GeoVax Labs: securities offering

Cover page 7 changes

As filed with the Securities and Exchange Commission on June 7, August 6, 2024

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SUBJECT TO COMPLETION, DATED JUNE 7, AUGUST 6, 2024

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1,605,688 2,170,000 Shares of Common Stock

This prospectus relates to the resale of up to an aggregate of 1,605,688 2,170,000 shares (the "2024 Warrant Shares") of our common stock, par value $0.001 per share (the "Common Stock"), issuable upon the exercise of that certain common stock purchase warrant (the "2024 Common Warrant") issued in a private placement on May 21, July 12, 2024 by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company ("Armistice").

We will not receive any proceeds from the sale of the 2024 Warrant Shares covered by this prospectus by the Selling Stockholder (as defined herein). All net proceeds from the sale of the 2024 Warrant Shares covered by this prospectus will go to the Selling Stockholder. However, we will receive the proceeds from any cash exercise of the 2024 Common Warrant. See "Use of Proceeds."

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Our Common Stock issued to investors is listed on the Nasdaq Capital Market LLC ("Nasdaq") under the symbol "GOVX." On June 5, August 2, 2024, the last reported sale price of our common stock was $1.80 $1.92 per share.

Investing in our shares of common stock involves a high degree of risk. The risks are described in the " Risk Factors " section beginning on page 7 8 of this prospectus. You should also consider the risk factors described or referred to in any applicable prospectus supplement before investing in these securities.

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Prospectus summary 61 changes

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GeoVax Labs, Inc. ("GeoVax" or "the Company") is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor various cancers using novel proprietary platforms. GeoVax's product pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancers. Additional research and development programs include preventive vaccines against Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg) and Zika virus, and malaria, as well as immunotherapies for multiple solid tumors. The Company's portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 155 granted or pending patent applications spread over 24 patent families.

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The table below summarizes the status of our product development programs, which are discussed in greater detail in the following pages.

Coronavirus Vaccines

COVID-19 (Booster to mRNA vaccines)

COVID-19 (Primary vaccine for immunocompromised patients)

COVID-19 (Booster for Chronic Lymphocytic Leukemia patients)

Clinical – Phase 2 (Investigator Initiated Trial)

Solid Tumors (Advanced Head and Neck Cancer)*

Clinical – Phase 1/2

Preclinical/IND-Enabling

Other Infectious Disease Vaccines

Preclinical/IND-Enabling

Hemorrhagic Fever Viruses

Preclinical/IND-Enabling

Preclinical/IND-Enabling

The tables below summarize the status of our product development programs, which are in various stages of development, the most significant of which are described further below along with recent developments.

Clinical Development Programs

BARDA Project NextGen

10,000 Patient Comparison Study

Immunocompromised/Stem Cell Transplant Patients (NCT04977024)

Immunocompromised/Chronic Lymphocytic Patients (NCT05672355)

Healthy Adults (NCT04639466)

Effect on Targeted Tumors (NCT03754933)

Squamous Cell Head & Neck Cancer

First Recurrence Therapy in Combination

with Immune Checkpoint Inhibitor

Preclinical Development Programs

Humanized Mouse Model (completed)

Pan-Coronavirus Vaccine

Humanized Mouse Model (completed)

Ebola Zaire Vaccine**

Non-Human Primate (completed)

Ebola Sudan Vaccine**

Non-Human Primate (completed)

Non-Human Primate (completed)

Mouse Model (completed)

Mpox & Smallpox Vaccine

Regulatory Discussions & Manufacturing Scale-up

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GEO-CM04S1 – Immunocompromised/Cell Transplant Phase 2 Trial

GEO-CM04S1 is undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal COVID-19 booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. Patient enrollment was completed in September 2023.

Our corporate strategy is to advance, protect and exploit our differentiated vaccine/immunotherapy platform vaccine and oncology platforms leading to the successful development of preventive and therapeutic vaccines interventions against infectious diseases and various cancers. With our design and development capabilities, we are progressing and validating an array of cancer treatment and infectious disease immunotherapy and vaccine product candidates. Our goal is to advance products through to human clinical testing, registration and commercialization in the U.S, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization outside of the U.S. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.

Recent Development – BARDA Project NextGen Award – GEO-CM04S1 Phase 2b Trial On June 18, 2024, we announced our receipt of an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, our dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Preparations for the Phase 2b study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network. The direct award to GeoVax of $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of $343 million from the Project NextGen program to Allucent, a global clinical research organization (CRO), to execute the clinical trial as part of BARDA's Clinical Studies Network. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is expected to be $367-388 million GEO-CM04S1 – Immunocompromised/Cell Transplant Phase 2 Trial ● GEO-CM04S1 is undergoing a Phase 2 multi-site clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in high-risk immunocompromised patients (e.g. patients with blood cancers who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy). Data published from the open-label safety lead-in portion of the trial indicating indicates that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including broad and durable neutralizing antibodies, antibody and T cell responses.

GEO-CM04S1 – Healthy Adult Booster Phase 2 Trial

A Phase 2 trial of GEO-CM04S1 (ClinicalTrials.gov Identifier: NCT04639466), evaluating two vaccine does levels as a heterologous COVID-19 booster vaccine to current FDA-approved mRNA vaccines from Pfizer/BioNTech and Moderna ● In September 2023, we announced completion of enrollment. The trial protocol requires the subjects be followed for 12 months and the last data collection points are scheduled towards the end September 2024. Safety and immune response readouts from this study should be available towards the end of 2024 or early 2025.

In February 2024, we announced positive interim safety and immune responses findings following vaccine administration. Consolidated data (blinded to vaccine dose) from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5.

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Interim data presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference in July 2023, indicated that administration of Gedeptin® is safe and feasible, with observation of tumor growth impairment in a majority of the patients.

In January 2024, we announced closure of patient enrollment for this trial. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of 2024. Our intent is to discuss a follow-on protocol with the FDA for a Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal, in conjunction with a complete review of the results of the current trial. We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.

GEO-CM04S1 is undergoing an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355), evaluating its use as a COVID-19 booster vaccine booster in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine. Interim data results are scheduled for Q3 2024.

Gedeptin ® – Advanced Head and Neck Cancer Phase 1/2 1b/2a Trial

Gedeptin® is undergoing recently completed a Phase 1/2 1b/2a clinical trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC). This trial is was being funded in part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The trial is designed to inform the design of a larger patient trial that also may involve patients with other anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.

We recently convened a special clinical advisory board to conduct a comprehensive review of the PNP-002 trial results, together with the previously completed Phase 1 trial (PNP-001). This review concluded that Gedeptin demonstrated an acceptable safety and efficacy profile to support continued development. In addition, the therapy has demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin therapy in an expanded Phase 2 clinical trial.

We have initiated activities in support of a Phase 2 trial in first-recurrence head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint. We have initiated the necessary planning activities, including protocol development, manufacturing and CRO selection, with the trial activation anticipated during the first half of 2025.

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On May 10, 2024, we conducted a bridge financing through the issuance and sale of 10% Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $150,000 to members of our Board of Directors and senior management. The Notes are unsecured, bear interest at a rate of 15% per annum, and mature upon the earlier of: (i) six months from the issue date; or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $5 million.

Other Recent Developments

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On May 16, July 11, 2024, the Company entered into a placement agency agreement (the "Placement Agency Agreement") with Roth Capital Partners, LLC ("Roth") and a securities purchase agreement (the "Purchase Agreement") with a purchaser pursuant to which the Company agreed to sell, in a registered direct offering (the "Registered Direct Offering"), an aggregate of (i) 220,000 458,632 shares (the "Shares") of the Company's Common Stock, and (ii) pre-funded warrants to purchase up to an aggregate of 582,844 626,368 shares of Common Stock (the "Pre-Funded Warrants," and the shares of Common Stock issuable upon exercise thereof, the "Pre-Funded Warrant Shares"). In a concurrent private placement, the Company offered 2024 Common Warrants to the purchaser, with each warrant exercisable to purchase one share of Common Stock, with two 2024 Common Warrants to accompany each Share of Common Stock or Pre-Funded Warrant sold in the Offering, and to purchase in the aggregate up to 1,605,688 2,170,000 shares of Common Stock (the "Common Warrant Shares"). The public offering price for each Share was $1.68 $2.86 and the public offering price for each Pre-Funded Warrant was $1.67999. $2.85999. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire five years from the date of issuance. may be exercised at any time until exercised in full. The 2024 Common Warrants have an exercise price of $1.68 $2.86 per share, are immediately exercisable upon stockholder approval and will expire five years from the date of issuance. such stockholder approval. The net proceeds of the offering, after deducting Roth's fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the 2024 Common Warrants, is approximately $1,180,000. $2.8 million. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The offering closed on May 21, July 12, 2024.

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1,605,688 2,170,000 shares of Common Stock by the Selling Stockholder, consisting entirely of shares of Common Stock issuable upon the exercise of the 2024 Common Warrant.

Shares of common stock outstanding prior to this offering

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Unless otherwise indicated, the number of shares of our common stock outstanding prior to this offering is based on 2,528,309 5,263,700 shares of Common Stock outstanding as of June 5, August 6, 2024, and excludes as of such date:

1,605,688 2,170,000 shares of common stock issuable upon the exercise of the 2024 Common Warrant with an exercise price of $1.68 $2.86 per share;

2,409,091 2,362,937 shares of common stock issuable upon the exercise of other outstanding warrants with a weighted average exercise price of $6.71 $7.39 per share ● 333,648 shares of common stock which are reserved for issuance under our 2020 and 2023 Stock Incentive Plans, of which 133,648 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $28.39 per share.

Risk factors 5 changes

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As a research and development-focused company, we have had no product revenue to date and revenues from our government grants and other collaborations have not generated sufficient cash flows to cover operating expenses. Since our inception, we have incurred operating losses each year due to costs incurred in connection with research and development activities and general and administrative expenses associated with our operations. We incurred a net loss of approximately $26 million for the year ended December 31, 2023 and of approximately $5.9 $10.9 million for the three six months ended March 31, June 30, 2024. We expect to incur additional operating losses and expect cumulative losses to increase as our research and development, preclinical, clinical, and manufacturing efforts expand. Our ability to generate revenue and achieve profitability depends on our ability to successfully complete the development of our product candidates, conduct preclinical tests and clinical trials, obtain the necessary regulatory approvals, and manufacture and market or otherwise commercialize our products. Unless we are able to successfully meet these challenges, we will not be profitable and may not remain in business.

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We are obligated to issue additional shares of our common stock in connection with our outstanding warrants if the warrant holders choose to exercise them. In addition to the 2024 Common Warrant, there are warrants exercisable for approximately 2.4 million shares at with a weighted average exercise prices ranging from $-0- to $195 price of $7.39 per share. The exercise of these warrants will cause us to issue additional shares of our common stock and will dilute the percentage ownership of our shareholders.

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Our common stock (GOVX) and related warrants (GOVXW) are currently listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price, and certain corporate governance requirements. There can be no assurances that we will be able to continue to comply with the applicable listing standards.

Our common stock (GOVX) and related warrants (GOVXW) are currently listed On Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price, and certain corporate governance requirements. There can be no assurances that we will be able to continue to comply with the applicable listing standards. For example, on May 23, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq notifying the Company that it no longer complied with the $2,500,000 minimum stockholders' equity required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1) (the "Stockholders' Equity Requirement"), because the Company's stockholders' equity as reported in its Form 10-Q for the period ended March 31, 2024 did not meet the required minimum, and as of the date of the Notice, the Company did not meet the alternatives of market value of listed securities or net income from continuing operations (together with the Stockholders' Equity Requirement, the "Listing Rule"). We are currently reviewing potential transactions that, if implemented, could remedy the shortfall in our stockholders' equity. We do not know at this time, however, whether we will be able to remedy the non-compliance. If we are unable to maintain compliance with these Nasdaq requirements, our Common Stock and warrants will be delisted from Nasdaq. In that event, and if our Common Stock is not then eligible for quotation on another market or exchange, trading of our Common Stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the OTC Pink. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our Common Stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on an exchange.

On July 18, 2024, we received notice from Nasdaq granting our request for an extension of time to regain compliance with the Stockholders' Equity Requirement until November 19, 2024. We are currently reviewing potential transactions that, if implemented, could remedy the shortfall in our stockholders' equity. We do not know at this time, however, whether we will be able to remedy the non-compliance. If we are unable to maintain compliance with these Nasdaq requirements, our Common Stock and warrants will be delisted from Nasdaq. In that event, and if our Common Stock is not then eligible for quotation on another market or exchange, trading of our Common Stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the OTC Pink. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our Common Stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on an exchange.

Use of proceeds 1 change

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We will receive proceeds from any cash exercise of the 2024 Common Warrant and related issuance of shares of common stock. If the 2024 Common Warrant is exercised for cash in full, the gross proceeds would be approximately $2.7 $6.2 million. We intend to use the net proceeds from the exercise of the 2024 Common Warrant, if any, for general corporate purposes and working capital.

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Capitalization 6 changes

The following table sets forth our capitalization as of March 31, June 30, 2024:

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on an as adjusted basis to give effect to (i) the issuance and sale by us of 802,844 1,085,000 shares of common stock in the Registered Direct Offering (inclusive of 582,844 626,368 shares of common stock issuable upon the exercise of pre-funded warrants), (ii) receipt of the gross proceeds from the registered direct offering after deducting commissions and offering expenses payable by us, and (iii) the issuance of 1,605,688 2,170,000 shares of common stock issuable upon the exercise of the 2024 Common Warrant at a price of $1.68 $2.86 per share.

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As of March 31, 2024

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Total stockholders' equity (deficiency)

The table and discussion above are based on 2,308,309 4,178,700 shares of common stock outstanding as of March 31, June 30, 2024, and 4,716,841 7,433,700 shares as adjusted, and do not include, as of that date:

2,409,091 2,362,937 shares of common stock issuable upon the exercise of other outstanding warrants with a weighted average exercise price of $6.71 $7.39 per share ● 333,648 shares of common stock which are reserved for issuance under our 2020 and 2023 Stock Incentive Plans, of which 133,648 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $28.39 per share.

Business 74 changes

GeoVax Labs, Inc. ("GeoVax" or "the Company") is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor various cancers using novel proprietary platforms. GeoVax's product pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancers. Additional research and development programs include preventive vaccines against Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg) and Zika virus, and malaria, as well as immunotherapies for multiple solid tumors. The Company's portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 155 granted or pending patent applications spread over 24 patent families, which are discussed in greater detail in the "Our Intellectual Property" section.

Recent Development -- BARDA Project NextGen Award – Phase 2b Trial

On June 18, 2024, we announced our receipt of an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, our dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. Under the agreement GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network. The direct award to GeoVax of $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of $343 million from the Project NextGen program to Allucent, a global clinical research organization (CRO), to execute the clinical trial as part of BARDA's Clinical Studies Network. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is expected to be $367-388 million.

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Coronavirus/COVID-19 Vaccines

Booster to mRNA vaccines

Clinical – Phase 2 (enrollment completed)

Primary vaccine for immunocompromised/cell transplant patients

Clinical – Phase 2 (actively enrolling)

Booster for immunocompromised/CLL patients

Clinical – Phase 2 (actively enrolling)

Solid Tumors (Advanced Head and Neck Cancer)*

Clinical – Phase 1/2 (enrollment completed)

Preclinical/IND-Enabling

Other Infectious Disease Vaccines

Preclinical/IND-Enabling

Hemorrhagic Fever Viruses

Preclinical/IND-Enabling

Preclinical/IND-Enabling

The table tables below summarizes summarize the status of our product development programs, which are discussed in greater detail in the following pages.

Clinical Development Programs

BARDA Project NextGen

10,000 Patient Comparison Study

Immunocompromised/Stem Cell Transplant Patients (NCT04977024)

Immunocompromised/Chronic Lymphocytic Patients (NCT05672355)

Healthy Adults (NCT04639466)

Effect on Targeted Tumors (NCT03754933)

Preclinical Development Programs

Humanized Mouse Model (completed)

Pan-Coronavirus Vaccine

Humanized Mouse Model (completed)

Ebola Zaire Vaccine**

Non-Human Primate (completed)

Ebola Sudan Vaccine**

Non-Human Primate (completed)

Non-Human Primate (completed)

Mouse Model (completed)

Mpox & Smallpox Vaccine

Regulatory Discussions &

Manufacturing Scale-up

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Based on our research, there are currently forty Vaccines currently authorized for use in one or more countries around the world, including four in the United States These vaccines are primarily designed to induce antibodies specific for the S protein of SARS-CoV-2 but rely on different mechanisms for presentation or expression of the S antigen, including recombinant proteins, whole inactivated virus, defective adenovirus vectors (three different types) or mRNA. Unfortunately, the continued adaptation and mutation of SARS-CoV-2 has resulted in the emergence of variants that are not optimally neutralized by antibodies induced by currently available vaccines, reducing clinical efficacy. This has required the continued adjustment of vaccine composition and the repeated administration of booster doses. Moreover, these current vaccines tend to stimulate only modest T-cell responses, which have been shown to be critical to critical for induction of long-term immune memory and for protection against severe COVID-19 disease. Recently, the FDA indicated the likely need for continued vaccine adjustments and boosters at least annually, similar to the approach used for influenza virus vaccines.

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Given the serious impact of other respiratory viruses in this vulnerable patient population, it is anticipated that hematology recipients of cell therapy may develop severe clinical disease, profoundly impacting morbidity and survival. Increasingly, there is evidence of the high risk of severe morbidity, hospitalization and death resulting from SARS-CoV-2 in hematology patients. The efficacy and safety of a SARS-CoV-2 vaccine remains to be established in the different immunocompromised patient populations and it is likely that candidate SARS-CoV-2 vaccines may differ in their efficacy and safety for these patients.

GEO-CM04S1 -- BARDA Project NextGen Award – Phase 2b Trial

On June 18, 2024, we announced our receipt of an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, our dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. Under the agreement GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network. The direct award to GeoVax of $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of $343 million from the Project NextGen program to Allucent, a global clinical research organization (CRO), to execute the clinical trial as part of BARDA's Clinical Studies Network. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is expected to be $367-388 million.

Funding for this project is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. GeoVax's vaccine candidate provides many of the features identified, including broader protection among variants of concern (VOC) and a longer duration of protection.

GeoVax's role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) 75A50123D00005.

Allucent's role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract 75A50120D00016/75A50123F33005.

GEO-CM04S1 for Immunocompromised/Cell Transplant Patients – The CDC and other global public health agencies identify immunocompromised patients, including patients with cancer, particularly those who have received treatment for hematologic malignancy, as highest risk for SARS-CoV-2 disease. SARS-CoV-2 infection can be very serious in this these vulnerable population of hematology patient groups, with hematologic cancer patients, including those receiving autologous (auto) and allogeneic (allo) hematopoietic cell transplant (HCT), and recipients of chimeric antigen receptor (CAR)-T cell therapies among the most vulnerable.

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GEO-CM04S1 is being studied in an ongoing Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) to evaluate its safety and immunogenicity as a primary vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in blood cancer patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. MVA-vector based vaccines tend to produce an immune response quickly – in less than 14 days – with only mild side effects. The trial is also the first to compare an investigational multi-antigenic SARS-CoV-2 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccines from Pfizer/BioNTech and Moderna in people who are immunocompromised. Such patients have often shown a suboptimal immune response after receiving currently available COVID-19 vaccines.

GEO-CM04S1 is also being studied as a booster vaccine in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355), ), as a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL). Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to their compromised ability to generate protective antibody responses against COVID infections or vaccinations. to currently available vaccines. GEO-CM04S1 may be more effective at inducing protective immunity in CLL patients since MVA strongly induces T cell expansion even in the background of immunosuppression. Targeting both the S and N protein antigens broaden the specificity of the immune responses and can protect mitigate against the loss of efficacy associated with the reduced inadequate antibody responses. The study is examining the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm.

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The Phase 1 trial of GEO-CM04S1 (known at the time as COH-CM04S1) was designed as a dose-escalation safety study in healthy individuals between the ages of 18 to 55, who had not been previously infected or vaccinated with SARS-CoV-2. The primary objectives were to evaluate the safety, tolerability and immunogenicity of the GEO-CM04S1 administered at three different dose levels by intramuscular (IM) injection. Follow-up studies of the volunteers are continuing to better characterize their immune responses.

The Phase 2 booster study, for which patient enrollment was completed in September 2023, includes 63 healthy adults who were previously vaccinated with one of the FDA-approved SARS-CoV-2 mRNA vaccines, manufactured by either Pfizer/BioNTech or Moderna. The study is designed as a comparison trial to evaluate the safety profile and immunogenicity of 2 dose levels of GEO-CM04S1 when administered as a heterologous booster. The immunological responses measured throughout the study will include SARS-CoV-2 binding antibodies, as well as neutralizing antibody and T-cell responses against SARS-CoV-2 variants of concern (VOC), including the Delta and contemporaneous Omicron variants. We expect data from this trial, which included a 1-year follow-up, to be available towards the end of 2024 or early 2025.

In February 2024, we announced positive initial safety and immune response findings at one month following vaccine administration. While the study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both binding antibodies, as well as neutralizing antibodies against multiple SARS-CoV-2 variants (including contemporaneous Omicron variants) and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.

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The trial design involves repeat administration using Gedeptin followed by systemic fludarabine phosphate, in order to gain preliminary information on the utility of multiple cycles of Gedeptin therapy, prior to expansion towards a larger patient trial. The initial stage of the study is being funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. This trial will guide the design of larger studies involving patients at earlier stages in the disease process. These studies may lead to labeling discussions with the FDA and initiation of further Gedeptin investigations including in combination with immune checkpoint inhibitors for additional cancerous and non-cancerous tumor indications.

In GDEPT, a replication-deficient adenovirus vector is used to infect and transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a an inactive prodrug into an active antitumor compound, in situ . A cycle of Gedeptin therapy consists of intra-tumoral injections of Gedeptin followed by administration of a prodrug, fludarabine phosphate, over a pre-defined time period. A Phase 1 dose ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the therapy to be well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

We recently completed a multi-site Phase 1/2a 1b/2a trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. is ongoing, with patient enrollment closed This trial was funded in December 2023. part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.

The PNP-002 trial design involved repeat administration using Gedeptin followed by systemic fludarabine phosphate, in order to gain preliminary information on the utility of multiple cycles of Gedeptin therapy. This trial was intended to guide the design of larger studies involving patients at earlier stages in the disease process.

We recently convened a special clinical advisory board to conduct a comprehensive review of the PNP-002 trial results, together with the previously completed Phase 1 trial (PNP-001). This review concluded that Gedeptin demonstrated an acceptable safety and efficacy profile to support continued development. In addition, the therapy has demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin therapy in an expanded Phase 2 clinical trial.

We have initiated activities in support of a Phase 2 trial in first-recurrence head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint. We have initiated the necessary planning activities, including protocol development, manufacturing and CRO selection, with the trial activation anticipated during the first half of 2025.

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MVA as Smallpox and Mpox Vaccine - MVA was originally developed for use as a smallpox vaccine more than 30 years ago. Its preferred use is for individuals with compromised immune systems; individuals that would be put at risk if administered the normal smallpox vaccine ("vaccinia") which can replicate in human cells. It is also approved as the vaccine for other orthopox vaccines, including Mpox. As such, an added potential benefit of our vaccines is that in those regions where Mpox or smallpox are of concern, vaccines built on an MVA vaccine platform will likely also provide offer the prospect of protection against Mpox and smallpox.

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Our initial preclinical studies in rodents and nonhuman primates for our MVA-VLP-EBOV GEO-EM01-Z vaccine candidate have shown significant levels of protection against lethal doses of EBOV. Recent studies in lethal challenge guinea pig models demonstrated that GeoVax vaccines MVA-VLP-SUDV GEO-EM01-S and MVA-VLP-MARV GEO-MM01 conferred 100% protection from death. These vaccines were subsequently evaluated in a rigorous cynomolgus macaque infectious challenge model. Vaccination protected nonhuman primates from viremia, weight loss and death following challenge with a dose of Sudan or Marburg virus that is lethal in nonvaccinated animals. Evaluation of immune responses following vaccination demonstrated presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. The nonhuman primate studies conducted in collaboration with NIAID and the U.S. Department of Defense (DoD) have been completed and potential clinical development programs are being considered.

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GEO-MM02 for Malaria Vaccine – Exploratory Research – According to recent data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite's life cycle. GeoVax's MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite's life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.

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Further development of our Hemorrhagic Fever, Zika, Malaria and HIV programs will be dependent upon additional funding support via federal grants, corporate collaborations, or other sources.

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GeoVax believes that its vaccine programs in Ebola, Sudan, Marburg, Lassa Fever, Malaria and Zika may each be eligible for a PRV and we intend to apply for a PRV at the appropriate time. There can be no assurance, however, that we will qualify or be approved for a PRV.

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The terms of the Gedeptin License, include (i) an upfront payment at closing, (ii) milestone payments due upon the achievement of selected development and regulatory events, and (iii) quarterly support payments for the lesser period of three years or the Company's filing for FDA approval of its Biologics License Application on the use of Gedeptin for the treatment of head and neck cancer in humans. The Company will also pay tiered percentage annual royalties in the low-to-mid teens on Net Sales (as defined in the Gedeptin License) of products covered under the Gedeptin License on a country-by-country and product-by-product basis, subject to specified reductions. The Company also issued a warrant to PNP, exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 6,667 6,668 shares of the Company's common stock at an exercise price of $195.00 per share. The Gedeptin License will remain in effect during the original term, which concludes upon FDA approval of a generic or biosimilar product, and then will automatically renew for 5-year additional terms, subject to customary termination rights.

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Harriet L. Robinson, PhD.

Olivera J. Finn, PhD

Distinguished Professor of Immunology and Surgery, University of Pittsburgh Barney S. Graham, MD, PhD Senior Investigator (retired), Vaccine Research Center, NIAID Teresa Lambe, PhD, OBE, FMedSCi.

Calleva Head of Vaccine Immunology, Oxford Vaccine Group, University of Oxford Stanley A. Plotkin, MD Professor Emeritus, University of Pennsylvania, Adjunct Professor, Johns Hopkins University Harriet L. Robinson, PhD.

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Stanley A. Plotkin, MD

Scott C. Weaver, PhD

Professor Emeritus, University of Pennsylvania, Adjunct Professor, Johns Hopkins University Barney S. Graham, MD, PhD Senior Investigator (retired), Vaccine Research Center, NIAID Scott C. Weaver, PhD Director, University of Texas Medical Branch Institute for Human Infections and Immunity Olivera J. Finn, PhD Distinguished Professor of Immunology and Surgery, University of Pittsburgh Properties Our principal executive offices are located in Smyrna, Georgia, where we lease approximately 8,400 square feet of office and laboratory space. Our lease for the premises is currently scheduled to terminate on December 31, 2025. We do not currently own any real property. We believe that our current facilities are adequate to meet our immediate needs, but that if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.

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We currently have seventeen fifteen full-time employees. None of our employees are covered by collective bargaining agreements and we believe that our employee relations are good. We also engage consultants and independent contractors to fulfill key roles and/or provide expert services on both an ongoing and short-term basis.

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MD&A 62 changes

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GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and solid tumor cancers using novel vector vaccine platforms. GeoVax's product pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancer. Additional research and development programs include preventive vaccines against Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), and Zika virus, and malaria, as well as immunotherapies for multiple solid tumors.

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GEO-CM04S1 – Immunocompromised/Cell Transplant Phase 2 Trial

GEO-CM04S1 – Healthy Booster Phase 2 Trial

GEO-CM04S1 is undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal COVID-19 booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. Patient enrollment was completed in September 2023.

GEO-CM04S1 – Immunocompromised/CLL Trial Phase 2 Trial

GEO-CM04S1 – Next Generation COVID-19 Vaccine:

On June 12, 2024, GeoVax was awarded a contract (the "BARDA Contract") through the Rapid Response Partnership Vehicle (RRPV) to advance the clinical development of GEO-CM04S1. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The original direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of approximately $343 million through its Clinical Studies Network to Allucent, a global clinical research organization, to execute the clinical trial as part of BARDA's Clinical Studies Network.

GEO-CM04S1 is currently undergoing a Phase 2 multi-site clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in high-risk immunocompromised patients (e.g. patients with blood cancers who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy). Data published from the open-label safety lead-in portion of the trial indicating indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including broad and durable neutralizing antibodies, antibody and T cell responses.

GEO-CM04S1 is also undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating two vaccine dose levels as a heterologous COVID-19 booster vaccine to current FDA-approved mRNA vaccines from Pfizer/BioNTech and Moderna. In February 2024, we announced positive interim safety and immune responses findings following vaccine administration. Consolidated data (blinded to vaccine dose) from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5.

GEO-CM04S1 is undergoing An investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 is evaluating its use as a COVID-19 booster vaccine booster in patients with chronic lymphocytic leukemia (CLL) compared to the Pfizer/BioNTech mRNA-based vaccine.

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Interim data presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference in July 2023, indicated that administration of Gedeptin® is safe and feasible, with observation of tumor growth impairment in a majority of the patients.

In January 2024, we announced closure of patient enrollment for this trial. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of 2024. Our intent is to discuss a follow-on protocol with the FDA for a Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal, in conjunction with a complete review of the results of the current trial. We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.

MVA-Based Vaccine Manufacturing Process Development

In March 2024, we announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for our MVA-based vaccines, with the release of the first lot of GEO-CM04S1 produced with a commercial manufacturing platform. This marked the successful completion of the transfer and scale-up of manufacturing to Oxford Biomedica, the Company's cGMP (current Good Manufacturing Procedures) manufacturing partner.

Intellectual Property Development

In January 2024, the U.S. Patent and Trademark Office issued Patent No. 11,857,611 to GeoVax, pursuant to patent application No. 17/726,254 titled "Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria". The allowed claims cover compositions comprising GeoVax's modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the allowed claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.

In February 2024, the U.S. Patent and Trademark Office issued Patent No. 11,896,657 to GeoVax, pursuant to patent application No. 17/584,231 titled "Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40)." The allowed claims generally cover GeoVax's vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.

In February 2024, the U.S Patent and Trademark Office issued Patent No. 11,897,919 to GeoVax, pursuant to patent application No. 17/409,574 titled "Multivalent HIV Vaccine Boost Compositions and Methods of Use." The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax's vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.

In February 2024, the Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company's Patent Application No. 2022-153352 titled " Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen ." The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax's MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims. This represents an extension of the GeoVax MVA-VLP platform that was originally developed for vaccines targeting infectious diseases.

Effective January 31, 2024, following approval by our stockholders at a special meeting held on January 16, 2024, we effected a reverse stock split of our common stock at a ratio of 1-for-15. The purpose of the reverse split was to regain compliance with the $1.00 minimum bid price required for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). On the effective date, every fifteen issued and outstanding shares of our common stock was converted automatically into one share of the Company's Common Stock without any change in the par value per share, and our publicly-traded warrants were adjusted to require fifteen warrants to be exercised to receive one share of common stock at a price of $75 per share.

Gedeptin® is undergoing recently completed a Phase 1/2 clinical trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC). This trial is being funded in part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The trial is designed to inform the design of a larger patient trial that also may involve patients with other anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.

We recently convened a special clinical advisory board to conduct a comprehensive review of the PNP-002 trial results, together with the previously completed Phase 1 trial (PNP-001). This review concluded that Gedeptin demonstrated an acceptable safety and efficacy profile to support continued development. In addition, the therapy has demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin therapy in an expanded Phase 2 clinical trial.

We have initiated activities in support of a Phase 2 trial in first-recurrence head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint. We have initiated the necessary planning activities, including protocol development, manufacturing and CRO selection, with the trial activation anticipated during the first half of 2025.

Our additional research programs for vaccines and immunotherapies at various stages of preclinical development.

On May 23, 2024, we received a notice from the Listing Qualifications Department of Nasdaq notifying the Company that it no longer complied with the $2,500,000 minimum stockholders' equity required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1) (the "Stockholders' Equity Requirement"), because the Company's stockholders' equity as reported in its Form 10-Q for the period ended March 31, 2024 did not meet the required minimum. On July 18, 2024, we received notice from Nasdaq granting our request for an extension of time to regain compliance with the Stockholders' Equity Requirement until November 19, 2024. We are currently reviewing potential transactions that, if implemented, could remedy the shortfall in our stockholders' equity. There can be no assurance, however, whether we will be able to remedy the non-compliance.

Our revenues to date have been related to government grants and contracts and other collaborative arrangements in support of our product development activities. We have not generated any revenues to date from the sale of the products we are developing. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization.

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process development expenses incurred internally and externally to improve the efficiency and yield of the bulk vaccine;

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Our general and administrative expenses consist primarily of personnel costs in our executive, finance and investor relations, business development and administrative functions, including stock-based compensation. Other general and administrative expenses include consulting fees, professional service fees for accounting and legal services, lease expenses related to our offices, insurance premiums, intellectual property costs incurred in connection with filing and prosecuting patent applications, depreciation and other costs. We expect our general and administrative expenses to continue to increase in the future as we support expanded research and development activities, prepare for potential commercialization of our current and future product candidates, maintain compliance with requirements of Nasdaq and the Securities and Exchange Commission, SEC, and other general corporate activities.

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The following table summarizes tables summarize our results of operations for the years ended December 31, 2023 and 2022 and for the three-month and six-month periods ended March 31, June 30, 2024 and 2023:

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Three Months Ended March 31, June 30,

Revenue from government contract

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Six Months Ended June 30,

Revenue from government contract

Research and development

General and administrative

Total operating expenses

Loss from operations

Revenue from Government Contract and Grants

There were no Government grant revenues during 2023 or during were $-0- and $81,526 for the three-month period years ended March December 31, 2024. 2023 and 2022, respectively. As of December 31, 2022, all grant funds available for use directly by GeoVax were expended.

During the three-month and six-month periods ending June 30, 2024, we reported $300,677 of revenues associated with the BARDA Contract. There were no revenues from government contracts reported during the comparable 2023 periods.

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Our research and development expenses were $4,425,728 for the three-month period ended March 31, 2024, as compared to $2,819,189 for the comparable 2023 period, representing an increase of $1,606,539 (57%). The increase during 2024 relates primarily to costs of manufacturing materials for use in our clinical trials and other related costs, personnel costs, and costs of preclinical research activities. Research and development expense for 2024 and 2023 includes stock-based compensation expense of $53,099 and $77,873, respectively, associated with employee stock options.

For the three-month and six-month periods ending June 30, 2024, research and development expenses decreased by $442,860 (9.4%) and increased by $1,163,679 (15.4%), respectively, versus the comparable 2023 periods. The overall increase during the six-month period of 2024 versus 2023 relates primarily to costs of manufacturing materials for use in our clinical trials of GEO-CM04S1 and Gedeptin and costs of various contracted research activities. Research and development expenses for the three-month and six-month periods of 2024 include stock-based compensation expense of $51,170 and $104,269, respectively; as compared to $76,770 and $154,643, respectively, for the comparable 2023 periods.

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Our general and administrative expenses were $1,457,353 for the three-month period ended March 31, 2024, as compared to $1,451,425 for the comparable 2023 period, representing an increase of $5,928 (0.4%). General and administrative expense for 2024 and 2023 includes stock-based compensation expense of $104,637 and $168,166, respectively, associated with employee and consultant stock options and stock awards.

Our general and administrative expenses were $6,022,173 for the year ended December 31, 2023, as compared to $4,983,611 for 2022, representing an increase of $1,035,562 (21%). The increase during 2023 relates primarily to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses. General and administrative expense expenses for 2023 and 2022 includes include stock-based compensation expense of $783,863 and $677,043, respectively, associated with employee and consultant stock options and stock awards.

For the three-month and six-month periods ending June 30, 2024, general and administrative expenses decreased by $373,063 (25.6%) and $367,135 (12.6%), respectively, versus the comparable 2023 periods. The overall decrease during the 2024 periods relates primarily to lower stock-based compensation expense, consulting costs, legal and patent costs and travel costs. General and administrative expense for the three-month and six-month periods of 2024 includes stock-based compensation expense of $50,471 and $155,107, respectively; as compared to $192,743 and $360,909, respectively, for the comparable periods of 2023.

Other Income (Expense)

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Interest income for the three-month periods ended March 31, 2024 and 2023 was $32,949 and $232,698, respectively. The decrease during 2024 is attributable to lower cash balances.

Interest income for the three-month and six-month periods ended June 30, 2024 was $5,471 and $38,420, respectively, as compared to $251,201 and $483,899, respectively, for comparable periods of 2023. The overall decrease during the 2024 periods is primarily attributable to cash available for investment. Interest expense for the three-month and six-month periods ended June 30, 2024 was $7,292, associated with certain notes payable issued during May 2024. There was no interest expense during the comparable periods of 2023.

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The following table summarizes our liquidity and capital resources as of March 31, June 30, 2024 and December 31, 2023 and 2022:

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The following tables summarize our cash flows for the years ended December 31, 2023 and 2022, and the three-month six-month periods ended March 31, June 30, 2024 and 2023:

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Three Months Ended March 31,

Six Months Ended June 30,

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Operating Activities – Net cash used in operating activities of $25,173,639 for the year ended December 31, 2023 was primarily due to our net loss of $25,966,762, offset by non-cash items such as depreciation and amortization expense and stock-based compensation expense, and by changes in our working capital accounts. Net cash used in operating activities of $19,030,208 for 2022 was primarily due to our net loss of $14,021,125, offset by non-cash items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts.

Net cash used in operating activities of $5,683,730 $7,624,778 for the three six months ended March 31, June 30, 2024, was primarily due to our net loss of $5,850,132, $10,914,174, offset by non-cash charges items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts. Net cash used in operating activities of $3,762,872 $9,800,016 for the three six months ended March 31, June 30, 2023, was primarily due to our net loss of $4,037,916, $9,965,536, offset by non-cash charges items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts.

Investing Activities – Net cash used in investing activities was $48,946 and $134,258 for the years ended December 31, 2023 and 2022, respectively, and relates to purchases of property and equipment. There were no cash flows from investing activities for the three-month periods ended March 31, 2024 and 2023.

Net cash used in investing activities was $-0- and $23,805 for the six-month periods ended June 30, 2024 and 2023, respectively, and relates primarily to purchases of laboratory equipment.

Financing Activities – Net cash provided by financing activities was $4,062,442 for the year ended December 31, 2023, consisting of net proceeds from the exercise of warrants. Net cash provided by financing activities was $35,353,328 for 2022, consisting of (i) aggregate net proceeds of $27,727,194 from offerings of our common stock and (ii) $7,626,134 of net proceeds from the exercise of warrants. There were no cash flows from financing activities for the three-month periods ended March 31, 2024 and 2023.

Net cash provided by financing activities was $2,733,901 and $-0- for the six-month periods ended June 30, 2024 and 2023, respectively. Net cash provided by financing activities for the 2024 period relates to net proceeds from issuance of notes payable, offerings of our common stock and warrants, and exercise of previously issued warrants.

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On May 10, 2024, we conducted a bridge financing through the issuance and sale of 10% Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $150,000 to members of our Board of Directors and senior management. The Notes are unsecured, bear interest at a rate of 15% per annum, and mature upon the earlier of (i) six months from the issue date or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $5 million.

On May 16, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which we agreed to sell, in the Registered Direct Offering, an aggregate of (i) 220,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 582,844 shares of common stock. In a concurrent private placement, we issued warrants to the investor to purchase up to 1,605,688 shares of common. The transaction closed on May 21, 2024 and net proceeds to us, after deducting placement agent fees and expenses and other offering expenses, was approximately $1,180,000.

On July 12, 2024, we closed an offering of our common stock and warrants. Net proceeds to us after deducting placement agent commissions and other offering expenses were approximately $2.8 million.

As of the date of this prospectus, our existing cash and cash equivalents were are insufficient to fund our operations significantly beyond the second third quarter of 2024 without additional funding, which we are actively pursuing. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources. We also continue to be in advanced discussions with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), for a potential award as part of Project NextGen, an initiative to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19. We are highly encouraged by the negotiations with BARDA thus far, but there is no assurance that such an award may be made.

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Management 1 change

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Mark J. Newman, Ph.D . Dr. Newman joined the Company as our Chief Scientific Officer on August 25, 2020 on a part-time basis, becoming a full-time employee effective March 1, 2022. Dr. Newman, who previously served the Company as vice president of research and development from 2010 to 2013, worked for the Company on a part-time basis until March 2022, at which time he became a full-time employee. Prior, he served senior management positions at PaxVax, Pharmexa A/S, Epimmune, Vaxcel, Apollon, and Cambridge Biotech. During his 30-year career he shepherded the development of experimental vaccine and adjuvant products through preclinical research and into Phase 1 & 2 clinical testing. He is widely published in peer review publications and holds 10 U.S. patents. He holds a dual B.Sc/M.Sc. degree in Agriculture and Pre-Veterinary Medicine from the Ohio State University and a his Ph.D. in Immunology at the John Curtin School for Medical Research, The Australian National University, Canberra.

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Certain relationships and related person transactions 4 changes

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On December 2, 2023, we entered into a common stock warrant exercise inducement offer letter (the "Inducement Letter") with the holder (the "Holder") of existing warrants to purchase shares of the Company's common stock at an exercise price of $48.90 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $24.75 per share issued on May 27, 2022 (together, the "Existing Warrants"), pursuant to which the Holder agreed to exercise for cash its Existing Warrants to purchase an aggregate of 704,499 shares of the Company's common stock, at a reduced exercised price of $6.21 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 1,408,998 shares of Common Stock with an exercise price of $6.21 per share, exercisable at any on or after six months from the date of issuance and will expire five and one-half (5 ½) years following the date of issuance. Effective May 16, 2024, the exercise price of the 2023 Common Warrant was reduced from $6.21 to $1.68 per share, resulting from the registered direct offering occurring on that date (see below). On June 27 and 28, 2024, we issued an aggregate of 826,998 shares of Common Stock upon the partial exercise of the 2023 Common Warrant.

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On May 16, 2024, the Company entered into a placement agency agreement (the "Placement Agency Agreement") with Roth Capital Partners, LLC (the "Roth") and the a Securities Purchase Agreement with a purchaser pursuant to which the Company agreed to sell, in the a registered direct offering an aggregate of (i) 220,000 shares of (the Company's "May 2024 Shares") of Common Stock and (ii) Pre-Funded Warrants (the "May 2024 Pre-Funded Warrants") to purchase up to an aggregate of 582,844 shares of Common Stock. ("Pre-Funded Warrant Shares"). In a concurrent private placement, the Company offered common stock purchase warrants (the "May 2024 Common Warrants") to the purchaser, with each warrant exercisable to purchase one share of Common Stock, with two May 2024 Common Warrants to accompany each May 2024 Share of Common Stock or May 2024 Pre-Funded Warrant sold in the offering, and to purchase in the aggregate up to 1,605,688 Common Warrant shares of Common Stock. The public offering price for each May 2024 Share was $1.68 and the public offering price for each May 2024 Pre-Funded Warrant was $1.67999. The May 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire five years from the date of issuance. The May 2024 Common Warrants have an exercise price of $1.68 per share, are immediately exercisable following stockholder approval and will expire five years from the date of issuance. The net proceeds of the offering, after deducting the Roth's fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the May 2024 Common Warrants, is approximately $1,180,000. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The offering closed on May 21, 2024. On June 18, 2024, we issued 582,844 shares of Common Stock upon the full exercise of the May 2024 Pre-Funded Warrants.

July 2024 Registered Direct Offering

On July 11, 2024, the Company entered into a placement agency agreement with Roth and the Purchase Agreement with a purchaser pursuant to which the Company agreed to sell, in the Registered Direct Offering (i) 458,632 shares of the Company's Common Stock, and (ii) Pre-Funded Warrants to purchase up to 626,368 shares of Common Stock ("Pre-Funded Warrant Shares"). In a concurrent private placement, the Company offered 2024 Common Warrants to the purchaser, with each warrant exercisable to purchase one share of Common Stock, with two 2024 Common Warrants to accompany each share of Common Stock or Pre-Funded Warrant sold in the offering, and to purchase up to 2,170,000 Common Warrant Shares. The public offering price for each Share was $2.86 and the public offering price for each Pre-Funded Warrant was $2.85999. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire five years from the date of issuance. The 2024 Common Warrants have an exercise price of $2.68 per share, are immediately exercisable following stockholder approval and will expire five years from the date of such stockholder approval. The net proceeds of the offering, after deducting Roth's fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the 2024 Common Warrants, is approximately $2,835,000. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The offering closed on July 12, 2024. On July 18 and 23, 2024, we issued 376,368 and 250,000 shares of Common Stock, respectively, upon the full exercise of the Pre-Funded Warrants.

Security ownership of principal stockholders, directors and officers 3 changes

Based solely upon information made available to us, the following table sets forth information with respect to the beneficial ownership of our common stock as of June 5, August 6, 2024 by (i) each principal stockholder, (ii) each director; (iii) each of the executive officers named in the summary compensation table; and (iv) all executive officers and directors as a group. Other than Armistice we do not know of any person who beneficially owns more than 5% of our common stock as of June 5, August 6, 2024. Except as otherwise indicated in footnotes to this table or, where applicable, to the extent authority is shared by spouses under community property laws, to our knowledge, the holders listed below have sole voting and investment power with respect to all shares of common stock beneficially owned by them.

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This table is based upon information supplied by officers and directors, and with respect to principal stockholders, any Schedules 13D and 13G filed with the SEC. Beneficial ownership is determined in accordance with the rules of the SEC. Applicable percentage ownership is based on 2,528,309 5,263,700 shares of Common Stock outstanding as of June 5, August 6, 2024. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of Common Stock subject to options or warrants currently exercisable, or exercisable within 60 days after June 5, August 6, 2024 (subject to specified limits), at any time at the option of the holder, are deemed outstanding.

These shares are directly held by Armistice and may be deemed to be indirectly beneficially owned by: (i) Armistice Capital, LLC ("Armistice Capital"), as the investment manager of Armistice; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice Capital and Steven Boyd disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein. The number of shares beneficially owned includes (i) 220,000 shares of common stock, (ii) 238,000 shares of common stock issuable upon the exercise of pre-funded warrants issued in December 2023, (iii) 1,408,998 582,000 shares of common stock issuable upon the exercise of common warrants issued in December 2023, (iv) 582,844 (ii) 1,605,688 shares of common stock issuable upon the exercise of pre-funded common warrants issued in May 2024, and (v) 1,605,688 (iii) 2,170,000 shares of common stock issuable upon the exercise of the 2024 Common Warrant, each of which are subject to beneficial ownership limitations that prohibit Armistice from exercising any portion of a warrant that would result in Armistice owning a percentage of our outstanding common stock exceeding the ownership limitations contained within each instrument (9.99% and 4.99%, respectively) after giving effect to the issuance of common stock in connection with Armistice's exercise. The percentage of shares owned assumes the exercise of all warrants held by Armistice, up to the beneficial ownership limitations described above. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.

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Selling stockholder 3 changes

The common stock being offered by the Selling Stockholder are those issuable to such Selling Stockholder, upon exercise of the 2024 Common Warrant, consisting of 1,605,688 2,170,000 shares of common stock. For additional information regarding the issuances issuance of those Warrants, see "Prospectus Summary–Recent Developments–Registered Direct Offering" above. We are registering the shares of common stock issuable upon exercise of the 2024 Common Warrant in order to permit the Selling Stockholder to offer the shares for resale from time to time. Except for as noted in this prospectus, the Selling Stockholder has had any material relationship with us within the past three years.

The table below lists the Selling Stockholder and other information regarding the beneficial ownership of the shares of common stock by such Selling Stockholder. The second column lists the number of shares of common stock beneficially owned by the Selling Stockholder as of June 5, August 6, 2024. The third column lists the shares of common stock being offered by this prospectus by the Selling Stockholder.

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The number of shares beneficially owned includes 1,605,688 2,170,000 shares of common stock issuable upon exercise of the 2024 Common Warrant. The warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the Selling Stockholder from exercising that portion of the warrants that would result in the Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares owned before and after this offering assumes the exercise of all warrants held by the Selling Stockholder, notwithstanding the existence of the beneficial ownership limitations described above.

Description of the securities 1 change

4 unchanged paragraphs

As of June 5, August 6, 2024, there were 2,528,309 5,263,700 shares of common stock outstanding and no shares of preferred stock outstanding. As of June 5, August 6, 2024, there are outstanding warrants to purchase 4,014,779 4,532,937 shares of common stock with a weighted average exercise price of $4.70 $5.22 per share. An additional 333,648 shares of common stock are reserved for issuance under our 2020 and 2023 Stock Incentive Plans, of which 133,648 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $28.39 per share.

27 unchanged paragraphs

Financial statements 38 changes

CONDENSED CONSOLIDATED BALANCE SHEETS

Cash and cash equivalents

Total current assets

Property and equipment, net

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Total current liabilities

Commitments (Note 4)

Stockholders' equity:

Common stock, $ .001 par value:

Authorized shares – 150,000,000 and 600,000,000 at March 31, 2024 and December 31, 2023, respectively Issued and outstanding shares – 2,308,309 and 1,977,152 at March 31, 2024 and December 31, 2023, respectively 2,308 1,977 Additional paid-in capital 110,265,884 110,125,146 Accumulated deficit ( 110,213,917 ) ( 104,363,785 ) Total stockholders' equity 54,275 5,763,338 Total liabilities and stockholders' equity $ 3,358,182 $ 9,283,219 See accompanying notes to condensed consolidated financial statements.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Three Months Ended March 31,

Research and development

General and administrative

Total operating expenses

Loss from operations

Net loss per common share

Weighted average shares outstanding

See accompanying notes to condensed consolidated financial statements.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ' EQUITY (Unaudited) Three Months Ended March 31, 2024 Total Common Stock Additional Accumulated Stockholders' Shares Amount Paid-in Capital Deficit Equity Balance at December 31, 2023 1,977,152 $ 1,977 $ 110,125,146 $ ( 104,363,785 ) $ 5,763,338 Issuance of common stock for services 6,703 37,493 - 37,500 Issuance of common stock upon warrant exercise 269,032 ( 269 ) - - Fractional share roundup following reverse split 55,422 ( 55 ) - - Stock option expense - - 103,569 - 103,569 Net loss for the three months ended March 31, 2024 - - - ( 5,850,132 ) ( 5,850,132 ) Balance at March 31, 2024 2,308,309 $ 2,308 $ 110,265,884 $ ( 110,213,917 ) $ 54,275 Three Months Ended March 31, 2023 Total Common Stock Additional Accumulated Stockholders' Shares Amount Paid-in Capital Deficit Equity Balance at December 31, 2022 1,755,664 $ 1,756 $ 104,995,301 $ ( 78,397,023 ) $ 26,600,034 Issuance of common stock for services 7,246 74,993 - 75,000 Stock option expense - - 228,039 - 228,039 Net loss for the three months ended March 31, 2023 - - - ( 4,037,916 ) ( 4,037,916 ) Balance at March 31, 2023 1,762,910 $ 1,763 $ 105,298,333 $ ( 82,434,939 ) $ 22,865,157 See accompanying notes to condensed consolidated financial statements.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Three Months Ended March 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation expense

Stock-based compensation expense

Changes in assets and liabilities:

Prepaid expenses and other current assets

Accounts payable, accrued expenses and other liabilities

Net cash used in operating activities

Cash flows from investing activities:

Cash flows from financing activities:

Net decrease in cash and cash equivalents

Cash and cash equivalents at beginning of period

Cash and cash equivalents at end of period

See accompanying notes to condensed consolidated financial statements.

Condensed Consolidated Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023 Condensed Consolidated Statements of Operations for the three-month and six-month periods ended June 30, 2024 and 2023 (unaudited) Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficiency) for the three-month and six-month periods ended June 30, 2024 and 2023 (unaudited) Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2024 and 2023 (unaudited)

Notes to the financial statements 32 changes

1 unchanged paragraph

The Company is focused on developing immunotherapies and vaccines against cancers and infectious diseases using novel vector vaccine platforms. GeoVax's product pipeline includes ongoing human clinical trials for a next-generation Covid-19 vaccine and a gene-directed therapy for advanced head and neck cancer. Additional preclinical research and development programs include preventive vaccines against Mpox (monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever), Zika virus, and malaria, as well as immunotherapies for solid tumors.

The Company is focused on developing human vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers using novel proprietary platforms. GeoVax's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which it was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In addition, the lead oncological clinical program is Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, which is currently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. Additional preclinical research and development programs include preventive vaccines against Mpox (formerly known as monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, and Marburg), and Zika virus, as well as immunotherapies for solid tumors.

1 unchanged paragraph

We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 those accounting policies that we consider significant in determining our results of operations and financial position. During the three six months ended March 31, June 30, 2024, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.

2 unchanged paragraphs

We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. Our existing cash resources are insufficient to continue our planned operations beyond the second third quarter of 2024 without additional funding, which we are actively pursuing. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company's ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company's planned operations, but that our plans do not fully alleviate the substantial doubt about the Company's ability to operate as a going concern.

1 unchanged paragraph

The accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock split described in Note 5. 6.

1 unchanged paragraph

During the three six months ended March 31, June 30, 2024, there have been no new accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements.

17 unchanged paragraphs

Accrued clinical trial costs

Accrued contract manufacturing costs

2 unchanged paragraphs

Notes Payable – Related Parties

On May 10, 2024, we issued 10 % Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $ 150,000 to members of our Board of Directors and senior management, in exchange for gross cash proceeds to us of $ 135,000 . The Notes are unsecured, bear interest at a rate of 15 % per annum, and mature upon the earlier of (i) six months from the issue date or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $ 5 million. We recorded a total debt discount of $ 15,000 upon the issuance of the Notes. Interest expense associated with the Notes was $ 7,292 for the three-month period ended June 30, 2024, consisting of $ 4,167 of debt discount amortization and $ 3,125 of accrued interest payable.

Operating Lease. We lease approximately 8,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2025. Rent expense for the three-month and six-month periods ended March 31, June 30, 2024 and 2023 was $ 46,764 and $ 93,528 , respectively, as compared to $ 45,414 and $ 90,828 , respectively, for the same periods of 2023. Future minimum lease payments total $ 140,292 93,528 in 2024, and $ 192,708 in 2025 although the lease may be terminated at any time by either party with one hundred eighty days written notice.

1 unchanged paragraph

Other Commitments . In the normal course of business, we enter into various contracts and purchase commitments including those with contract research organizations ("CROs") and for clinical trial services, contract manufacturing organizations ("CMOs") for clinical trials services and production of materials for use in our clinical trials, and other independent contractors or academic institutions for preclinical research activities and other services and products. Most contracts are generally cancellable, with notice, at the Company's option. Payments due upon cancellation may consist of payments for services provided or expenses incurred to date, or cancellation penalties depending on the time of cancellation.

2 unchanged paragraphs

On May 21, 2024, we closed a registered direct offering of 220,000 shares of common stock and pre-funded warrants to purchase an aggregate of 582,844 shares of common stock (the "May 2024 Pre-Funded Warrants"). In a concurrent private placement, we issued common warrants to the purchaser to purchase up to 1,605,688 shares of common stock at an exercise price of $ 1.68 per share (the "May 2024 Common Warrants"). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $ 1.2 million. As noted under " Warrant Exercises " below, the May 2024 Pre-Funded Warrants were exercised in full during June 2024.

During the first quarter of 2024, we issued 269,032 shares of our common stock upon the exercise of prefunded warrants issued in December 2023 (the "December 2023 Pre-Funded Warrants"). During June 2024, we issued 238,000 and 582,844 shares of our common stock upon the exercise of the December 2023 Pre-Funded Warrants and the May 2024 Pre-Funded Warrants, respectively; and 2,549 shares of our common stock upon the cashless exercise of 4,000 warrants issued in June 2020. Also during June 2024, we issued 826,998 shares of our common stock upon the exercise of common warrants issued in December 2023, with net cash proceeds to us of approximately $ 1.4 million.

Other Common Stock Transactions

During January 2024, we issued 6,703 shares of our common stock pursuant to a professional relations and consulting agreement and we issued 55,422 shares of our common stock for the roundup of fractional shares associated with the reverse stock split. In February and March 2024, we issued 133,032 and 136,000 shares of our common stock, respectively, pursuant to the exercise of prefunded warrants.

We have stock-based incentive plans (the "Plans") pursuant to which our Board of Directors may grant stock options and other stock-based awards to our employees, directors and consultants. During the three six months ended March 31, June 30, 2024, 961 stock options were cancelled and there were no new grants of stock options or other transactions related to the Plans. As of March 31, June 30, 2024, there are 133,648 stock options outstanding, with a weighted-average exercise price of $ 28.39 per share and a weighted-average remaining contractual term of 7.9 7.7 years. Including the outstanding stock options, a total of 333,648 shares of our common stock are reserved for future issuance pursuant to the Plans.

1 unchanged paragraph

We have issued stock purchase warrants in connection with past financing and licensing transactions. As described under "Common Stock Transactions" above, during the three months ended March 31, 2024, we issued 269,032 shares of our common stock pursuant to the exercise of prefunded warrants; there were no other transactions related to our stock purchase warrants. The table below summarizes information concerning warrants outstanding as of March 31, 2024.

Outstanding at March 31, 2024

The table below summarizes information concerning warrants outstanding as of June 30, 2024.

Outstanding at June 30, 2024

1 unchanged paragraph

On May 10, 2024, we conducted a bridge financing through the issuance and sale of 10 % Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $ 150,000 to members of our Board of Directors and senior management. The Notes are unsecured, bear interest at a rate of 15 % per annum, and mature upon the earlier of (i) six months from the issue date or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $ 5 million.

Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individuals individual to whom the awards are award is granted. Stock-based compensation expense related to stock option grants was $ 103,569 101,640 and $ 228,039 205,209 during the three-month and six-month periods ended March 31, June 30, 2024, and 2023, respectively, as compared to $ 226,013 and $ 454,052 , respectively, during the same periods of 2023. As of March 31, June 30, 2024, there is $ 451,023 342,156 of unrecognized compensation expense that we expect to recognize over a weighted-average period of 1.3 1.1 years.

We have also issued shares of our restricted common stock to consultants and recognize the related expense over the terms of the related agreements. During the three-month and six-month periods ended March 31, June 30, 2024 and 2023 we recorded stock-based compensation expense of $- 54,167 0 - and $ 18,000 54,167 , respectively, associated with common stock issued for consulting services, as compared to $ 43,500 and $ 61,500 , respectively, for the same periods of 2023.

Revenue from Government Contract

On June 12, 2024, GeoVax was awarded a contract (the "BARDA Contract") through the Rapid Response Partnership Vehicle (RRPV) to advance the clinical development of GEO-CM04S1, the Company's next-generation COVID-19 vaccine. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Under the BARDA Contract, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The direct award to GeoVax of approximately $ 24.3 million, which may increase to as much as $ 45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of approximately $ 343 million through its Clinical Studies Network to support execution of the study by Allucent, a global clinical research organization.

GeoVax's role in the project is being funded in whole or in part with federal funds from BARDA under Other Transaction 75A50123D00005. Allucent's role in the project is being funded in whole or in part with federal funds from BARDA under contract 75A50120D00016/75A50123F33005.

During the three-month and six-month periods ending June 30, 2024, GeoVax recognized revenue of $ 300,677 associated with the BARDA contract. We record revenue associated with this contract as the reimbursable costs are incurred.

Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company's potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 1,721,895 2,496,585 and 1,029,529 1,027,084 shares at March 31, June 30, 2024 and 2023, respectively.

No provision for income taxes was recorded in either of the three-month six-month periods ended March 31, June 30, 2024 and 2023. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of March 31, June 30, 2024.

July 2024 Offering. On July 12, 2024, we closed a registered direct offering of 458,632 shares of common stock and pre-funded warrants to purchase an aggregate of 626,368 shares of common stock (the "July 2024 Pre-Funded Warrants"). In a concurrent private placement, we issued common warrants to the purchaser to purchase up to 2,170,000 shares of common stock at an exercise price of $ 2.86 per share (the "July 2024 Common Warrants"). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $ 2.8 million. On July 18 and 23, 2024, we issued an aggregate of 626,368 shares of common stock upon full exercise of the July 2024 Pre-Funded Warrants.

70 unchanged paragraphs

Note 5: Stockholders ' Equity 1 change

61 unchanged paragraphs

1,605,688 2,170,000 Shares of Common Stock

1 unchanged paragraph

Exhibits 13 changes

1 unchanged paragraph

Form of Stock Certificate representing the Company' ' s Common Stock, par value $0.001 per share (24) 4.2 Form of Common Stock Purchase Warrant, dated September 29, 2020 (11) 4.3 Form of Warrant Agent Agreement (10) 4.4 Form of Warrant issued to certain Management Creditors, dated September 29, 2020 (10) 4.5 Form of Common Stock Purchase Warrant, dated June 26, 2020 (9) 4.6 Form of Underwriters Warrant Agreement dated February 11, 2021 (14) 4.7 Form of Common Stock Purchase Warrant, dated September 28, 2021 (16) 4.8 Common Stock Purchase Warrant, dated December 2, 2023 (23) 4.9 Form of Pre-Funded Warrant, dated May 21, 2024 (26) 4.10 Form of Common Warrant, dated May 21, 2024 (26) 4.11 Form of Pre-Funded Warrant, dated July 12, 2024 (28) 4.12 Form of Common Warrant, dated July 12, 2024 (28) 5.1* Opinion of Womble Bond Dickinson (US) LLP 10.1** Employment Agreement between GeoVax Labs, Inc. and David A. Dodd (5) 10.2** Employment Agreement between GeoVax, Inc. and Mark W. Reynolds (3) 10.2.1** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Mark W. Reynolds (4) 10.3** Employment Agreement between GeoVax, Inc. and Mark J. Newman, PhD, as Amended and Restated March 9, 2022 (18) 10.3.1** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Mark J. Newman, PhD (19) 10.4** Employment Agreement between GeoVax, Inc. and Kelly T. McKee, MD (21) 10.4.1** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Kelly T. McKee, MD (21) 10.5** Employment Agreement between GeoVax, Inc. and John W. Sharkey, PhD (19) 10.5.1** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and John W. Sharkey, PhD (19) 10.6** GeoVax Labs, Inc. 2020 Stock Incentive Plan, as amended and restated August 11, 2021 (8) 10.6.1** Form of Non-Qualified Stock Option Agreement (2020 Stock Incentive Plan) (15) 10.6.2** GeoVax Labs, Inc. 2023 Stock Incentive Plan (20) 10.7 License Agreement (as amended and restated) between GeoVax, Inc. and Emory University (2) 10.8 Patent and Biological Materials License Agreement with the National Institute of Allergy and Infectious Diseases, dated October 22, 2020 (12) *** 10.9 Patent and Biological Materials License Agreement for Internal Research Use with the National Institute of Allergy and Infectious Diseases, dated November 25, 2020 (13) *** 10.10 Office and Laboratory Lease between UCB, Inc. and GeoVax, Inc. (7) 10.10.1 Amendment to Office Lease Agreement between UCB, Inc. and GeoVax, Inc. (21) 10.11 Summary of the GeoVax Labs, Inc. Director Compensation Plan (18) 10.12 Assignment and License Agreement by and between GeoVax, Inc. and PNP Therapeutics, Inc. dated September 28, 2021 (16) *** 10.13 Exclusive License Agreement by and between GeoVax, Inc. and City of Hope, dated November 9, 2021 (17) *** 10.13.1 Amendment to Exclusive License Agreement, dated April 11, 2023, between GeoVax, Inc. and City of Hope (22) *** 10.14 Inducement Letter, dated December 2, 2023 (23) 10.15 Securities Purchase Agreement, dated May 16, 2024 (26) 10.15 Securities Purchase Agreement, dated July 11, 2024 (28) 10.16 RRPV Base Agreement No. 2024-564, dated April 2, 2024, by and between GeoVax, Inc. and Advanced Technology International (29) 10.17 RRPV Project Award No. 001, dated June 12, 2024, by and between Advanced Technology International (RRPV Consortium Management Firm) and GeoVax, Inc. (29) 21.1 Subsidiaries of the Registrant (6) 23.1* Consent of Wipfli LLP (U.S. PCAOB Auditor Firm ID 344) 23.2* Consent of Womble Bond Dickinson (US) LLP (included in Exhibit 5.1) 107* Filing Fee Table II-4 101.INS Inline XBRL Instance Document (1) 101.SCH Inline XBRL Taxonomy Extension Schema Document (1) 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document (1) 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document (1) 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document (1) 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document (1) II-4 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) 107* Filing Fee Table ___________________ * Filed herewith.

1 unchanged paragraph

Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as the Company has determined (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the Company if publicly disclosed.

11 unchanged paragraphs

Incorporated by reference from the registrant's Current Report on Form 8-K filed October 26, 2020. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as the Company has determined (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the Company if publicly disclosed.

Incorporated by reference from the registrant's Current Report on Form 8-K filed November 30, 2020. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as the Company has determined (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the Company if publicly disclosed.

Incorporated by reference from the registrant's Current Report on Form 8-K filed October 26, 2020.

Incorporated by reference from the registrant's Current Report on Form 8-K filed November 30, 2020.

2 unchanged paragraphs

Incorporated by reference from the registrant's Current Report on Form 8-K filed September 29, 2021. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and (ii) the Company customarily and actually treats the omitted information as private or confidential.

Incorporated by reference from the registrant's Current Report on Form 8-K filed November 10, 2021. Pursuant to 399 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and (ii) the Company customarily and actually treats the omitted information as private or confidential.

Incorporated by reference from the registrant's Current Report on Form 8-K filed September 29, 2021.

Incorporated by reference from the registrant's Current Report on Form 8-K filed November 10, 2021.

4 unchanged paragraphs

Incorporated by reference from the registrant's Quarterly Report on Form 10-Q filed May 4, 2023. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and (ii) the Company customarily and actually treats the omitted information as private or confidential.

Incorporated by reference from the registrant's Quarterly Report on Form 10-Q filed May 4, 2023.

5 unchanged paragraphs

Incorporated by reference from the registrant's Current Report on Form 8-K filed July 12, 2024 (29) Incorporated by reference from the registrant's Quarterly Report on Form 10-Q filed August 6, 2024.

Undertakings 1 change

16 unchanged paragraphs

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Smyrna, State of Georgia, on June 7, August 6, 2024.

12 unchanged paragraphs