GeoVax Labs (GOVX) Q2 2025 Earnings Call July 28, 2025 04:30 PM ET Company ParticipantsDavid Dodd - Chairman, President & CEOMark Reynolds - CFOJohn W. Sharkey - VP - Business DevelopmentKelly McKee - Chief Medical OfficerJames Molloy - MD & Equity Research - Biotechnology and Specialty PharmaceuticalsConference Call ParticipantsJonathan Aschoff - MD & Senior Research AnalystRobert Leboyer - Senior Biotechnology AnalystJohn Vandermosten - Senior AnalystOperatorGood afternoon, and welcome, everyone, to the G ...

GeoVax Labs (GOVX) Q2 2025 Earnings Call July 28, 2025 04:30 PM ET Speaker0Good afternoon, and welcome, everyone, to the Geovac Second Quarter twenty twenty five Corporate Update Call. My name is Michelle, and I'll facilitate today's call. With me are David Dodd, Chairman and CEO Mark Reynolds, Vice President and Chief Financial Officer Mark Newman, Ph. D. Chief Scientific Officer Kelly McKee, MD Miles per hour Chief Medical Officer, and John Sharkey, PhD Vice President Business Development.At this time, al ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (678) 384-7220 Commission File Number: 001-39563 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) of incorporation or organization) 1900 Lake Park D ...

GeoVax Labs (GOVX) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Company Participants David Dodd - Chairman, President & CEOMark Reynolds - CFOJames Molloy - Managing Director, Equity Research, Biotechnology & Specialty PharmaceuticalsJeffrey Kraws - Co-Founder & CEO Conference Call Participants Robert Leboyer - Senior Biotechnology Analyst Operator Good afternoon, and welcome everyone to the GeoVax First Quarter twenty twenty five Corporate Update Call. My name is Michelle, and I will facilitate today's c ...

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) GeoVax reported significant progress across its key clinical programs in Q1 2025, advancing its multi-antigen COVID-19 vaccine, Mpox/smallpox vaccine, and Gedeptin® oncology program while maintaining focus on unmet needs in oncology, infectious diseases, and biodefense [GEO-CM04S1 (COVID-19 Vaccine)](index=1&type=section&id=GEO-CM04S1%20%28COVID-19%20Vaccine%29) The GEO-CM04S1 program is advancing in Phase 2 trials for immunocompromised patients, with healthy adult booster trial data expected in Q2 2025 and continued enrollment in a CLL patient study after early termination of the mRNA vaccine arm - Despite the unexpected termination of the Project NextGen award by BARDA, GeoVax remains committed to advancing GEO-CM04S1[3](index=3&type=chunk) - Data readout for the healthy adult booster trial is expected in the **second quarter of 2025**[1](index=1&type=chunk)[5](index=5&type=chunk) - In the Chronic Lymphocytic Leukemia (CLL) patient study, the Data Safety Review Board recommended early termination of the mRNA arm, while the GEO-CM04S1 arm continues to enroll[5](index=5&type=chunk) - The company estimates the market potential for its COVID-19 vaccine at over **$30 billion**[8](index=8&type=chunk) [Gedeptin® (Oncology)](index=1&type=section&id=Gedeptin%C2%AE%20%28Oncology%29) The Gedeptin® program is advancing to a Phase 2 clinical trial for recurrent head and neck cancer in combination with an immune checkpoint inhibitor, having received Orphan Drug designation and showing potential for other solid tumors - Gedeptin® is advancing to a **Phase 2 trial** for recurrent head and neck cancer in combination with an immune checkpoint inhibitor[1](index=1&type=chunk)[4](index=4&type=chunk)[8](index=8&type=chunk) - Gedeptin® has received **Orphan Drug designation** for use in advanced head & neck cancer patients[8](index=8&type=chunk) - The estimated market potential for Gedeptin® in head and neck cancer is over **$15 billion**[8](index=8&type=chunk) [GEO-MVA (Mpox/Smallpox Vaccine)](index=1&type=section&id=GEO-MVA%20%28Mpox%2FSmallpox%20Vaccine%29) GeoVax plans to initiate clinical trials for its GEO-MVA Mpox/smallpox vaccine candidate in H2 2025, having successfully produced cGMP clinical product to provide a U.S.-developed biosecurity alternative - Clinical evaluation of GEO-MVA is expected to begin in the **second half of 2025**[1](index=1&type=chunk)[4](index=4&type=chunk)[8](index=8&type=chunk) - The company has successfully produced **cGMP clinical product** for GEO-MVA in preparation for clinical trials[8](index=8&type=chunk) - The estimated market potential for GEO-MVA is over **$10 billion**[8](index=8&type=chunk) [Corporate and Strategic Developments](index=2&type=section&id=Corporate%20and%20Strategic%20Developments) GeoVax is scaling MVA manufacturing for global reach, establishing a UK presence for European partnerships, and appointed Dr. Senthil Ranganathan to support commercialization efforts - Advancing continuous cell line manufacturing for MVA-based vaccines to enable scalable, cost-effective production[7](index=7&type=chunk) - Announced a plan to establish a strategic presence in the United Kingdom to advance manufacturing and European collaborations[9](index=9&type=chunk) - Appointed Senthil Ranganathan, Ph.D., as Vice President, Technical Development & CMC Operations, to focus on product authorization and commercialization[9](index=9&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) GeoVax reported a net loss of $5.4 million in Q1 2025, an improvement from the prior year, with $1.6 million in government contract revenue and increased R&D and G&A expenses, while cash improved to $7.4 million [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) Q1 2025 saw a narrowed net loss of $5.4 million, $1.6 million in government contract revenue, increased R&D and G&A expenses, and a cash balance of $7.4 million | Metric | Q1 2025 (Millions USD) | Q1 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Revenue | $1.6 | $0 | +$1.6 | | R&D Expenses | $5.4 | $4.4 | +$1.0 | | G&A Expenses | $1.7 | $1.5 | +$0.2 | | Net Loss | $5.4 | $5.9 | -$0.5 | | Date | Cash Balance (Millions USD) | | :--- | :--- | | March 31, 2025 | $7.4 | | Dec 31, 2024 | $5.5 | [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Detailed financial tables for Q1 2025 show a net loss of $5.358 million or ($0.45) per share, with total assets of $10.833 million and stockholders' equity of $7.898 million as of March 31, 2025 | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue from government contract (Thousands USD) | $1,637 | $- | | Research and development (Thousands USD) | $5,355 | $4,426 | | General and administrative (Thousands USD) | $1,687 | $1,457 | | Loss from operations (Thousands USD) | $(5,405) | $(5,883) | | Net loss (Thousands USD) | $(5,358) | $(5,850) | | Net loss per common share (USD) | $(0.45) | $(2.47) | | Weighted average common shares outstanding | 11,954,797 | 2,367,050 | | Metric | March 31, 2025 | Dec. 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents (Thousands USD) | $7,439 | $5,507 | | Total assets (Thousands USD) | $10,833 | $8,156 | | Total liabilities (Thousands USD) | $2,935 | $3,107 | | Stockholders' equity (Thousands USD) | $7,898 | $5,049 | | Common shares outstanding | 13,839,478 | 10,536,875 | [Conference Call Information](index=3&type=section&id=Conference%20Call%20Information) GeoVax will host a conference call and live audio webcast on May 1, 2025, at 4:30 p.m. ET to discuss financial results and provide a corporate update, with an archive available on the investor relations website - A conference call is scheduled for **May 1, 2025, at 4:30 p.m. ET** to review financial results and corporate developments[14](index=14&type=chunk) - An archive of the audio webcast will be available on the GeoVax website for at least **90 days** following the event[16](index=16&type=chunk) [Company Overview and Forward-Looking Statements](index=4&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) GeoVax is a clinical-stage biotechnology company developing novel vaccines and cancer therapies, with the report including standard forward-looking statements subject to various risks and uncertainties - GeoVax is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers[18](index=18&type=chunk) - The report contains forward-looking statements subject to risks and uncertainties, including clinical trial outcomes, regulatory approvals, manufacturing, and competition[19](index=19&type=chunk)

GeoVax Labs (GOVX) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome everyone to the GeoVax First Quarter twenty twenty five Corporate Update Call. My name is Michelle, and I will facilitate today's call. With me are David Dodd, Chairman and CEO Mark Reynolds, Chief Financial Officer Mark Newman, Ph. D. Chief Scientific Officer Kelly McKee, MD, Miles per hour, Chief Medical Officer and John Sharkey, PhD, Vice President, Business Development. At this time, all participants a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39563 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization ...

[GeoVax 2024 Year-End Financial Results and Business Update](index=1&type=section&id=GeoVax%20Reports%202024%20Year-End%20Financial%20Results%20and%20Provides%20Business%20Update) This report summarizes GeoVax's 2024 financial performance and key business developments, including significant clinical trial progress and strategic initiatives [CEO Statement and Business Highlights](index=1&type=section&id=CEO%20Statement%20and%20Business%20Highlights) David Dodd, Chairman and CEO, highlighted 2024 as a pivotal year, marked by a significant BARDA Project NextGen award of nearly $400 million to advance the GEO-CM04S1 COVID-19 vaccine, building on positive clinical data and advancing the GEO-MVA vaccine for Mpox and smallpox - Received a BARDA Project NextGen award of nearly **$400 million** to advance the GEO-CM04S1 vaccine in a Phase 2b clinical trial[4](index=4&type=chunk) - Reported positive initial safety and immune response data from the Phase 2 trial of GEO-CM04S1 as a booster for adults who previously received mRNA vaccines, observing statistically significant increases in neutralizing antibody responses[4](index=4&type=chunk) - Advancing manufacturing capabilities and development of GEO-MVA, a vaccine candidate for protection against Mpox and smallpox, to address urgent public health needs[5](index=5&type=chunk) [Clinical Trial Progress and Operational Developments](index=2&type=section&id=Clinical%20Trial%20Progress%20and%20Operational%20Developments) The company reported significant progress across its clinical pipeline, including advancing the BARDA-funded Phase 2b trial for the COVID-19 vaccine GEO-CM04S1, planning a new Phase 2 trial for the cancer therapy Gedeptin®, and preparing for clinical evaluation of the Mpox/Smallpox vaccine GEO-MVA [GEO-CM04S1 (COVID-19 Vaccine)](index=2&type=section&id=GEO-CM04S1) Progress for the next-generation COVID-19 vaccine, GEO-CM04S1, is centered on the BARDA-funded 10,000-participant Phase 2b trial, with clinical sites confirmed and manufacturing underway, also being evaluated in immunocompromised patients and as a booster in healthy adults - Preparations are ongoing for the 10,000-participant, randomized, Phase 2b BARDA Project NextGen trial to compare GEO-CM04S1 with an FDA-approved mRNA vaccine[1](index=1&type=chunk)[10](index=10&type=chunk) - In the Phase 2 trial for patients with chronic lymphocytic leukemia (CLL), the DSMB recommended continuing enrollment for the GEO-CM04S1 arm after the mRNA control arm failed to meet its primary endpoint[10](index=10&type=chunk) - Enrollment is complete in the Phase 2 booster study for healthy adults, with data readouts anticipated in the first half of 2025[1](index=1&type=chunk)[10](index=10&type=chunk) - The estimated market potential for GEO-CM04S1 is over **$30 billion**[10](index=10&type=chunk) [Gedeptin® (Cancer Therapy)](index=2&type=section&id=Gedeptin%C2%AE) GeoVax is advancing its cancer therapy, Gedeptin®, with plans for a Phase 2 clinical trial to evaluate it as a neoadjuvant therapy in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer, holding FDA Orphan Drug designation and addressing a market estimated at over $15 billion - Planning is underway for a Phase 2 clinical trial of Gedeptin® combined with an immune checkpoint inhibitor for recurrent Head & Neck (H&N) cancer[1](index=1&type=chunk)[10](index=10&type=chunk) - The planned trial will be a single-cycle study in approximately 36 patients, with pathologic response rate as the primary endpoint[10](index=10&type=chunk) - Gedeptin® has FDA Orphan Drug designation and an estimated market potential of over **$15 billion**, with potential application in other solid tumors[10](index=10&type=chunk) [Mpox and Smallpox Vaccine Platform (GEO-MVA)](index=3&type=section&id=Mpox%20and%20Smallpox%20Vaccine%20Platform) The company is preparing for the clinical evaluation of its GEO-MVA vaccine candidate for Mpox and Smallpox, with trials expected to begin in the second half of 2025, having successfully manufactured a cGMP clinical batch in 2024 and actively seeking strategic partnerships - Clinical evaluation of GEO-MVA, a vaccine for Mpox and Smallpox, is expected to begin in the second half of 2025[1](index=1&type=chunk)[17](index=17&type=chunk) - A clinical batch of GEO-MVA was successfully manufactured under cGMP standards in 2024[17](index=17&type=chunk) - The company is pursuing strategic partnerships with governments and NGOs to maximize the reach of its GEO-MVA platform, which addresses an estimated market of over **$10 billion**[17](index=17&type=chunk) [Corporate and Financial Overview](index=3&type=section&id=Corporate%20and%20Financial%20Overview) GeoVax strengthened its corporate position in 2024 by expanding its intellectual property portfolio and planning a strategic entry into the UK, while financially reporting its first-ever revenue of $4.0 million from a government contract, a slightly reduced net loss of $25.0 million, and ending the year with a cash balance of $5.5 million [Corporate and Intellectual Property Developments](index=3&type=section&id=Corporate%20and%20Intellectual%20Property%20Developments) In 2024, GeoVax expanded its intellectual property assets to over 130 granted or pending patents and announced a plan to establish a strategic presence in the United Kingdom to foster European collaborations, manufacturing partnerships, and technology licensing - Announced a plan to establish a strategic presence in the United Kingdom to advance European partnerships and collaborations[17](index=17&type=chunk) - The company's intellectual property portfolio was strengthened and now includes over **130 granted or pending patents** across 23 different families[17](index=17&type=chunk) [2024 Full Year Financial Results](index=3&type=section&id=2024%20Full%20Year%20Financial%20Results) For the fiscal year 2024, GeoVax recorded **$4.0 million** in revenue from its BARDA government contract, a new revenue stream, with the net loss narrowing to **$25.0 million** compared to **$26.0 million** in 2023, R&D expenses rising to **$23.7 million**, and G&A expenses falling to **$5.4 million**, concluding the year with **$5.5 million** in cash and cash equivalents Condensed Consolidated Statements of Operations (Year Ended Dec 31) | | 2024 (in thousands) | 2023 (in thousands) | | :--- | :--- | :--- | | Revenue from government contract | $ 3,955 | $ - | | Research and development | $ 23,714 | $ 20,721 | | General and administrative | $ 5,385 | $ 6,022 | | **Net loss** | **$ (24,992)** | **$ (25,967)** | | Net loss per common share | $ (4.82) | $ (14.29) | Condensed Consolidated Balance Sheet (As of Dec 31) | | 2024 (in thousands) | 2023 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $ 5,507 | $ 6,453 | | Total assets | $ 8,156 | $ 9,283 | | Total liabilities | $ 3,107 | $ 3,520 | | Stockholders' equity | $ 5,049 | $ 5,763 | - The increase in R&D expenses to **$23.7 million** was primarily due to costs of manufacturing materials for clinical trials of GEO-CM04S1 and other costs associated with the BARDA contract[13](index=13&type=chunk) - G&A expenses decreased to **$5.4 million** from **$6.0 million** in 2023, mainly due to lower stock-based compensation, consulting, and patent costs[14](index=14&type=chunk)

GeoVax Labs, Inc. (NASDAQ:GOVX) Q4 2024 Earnings Conference Call March 27, 2025 4:30 PM ET Company Participants Max Gadicke - Precision AQ, Investor Relations David Dodd - Chairman, President & CEO Mark Reynolds - Chief Financial Officer Kelly McKee - Chief Medical Officer John Sharkey - Vice President, Business Development Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Robert LeBoyer - Noble Capital Markets Laura Suriel - Alliance Global Partners Operator Good afternoon. And welcome ...

GeoVax Labs (GOVX) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Dodd - Chairman, President & CEOMark Reynolds - CFOJohn Sharkey - Vice President of Business DevelopmentKelly McKee - Chief Medical OfficerLaura Suriel - Equity Research Associate Conference Call Participants Max Gadicke - Investor relations & Senior AnalystJonathan Aschoff - Managing Director, Senior Research AnalystRobert Leboyer - Senior Biotechnology Analyst Operator Good afternoon, and welcome everyone to the ...