Financial Data and Key Metrics Changes - For the six months ended June 30, 2025, the company reported revenues of $2.5 million compared to $301,000 in 2024, primarily due to the BARDA Project NextGen contract that began in June 2024 [16] - Research and development expenses increased to $10 million in 2025 from $8.7 million in 2024, representing a 16% increase, mainly associated with the BARDA contract and other programs [17] - General and administrative expenses rose to $3.2 million in 2025 from $2.5 million in 2024, a 27% increase attributed to higher investor relations consulting costs and stock-based compensation [18] - The net loss for the six-month period in 2025 was approximately $10.7 million or $0.79 per share, compared to a net loss of $10.9 million or $4.68 per share in 2024 [18] Business Line Data and Key Metrics Changes - The company is focused on advancing its product candidates, including GEO MVA, GEO CM04S1, and Gideptin, which address significant unmet healthcare needs [5][14] - The advanced MVA manufacturing process is expected to provide a competitive advantage in the production of MVA-based vaccines and therapies [6] Market Data and Key Metrics Changes - The company anticipates significant governmental interest in U.S.-based supply chains, particularly in light of the current overdependence on non-U.S. suppliers [9] - The company is engaged in discussions with various stakeholders, including the White House and WHO, regarding the progress of GEO MVA [9] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, focusing on expedited registration pathways and establishing partnerships for worldwide development and commercialization [14] - The strategic focus for 2025 includes advancing GEO MVA to clinical evaluation readiness, progressing GEO CM04S1 for immunocompromised patients, and enhancing the advanced MVA manufacturing process [14] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the progress and outlook for its product portfolio, particularly in light of recent guidance from the European Medicines Agency for GEO MVA [5][6] - The company is committed to addressing the medical needs of immunocompromised patients with its COVID-19 vaccine candidate, GEO CM04S1, which is expected to provide a more robust immune response [10][11] Other Important Information - The company completed CGMP production and quality release of the clinical batch of GEO MVA vaccine material, with plans to produce additional product for potential emergency use distribution [8] - The company has initiated discussions for potential collaborations in the long-term development and commercialization of Gideptin [14] Q&A Session Summary Question: Regarding the new patch method for the MDA vaccine - The company does not intend to use the patch for the clinical program and plans to utilize the standard vaccine delivery method [24] Question: Is the making of enough vaccine product a limiting step for the trial start? - The vaccine is largely manufactured, and various components need to come together before the trial can start [26] Question: What is the expected start date for the Gideptin trial? - The target start date for the Gideptin trial is the second half of 2026 [51] Question: Can you elaborate on the major pathological response endpoint for Gideptin? - The major pathological response is defined by the extent of response in the resected tumor tissue, with a primary endpoint focused on pathological response [45] Question: What is the status of the BARDA manufacturing proposal? - The company was selected for funding but is currently in a holding pattern pending funding availability [65]

Financial Data and Key Metrics Changes - For the six months ended June 30, 2025, the company reported revenues of $2.5 million compared to $301,000 in 2024, primarily due to the BARDA Project NextGen contract that began in June 2024 [15] - Research and development expenses increased to $10 million in 2025 from $8.7 million in 2024, representing a 16% increase, mainly associated with the BARDA contract and the Gideptin and GEO MVA programs [16] - General and administrative expenses rose to $3.2 million in 2025 from $2.5 million in 2024, a 27% increase attributed to higher investor relations consulting costs and stock-based compensation [17] - The net loss for the six-month period in 2025 was approximately $10.7 million or $0.79 per share, compared to a net loss of $10.9 million or $4.68 per share in 2024 [17] - Cash balances decreased to $3.1 million as of June 30, 2025, from $5.5 million at the end of 2024, reflecting $10.3 million used in operating activities [18] Business Line Data and Key Metrics Changes - The company is focused on advancing its product candidates, including GEO MVA, GEO CM04S1, and Gideptin, which address significant unmet healthcare needs [5][13] - The advanced MVA manufacturing process is expected to provide a competitive advantage in the production of MVA-based vaccines and therapies [6] Market Data and Key Metrics Changes - There is significant governmental interest in U.S.-based supply chains, highlighting a shift towards onshoring initiatives [8] - The company is engaged in discussions with various stakeholders, including the White House and WHO, regarding the clinical inventory of GEO MVA [8] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, focusing on expedited registration pathways and strategic partnerships for worldwide development and commercialization [13] - The strategic priority for 2025 includes advancing GEO MVA to clinical evaluation readiness and focusing on oncology related to Gideptin [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress and outlook for their product portfolio, particularly in addressing critical healthcare needs [5] - The company anticipates that the advanced MVA manufacturing process will significantly enhance production capabilities [6] Other Important Information - The company plans to produce additional vaccine material for clinical evaluation and potential emergency use distribution prior to formal market authorization [6] - The company is exploring various funding strategies to support development programs, including strategic partnerships and additional stock offerings [19] Q&A Session Summary Question: Regarding the new patch method for the MDA vaccine - The company does not intend to use the patch for the clinical program and plans to utilize standard vaccine delivery [24] Question: Is the making of enough vaccine product a limiting step for the trial start? - The vaccine is largely manufactured, but multiple components need to come together before starting the trial [26] Question: Clarification on R&D expenses - The reported R&D expense was $10 million for the six-month period, not for the quarter [31] Question: Details on the MVA trials and immuno-bridging study - The immuno-bridging trial will compare the immune response of GMBA to MVABN without requiring animal efficacy studies [38] Question: Will the trial data be applicable for U.S. approval? - The data from the trial will support discussions with the FDA regarding potential approval [40] Question: Updates on Gideptin trial endpoints - The primary endpoint will be major pathological response, with a secondary endpoint of disease-free survival after one year [43] Question: Start date for Gideptin trial - The target start date for the Gideptin trial is the second half of 2026 [50] Question: Status of BARDA manufacturing proposal - The company’s proposal for the manufacturing process has been selected but is dependent on funding availability [64]

Financial Data and Key Metrics Changes - Revenues associated with the BARDA contract were approximately $4 million in 2024 compared to zero in 2023, as the contract began in June 2023 [19] - Research and development expenses increased to $23.7 million in 2024 from $20.7 million in 2023, representing a 14% increase [20] - General and administrative expenses decreased to $5.4 million in 2024 from $6 million in 2023, an 11% decrease [21] - Net loss for 2024 was approximately $25 million or $4.82 per share, compared to a net loss of $26 million or $14.29 per share in 2023 [21][22] Business Line Data and Key Metrics Changes - The BARDA contract is a cost reimbursement contract, meaning revenues correlate directly with billable personnel time and incremental expenses incurred [19] - The total contract value to GeoVax is $26 million but may increase to as much as $45 million [20] Market Data and Key Metrics Changes - The WHO declared mpox as a public health emergency of international concern, emphasizing the need for additional vaccine supply options [14][15] - There is significant government interest in U.S.-based supply chains, reflecting a shift from reliance on non-U.S. suppliers [16] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, focusing on expedited registration pathways [9] - Strategic focus on oncology, particularly related to Godeptin, remains a major priority for 2025 [17] - The company is actively pursuing partnerships and collaborations to support worldwide development and commercialization [9][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of CM04S1 as a next-generation COVID-19 vaccine, particularly for immunocompromised populations [12][58] - The company is in regular contact with BARDA, maintaining a positive relationship and continuing to meet development milestones [52][59] Other Important Information - The company has produced sufficient product to support anticipated clinical evaluations and potential additional clinical use [7] - The advanced MVA manufacturing process is expected to enable efficient production and distribution of MVA-based vaccines [17] Q&A Session Summary Question: Could GeoVax sell product without clinical testing due to the urgency of the mpox threat? - Management indicated that while typically not possible, there may be opportunities for emergency use licensing depending on recognized need, especially given the significant demand in Africa [26][27] Question: How is GeoVax ensuring equitable vaccine access in low-income countries? - The company has been in discussions with African health ministries and European regulatory agencies to ensure equitable access and is actively building relationships with organizations like UNICEF [28][30] Question: What is needed to start the next GIDEPTIN trial? - Management stated that they are continuing to manufacture the product and expect to initiate the clinical trial in the mid to latter part of next year [31][33] Question: How will efficacy and safety be tested for the MVA vaccine? - The standard approach involves non-human primate studies to show efficacy, with discussions ongoing with regulators about potential animal testing [37][39] Question: What are the expected timelines for data readouts from ongoing trials? - Management expects readouts for the blood cancer patient study in early to mid-2026 and anticipates interim data presentations for the CLL study before the end of the year [47][50] Question: How might changes in COVID-19 funding affect the company? - Management reported that discussions with BARDA remain positive, with no indications to slow down operations, and they are working under the assumption that clinical trials will proceed as planned [51][52][59]