Financial Data and Key Metrics Changes - Revenues associated with the BARDA contract were approximately $4 million in 2024 compared to zero in 2023, as the contract began in June 2023 [27] - Research and development expenses increased to $23.7 million in 2024 from $20.7 million in 2023, representing a 14% increase [28] - Net loss for 2024 was approximately $25 million, or $4.82 per share, compared to $26 million, or $14.29 per share in 2023 [30] Business Line Data and Key Metrics Changes - The BARDA contract is a cost reimbursement contract, with total contract value to GeoVax at $26 million, potentially increasing to $45 million [27] - General and administrative expenses decreased to $5.4 million in 2024 from $6 million in 2023, an 11% decrease [29] Market Data and Key Metrics Changes - The WHO declared Mpox a public health emergency of international concern, emphasizing the need for expanded vaccine supply [19] - There is significant government interest in U.S.-based supply chains, reflecting a shift towards onshoring initiatives [21] Company Strategy and Development Direction - The company aims to establish business partnerships and collaborations for worldwide development, commercialization, and distribution of its vaccines [11] - The focus for 2025 includes advancing the GEO-CM04S1 vaccine, particularly in relation to the Project NextGen initiative [11] Management's Comments on Operating Environment and Future Outlook - Management highlighted the critical need for additional vaccine supply options for Mpox, with Africa needing 20 to 25 million doses [38] - The company remains in close contact with BARDA, with indications that operations will continue as planned despite uncertainties in Washington [70] Other Important Information - The company is actively progressing with the advanced MVA manufacturing process to produce vaccines more efficiently [22] - The anticipated clinical evaluation for the GEO-MVA vaccine is expected to begin in the second half of the year [9] Q&A Session Summary Question: Could GeoVax sell product without clinical testing given the urgency of the Mpox threat? - Management indicated that while there is a major need for vaccines, the ability to sell without clinical testing is uncertain and would depend on emergency use licensing [38] Question: How is GeoVax working with international partners for equitable vaccine access? - Management has been in discussions with African health ministries and European regulatory agencies to ensure equitable access and manufacturing [41] Question: What is needed to start the next Gedeptin trial? - Management stated that sufficient product supply is being manufactured, and the trial is likely to initiate in the mid to latter part of next year [45] Question: How will efficacy and safety be tested for the MVA vaccine? - Management explained that animal studies may run in parallel with clinical trials, focusing on immunological endpoints [52][54] Question: What are the timelines for data readouts for the Phase 2 trials? - Management expects readouts for the blood cancer patient study in early to mid-2026 and for the CLL study to be fully enrolled by the end of the year [64][66] Question: How might changes in COVID-19 funding affect the company? - Management reported ongoing positive communication with BARDA, with no current indications to slow down operations [70]

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

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]

As filed with the Securities and Exchange Commission on September 6, 2024 Registration No. 333- 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080 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 ...

As filed with the Securities and Exchange Commission on September 6, 2024 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) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, ...

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]

As filed with the Securities and Exchange Commission on August 6, 2024 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) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Su ...

Core Viewpoint - GeoVax Labs, Inc. is advancing its Gedeptin® cancer therapy into an expanded Phase 2 clinical trial, focusing on its efficacy and safety in combination with an immune checkpoint inhibitor for treating first-recurrence head and neck cancer [1][2][4]. Group 1: Clinical Development Plans - The company plans to initiate a novel Phase 2 clinical trial to evaluate the combination of Gedeptin and an immune checkpoint inhibitor, aiming to support neoadjuvant therapy [2][4]. - The trial will focus on squamous cell head and neck cancer, with the primary endpoint being the pathologic response rate in approximately 36 patients [13]. - The trial activation is anticipated during the first half of 2025, with necessary planning activities already underway [13]. Group 2: Funding and Regulatory Status - The current study is partially funded by the FDA through its Orphan Products Clinical Trials Grants Program, and Gedeptin has received orphan drug status for treating specific oral and pharyngeal cancers [3]. - The therapy has demonstrated acceptable safety and efficacy in previous trials, supporting its continued development [9]. Group 3: Technology Overview - Gedeptin utilizes a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT), which selectively targets tumor cells to convert a non-toxic prodrug into an active antitumor compound [5]. - The therapy has shown sufficient tumor stabilization and reduction activity in heavily pretreated patients, indicating its potential effectiveness [9][10]. Group 4: Company Background - GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on developing immunotherapies and vaccines for cancer and infectious diseases [6][14]. - The company has a strong intellectual property portfolio and a leadership team with extensive experience in life sciences [14].