GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax first quarter 2025 corporate update call. My name is Michelle and I'll facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, PhD, Chief Scientific Officer, Kelly McKee, MD, MPH, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. At this time, all participants are in a list-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I'm turning the call over to Max Gattaca of PrecisionAQ.

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. 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 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. Thank you.

Welcome to the first quarter 2025 Geovax Corporate Update Call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions that you may have. We remain confident in the continued progress and compelling outlook for our portfolio of GEO CMO 4S1, GEO MVA, Gedefin, and the advanced MVA manufacturing process. Each of our product development candidates addresses critically important unmet healthcare needs, providing opportunities for expedited registration paths, and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide. We also anticipate that the advanced MVA manufacturing process will provide a gain advantage in production of MVA-based vaccines and therapies. We also wish to welcome Dr. Cynthia Raganathan to Giavax at our Vice President, Technical Development and CMC Operations, joining our team to guide our transition to the next phase for registration and commercialization of our exciting portfolio. Before going any further, let me first address the recent Project NextGen stop work order. Following the close of first quarter, on April the 11th, we unexpectedly received the stop work order notice relative to the BARDA Project NextGen program. The notice indicated that BARDA has decided to terminate the contract for convenience to the government pursuant to the terms of the project agreement. We can only assume this relates to the ongoing government efficiency efforts. We had no prior indication that the notice was forthcoming and were surprised by the notice as both the GFX internal team, our external contractors and consultants were making good progress and had a Very good. Productive working relationship with the technical team at BARDA. Determination in no way implies any concerns as to the safety or potential efficacy of GO-CMO-4S1 or the underlying NVA vaccine vector technology. Nor will determination impact the ongoing phase two clinical trials of CMO-4S1, primarily investigating our vaccine in immunocompromised patient populations. The funding from BARDA pursuant to the project agreement was mostly earmarked for incremental spending, with a large portion going directly to the external clinical research organization to conduct the clinical trial. Given the structure of the award, the financial impact to GEOVAX is estimated at less than $750,000 annually toward reimbursement of existing personnel overhead costs. As a result, we don't anticipate any significant changes to our ongoing operations. The decision by BARDA to terminate our contract is very disappointing to GFX and our stakeholders. However, we remain committed to CMO4S1 as a critically needed next generation multi-antigen COVID-19 vaccine, providing the potential for a more robust immune response against emerging variants, improved durability versus the first generation single antigen COVID-19 vaccine, and especially in addressing the immune protection among those patients with compromised immune systems. During the Q&A session, we welcome the opportunity to address any further questions that you may have. Our current CMO4S1 studies will continue, especially our focus on achieving the completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia patients. One of the highest risk groups in the need of reducing the risk of severe infection, hospitalization, and risk of death coming from COVID-19. Demonstrating the potential superior value of CMO4S1 among immunocompromised patients remains our focus for the development of differentiation for the first-generation and other single antigen-focused COVID-19 vaccine. The medical need for a COVID-19 vaccine such as CMO4S1 is substantial given that we estimate over 40 million adults in the United States have medical conditions rendering their immune systems inadequately responsive to the first generation and other single antigen vaccine. Worldwide, we estimate over 400 million at such risk. In addition, we believe that CMO4S1 provides the potential for a better booster to the first generation single antigen vaccines. During 2025, we anticipate multiple presentations of clinical results for CMO4S1, including the World Vaccine Congress presentation last week. In addition, presentations are scheduled for the European Hematology Association, the International Workshop on Chronic Lymphocytic Leukemia, the American Association of Immunologists, the Keystone Vaccinology, and additional conferences underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. These presentations will undoubtedly also serve as important catalysts for ongoing strategic partnership discussions. Relative to GEO-MVA, our vaccine candidate against MPOCs and smallpox, we recently completed CGMP production and quality release of the clinical batch of vaccine material. We anticipate having vaccine available for clinical evaluation later this year. We're pleased to state that we have produced sufficient amount of products to support the anticipated clinical evaluation, as well as additional product in support of additional clinical use in conjunction with various stakeholder discussions that we have underway. We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. Relative to our plans for a Phase II gadeptin trial in head and neck cancer, the clinical operations plans are underway as we complete the necessary regulatory aspects of product manufacturing in support of the trial. Just this week, Dr. Mark Pfeifus presented at the AACR meeting in Chicago. reviewing the clinical results thus far and our plans for the Phase II study. In addition to the upcoming Phase II trial, we also plan additional studies of gadeptin addressing other solid tumors beyond head and neck cancer. We believe that gadeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long-term. Overall, our goal is to successfully develop innovative cancer therapies and infectious disease vaccines addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate establishing business partnerships and collaborations in support of the worldwide development, commercialization, and distribution of our portfolio products. Our priorities and anticipated milestones for 2025 remain focused on, first, advancing GeoCMO4S1 for immune-compromised populations. Secondly, advancing GeoMVA to clinical evaluation. I'll note the significant governmental interest exists relative to the U.S.-based supply chain versus the current over-dependence on non-U.S. suppliers. The strong sentiment in favor of such on-shoring initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders, such as the White House, congressional representatives, HHS, BARDA, WHO, the AFCA CDC, and others regarding our having produced a CGMP clinical batch of GLMVA vaccine planned for use in the upcoming clinical study, as well as other potential uses. In fact, WHO and other stakeholders have underscored the critical need for expanded MPOCS vaccine supply as a priority for WHO and other public health agencies worldwide. Lastly, our focus on oncology specifically related to gadeptin is a major priority for the future of GeoVac. We have high expectations for the potential broad utilization of gadeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. We continue to progress towards the invitation of our phase two study to evaluate gadeptin in combination with immune checkpoint inhibitor among patients with locally recurrent head and neck splenic cell carcinomas following primary therapy and for whom reception with curative intent is planned. Our clinical operations plans for this trial, as I mentioned, are coming together nicely, along with the regulatory aspects and necessary product manufacturing in support of the Phase II study. As I previously noted, this week Dr. Pike has provided an overview of the definite American Association of Cancer Research, In addition, we're planning various animal validation studies, further building a compelling basis of the potential value of gadeptin addressing various solid tumors. Overall, we're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. Now I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer, for a review of our recent results of financial status. Mark. Thank you, David. The details of our first quarter 2025 financial results are summarized in today's press release. I'll start my review with our income statement. Revenues associated with the BARDA contract were $1.6 million in 2025 versus zero in 2024 as the contract began during June of last year. As David mentioned, we received a stop work order from BARDA in April with the expectation that the contract is to be terminated. So there will be a final settlement amount billed to BARDA during Q2 of this year, and then nothing more going forward. But as a reminder, this is a cost reimbursement contract, with the vast majority of the contracts earmarked for new incremental spending. So the net financial impact to GVAC is expected to be less than $750,000 annually for a billable personnel time and overhead. Research and development expenses were $5.4 million in 2025 versus $4.4 million in 2024, representing an increase of roughly $1 million, or 21%. The increase during 2025 is primarily related to costs associated with the BARDA contract, as well as our GADEPTIN and GEO-MVA programs. These costs were partially offset by lower costs related to the CMO4S1 clinical trials. General administrative expenses were $1.7 million in 2025 versus $1.5 million in 2024, representing an increase of $200,000 or 16% associated with higher investor relations consulting costs and stock-based compensation expense. Interest income was $47,000 in 2025 compared with $33,000 in 2024. So overall net loss for the first quarter of 2025 was approximately 5.4 million, or 45 cents per share, versus 5.9 million in 2024, or $2.47 per share. Turning now to the balance sheet, our cash balances at March 31st were 7.4 million as compared to 5.5 million at December 31st, reflective of $6 million used in operating activities, offset by 7.9 million in financing transactions. Our outstanding common shares currently stand at $15.2 million following recent financing activity. Including the ongoing GEO CMO 4S1 clinical trials continues to be a top priority for us in terms of our operational focus. These trials were unaffected by the bar to stop work order. We also expect to accelerate our plans for clinical trials associated with the GEO MVA and Gidepton programs. Supporting these clinical programs will be the most significant use of our cash in the foreseeable future. We continue to explore various strategies to fund our development programs through several valuation inflection points and to extend our cash runway. These could come in the form of strategic partnerships, non-dilutive funding, and additional offerings of our common stock. I'll be happy to answer any questions during the Q&A, and now I'll turn the call back over to David. Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Sharkey, our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively. I'll now turn the call over to the operator for instructions on the question and answer period.