GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVac second quarter 2025 corporate update call. My name is Michelle and I'll facilitate today's call. With me are David Dodd, Chairman, CEO, Mark Reynolds, Vice President, 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 listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Please note the following. Certain statements in this presentation may constitute forward-looking statements within the meanings 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 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 second quarter of 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 MVA, GEO CMO 4S1, GADEPTIN, 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 game-changing advantage in production of MVA-based vaccines and therapies. Today, I'll start with the recent exciting updates regarding GeoMVA, our vaccine candidate against mpox and smallpox. In June, we announced the receipt of guidance from the European Medicines Agency, referred to as the EMA, providing an expedited development path for GeoMVA. This is most encouraging news in that it provides the potential for GEOVAX to achieve marketing authorization and revenue generation sooner, allowing us to bypass phase one and phase two clinical trials and proceed directly to a phase three immunobridging trial. In addition, we continue to engage in dialogue with various stakeholders that may result in emergency use distribution of GEO-MVA prior to formal market authorization. Relative to GLMVA, 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 note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential additional use in conjunction with various stakeholder discussions that are underway. We believe that GLMVA 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. I'll note the significant governmental interest exists relative to U.S.-based supply chains versus the current overdependence on non-U.S. suppliers. The strong sentiment in favor of such on-shoring initiative is 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, WHO, the Africa CDC, and others regarding our progress relative to CGMP clinical inventory of GLMVA. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. We remain committed to GEOCMO4S1, our multi-antigen vaccine against COVID-19, especially as a critically needed vaccine for use among the over 40 million immunocompromised adults in the U.S., as well as the over 400 million worldwide. Based on the clinical data results thus far, We believe that GEOCMO4S1 provides potential for a more robust immune response against emerging variants, improved durability versus the first generation single antigen COVID-19 vaccines, and especially in addressing the immune protection among those patients with compromised immune systems. Our current CMO4S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received stem cell transplants and on completion of the investigator-initiated Phase II trial among chronic lymphocytic leukemia, or CLL, patients, one of the highest risk groups in need of reducing the risk of severe infection, hospitalization, and the risk of death. Demonstrating the potential superior value of CMO4S1 among immunocompromised patients remains our focus for development of differentiation from the first-generation and other single antigen-focused COVID-19 vaccines. The medical need for a COVID-19 vaccine such as CMO4S1 remains substantial for those with medical conditions rendering their immune systems inadequately responsive to the first-generation and other single antigen vaccines. placing them at a continued risk for the severe disease, hospitalization, and the risk of death. In fact, during second quarter, a second site located at the City of Hope facility in Orange County, California, the Lenore Foundation Cancer Center, initiated CLL patient enrollment into this trial. We also believe that CMO4S1 provides the potential for a better booster to the first-generation single antigen vaccines. During the remainder of 2025, multiple presentations of clinical results for CMO4S1 will continue, including the recent presentations at the World Vaccine Congress, the Keystone Symposia, and the European Hematology Association. Upcoming presentations in the remainder of this year include the International Workshop on Chronic Lymphocytic Leukemia, the World Vaccine Congress Europe, the European Society of Clinical Microbiology and Infectious Disease, and additional conferences underscoring the important potential medical value of this unique next-generation COVID-19 vaccine. We also expect that these presentations will continue to provide important catalysts for strategic partnership discussions. Relative to our plans for a Phase II gadeptin trial in head and neck cancer, the clinical operations plans, product manufacturing support of the trial, and the necessary regulatory aspects continue. During second quarter, Dr. Mark Pipus presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase II study. Following the recent impressive results of the Keynote 689 study presented at ASCO, we've modified the Gidepton Phase II study protocol, changing the target population to first-line therapy, mimicking Keynote 689 trial as historical control. As such, our focus will be on evaluating neoadjuvant gadeptin and PEMBRO, offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma of the head and neck who are being considered for surgical resection with curative intent. Our primary endpoint will be major pathological response. Relative to the initiation of this study, we anticipate that this protocol modification will still allow us to initiate the trial during second half 2026. We believe that gadeptin has the potential to address multiple solid tumors, especially via combination therapy providing significant value long-term. We also plan additional studies of gadeptin addressing other solid tumors beyond head and neck cancer. We're also engaging in various discussions related to potential collaborations in the long-term development and commercialization of gadeptin. 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 worldwide development, registration, commercialization, and distribution. Our priorities and anticipated milestones for 2025 remain focused on advancing GeoMVA to clinical evaluation readiness, advancing GeoCMO4S1 for immune-compromised patients, advancing the progress of the advanced MVA manufacturing process, and on our focus in oncology, specifically related to gadeptin, this is a major priority for the future of Geovax. We hold high expectations for the potential broad utilization of gadeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. 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, GEOVAC's Chief Financial Officer, for a review of our recent results and financial status. Mark?

Thank you, David. The details of our second quarter 2025 financial results are summarized in today's press release. I'll start the review with our income statement. During the six months ended June 30, 2025, we reported revenues of $2.5 million versus $301,000 in 2024. This relates to the BARDA project next-gen contract that began during June 2024. As we previously discussed during our Q1 earnings call, In April of this year, the contract was terminated as part of the Government Sufficiency Program, or DOGE, so we won't report any further revenues from this contract beyond Q2. But as a reminder, this is a cost reimbursement contract with the majority of the contract earmarked for incremental spending, so the net impact determination on our overall cash flow projection is less than $750,000 annually. Research and development expense was $10 million during the six-month period in 2025 versus $8.7 million in 2024, representing an increase of roughly $1.4 million, or 16%. This increase during 2025 is primarily associated with costs for the BARDA contract, as well as our GDEPTN and GEO MVA programs. Costs are partially offset by lower costs related to the GEO CMO4S1 clinical trials. General administrative expense was $3.2 million for 2025 versus $2.5 million in 2024, representing an increase of $686,000, or 27%, associated primarily with higher investor relations consulting costs and stock-based compensation expense. Other income and expense was $96,000, in 2025 as compared to 31,000 in 2024, primarily reflecting lower interest income due to lower cash balances. So overall, net loss for the six-month period in 2025 was approximately 10.7 million, or 79 cents per share, versus 10.9 million in 2024, or $4.68 per share. Turning now to the balance sheet, our cash balances at June 30, 2025 were $3.1 million as compared to $5.5 million at December 31, 2024, reflective of $10.3 million used in operating activities, offset by $7.9 million in financing transactions. I'll note also that subsequent to June 30, we concluded a follow-on public offering in July of almost $6 million in net proceeds that bolstered our cash balances. Our outstanding common shares currently stand at $25.2 million, reflecting the recent financing activity. Concluding our ongoing CMO4S1 clinical trials continues to be a top priority in terms of our operational focus. We've also accelerated plans for clinical trials associated with the GEO, MVA, and GADEPTIN programs. Supporting these clinical programs will be the most significant use of our cash for the foreseeable future. We continue to explore various strategies to fund the development programs through several valuation inflection points and extend our cash runway. These could include strategic partnerships, non-diluted 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 to David. Thank you, Mark.