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 ...

PART I [Business](index=4&type=section&id=ITEM%201.%20BUSINESS) A clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancers using proprietary platforms - GeoVax is a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumor cancers using novel proprietary platforms[14](index=14&type=chunk) - The lead clinical program, GEO-CM04S1, is a next-generation COVID-19 vaccine supported by a **BARDA-funded contract** for a 10,000-participant, randomized, Phase 2b clinical trial anticipated to start in the second half of 2025[14](index=14&type=chunk)[23](index=23&type=chunk) - The lead oncology program is Gedeptin®, a novel oncolytic solid tumor therapy that recently completed a Phase 1/2 trial for advanced head and neck cancers[14](index=14&type=chunk)[42](index=42&type=chunk) - The company is developing GEO-MVA, a vaccine targeting Mpox and smallpox, positioning GeoVax to be the **first U.S.-based supplier** of an MVA vaccine for these threats[14](index=14&type=chunk)[47](index=47&type=chunk) Clinical Development Pipeline Summary | Product | Indication | Trial Phase | Status | | :--- | :--- | :--- | :--- | | **GEO-CM04S1** | COVID-19 | Phase 2b (BARDA) | Initiation 2H 2025 | | | COVID-19 (Immunocompromised) | Phase 2 | Currently enrolling | | | COVID-19 (CLL Booster) | Phase 2 | Currently enrolling | | | COVID-19 (Healthy Adult Booster) | Phase 2 | Enrollment closed, data mid-2025 | | **Gedeptin®** | Head & Neck Cancer | Phase 2 (ICI Combo) | Planned | Research and Development Expenditures | Year | R&D Expense (in millions) | | :--- | :--- | | 2024 | $23.7 | | 2023 | $20.7 | [Risk Factors](index=20&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks including operating losses, a "going concern" opinion, and a critical need for additional funding - The company has a history of operating losses, incurring a net loss of approximately **$25 million** for the year ended December 31, 2024, and expects losses to continue[129](index=129&type=chunk) - Auditors have issued a **"going concern" opinion**, reflecting substantial doubt about the company's ability to continue operations without raising additional capital[130](index=130&type=chunk) - A significant portion of funding for the GEO-CM04S1 vaccine is expected from a U.S. government contract which **BARDA can terminate for convenience** at any time[134](index=134&type=chunk)[135](index=135&type=chunk) - The company faces risks related to its intellectual property, including the inability to obtain or maintain patent protection and the possibility of infringing on third-party patents[161](index=161&type=chunk)[165](index=165&type=chunk) - The market price of the company's common stock is highly volatile, and the potential exercise of approximately **12.2 million outstanding warrants** could cause significant shareholder dilution[181](index=181&type=chunk)[184](index=184&type=chunk) [Unresolved Staff Comments](index=31&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company reports that it has no unresolved comments from the SEC staff - None[193](index=193&type=chunk) [Cybersecurity](index=31&type=section&id=ITEM%201C.%20CYBERSECURITY) The Board oversees cybersecurity risk, with management responsible for implementation, and no material threats are currently identified - The Board's Nominating and Governance Committee (NGC) has been assigned oversight of cybersecurity matters[194](index=194&type=chunk) - Management, with the Chief Financial Officer overseeing the IT function, is responsible for implementing the company-wide cybersecurity strategy[195](index=195&type=chunk) - The company does not believe there are currently any known risks from cybersecurity threats that are **reasonably likely to materially affect** its business, strategy, or financial condition[196](index=196&type=chunk) [Properties](index=31&type=section&id=ITEM%202.%20PROPERTIES) GeoVax leases approximately 8,400 square feet of office and laboratory space in Smyrna, Georgia, and owns no real property - The company's principal executive offices are located in a leased space of approximately **8,400 square feet** in Smyrna, Georgia[197](index=197&type=chunk) - The current lease is scheduled to terminate on **December 31, 2025**[197](index=197&type=chunk) [Legal Proceedings](index=31&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[198](index=198&type=chunk) [Mine Safety Disclosures](index=31&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Not applicable[199](index=199&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=32&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on Nasdaq as "GOVX", no dividends are paid, and no shares were repurchased in Q4 2024 - The company's common stock is traded on The Nasdaq Capital Market under the symbol **"GOVX"**[201](index=201&type=chunk) - GeoVax has **never declared or paid cash dividends** on its common stock and does not anticipate doing so in the foreseeable future[202](index=202&type=chunk) - The company **did not repurchase any of its equity securities** during the fourth quarter of 2024[204](index=204&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=ITEM%207.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) The company reported $4.0 million in revenue and a $25.0 million net loss for 2024, with existing cash funding operations only into Q3 2025 Results of Operations Summary (in thousands) | | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue from government contract | $3,955 | $0 | $3,955 | | Research and development | $23,714 | $20,721 | $2,993 | | General and administrative | $5,385 | $6,022 | ($637) | | **Loss from operations** | **($25,144)** | **($26,743)** | **$1,599** | | **Net loss** | **($24,992)** | **($25,967)** | **$975** | - Revenue of **$3,974,576 in 2024** was entirely from the ATI-RRPV (BARDA) Contract, with no revenue in 2023[222](index=222&type=chunk) - R&D expenses **increased by 14%** in 2024 to $23.7 million, mainly due to costs for the ATI-RRPV Contract, Gedeptin, and GEO-MVA programs[223](index=223&type=chunk) - G&A expenses **decreased by 11%** in 2024 to $5.4 million, primarily due to lower stock-based compensation, consulting, and patent costs[224](index=224&type=chunk) Liquidity and Capital Resources Summary (in thousands) | | As of Dec 31, 2024 | As of Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,507 | $6,453 | | Working capital | $4,828 | $4,366 | - The company believes its existing cash and cash equivalents are sufficient to fund operations **only into the third quarter of 2025**, raising substantial doubt about its ability to continue as a going concern[232](index=232&type=chunk)[233](index=233&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Market risk is limited to interest income sensitivity on short-term investments, with no use of derivative financial instruments - The company's market risk is primarily limited to **interest income sensitivity** on its short-term investments in money market funds[238](index=238&type=chunk) - The company **does not utilize any derivative financial instruments** or foreign currency instruments[238](index=238&type=chunk) [Financial Statements and Supplementary Data](index=40&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section references the company's consolidated financial statements, supplementary data, and auditor's report found from page F-1 - The company's consolidated financial statements for the years ended December 31, 2024 and 2023, along with the auditor's report, are set forth on pages F-1 to F-17 of the Annual Report[240](index=240&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=40&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) The company reported no disagreements with its accountants on accounting principles, practices, or financial statement disclosure - There were **no disagreements** with the company's accountants on matters of accounting or financial disclosure[241](index=241&type=chunk) [Controls and Procedures](index=40&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that as of December 31, 2024, the company's disclosure controls and internal controls were effective - The Chief Executive Officer and Chief Financial Officer concluded that as of December 31, 2024, the company's disclosure controls and procedures were **effective**[243](index=243&type=chunk) - Management concluded that as of December 31, 2024, the company's internal control over financial reporting was **effective**[244](index=244&type=chunk) PART III This section incorporates information by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders - Information required by Items 10 through 14 is **incorporated by reference** from the company's definitive proxy statement for its 2025 annual meeting of stockholders[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=42&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all documents filed as part of the 10-K report, including financial statements and material contracts - This item lists the financial statements, financial statement schedules, and all exhibits filed with the report[255](index=255&type=chunk)[256](index=256&type=chunk) - Key exhibits include license agreements with the National Institute of Allergy and Infectious Diseases, PNP Therapeutics, Inc., and City of Hope, as well as the RRPV Project Award agreement with Advanced Technology International[257](index=257&type=chunk) Consolidated Financial Statements [Report of Independent Registered Public Accounting Firm](index=47&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report confirms fair presentation of financial statements but includes a "going concern" emphasis of matter paragraph - The auditor's report contains an "Emphasis of a Matter" paragraph expressing **substantial doubt** about the Company's ability to continue as a **going concern**[270](index=270&type=chunk) [Consolidated Financial Statements](index=48&type=section&id=Consolidated%20Financial%20Statements) The financial statements show total assets of $8.2 million, a net loss of $25.0 million, and a $0.9 million decrease in cash for 2024 Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Current Assets** | $7,935 | $7,886 | | **Total Assets** | **$8,156** | **$9,283** | | **Total Current Liabilities** | $3,107 | $3,520 | | **Total Stockholders' Equity** | **$5,049** | **$5,763** | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Revenue from government contract | $3,955 | $0 | | Total operating expenses | $29,099 | $26,743 | | **Net loss** | **($24,992)** | **($25,967)** | | **Net loss per common share** | **($4.82)** | **($14.29)** | Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($24,676) | ($25,174) | | Net cash used in investing activities | ($21) | ($49) | | Net cash provided by financing activities | $23,751 | $4,062 | | **Net decrease in cash** | **($946)** | **($21,160)** | [Notes to Consolidated Financial Statements](index=52&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail the "going concern" uncertainty, a 1-for-15 reverse stock split, equity offerings, and revenue from the BARDA contract - The company believes its existing cash resources will be sufficient to continue planned operations **only into the third quarter of 2025**, which raises substantial doubt about its ability to continue as a going concern[292](index=292&type=chunk) - In January 2024, the company effected a **one-for-fifteen reverse stock split** of its common stock, and all share and per-share data have been retroactively restated[318](index=318&type=chunk) - During 2024, the company raised approximately **$21.4 million in net proceeds** from four registered direct offerings and an "At-the-Market" (ATM) program[229](index=229&type=chunk) - In June 2024, the company was awarded the ATI-RRPV Contract funded by BARDA, which provides direct funding of approximately **$26.2 million** (potentially up to $45 million) for its GEO-CM04S1 Phase 2b trial[344](index=344&type=chunk)[345](index=345&type=chunk) - As of December 31, 2024, the company has a federal net operating loss (NOL) carryforward of approximately **$116.8 million** and R&D tax credits of **$5.5 million**, but a full valuation allowance has been established against these deferred tax assets[341](index=341&type=chunk)[342](index=342&type=chunk)

Core Insights - GeoVax Labs, Inc. is making significant progress in its clinical trials, particularly with the GEO-CM04S1 COVID-19 vaccine and Gedeptin for head and neck cancer [1][2][4] Clinical Development Updates - The BARDA Project NextGen Phase 2b trial for GEO-CM04S1 is set to initiate with confirmed sites and a target of 10,000 participants to compare its efficacy against an FDA-approved mRNA COVID-19 vaccine [4][2] - Interim results from existing Phase 2 clinical studies are expected in Q4 2024, including trials for immunocompromised patients and booster trials for healthy adults [4] - Gedeptin is on track for a Phase 2 trial in first recurrent head and neck cancer patients, anticipated to start in the first half of 2025 [3][5] Vaccine Development - The GEO-MVA vaccine candidate for Mpox is progressing, with a cGMP clinical batch expected to be completed in Q4 2024 [3][7] - The MVA vaccine is recognized for its safety and efficacy, and is currently stockpiled in the U.S. for potential bioterrorism threats [7] Financial Performance - For Q3 2024, GeoVax reported a net loss of $5.82 million, or $0.91 per share, an improvement from a net loss of $8.41 million, or $4.75 per share, in Q3 2023 [10] - Revenue from government contracts related to the BARDA Project NextGen award was $2.79 million for Q3 2024, with no revenues reported in the same period of 2023 [10] - Research and development expenses increased to $7.40 million for Q3 2024, compared to $6.95 million in Q3 2023, primarily due to manufacturing costs for clinical trials [10] Corporate Developments - GeoVax appointed Dr. Teresa Lambe to its Scientific Advisory Board, enhancing its expertise in vaccinology and immunology [9] - The company reported cash balances of $8.59 million as of September 30, 2024, an increase from $6.45 million at the end of 2023 [10][17]

Core Insights - GeoVax Labs, Inc. is participating in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, where its Chairman & CEO, David Dodd, will discuss innovative therapies for solid tumors [1][2] Company Overview - GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on developing vaccines for infectious diseases and therapies for solid tumor cancers [3] - The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine, which is currently in three Phase 2 clinical trials and has received a BARDA-funded contract for a 10,000-participant Phase 2b clinical trial [3] - In oncology, GeoVax is evaluating Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers [3] - The company holds a strong intellectual property portfolio and worldwide rights for its technologies and products [3]

Core Insights - GeoVax Labs, Inc. has appointed Professor Teresa Lambe to its Scientific Advisory Board, enhancing its leadership in vaccine development [1][4] - Professor Lambe is recognized for her pivotal role in the Oxford/AstraZeneca COVID-19 vaccine program and has received multiple prestigious awards for her contributions to science and public health [2][3] Company Overview - GeoVax is a clinical-stage biotechnology company focused on developing vaccines for infectious diseases and therapies for solid tumor cancers [5] - The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine, which is currently undergoing a 10,000-participant Phase 2b clinical trial funded by BARDA [5] - In oncology, GeoVax is evaluating Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers [5] Research and Development Focus - Professor Lambe's research aims to design vaccination strategies based on understanding the protective immune response post-infection, with ongoing projects targeting outbreak pathogens such as Ebola and Marburg viruses [3] - GeoVax's vaccine development efforts align with Professor Lambe's expertise, particularly in addressing high-risk and immunocompromised populations [4]

Company plans Phase 2 trial in first-recurrence head & neck cancer, in combination with immune checkpoint inhibitor ATLANTA, GA, July 31, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (NASDAQ:GOVX), a clinicalstage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review. "We are pleased to announce the plans for this novel, exp ...

ATLANTA, GA, July 31, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review. The primary goal of the planned Phase 2 trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrenc ...

Company plans Phase 2 trial in first-recurrence head & neck cancer, in combination with immune checkpoint inhibitor ATLANTA, GA, July 31, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (NASDAQ:GOVX), a clinicalstage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review. GeoVax and a specially convened clinical advisory committ ...

Core Insights - The article highlights the relevance of GeoVax's stock (GOVX) due to its advancements in developing a next-generation Covid-19 vaccine, GEO-CM04S1, which has received funding from the Biomedical Advanced Research and Development Authority (BARDA) [2][3][5] Company Developments - GeoVax has partnered with Allucent to conduct a Phase 2b clinical trial for its GEO-CM04S1 Covid vaccine, which has led to a significant increase in GOVX stock price, rising over 110% before some gains were pared back [5] - The Phase 2b trial will involve 10,000 participants and aims to evaluate the efficacy of GEO-CM04S1 against an already approved Covid vaccine, with the unique feature of delivering multiple antigens in a single dose [8] Industry Context - The ongoing concern regarding Covid-19, particularly among vulnerable populations with chronic diseases, underscores the need for more effective vaccines, thereby enhancing the relevance of GeoVax's developments in the biotech sector [3]

Exhibit 99.1 GeoVax Reports First Quarter 2024 Financial Results and Provides Business Update Presented data on GEO-CM04S1 at World Vaccine Congress, delineating the unique immune system driven mechanisms that contribute to the broad ef icacy of the vaccine candidate Significant milestone achieved towards implementation of a commercially validated manufacturing system Progress across pipeline with planned data readouts for GEO-CM04S1 in multiple trials and Gedeptin® in healthy patient boost trial on track f ...