Summary of GeoVax Labs Conference Call Company Overview - **Company Name**: GeoVax Labs - **Ticker Symbol**: GOVX - **Location**: Smyrna, Georgia - **Focus Areas**: Infectious diseases, oncology, and vaccines [1][3] Key Points and Arguments Investment Thesis - GeoVax has multiple clinical stage programs with potential revenue generation within the next three to four years [4][19] - The company has transitioned from a preclinical stage to phase two and is now moving directly to phase three for certain products, which is considered a de-risked approach [4][10] Upcoming Catalysts - **GEO-MVA**: A modified vaccinia Ankara vaccine that has been granted an expedited development path, allowing it to skip phase one and two trials and go directly to an immunobridging trial [10][11] - The trial is expected to start in the second half of the year, with a quick readout anticipated [11] - There is a significant global demand for the vaccine, particularly in Africa, which requires 25 million doses annually, while the current supplier can only provide 2 to 5 million doses [11][12] COVID-19 Vaccine Development - **GEO-CM04S1**: A multi-antigen vaccine against COVID-19 that has completed three phase 2 clinical trials [12][13] - The trials include comparisons against mRNA vaccines, with promising interim results indicating better performance than Pfizer's vaccine in certain patient populations [14][15] Oncology Focus - **Gedeptin**: A gene therapy for solid tumors, particularly head and neck cancers, showing improved performance when combined with Keytruda [17][18] - Plans for a phase 2 trial are underway, with the potential for accelerated regulatory pathways based on interim results [18][30] Manufacturing and Supply Chain - The company is working on improving the manufacturing process for MVA to increase supply and reduce costs [20][21] - A new continuous cell line method is being developed to streamline production [20] Financial Needs and Strategy - Annual capital needs are estimated at $30-$35 million, with recent fundraising efforts only covering a small portion of this requirement [19][31] - The company is exploring non-dilutive funding and strategic partnerships to reduce reliance on equity financing [31] Additional Important Information - GeoVax holds over 130 patents across 22 families, indicating a strong intellectual property position [22] - The competitive landscape includes a focus on breaking the monopoly held by Bavarian Nordic in the MVA market, which reported over $400 million in sales in 2024 [26] - The company is actively engaging with global health organizations like WHO and the International Vaccine Institute to drive its initiatives forward [12][23] Conclusion GeoVax Labs is positioned to capitalize on significant opportunities in the vaccine and oncology markets, with a focus on innovative multi-antigen approaches and expedited regulatory pathways. The company is addressing critical public health needs while navigating financial challenges through strategic partnerships and improved manufacturing processes.

Registration No. 333-[____] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1955 Lake Park Drive, Suite 300, Smyrna, Georgia 30080, (678) 384-7220 (Address, includin ...

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, the company reported revenues of $2.5 million, down from $3.1 million in 2024, primarily due to the termination of the BARDA Project NextGen contract [13][15] - Research and development expenses for Q3 2025 were $5 million, compared to $7.4 million in 2024, with a nine-month total of $15.1 million versus $16.1 million in 2024 [13][14] - The overall net loss for Q3 2025 was $6.3 million, compared to $5.8 million in 2024, and the year-to-date net loss was $17 million versus $16.7 million in 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing multiple product candidates, including GEO-MVA, GEO-CM04S1, and Gadeptin, with a focus on addressing unmet healthcare needs [4][11] - GEO-MVA has received guidance from the European Medicines Agency for an expedited development path, allowing the company to bypass earlier clinical trial phases [5][6] - GEO-CM04S1 is recognized as a critical vaccine for immunocompromised adults, with ongoing studies focusing on this population [7][8] Market Data and Key Metrics Changes - There is significant government interest in U.S.-based supply chains for vaccines, reflecting a shift towards onshoring initiatives [6] - The company is experiencing increased interest from industry partners and funding organizations, particularly in relation to its vaccine candidates [4][5] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, with a focus on expedited registration pathways [11][12] - Strategic partnerships and collaborations are being pursued to support the development and commercialization of its product candidates [11][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress and outlook for its product portfolio, highlighting the potential for GEO-MVA to address global vaccine needs [4][5] - The company is actively engaging with stakeholders, including government entities and international organizations, to advance its vaccine programs [6][38] Other Important Information - The company is exploring various funding strategies to support its clinical programs, including strategic partnerships and non-dilutive funding [15] - The focus remains on advancing clinical evaluations for GEO-MVA and GEO-CM04S1, as well as Gadeptin for oncology applications [11][12] Q&A Session Summary Question: Is there a scenario that could lead to MVA being used by governments before clinical trials? - Management indicated that emergency use licensing through WHO may be possible, but not prior to clinical evaluation [19][20] Question: Can you provide insights on potential collaborations or partnerships? - Management stated that they hold worldwide rights for their product assets and are open to proposals from potential partners, focusing on global registration [27][28] Question: What are the plans for the needle-free administration method for GEO-MVA? - The company is evaluating non-traditional delivery methods in collaboration with Vaxxas and is in discussions regarding manufacturing plans [32][34] Question: Which regions are most supportive of the vaccine programs? - Management highlighted significant interest in the Southern Hemisphere for GEO-MVA and ongoing concerns regarding mpox outbreaks in various regions [38][40] Question: Will there be a biosimilar version of Pembro available by the time Gadepin is approved? - Management expressed uncertainty but noted potential interest in developing Gadepin with various immune checkpoint inhibitors [43]

Financial Performance - Net loss for Q3 2025 was $6,318,914, or $0.31 per share, compared to a net loss of $5,815,468, or $0.91 per share in Q3 2024[9] - Revenue for Q3 2025 was $0, down from $2,789,484 in Q3 2024, with total government contract revenues for the nine-month period at $2,489,145, compared to $3,090,161 in 2024[10] - The company reported a total net loss of $17,046,348 for the nine-month period ended September 30, 2025, compared to $16,729,642 in 2024[9] Expenses and Liabilities - Research and development expenses decreased to $5,043,504 in Q3 2025 from $7,402,884 in Q3 2024, primarily due to the termination of the BARDA contract[13] - Cash balances as of September 30, 2025, were $5,008,997, down from $5,506,941 at December 31, 2024[15] - The total liabilities decreased to $1,824,000 as of September 30, 2025, from $3,107,000 at December 31, 2024[27] Vaccine Programs and Developments - The GEO-CM04S1 COVID-19 vaccine program showed robust immune responses in CLL patients, achieving its immunogenicity target and prompting the discontinuation of the comparator mRNA arm[12] - GeoVax is expanding its Gedeptin® oncology program into new solid tumor indications, with plans for a Phase 2 trial in head and neck cancer targeted for 2H 2026[12] - The company is advancing its GEO-MVA vaccine in response to the global Mpox public health emergency, supported by favorable scientific advice from the EMA[6] - GeoVax's multi-antigen vaccine platforms align with U.S. policy priorities for pandemic preparedness and domestic manufacturing[12]

Financial Performance - Total current assets decreased to $6,517,248 as of September 30, 2025, down from $7,934,883 on December 31, 2024, representing a decline of approximately 18%[13] - Revenue from government contracts was $0 for the three months ended September 30, 2025, compared to $2,789,484 for the same period in 2024, indicating a decrease of 100%[15] - The net loss for the nine months ended September 30, 2025, was $17,046,348, compared to a net loss of $16,729,642 for the same period in 2024, reflecting an increase in loss of approximately 2%[19] - The company reported a basic and diluted net loss per common share of $0.31 for the three months ended September 30, 2025[15] - The net loss for the three-month period ended September 30, 2025, was $6,318,914, an increase of $503,446 compared to the net loss of $5,815,468 in the same period in 2024[65] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $19,686,436, slightly down from $19,890,039 in the same period of 2024, a decrease of about 1%[15] - Total operating expenses for the three-month period ended September 30, 2025, were $6,373,215, down from $8,644,060 in the same period in 2024, a decrease of $2,270,845[65] - General and administrative expenses increased by $88,535 (7.1%) for the three-month period and $774,787 (20.5%) for the nine-month period ended September 30, 2025, compared to the same periods in 2024[68] Cash Flow and Financing - Cash and cash equivalents at the end of the period were $5,008,997, down from $8,592,523 at the end of September 30, 2024, a decrease of about 42%[19] - Net cash used in operating activities for the nine months ended September 30, 2025, was $16,512,193, primarily due to a net loss of $17,046,348[70] - Net cash provided by financing activities was $16,041,861 for the nine-month period ended September 30, 2025, compared to $19,082,548 for the same period in 2024[72] - The company closed a registered direct offering of common stock and warrants in the first quarter of 2025, generating approximately $7.9 million in net proceeds[74] - The company raised $15,885,652 from the sale of common stock and warrants during the nine months ended September 30, 2025[19] - As of September 30, 2025, the company believes existing cash and cash equivalents are sufficient to fund operations into December 2025[76] - The company anticipates needing substantial additional funding to support ongoing operations and product development[78] - The sale of additional equity may result in dilution to stockholders, and the company may also consider debt financing, which could impose operational restrictions[79] Research and Development - GeoVax's lead clinical program, GEO-CM04S1, is currently in three Phase 2 clinical trials targeting COVID-19[22] - The company is developing a vaccine targeting Mpox and smallpox, with a Phase 3 immuno-bridging study expected to initiate in late 2026[22] - The company plans to initiate a Phase 3 trial for the GEO-MVA vaccine candidate in 2026, bypassing traditional Phase 1 and 2 studies[56] - The company received a development award from BARDA to support the advancement of GEO-CM04S1 into a Phase 2b study, which was later terminated[56] - The company is developing a continuous avian cell line manufacturing platform to enhance the production of its Modified Vaccinia Ankara (MVA)-based vaccines[56] - The company expects research and development expenditures to increase as it advances existing and future product candidates through clinical trials[58] - Research and development expenses decreased by $2,359,380 (31.9%) for the three-month period and by $978,390 (6.1%) for the nine-month period ended September 30, 2025, compared to the same periods in 2024[67] - Research and development expenses for the three-month and nine-month periods of 2025 included stock-based compensation of $130,323 and $390,962, respectively[67] Stockholder Equity - Stockholders' equity decreased to $4,907,078 as of September 30, 2025, from $5,048,535 on December 31, 2024, a decline of approximately 3%[13] - The company has 40,027,849 outstanding warrants as of September 30, 2025, with a weighted average exercise price of $0.70[41] - The company expects to recognize $1,619,481 of unrecognized stock-based compensation expense over a weighted-average period of 2.1 years as of September 30, 2025[44] - Stock-based compensation expense for the nine-month period ended September 30, 2025, was $863,030, an increase of approximately 157.5% compared to $335,132 for the same period in 2024[44] Other Financial Metrics - Total prepaid expenses decreased from $1,768,533 on December 31, 2024, to $1,508,251 on September 30, 2025, a reduction of approximately 14.7%[28] - Total accrued expenses decreased from $1,257,572 on December 31, 2024, to $847,766 on September 30, 2025, a reduction of approximately 32.5%[28] - Interest income for the three-month and nine-month periods ended September 30, 2025, was $54,301 and $150,943, respectively, compared to $53,191 and $91,611 for the same periods in 2024[69] - The company remains in a cumulative loss position with no provision for income taxes recorded as of September 30, 2025[49] - The company has not generated any revenue from product sales to date, relying solely on government grants and contracts[55] - The company has not generated any product revenue to date and does not expect to do so until regulatory approval is obtained[73]

As Filed with the Securities and Exchange Commission on October 17, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080, (678) 384-7220 (Address, incl ...

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].