'll be your conference operator today. At this time, I would like to welcome everyone to the GeoVax second quarter earnings conference call. I'll turn the call over to Gabrielle.
Thank you. 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 product candidates with the desired characteristics in a timely manner, and such products will be safe for human use. Geovax's vaccines will effectively prevent targeted infections in humans. GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. There is development of competitive products that may be more effective or easier to use than GeoVax's products. 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 that force 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?
Good afternoon, and thank you for participating in the GFX corporate update call. This year, we've expanded patient enrollment in support of the GADEPTIN Phase 2 clinical trial and the two Phase 2 trials for GEO-CMO4-S1, as well as announcing the initiation of the third Phase 2 clinical program, evaluating this next-generation COVID-19 vaccine as a booster among patients with chronic lymphocytic leukemia. We also recently expanded our rights related to CMO4S1 to include Omicron variants, monkeypox, and smallpox, further differentiating our COVID-19 vaccine. While the clinical development progress of GADEPT and CMO4S1 remain our priority, we are also focused on GEO-MVA, our vaccine against monkeypox and smallpox, as well as the implementation of the transformative MVA continuous cell line manufacturing process. During the second quarter, we progressed each of these priority initiatives. Currently, we are funded into 2024, and we anticipate further strengthening our balance sheet as a result of supportive stock activities, business development initiatives, and non-dilutive opportunities related to government and NGO funding. As recently announced, interim data from the current Gidepton Clinical Program was presented in July at the American Association for Cancer Research and the American Head and Neck Society joint conference on head and neck cancers. We are pleased and encouraged by the results, noting no dose-limiting toxicities or serious adverse events definitely attributable to treatment, with impaired growth in targeted lesions observed in the majority of the patients. We anticipate completion of the current clinical program shortly, and we are already planning the next stage of clinical development relative to this promising therapy. There are approximately 67,000 new cases of head and neck cancers annually in the U.S. and approximately 13,000 deaths. This represents our initial targeted patient population. Worldwide, there are approximately 900,000 new cases of head and neck cancers annually and approximately 400,000 deaths. Patients suffering from advanced head and neck cancer represent a critical unmet medical need. We are excited about the outlook and promise of gadeptin therapy against numerous tumors and cancers. We foresee significant opportunity addressing various tumors as monotherapy, as well as the potential combo therapy, administering gadeptin in conjunction with other therapies, such as immune checkpoint inhibitors. We anticipate publication of compelling preclinical evaluation of gadeptin use in combination with ICIs later this year. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use for which business development activities have been initiated. We hold worldwide rights for the use of Godeptin and all indications. The vast array of unmet medical needs within oncology represents significant opportunities for GFX to advance novel approaches addressing various cancer patient needs worldwide. Increasingly, we are participating in various oncology conferences some of which we expect GADEPTIN presentations, and with others, GADEPTIN partnering discussions. GEOCMO4S1, our next-generation COVID-19 vaccine, differentiates from the currently authorized COVID-19 vaccines in targeting both the antibody and cellular arms of the immune system, focused on providing a more robust and durable protection than the current vaccines. This is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapies are inadequate. Such populations include those with various blood cancers, renal disease, sickle cell anemia, HIV-positive, autoimmune diseases such as lupus, and those on immune-suppressive therapy. In general, patient groups with ablated immune systems unable to respond adequately to approved mRNA Vaccines are at such high risk. In the U.S., there are approximately 12 to 15 million immune compromised individuals. Worldwide, there are an estimated 200 plus million. This is a major critical need for next generation COVID-19 vaccines to support such individuals. And we believe that CMO4S1 is the leading next generation vaccine in clinical development. During second quarter, the White House announced Project NextGen, a $5 billion initiative, the follow-on from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, being particularly interested in novel vaccine candidates already in clinical trials. We believe the CMO4S1 is a leading example of the desired next-generation COVID-19 vaccines. We have considerable interest both domestically and internationally in participating in our clinical development program. We believe that an opportunity for an expedited regulatory path likely exists due to our focus on high-risk populations unserved by the current COVID-19 vaccines and monoclonal antibody therapies. Also, we anticipate partnering and collaborations in support of worldwide commercialization and distribution. Regarding Project NextGen, all we can say at this time is that we're deeply involved in the process and discussions. We hope to provide further updates soon. For the remainder of 2023, we are focused on accelerating efforts in support of the Depton and CMO4 S1 Phase II clinical programs, advancing our MVA vaccine specific for mpox and smallpox into development, and further advancement of our program focused on improved MVA manufacturing processes. We also anticipate opportunities to add additional capital in support of these programs, accelerating the pace of progress and reporting a milestone in capital. Now I'd like to turn the presentation over to Mark Reynolds, GVAC's Chief Financial Officer, for a review of our recent results and financial status. Mark?
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