Summary of GeoVax Labs Conference Call Company Overview - **Company**: GeoVax Labs (NasdaqCM:GOVX) - **Industry**: Biotechnology - **Focus**: Development of novel vaccines for infectious diseases and therapies for solid tumor cancers [1] Core Points and Arguments - **Public Health Issue**: The unmet needs of immunocompromised patients, particularly in the context of COVID-19, are significant. Current vaccines are inadequate for these populations [2][3] - **Limitations of Current Vaccines**: Existing mRNA vaccines (Pfizer, Moderna, Novavax) are first-generation and have limited breadth of protection. They require reconfiguration for new variants and have a short efficacy duration of about three to six months [3] - **Target Population**: Over 40 million individuals in the U.S. and over 400 million worldwide are at high risk due to medical conditions that impair their immune response [4] - **GeoVax's Solution**: The GEO-CM04S1 vaccine is designed to address the limitations of current vaccines, providing adequate protection for high-risk groups, including blood cancer patients and those with chronic lymphocytic leukemia [5][6] - **Clinical Trials**: Two active clinical trials are underway, showing promising immune responses that exceed those of mRNA vaccines. The trials focus on blood cancer patients who do not respond to existing vaccines [6][7] Financial Status and Plans - **Funding**: GeoVax raised funds in early July and plans to raise an additional $12 million to $15 million by the end of the year to support ongoing programs [9] - **Market Interest**: The recent acquisition of Bavarian Nordic for $3 billion has generated interest in GeoVax, although the company remains focused on advancing its programs without speculation on potential acquisitions [10] Regulatory Environment - **FDA Interaction**: The company reports minimal impact from the short-staffed FDA, maintaining active communication and progress on current programs [11] Stock Price and Investor Relations - **Stock Valuation**: Analysts suggest the stock could be valued between $5 to $12 per share, indicating it is currently undervalued. GeoVax aims to enhance transparency and communication with investors to boost stock activity and liquidity [12][13][15] Additional Notes - **Upcoming Milestones**: GeoVax has several programs advancing, including a vaccine for mpox/smallpox and therapies for solid tumors, with updates expected in the near future [7][8]

Summary of GeoVax Labs FY Conference Call Company Overview - **Company Name**: GeoVax Labs (NasdaqCM:GOVX) - **Industry**: Biotechnology - **Focus**: Development of vaccines and immunotherapies for infectious diseases and cancers, particularly targeting unserved or underserved populations [1][2] Core Points and Arguments - **Clinical Stage**: GeoVax is a phase two clinical stage company with a strong emphasis on patented products, which is critical for differentiation in the market [2][4] - **Global Market Opportunities**: - **GEO-MVA**: Candidate for mpox and smallpox vaccine with an annual global market opportunity exceeding $11 billion [8][12] - **GEO-CM04S1**: Multi-antigen next-generation COVID-19 vaccine targeting over 40 million immunocompromised individuals in the U.S. and over 400 million worldwide, representing a market opportunity of more than $30 billion [8][19] - **Gedeptin**: A gene-directed prodrug enzyme therapy for solid tumors, particularly head and neck cancer, with a commercial opportunity of over $15 billion [9][20] Development Pathways - **Expedited Development**: GeoVax has received an expedited development pathway from the European Medicines Agency (EMA), allowing them to bypass phase one trials for GEO-MVA and only conduct a phase three immuno-bridging trial [7][12] - **Regulatory Alignment**: The company aims to align with bipartisan healthcare priorities, focusing on multivalent, multi-antigen vaccines [5][6] Clinical Trials and Results - **Current Trials**: Three phase two trials are underway, including trials among immunocompromised blood cancer patients and healthy individuals who received mRNA vaccines [17][18] - **Comparative Efficacy**: Clinical data indicates that GeoVax's vaccine shows better efficacy than authorized vaccines, particularly in patients with chronic lymphocytic leukemia [15][18] Market Needs and Challenges - **Mpox Vaccine Demand**: The World Health Organization (WHO) has declared mpox a public health emergency, with a significant vaccine shortage highlighted by the Africa CDC's request for 25 million doses in 2025, while only 2 to 5 million can be supplied by the current single-source supplier [10][11] - **COVID-19 Vaccine Limitations**: Current single antigen vaccines have limited durability and require continuous updates, while GeoVax's multi-antigen vaccine shows durability of 8 to 12 months [13][15] Technological Innovations - **Manufacturing Advancements**: GeoVax is advancing its continuous cell line manufacturing process for its Modified Vaccinia Ankara (MVA) platform, aiming for faster, cost-effective production of vaccines [21][22] Conclusion - **Future Outlook**: GeoVax anticipates beginning to book revenues within the next three years, marking a significant transition towards commercialization [12]

Summary of Conference Call Records Company Overview GeoVax Labs - **Industry**: Biotechnology - **Focus**: Developing vaccines for infectious diseases and therapies for solid tumor cancers, including COVID-19 and MPOXX (monkeypox) [1][2] Bitfufu Inc - **Industry**: Cryptocurrency Mining - **Focus**: Bitcoin mining and mining services, including cloud mining and self-mining operations [24][25] Key Points from GeoVax Labs Business Goals and Focus - GeoVax is a clinical-stage biotech company targeting unserved or underserved populations for vaccine development [4] - The company has a strong patent portfolio, recently announcing a new broad patent for its multi-antigen COVID-19 vaccine [3] Market Opportunities - The global market opportunity for GeoMVA (MPOXX vaccine) exceeds $11 billion [4] - Over 40 million adults in the U.S. and 400 million worldwide have weakened immune systems that do not respond to current vaccines [5][6] Alignment with Government Initiatives - GeoVax aligns with bipartisan efforts for diverse vaccine development and long-term safety, emphasizing transparency in the vaccine industry [7][11] Capital Development Strategy - The company targets raising approximately $30 million annually through equity sales and non-dilutive funding [13][15] - Last year, GeoVax raised over $25 million, enabling continued progress on its programs [14] Competitive Landscape - Bavarian Nordic is currently the only supplier for the Impox MVA vaccine, and its acquisition by a private equity firm raises concerns about monopoly and pricing [18][19] - GeoVax plans to initiate a Phase 3 trial for its GeoMVA vaccine in the second half of next year, aiming for revenue generation within three years [20][21] Key Points from Bitfufu Inc Company Performance - Bitfufu reported a substantial increase in cloud mining revenue, with over half coming from new customers, indicating strong demand [30] - The company holds 1,784 Bitcoin on its balance sheet and has a mining capacity of 38.6 exahash [26][30] Strategic Developments - Bitfufu is acquiring more data centers to reduce leased capacity, which helps lower operational costs [27] - The company has seen a year-over-year decline in self-mining revenue due to the Bitcoin halving event [33] Financial Performance - Bitfufu reported EBITDA of $60.7 million, a significant increase from $8.3 million year-over-year [35] - The company has maintained profitability since its inception, distinguishing itself from many peers in the mining space [36] Growth Strategy - The company is focusing on vertical integration and horizontal innovation, with plans to expand its capacity to over a gigawatt by 2026 [37] - Bitfufu's cloud mining business accounted for 80% of its revenue in the second quarter, reflecting strong demand [38] Institutional Interest - There is a growing interest from institutional investors, particularly in using cloud mining as a corporate treasury strategy [43][44] Additional Important Insights - GeoVax's approach to vaccine development emphasizes expedited registration pathways and collaborations to mitigate risks [4] - Bitfufu's strategic framework with Bitmain allows access to a significant number of mining rigs, enhancing its competitive position [34] - Both companies are positioned to capitalize on their respective market opportunities, with GeoVax focusing on vaccine development and Bitfufu on expanding its mining capabilities and services [21][41]

Core Viewpoint - GeoVax Labs Inc. (GOVX) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1][2]. - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, particularly influenced by institutional investors [4][5]. Recent Performance and Outlook - GeoVax Labs is expected to earn -$1.44 per share for the fiscal year ending December 2025, with no year-over-year change, but analysts have raised their estimates by 13% over the past three months [8]. - The upgrade to Zacks Rank 2 positions GeoVax Labs in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Viewpoint - GeoVax Labs reported strong second quarter 2025 results with significant revenue growth but raised concerns about increased operating costs and cash reserves [1][5][10] Financial Performance - GAAP revenue reached $0.85 million, exceeding analyst estimates of $0.39 million, marking a year-over-year increase of 183.6% from $0.30 million in Q2 2024 [2][5] - GAAP earnings per share were a loss of $(0.35), slightly worse than the expected $(0.34) but a significant improvement from $(1.99) in Q2 2024, reflecting an 82.4% year-over-year improvement [2][6] - Net loss for the quarter was $(5.37) million, a slight increase from $(5.06) million in Q2 2024, while research and development expenses rose by 10.5% to $4.73 million [2][6] Business Overview - GeoVax specializes in developing vaccines and immunotherapies for infectious diseases and cancer, focusing on unmet medical needs [3] - The clinical pipeline includes three main product families: GEO-CM04S1 (COVID-19 vaccine), GEO-MVA (mpox and smallpox vaccine), and Gedeptin (gene-directed immunotherapy for cancers) [3] Strategic Focus - The company aims to accelerate clinical trial progress, expand its intellectual property portfolio, and improve manufacturing scalability [4] - Key success factors include advancing clinical trials, securing regulatory approvals, and forming strategic partnerships [4] Pipeline Progress - Revenue growth was driven by government contract revenues from the BARDA/RRPV Project NextGen award, which has since been terminated [5][10] - The GEO-MVA vaccine received positive regulatory feedback from the EMA, with plans to initiate a pivotal Phase 3 trial in late 2026, representing a market opportunity over $10 billion [7] - The GEO-CM04S1 vaccine is targeting immunocompromised patients, showing enhanced immune responses in clinical trials [8] Manufacturing and Intellectual Property - GeoVax is developing scalable vaccine manufacturing methods to address supply bottlenecks and has secured new U.S. patents for a malaria vaccine and expanded Gedeptin use [9] Future Outlook - The company ended the quarter with $3.09 million in cash, down from $5.51 million, and raised $5.6 million through a public offering to extend its cash runway [10] - Management did not provide formal guidance but emphasized advancing vaccine and oncology programs and building U.S.-based manufacturing capacity [11]

[Business Highlights](index=1&type=section&id=Business%20Highlights) GeoVax reported a pivotal second quarter, marked by significant clinical and regulatory achievements, underscoring the company's progress in both oncology and infectious disease preparedness - Received favorable European regulatory guidance for GEO-MVA, supporting a streamlined development pathway for its Mpox and smallpox vaccine[1](index=1&type=chunk)[2](index=2&type=chunk) - GEO-CM04S1 demonstrated superior immune responses in Chronic Lymphocytic Leukemia (CLL) patients compared to an authorized mRNA vaccine, with data presented at the EHA 2025 conference[1](index=1&type=chunk)[2](index=2&type=chunk) - Gedeptin® showed strong safety and efficacy data for treating solid tumors in a presentation at the AACR 2025 conference[1](index=1&type=chunk)[2](index=2&type=chunk) [Clinical Trial Progress and Operational Developments](index=1&type=section&id=Clinical%20Trial%20Progress%20and%20Operational%20Developments) The company detailed significant progress across its three lead programs, including a clear regulatory pathway for GEO-MVA, superior immunogenicity for GEO-CM04S1, and promising safety and efficacy for Gedeptin® [GEO-MVA (Mpox/Smallpox Vaccine)](index=1&type=section&id=GEO-MVA%20(Mpox%2FSmallpox%20Vaccine)) GeoVax received favorable Scientific Advice from the European Medicines Agency (EMA) for GEO-MVA, confirming a streamlined development process for market authorization in the EU - The EMA confirmed a single Phase 3 immuno-bridging trial is sufficient for potential market authorization in the EU, eliminating multiple common development steps[5](index=5&type=chunk) - GeoVax plans to initiate the Phase 3 trial in the second half of 2026[5](index=5&type=chunk) - The estimated market potential for GEO-MVA is over **$10 billion**[5](index=5&type=chunk) [GEO-CM04S1 (COVID-19 Vaccine)](index=2&type=section&id=GEO-CM04S1%20(COVID-19%20Vaccine)) GEO-CM04S1 demonstrated superior performance in multiple clinical settings, including enhanced T cell responses in CLL patients and cross-protective potential against Mpox - In CLL patients, GEO-CM04S1 showed significantly better T cell responses (IFN-γ secretion and AIM+) than an authorized mRNA vaccine, which failed its primary endpoint[9](index=9&type=chunk) - Unlike the mRNA vaccine, GEO-CM04S1 elicited statistically significant SARS-CoV-2 Nucleocapsid (N)-specific IgG and T cell responses[9](index=9&type=chunk) - The vaccine demonstrated dual protective potential, inducing immune responses against both SARS-CoV-2 and Mpox[9](index=9&type=chunk) - The estimated market potential for GEO-CM04S1 is over **$30 billion**[9](index=9&type=chunk) [Gedeptin® (Solid Tumor Therapy)](index=2&type=section&id=Gedeptin%C2%AE%20(Solid%20Tumor%20Therapy)) Clinical data highlighted Gedeptin's strong safety and efficacy profile in heavily pretreated patients with advanced solid tumors, showing promising survival rates with no dose-limiting toxicities - In a Phase 1/2 trial with eight heavily pretreated patients (median 4 prior therapies), Gedeptin® demonstrated a median Progression-Free Survival (PFS) and Overall Survival (OS) of **7.0 months**[9](index=9&type=chunk) - The treatment was well-tolerated, with no dose-limiting toxicities (DLTs) reported, with minimal injection site pain as the most common adverse event[9](index=9&type=chunk) - The estimated market potential for Gedeptin® is over **$15 billion**[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) For the second quarter of 2025, GeoVax reported a net loss of $5.4 million, or $0.35 per share, with increased R&D and G&A expenses, and a cash position of $3.1 million at quarter-end, bolstered by a $5.6 million financing in July 2025 Second Quarter Financial Performance (Amounts in Millions, Except Per Share Data) | Financial Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | **Net Loss** | $5.4M | $5.1M | Increased Loss | | **Loss Per Share** | $0.35 | $1.99 | Decreased (due to more shares) | | **Revenue** | $0.85M | $0.30M | +183% | | **R&D Expenses** | $4.7M | $4.3M | +9.6% | | **G&A Expenses** | $1.5M | $1.1M | +36.7% | - The BARDA/RRPV Project NextGen contract, which generated all revenue in the quarter, was terminated for convenience by the government[12](index=12&type=chunk) - Cash and cash equivalents were **$3.1 million** as of June 30, 2025, down from **$5.5 million** at December 31, 2024, with the company raising approximately **$5.6 million** in net proceeds from a public offering in July 2025[15](index=15&type=chunk) [Other Corporate Updates](index=3&type=section&id=Other%20Corporate%20Updates) GeoVax strengthened its intellectual property portfolio with new patents for a Malaria vaccine and Gedeptin® therapy, while enhancing leadership with a key appointment in technical development - Issued U.S. Patent No. **12,329,808** for a novel vaccine construct designed to prevent Malaria infection[16](index=16&type=chunk) - Received a Notice of Allowance for additional patent claims covering the synergistic use of Gedeptin® therapy with radiation for solid tumors[16](index=16&type=chunk) - Appointed Dr. Senthil Ranganathan, with over **20 years** of experience, as Vice President, Technical Development and CMC Operations[16](index=16&type=chunk) [Financial Tables](index=6&type=section&id=Financial%20Tables) The condensed consolidated financial statements provide detailed figures for the company's operations and financial position, showing an increase in revenue and operating expenses, and a decrease in total assets and stockholders' equity Condensed Consolidated Statements of Operations (Amounts in Thousands, Except Per Share Data) | Financial Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Revenue from government contract** | $2,489 | $301 | | **Research and development** | $10,083 | $8,703 | | **General and administrative** | $3,230 | $2,543 | | **Loss from operations** | $(10,824) | $(10,945) | | **Net loss** | $(10,727) | $(10,914) | | **Loss per common share** | $0.79 | $4.68 | Condensed Consolidated Balance Sheet (Amounts in Thousands, Except Share Data) | Financial Metric | June 30, 2025 | Dec. 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $3,094 | $5,507 | | **Total current assets** | $5,135 | $7,935 | | **Total assets** | $5,350 | $8,156 | | **Total liabilities** | $2,529 | $3,107 | | **Stockholders' equity** | $2,821 | $5,049 | | **Common shares outstanding** | 15,924,593 | 10,536,875 |

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]

PART I – FINANCIAL INFORMATION [Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the periods ended June 30, 2025, and 2024, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, highlighting a net loss of **$10.7 million** and substantial doubt about the company's ability to continue as a going concern Condensed Consolidated Balance Sheets (Unaudited) | | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Total current assets** | $5,135,548 | $7,934,883 | | **Total assets** | $5,350,420 | $8,155,867 | | **Total current liabilities** | $2,529,224 | $3,107,332 | | **Total stockholders' equity** | $2,821,196 | $5,048,535 | Condensed Consolidated Statements of Operations (Unaudited) | | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Revenue from government contract | $2,489,145 | $300,677 | | Research and development | $10,083,586 | $8,702,596 | | General and administrative | $3,229,635 | $2,543,383 | | **Loss from operations** | **$(10,824,076)** | **$(10,945,302)** | | **Net loss** | **$(10,727,434)** | **$(10,914,174)** | | **Net loss per common share** | **$(0.79)** | **$(4.68)** | Condensed Consolidated Statements of Cash Flows (Unaudited) | | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,300,078) | $(7,624,778) | | Net cash used in investing activities | $(27,612) | $- | | Net cash provided by financing activities | $7,914,611 | $2,733,901 | | **Net decrease in cash** | **$(2,413,079)** | **$(4,890,877)** | | **Cash at end of period** | **$3,093,862** | **$1,561,712** | - The company's existing cash resources are projected to be sufficient to fund planned operations only into the **fourth quarter of 2025**, which raises **substantial doubt** about its ability to continue as a going concern[22](index=22&type=chunk) - On April 11, 2025, the company was notified by Advanced Technology International (ATI) that BARDA had **terminated** the ATI-RRPV contract for the development of GEO-CM04S1 for the convenience of the government[39](index=39&type=chunk) - In March 2025, the company closed a registered direct offering, raising net proceeds of approximately **$4.1 million**. Additionally, during Q1 2025, the company sold shares through its ATM Program for net proceeds of approximately **$3.8 million**[29](index=29&type=chunk)[30](index=30&type=chunk) - Subsequent to the quarter end, on July 2, 2025, the company closed a public offering of units and warrants, raising net proceeds of approximately **$5.6 million**[42](index=42&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=11&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, and strategic focus, highlighting advancements in vaccine and immunotherapy programs, increased expenses, a **$10.7 million** net loss, and ongoing concerns about liquidity and going concern status [Overview and Recent Developments](index=11&type=section&id=Overview%20and%20Recent%20Developments) GeoVax, a clinical-stage biotech, provides updates on its vaccine and immunotherapy programs, including GEO-CM04S1 in Phase 2, Gedeptin® planning Phase 2, and GEO-MVA preparing for Phase 3 - GEO-CM04S1 (COVID-19 Vaccine): Currently in **three Phase 2 trials** evaluating its use as a primary vaccine in immunocompromised patients, a booster for CLL patients, and a heterologous booster for healthy individuals[19](index=19&type=chunk)[48](index=48&type=chunk) - Gedeptin® (Oncology): Completed a **Phase 1/2 trial** for advanced head and neck cancers, with planning underway for a **Phase 2 trial to start in 2026** evaluating Gedeptin with an immune checkpoint inhibitor[19](index=19&type=chunk)[50](index=50&type=chunk) - GEO-MVA (Mpox/Smallpox Vaccine): Following scientific advice from the EMA, the company intends to proceed directly to a **Phase 3 trial**, expected to initiate in **mid-2026**[50](index=50&type=chunk) - The development award from BARDA to support the GEO-CM04S1 Phase 2b study was **terminated** for convenience by the government on April 11, 2025[50](index=50&type=chunk) [Results of Operations](index=14&type=section&id=Results%20of%20Operations) Revenue from government contracts increased to **$2.5 million** but was terminated, while R&D and G&A expenses rose, resulting in a net loss of **$10.7 million** for the six months ended June 30, 2025 Comparison of Results for the Six Months Ended June 30 | | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Revenue from government contract | $2,489,145 | $300,677 | $2,188,468 | | Research and development | $10,083,586 | $8,702,596 | $1,380,990 (15.9%) | | General and administrative | $3,229,635 | $2,543,383 | $686,252 (27.0%) | | **Net loss** | **$(10,727,434)** | **$(10,914,174)** | **$186,740** | - The increase in R&D expenses was primarily due to program-specific costs for the ATI-RRPV Contract, Gedeptin, and GEO-MVA programs[61](index=61&type=chunk) - The increase in G&A expenses was mainly due to higher investor relations consulting costs and stock-based compensation expense[62](index=62&type=chunk) [Liquidity and Capital Resources](index=15&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and equivalents decreased to **$3.1 million** by June 30, 2025, with **$10.3 million** used in operations, despite **$7.9 million** from Q1 equity offerings and **$5.6 million** post-quarter, raising substantial doubt about going concern Liquidity and Cash Flow Summary | | June 30, 2025 ($) | Dec 31, 2024 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $3,093,862 | $5,506,941 | | Working capital | $2,606,324 | $4,827,551 | | **Cash Flow (Six Months Ended June 30)** | **2025 ($)** | **2024 ($)** | | Net cash used in Operating activities | $(10,300,078) | $(7,624,778) | | Net cash provided by Financing activities | $7,914,611 | $2,733,901 | - In Q1 2025, the company raised approximately **$7.9 million** in net proceeds from a registered direct offering and its ATM program[68](index=68&type=chunk) - Post-quarter, on July 2, 2025, a public offering of common stock and warrants yielded net proceeds of approximately **$5.6 million**[69](index=69&type=chunk) - Management believes existing cash is sufficient to fund operations only into the **fourth quarter of 2025**, and that plans to raise additional capital do not fully alleviate the **substantial doubt** about the company's ability to operate as a going concern[70](index=70&type=chunk)[71](index=71&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=17&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This disclosure is not applicable as the company qualifies as a smaller reporting company - This disclosure is not applicable to smaller reporting companies[76](index=76&type=chunk) [Controls and Procedures](index=17&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no significant changes in internal control over financial reporting - Management concluded that as of the end of the period, the company's disclosure controls and procedures were effective[78](index=78&type=chunk) - There were no significant changes in internal control over financial reporting during the three months ended June 30, 2025[79](index=79&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=18&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[82](index=82&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, GeoVax refers to its most recent Form 10-K for risk factors, as updates are not required in this report - As a smaller reporting company, GeoVax is not required to provide information on material changes from previously disclosed risk factors and refers to its most recent Form 10-K[83](index=83&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=18&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period not previously disclosed on a Form 8-K - There were no sales of unregistered equity securities during the period that were not previously reported on Form 8-K[84](index=84&type=chunk) [Defaults Upon Senior Securities](index=18&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[85](index=85&type=chunk) [Mine Safety Disclosures](index=18&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[86](index=86&type=chunk) [Other Information](index=18&type=section&id=Item%205.%20Other%20Information) Stockholders approved the 2025 Stock Incentive Plan on June 5, 2025, and no directors or Section 16 officers adopted or terminated Rule 10b5-1 trading arrangements - On June 5, 2025, stockholders approved the Company's 2025 Stock Incentive Plan[88](index=88&type=chunk) - No directors or Section 16 officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the reporting period[87](index=87&type=chunk) [Exhibits](index=19&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the 2025 Stock Incentive Plan, officer certifications, and XBRL documents - The list of exhibits includes the 2025 Stock Incentive Plan, CEO/CFO certifications, and XBRL data files[89](index=89&type=chunk)

Financial Data and Key Metrics Changes - Revenues associated with the BARDA contract were $1,600,000 in Q1 2025 compared to zero in Q1 2024, as the contract began in June 2024 [17] - The overall net loss for Q1 2025 was approximately $5,400,000 or $0.45 per share, compared to a net loss of $5,900,000 or $2.47 per share in Q1 2024 [19] - Cash balances at March 31, 2025, were $7,400,000, up from $5,500,000 at December 31, 2024 [20] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5,400,000 in Q1 2025 from $4,400,000 in Q1 2024, representing a 21% increase [18] - General and administrative expenses rose to $1,700,000 in Q1 2025 from $1,500,000 in Q1 2024, a 16% increase [19] Market Data and Key Metrics Changes - The company estimates that over 40 million adults in the United States and over 400 million worldwide have medical conditions rendering them inadequately responsive to first-generation vaccines [10] Company Strategy and Development Direction - The company aims to advance its product candidates, including GEO CM04S1 and GEO MVA, to address unmet healthcare needs and expedite registration paths [6][13] - There is a focus on establishing US-based manufacturing for MVA vaccines to reduce dependence on non-US suppliers [14][51] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the BARDA Project NextGen stop work order but remains committed to the development of the CM04S1 vaccine [8][9] - The company anticipates multiple presentations of clinical results for CM04S1 throughout 2025, which may serve as catalysts for strategic partnerships [11] Other Important Information - The company is actively exploring various funding strategies, including strategic partnerships and non-dilutive funding, to support its development programs [21] - The advanced MVA manufacturing process is expected to provide a competitive advantage in the production of MVA-based vaccines and therapies [7] Q&A Session Summary Question: Comparison with Vaxart's program and implications of the stop work order - Management highlighted distinct differences between their program and Vaxart's, noting that Vaxart had already dosed patients before the halt [24][25] Question: Impact of recent comments by HHS on vaccine trials - Management confirmed ongoing phase two trials and expressed confidence in the value of multi-antigen vaccines [31][34] Question: Next steps for trials based on healthy volunteers' results - The focus remains on immunocompromised populations, with plans for expanded trials if results are encouraging [40][43] Question: Safety and efficacy of the MPOXX vaccine - Management confirmed no adverse safety issues have been observed with the MVA vaccine, emphasizing its historical safety profile [48][49] Question: Support for US-based manufacturing - Management indicated ongoing discussions with government representatives regarding US-based manufacturing and expressed optimism for future funding [51][53]