GeoVax Labs: securities offering

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As filed with the Securities and Exchange Commission on June 14, 2022 January 2 , 2024

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CALCULATION OF REGISTRATION FEE

Title of Each Class of

Security Being Registered

Proposed Maximum Offering

Price per Security(2)

Common Stock, $0.001 par value per share (3)

(1) This registration statement also includes an indeterminate number of securities that may become offered, issuable or sold to prevent dilution resulting from stock splits, stock dividends and similar transactions, which are included pursuant to Rule 416 under the Securities Act of 1933, as amended.

(2) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c) promulgated under the Securities Act of 1933, as amended, based upon the average of the high and low prices of the common stock as reported on the Nasdaq Capital Market on June 10, 2022.

(3) Consists of (i) 9,090,910 shares of common stock issuable upon the exercise of pre-funded warrants issued in a private placement in May 2022 (the "Private Placement"), (ii) 12,121,214 shares of common stock issuable upon the exercise of preferred investment options issued in the Private Placement at an exercise price of $1.65 per share, (iii) 128,000 shares of common stock issuable upon the exercise of a warrant issued in a public offering in September 2020 at an exercise price of $5.50 per share and (iv) 72,000 shares of common stock issuable upon the exercise of a warrant issued in a public offering in February 2021 at an exercise price of $6.875 per share.

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SUBJECT TO COMPLETION, DATED June 14, 2022 JANUARY 2 , 2024

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This prospectus relates to the resale of up to an aggregate of 21,412,124 shares (the "Common Shares") of our common stock, par value $0.001 per share (the "Common Stock"), consisting of (i) 9,090,910 shares of Common Stock issuable upon the exercise of pre-funded warrants issued in the Private Placement (the "Pre-Funded Warrant"), (ii) 12,121,214 shares of Common Stock issuable upon the exercise of preferred investment options issued in the Private Placement at an exercise price of $1.65 per share (the "Preferred Investment Option"), (iii) 128,000 shares of Common Stock issuable upon the exercise of a warrant issued in a public offering in September 2020 at an exercise price of $5.50 per share (the "2020 Common Warrant") and (iv) 72,000 shares of Common Stock issuable upon the exercise of a warrant issued in a public offering in February 2021 at an exercise price of $6.875 per share (the "2021 Common Warrant" and together with the Pre-Funded Warrant, the Preferred Investment Option and the 2020 Common Warrant, the "Warrants" and, collectively with the Pre-Funded Warrant and Common Shares, the "Securities"). This prospectus relates to the resale of up to an aggregate of 21,212,124 Common Shares issuable upon the exercise of the Pre-Funded Warrant and the Preferred Investment Option by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company ("Armistice"), 128,000 Common Shares issuable upon the exercise of the 2020 Common Warrant by Maxim Partners LLC ("Maxim Partners" and together with Armistice, the "Selling Stockholders") and 72,000 Common Shares issuable upon the exercise of the 2021 Common Warrant by Maxim Partners.

21,412,124 21,134,968 Shares of Common Stock

This prospectus relates to the resale of up to an aggregate of 21,134,968 shares (the "2023 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 "2023 Common Warrant") issued in a private placement on December 2, 2023 by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company ("Armistice").

We will not receive any proceeds from the sale of the Common 2023 Warrant Shares covered by this prospectus by the Selling Stockholders. Stockholder. All net proceeds from the sale of the Common 2023 Warrant Shares covered by this prospectus will go to the Selling Stockholders. Stockholder. However, we may will receive the proceeds from any cash exercise of each of the Preferred Investment Option, the 2020 Common Warrant or the 2021 2023 Common Warrant. See "Use of Proceeds."

The Selling Stockholders Stockholder may sell all or a portion of the Common 2023 Warrant Shares stock covered by this prospectus from time to time in market transactions through any market on which our shares of common stock are then traded, in negotiated transactions or otherwise, and at prices and on terms that will be determined by the then prevailing market price or at negotiated prices directly or through a broker or brokers, who may act as agent or as principal or by a combination of such methods of sale. See "Plan of Distribution."

Our common stock and the warrants we issued to investors in a September 2020 public offering (the "September 2020 Warrants") are is listed on the Nasdaq Capital Market under the symbols "GOVX". and "GOVXW," respectively. On June 10, 2022, December 29, 2023, the last reported sale price of our common stock was $1.42 $0.36 per share. and the last reported sale price of the September 2020 Warrants was $0.56 per warrant.

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 6 7 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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The date of this prospectus is , 2022. 2024.

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SELLING STOCKHOLDERS

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About this prospectus 2 changes

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Neither we nor the Selling Stockholders Stockholder have authorized anyone to provide you with information different from that contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus prepared by us or on our behalf. Neither we nor the Selling Stockholders Stockholder take any responsibility for, or can provide any assurance as to the reliability of, any information other than the information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus prepared by us or on our behalf. We and the Selling Stockholders Stockholder are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are permitted. You should assume that the information appearing in this prospectus or in any free writing prospectus prepared by us is accurate only as of their respective dates or on the date or dates which are specified in such documents. Our business, financial condition, results of operations and prospects may have changed since those dates.

Neither we nor the Selling Stockholders Stockholder are offering to sell or seeking offers to purchase these securities in any jurisdiction where the offer or sale is not permitted. We have not done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities as to distribution of the prospectus outside of the United States.

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Prospectus summary 56 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 cancer solid tumor cancers using novel proprietary platforms. GeoVax's product pipeline includes ongoing human clinical trials in for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancer. cancers. Additional research and development programs include preventive vaccines against Zika Virus, Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan Marburg, and Lassa) Marburg) Zika virus, and malaria, as well as immunotherapies for multiple solid tumors. Our The Company's portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 70 115 granted or pending patent applications spread over 20 24 patent families, which are discussed in greater detail in the "Our Intellectual Property" section.

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We are currently developing a number of vaccines and immunotherapies for prevention or treatment of infectious diseases and cancers. The table below summarizes the status of our product development programs, which are discussed in greater detail under in the heading "Business" below. following pages.

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COVID-19 (Booster to mRNA vaccines)

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Preclinical/IND-Enabling

Cancer Immunotherapy

COVID-19 (Booster for Chronic Lymphocytic Leukemia patients)

Clinical – Phase 2 (Investigator Initiated Trial)

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Ebola, Marburg, Sudan**

Hemorrhagic Fever Viruses

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Preclinical/IND-Enabling

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Our pan coronavirus vaccine (GEO-CM02) has shown promising results in preclinical studies to date and with additional studies planned for 2022 to prepare for IND (Investigational New Drug) filing and subsequent human clinical trials.

Our additional research programs for treatment of solid tumors, and vaccines against Zika virus, malaria and hemorrhagic fever viruses are at various stages of preclinical development.

Our corporate strategy is to advance, protect and exploit our differentiated vaccine/immunotherapy technologies leading to the successful development of preventive and therapeutic vaccines and immunotherapies against infectious diseases and various cancers. Our goal is to advance products through to human clinical testing, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.

We have not generated any revenues from the sale of the products we are developing, and we do not expect to generate any such revenues for at least the next several years. 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. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.

On May 25, 2022, we entered into a Securities Purchase Agreement (the "PIPE Securities Purchase Agreement") with Armistice providing for the issuance and sale to Armistice in a private placement offering of 9,090,910 shares of our common stock issuable upon exercise of a pre-funded warrant and a preferred investment option to purchase up to 9,090,910 shares of common stock. Concurrently with the entrance into the PIPE Securities Purchase Agreement, we entered into another Securities Purchase Agreement (the "RD Securities Purchase Agreement") with the Armistice providing for the issuance and sale to Armistice in a registered direct offering of 1,050,000 shares of our common stock, a pre-funded warrant to purchase up to 1,980,304 shares of our common stock and a preferred investment option to purchase up to 3,030,304 shares of common stock. Aggregate gross proceeds from the private placement and registered direct offerings to the Company were approximately $20.0 million.

Our programs are in various stages of development, the most significant of which are summarized below along with recent developments:

GEO-CM04S1 – Immunocompromised Trial

GEO-CM04S1 is currently undergoing a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy, as a preventive COVID-19 vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in blood cancer high-risk immunocompromised patients (e.g. patients who have previously received a bone marrow either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor therapy (CAR) T cell therapy).

In September 2023, the journal, Vaccines, published data from the open-label safety portion of the trial indicating that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including neutralizing antibodies, and T cell responses.

In September 2023, preclinical vaccine efficacy data for GEO-CM02 were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, demonstrating that our multi-antigen SARS-CoV-2 vaccine, GEO-CM02, induced efficacious immune responses against the original Wuhan strain and BA.1 Omicron variant with a single dose. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines such as GEO-CM04S1, which are designed to induce both antibodies and T-cells to multiple viral structural proteins, can address the issue of viral variation and escape from the immune system.

In October 2023, we announced commencement of the planned site expansion for this trial to accelerate patient enrollment. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial is now open to eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and the Fred Hutchinson Cancer Center (Seattle, Washington).

GEO-CM04S1 – Healthy Booster Trial

In December 2021, patient enrollment began for GEO-CM04S1 is undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), of GEO-CM04S1, evaluating its use as a universal COVID-19 booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna.

In September 2023, we announced the completion of patient enrollment for this trial.

GEO-CM04S1 – CLL Trial

In July 2023, an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 began, evaluating its use as a COVID-19 booster vaccine in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine.

Gedeptin ® – Advanced Head and Neck Cancer Trial

Gedeptin® is currently undergoing a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck cancer, which squamous cell carcinoma (HNSCC). This trial is being conducted with funding support from 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.

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

Advanced Vaccine Manufacturing Process Development

In September 2023, GeoVax and ProBioGen AG announced the signing of a commercial license agreement for ProBioGen's AGE1.CR.pIX® suspension cell line. The agreement enhances our manufacturing capabilities for our entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio. This follows the May 2023 execution of a Master Services Agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of our vaccine candidates through late-stage development toward eventual commercialization. These agreements move the Company toward implementing a continuous cell line manufacturing system to provide lower-cost, scalable versatility for our entire MVA-based vaccine portfolio.

Intellectual Property Development

In October 2023, the U.S. Patent and Trademark Office issued a Notice of Allowance to GeoVax for 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 October 2023, the U.S Patent and Trademark Office issued a Notice of Allowance to GeoVax for 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 August 2023, the U.S. Patent and Trademark Office issued a Notice of Allowance to GeoVax for 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 July 2023, the U.S. Patent and Trademark Office issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company's patent application No. 15/543,139 titled "Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40), covering GeoVax's vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus.

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 $3.26 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $1.65 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 10,567,484 shares of the Company's common stock, at a reduced exercised price of $0.414 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 21,134,968 Common Shares with an exercise price of $0.414 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.

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We have received a going concern opinion from our auditors.

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We face intense competition and rapid technological change that could result in products that are superior to, or earlier to the market than, the products we will be commercializing or developing.

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Our success depends on our ability to obtain, maintain, protect and enforce our intellectual property and our proprietary technologies.

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Any inability to protect our or our licensors' intellectual property rights in the United States and foreign countries could limit our ability to manufacture prevent others from manufacturing or sell selling our products.

Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

The patent protection and patent prosecution for our product candidates is dependent in part on third parties.

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We may be delisted from the Nasdaq Stock Market.

A portion of the 2023 Common Stock Purchase Warrant is not exercisable until stockholder approval and may have limited value.

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21,412,124 shares of Common Stock by the Selling Stockholders, consisting of 9,090,910 shares of Common Stock issuable upon the exercise of the Pre-Funded Warrant, 12,121,214 shares of Common Stock issuable upon the exercise of the Preferred Investment Option, 128,000 shares of Common Stock issuable upon the exercise of the 2020 Common Warrant and 72,000 shares of Common Stock issuable upon the exercise of the 2021 Common Warrant.

9,090,910 shares of common stock issuable upon the exercise of the Private Pre-Funded Warrants with exercise prices of $0.0001 per share;

12,121,214 shares of common stock issuable upon the exercise of the Preferred Investment Options with exercise prices of $1.65 per share;

5,884,115 shares of common stock issuable upon the exercise of other outstanding warrants with a weighted average exercise price of $4.19 per share; and ● 1,500,000 shares of common stock which are reserved for issuance under our 2020 Stock Incentive Plan, of which 962,300 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $3.18 per share.

21,134,968 shares of Common Stock by the Selling Stockholder, consisting entirely of shares of Common Stock issuable upon the exercise of the 2023 Common Warrant.

Shares of common stock outstanding prior to this offering

12,547,829 29,657,287 shares of Common Stock.

We will not receive any proceeds from the sale of the shares of common stock by the Selling Stockholders. Stockholder. All net proceeds from the sale of the shares of common stock covered by this prospectus will go to the Selling Stockholders. Stockholder. However, we may will receive the proceeds from any cash exercise of each of the Preferred Investment Option, the 2020 Common Warrant and the 2021 2023 Common Warrant. See "Use of Proceeds."

Our common stock and the warrants we issued to investors in a September 2020 public offering (the "September 2020 Warrants") are is listed on the Nasdaq Capital Market under the symbols "GOVX". and "GOVXW," respectively.

Investment in our common stock involves a high degree of risk and could result in a loss of your entire investment. Before investing in our common stock, you should carefully read and consider the "Risk Factors" beginning on page 6 7 of this prospectus.

Unless otherwise indicated, the number of shares of our common stock outstanding prior to this offering is based on 12,547,829 29,657,287 shares of Common Stock outstanding as of June 10, 2022, and exclude as of such date: December 31, 2023.

Risk factors 43 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 $18.6 million, $3.0 million, $2.4 million, and $1.6 approximately $14 million for the years year ended December 31, 2021 and 2020 2022 and of approximately $18.4 million for the three nine months ended March 31, 2022 and 2021, respectively. September 30, 2023. 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.

We have received a going concern opinion from our auditors.

We have received a "going concern" opinion from our independent registered public accounting firm, reflecting substantial doubt about our ability to continue as a going concern. Our consolidated financial statements contemplate that we will continue as a going concern and do not contain any adjustments that might result if we were unable to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise additional capital and implement our business plan. If we are unable to achieve or sustain profitability or to secure additional financing on acceptable terms, we may not be able to meet our obligations as they come due, raising substantial doubts as to our ability to continue as a going concern. Any such inability to continue as a going concern may result in our stockholders losing their entire investment. There is no guarantee that we will become profitable or secure additional financing on acceptable terms.

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We expect that our current working capital will be sufficient to support our planned level of operations into early through the first quarter of 2024. We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations. In order to meet our operating cash flow needs we plan to seek sources of non-dilutive capital through government grant programs and clinical trial support. We may also plan additional offerings of our equity securities, debt, or convertible debt instruments. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects.

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In response to the COVID-19 pandemic, we have curtailed non-essential travel for our employees and are canceling or postponing in-person attendance at industry events. Currently, as a result of the work and travel restrictions related to the ongoing pandemic, several of our business activities are being conducted remotely which might be less effective than in-person meetings or in-office work. Despite these precautions, the necessary work within our laboratory and of our collaborators has continued without significant interruption. Although we continue to monitor the situation and may adjust our current policies as more information and guidance become available, temporarily suspending travel and limitations on doing business in-person has and could continue to negatively impact our business development efforts and create operational or other challenges, any of which could harm our business, financial condition and results of operations.

In addition, the COVID-19 pandemic could disrupt our operations due to absenteeism by infected or ill members of management or other employees because of our limited staffing. COVID-19 related illness could also impact members of our Board of Directors resulting in absenteeism from meetings of the directors or committees of directors, and making it more difficult to convene the quorums of the full Board of Directors or its committees needed to conduct meetings for the management of our affairs.

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We face intense competition and rapid technological change that could result in products that are superior to, or earlier to the market than, the products we will be commercializing or developing.

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The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "Affordable Care Act"), substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Affordable Care Act includes a number of provisions that are intended to lower healthcare costs, including provisions relating to prescription drug prices and government spending on medical products.

Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts by the former Trump administration to repeal or replace certain aspects of the statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our business. It is uncertain the extent to which any such changes may impact our business or financial condition.

There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products. There have been several Congressional inquiries and proposed bills, as well as state efforts, designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. In June 2017, the FDA issued a Drug Competition Action plan intended to lower prescription drug prices by encouraging competition from generic versions of existing products. In July 2018, the FDA issued a Biosimilar Action Plan, intended to similarly promote competition to prescription biologics from biosimilars. In August 2020, the Inflation Reduction Act included provisions to increase Medicare's ability to negotiate prescription drug prices.

Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. For example, in September 2017, the California State Assembly approved SB17, which requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before any scheduled increases in the prices of their products if they exceed 16% over a two-year period, and further requiring pharmaceutical companies to explain the reasons for such increase and, effective in 2016, Vermont passed a law requiring certain manufacturers identified by the state to justify their price increases.

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reimbursement coverage from Medicare, Medicaid, insurance companies and others;

the price and cost-effectiveness of our products, especially as compared to any competitive products; and the ability to maintain patent protection; and the market demand is not readily known.

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Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies.

In general, our commercial success will depend in part on our and our licensors' ability to obtain, maintain, protect, and enforce our intellectual property and proprietary technologies, including patent protection and trade secret protection for our product candidates, proprietary technologies and their uses as well as our ability to operate without infringing, misappropriating, or otherwise violating the intellectual property rights of others. If we or our licensors are unable to obtain, maintain, protect, or enforce our intellectual property rights or if our intellectual property rights are inadequate for our technology or our product candidates, our competitive position could be harmed, which could have a material adverse impact on our business, results of operations, financial conditions, and prospects. There can be no assurance that our patent applications will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technologies, nor can there be any assurance that the patents if issued will not be infringed, misappropriated, violated, designed around or invalidated by third parties. Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for our intellectual property is uncertain. Only limited protection may be available and may not adequately obtain, maintain, protect, and enforce our rights or permit us to gain or keep any competitive advantage. These uncertainties and/or limitations in our ability to properly obtain, maintain, protect, and enforce the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.

We cannot be certain that the claims in our in-licensed pending patent applications will be considered patentable by the U.S. Patent and Trademark Office, or USPTO, courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that claims that may ultimately issue from our patent applications will not be found invalid or unenforceable if challenged. If we or our licensors are unable to obtain or maintain patent protection with respect to our product candidates, our business, financial condition, results of operations, and prospects could be materially harmed.

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Future or existing patents issued to third parties may contain patent claims that conflict with those of our products. We expect to be subject to infringement claims from time to time in the ordinary course of business, and third parties could assert infringement claims against us in the future with respect to our current products or with respect to products that we may develop or license. Litigation or interference proceedings could force us to:

Our success will depend in part on our ability to operate without infringing the patents and proprietary rights of third parties. The manufacture, use and sale of new biologic products have been subject to substantial patent rights litigation in the pharmaceutical biopharmaceutical industry. These Such lawsuits generally often relate to the validity and or infringement of patents or other proprietary rights of third parties. Infringement litigation is prevalent with respect to generic versions of products for which the patent covering the brand name product is expiring, particularly since many companies that market generic products focus their development efforts on products with expiring patents. Pharmaceutical companies, biotechnology companies, universities, research institutions or other third parties may have filed patent applications or may have been granted patents that cover aspects of our products or our licensors' products, product candidates or other technologies.

Future or existing patents issued to third parties may contain patent claims that cover our products or their use or manufacture. In particular, the patent landscape in the COVID-19 vaccine space is crowded, and a large number of patent applications have been filed by numerous entities since January 2020, including for the use of certain SARS-CoV-2 antigens and antigenic combinations, including from Moderna, Janssen Pharmaceuticals, Inc., Sementis LTD., VaxBio, Inc., Oxford University, BioNTech, Ichan School of Medicine at Mount Sinai, Diosynvax LTD., The University of Alberta, University of Texas, and Tonix Pharmaceuticals. If a third party were to assert an infringement claim against us in the future with respect to our current products or with respect to products that we may develop or license, such litigation or interference proceedings could force us to:

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Any litigation or interference proceedings, regardless of their outcome, would likely may delay the regulatory approval process, be costly and require significant time and attention of our key management and technical personnel.

Any inability to protect our or our licensors ' intellectual property rights in the United States and foreign countries could limit our ability to manufacture prevent others from manufacturing or sell selling our products.

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Some of our patent families and our in-licensed patent families are in an early stage of prosecution and cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents are issued from such applications, and then only to the extent the issued claims cover the third-party technology. There can be no assurance that our patent applications will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technologies. There can be no assurance that the patents if issued will not be infringed, misappropriated, violated, designed around or invalidated by third parties. Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for our intellectual property is uncertain. Only limited protection may be available and may not adequately obtain, maintain, protect, and enforce our rights or permit us to gain or keep any competitive advantage. These uncertainties and/or limitations in our ability to properly obtain, maintain, protect, and enforce the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.

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Neither the U.S. Patent and Trademark Office nor the courts have established a consistent policy regarding the breadth of claims allowed in pharmaceutical patents. The allowance of broader claims may increase the incidence and cost of patent interference proceedings and the risk of infringement litigation. On the other hand, the allowance of narrower claims may limit the value of our proprietary rights.

Furthermore, even if our or our licensors' patent applications are granted, the patent term may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates have been or are obtained, once the patent life has expired, we may be open to competition from competitive products. Given the amount of time required for the development, testing, and regulatory review of product candidates, patents protecting our product candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.

Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing biotechnology patents is costly, time-consuming, and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us.

For example, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed into law on September 16, 2011, includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Further, because of a lower evidentiary standard in these USPTO post-grant proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Thus, the Leahy-Smith Act and its implementation can increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects. After March 2013, under the Leahy-Smith Act, the United States transitioned to a first inventor to file system in which, assuming that the other statutory requirements are met, the first inventor to file a patent application is entitled to the patent on an invention regardless of whether a third-party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before we file an application covering the same invention, could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Because patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product candidates and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our or our licensor's patents or patent applications. Even where we have a valid and enforceable patent, we may not be able to exclude others from practicing the claimed invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory license. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. Recent United States Supreme Court and Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. For example, recent Federal Circuit rulings such as Ariad Pharms., Inc. v. Eli Lilly & Co ., 598 F.3d 1336, 1340 (Fed. Cir. 2010) (en banc), Wyeth & Cordis Corp. v. Abbott Labs , 720 F.3d 1380 (Fed. Cir. 2013), Enzo Life Scis., Inc. v. Roche Molecular Sys., 928 F.3d 1340 (Fed. Cir. 2019), and Idenix Pharms. LLC v. Gilead Scis. Inc ., 941 F.3d 1149 (Fed. Cir. 2019), and Amgen Inc. v. Sanofi , 598 U.S. 594 (2023) have significantly heightened the standard for securing broad claims to pharmaceutical and biological products. In addition, recent Federal Circuit rulings such as In re Cellect , 81 F.4th 1216 (Fed. Cir. 2023) have expanded the bases for invalidating a patent under the judicially created doctrine of obviousness-type double patenting.

In addition to heightened patentability requirements, recent Supreme Court and Federal Circuit cases relating to biosimilar product approval under the BPCIA, have held that the "patent dance" provisions of the statute, which are intended to resolve any patent infringement issues before the approval of a biosimilar, are discretionary, and a biosimilar applicant can opt out by refusing to provide a copy of its application and manufacturing information to the biologic sponsor (see Sandoz Inc. v. Amgen Inc .,137 S. Ct. 1664 (2017). It may be that we do not learn of a biosimilar application until after FDA publishes its approval (see Immunex v. Samsung Bioepsis , 2:19-cv-117555-CCC-MF (D.N.J. Apr. 30, 2019). In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the United States federal courts, the USPTO, or similar authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents we might obtain in the future.

The patent protection and patent prosecution for our product candidates is dependent in part on third parties.

We or our licensors may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position. It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example, with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If we or our licensors, fail to establish, maintain, or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our licensors are not fully cooperative or disagree with us as to the prosecution, maintenance, or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

We rely on third parties to file and prosecute patent applications and maintain patents and otherwise protect the licensed intellectual property under some of our license agreements. We have not had and do not have primary control over these activities for some of our in-licensed patents or patent applications and other intellectual property rights. We cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. Pursuant to the terms of the license agreements with some of our licensors, the licensors may have the right to control enforcement of our licensed patents or defense of any claims asserting the invalidity of these patents and even if we are permitted to pursue such enforcement or defense, we will require the cooperation of our licensors. We cannot be certain that our licensors will allocate sufficient resources or prioritize their or our enforcement of such patents or defense of such claims to protect our interests in the licensed patents. Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might prevent us from continuing to license intellectual property that we may need to operate our business. If any of our licensors fail to appropriately prosecute and maintain patent protection for patents covering our product candidates, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using, and selling competing products.

In addition, even where we have the right to control patent prosecution of patents and patent applications we have acquired or licensed from third parties, we may still be adversely affected or prejudiced by actions or inactions of our predecessors or licensors and their counsel that took place prior to us assuming control over patent prosecution.

Our technology acquired or licensed from various third parties may be subject to retained rights. Our predecessors or licensors often retain certain rights under their agreements with us, including the right to use the underlying technology for non-commercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our predecessors or licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.

In addition, the research resulting in certain of our in-licensed patent rights and technology was funded in part by the United States government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a nonexclusive license authorizing the government to use the invention for noncommercial purposes. These rights may permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology. The United States government also has the right to take title to these inventions if the applicable licensor fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to United States industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations, and prospects.

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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. There are outstanding Pre-Funded Warrants exercisable for 9,090,910 Excluding the shares at a nominal of our common stock issuable upon exercise price, and other outstanding warrants of the 2023 Common Warrant, there are warrants exercisable for 18,005,329 approximately 31.6 million shares at exercise prices ranging from $1.65 $0.414 to $13.00 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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We currently do not meet certain of Nasdaq Capital Market ' s continued listing requirements and other Nasdaq rules. If we are unable to regain compliance, we are likely to be delisted. Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.

We are required to meet the continued listing requirements of the Nasdaq Capital Market and other Nasdaq rules, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price and certain other corporate governance requirements. For example, we are required to maintain a minimum bid price for our listed common stock of $1.00 per share. If we do not meet these continued listing requirements, our common stock could be delisted.

On December 6, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market, LLC ("Nasdaq") stating that Nasdaq has determined to delist the Company's securities from the Nasdaq Capital Market for failure to maintain a minimum bid price of $1.00 per share in accordance with Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Requirement").

The Company has appealed the Nasdaq determination and has requested a hearing (the "Hearing") before a Nasdaq Hearings Panel (the "Panel") to seek continued listing pending its return to compliance with the Bid Price Requirement. The Hearing request will stay the delisting of the Company's securities pending the Panel's decision. At the Hearing, which is scheduled for March 5, 2024, the Company intends to discuss the events that it believes will enable it to regain compliance, including a commitment to effect a reverse stock split, as soon as reasonably practicable, subject to applicable law and Nasdaq rules. In this regard, the Company plans to hold a Special Stockholders meeting on January 16, 2024 for the purpose of seeking stockholder approval for such reverse stock split.

Delisting from the Nasdaq Capital Market would cause us to pursue eligibility for trading of these securities on other markets or exchanges, or on the "pink sheets." In such case, our stockholders' ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices of these securities. There can be no assurance that our securities, if delisted from the Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the over-the-counter markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would also result in negative publicity, make it more difficult for us to raise additional capital, adversely affect the market liquidity of our securities, decrease securities analysts' coverage of us or diminish investor, supplier and employee confidence.

A portion of the 2023 Common Stock Purchase Warrant is not exercisable until stockholder approval and may have limited value.

Under Nasdaq Stock Market Rule 5635(d), the 2023 Common Warrant will only be exercisable up to 19.9% of the outstanding shares of our common stock until we obtain stockholder approval for the issuance of shares issuable upon exercise of the 2023 Common Warrant in excess of 19.9%. While we intend to promptly seek stockholder approval at a special meeting, there is no guarantee that such approval will be obtained. In the event that the price of a share of our common stock does not exceed the exercise price of the common stock purchase warrants during the period when the common stock purchase warrants are exercisable, the common stock purchase warrants may not have any value. Until such time as we obtain the stockholder approval, the 2023 Common Warrant may have limited value.

Use of proceeds 3 changes

We will not receive any proceeds from the sale of the shares of common stock by the Selling Stockholders. Stockholder. All net proceeds from the sale of the shares of common stock covered by this prospectus will go to the Selling Stockholders. Stockholder. We expect that the Selling Stockholder will sell their shares of common stock as described under "Plan of Distribution."

We may will receive proceeds from each of the any cash exercise of the Preferred Investment Option, the 2020 Common Warrant and the 2021 2023 Common Warrant and related issuance of shares of common stock. Each of the Preferred Investment Option, the 2020 Common Warrant and the 2021 Common Warrant, however, is exercisable on a cashless basis only under certain circumstances. If each of the Preferred Investment Option, the 2020 Common Warrant and the 2021 2023 Common Warrant is exercised for cash in full, the gross proceeds would be approximately $21.2 $8.7 million. We intend to use the net proceeds from the exercise of each of the Preferred Investment Option, the 2020 Common Warrant and the 2021 2023 Common Warrant, if any, for general corporate purposes and working capital.

Pending any use, as described above, we intend to invest the net proceeds in high-quality, short-term, interest-bearing securities. We can make no assurances that any of the Preferred Investment Option, the 2020 Common Warrant and the 2021 2023 Common Warrant will be exercised, or if exercised, that it will be exercised for cash, the quantity which will be exercised or in the period in which it will be exercised.

Determination of offering price 1 change

Each The Selling Stockholder will determine at what price it may sell the securities offered by this prospectus, and such sales may be made at fixed prices, prevailing market prices at the time of the sale, varying prices determined at the time of sale, or negotiated prices. For more information, see "Plan of Distribution."

Capitalization 7 changes

The following table sets forth our capitalization as of March 31, 2022: September 30, 2023:

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on an as adjusted basis to give effect to (i) the issuance and sale by us of 9,090,910 10,567,484 shares of common stock upon the exercise of the Pre-Funded Warrant issued in the Private Placement (ii) the issuance and sale by us (inclusive of 1,050,000 7,605,484 shares of common stock and issuable upon the exercise of pre-funded warrants), exercisable for 1,980,304 (ii) the issuance of 21,134,968 shares of common stock in issuable upon the registered direct offering concurrent to exercise of the Private Placement 2023 Common Warrant at the offering a price of $1.65 $0.414 per share and (iii) receipt of the gross proceeds from the Private Placement and registered direct offering after deducting commissions and offering expenses payable by us. and the use of proceeds therefrom.

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As of March 31, 2022

As of September 30, 2023

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12,121,214 shares of common stock issuable upon the exercise of the Preferred Investment Option with an exercise price of $1.65 per share;

The table and discussion above are based on 9,449,025 26,695,287 shares of common stock outstanding as of March 31, 2022, September 30, 2023, and 21,570,239 58,397,739 shares as adjusted, and do not include, as of that date:

5,884,115 2,816,631 shares of common stock issuable upon the exercise of other outstanding warrants with a weighted average exercise price of $4.19 $5.16 per share; and ● 1,500,000 5,018,800 shares of common stock which are reserved for issuance under our 2020 and 2023 Stock Incentive Plan, Plans, of which 602,000 2,018,800 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $2.79 $1.89 per share.

Business 104 changes

GeoVax Labs, Inc. ("GeoVax" or "the Company") is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer solid tumor cancers using novel proprietary platforms. GeoVax's product pipeline includes ongoing human clinical trials in for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancer. cancers. Additional research and development programs include preventive vaccines against Zika Virus, Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan Marburg, and Lassa) Marburg), Zika virus and malaria, as well as immunotherapies for multiple solid tumors. Our The Company's portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 70 115 granted or pending patent applications spread over 20 24 patent families, which are discussed in greater detail in the "Our Intellectual Property" section.

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We are currently developing a number of vaccines and immunotherapies for prevention or treatment of infectious diseases and cancers. The table below summarizes the status of our product development programs, which are discussed in greater detail in the following pages.

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COVID-19 (Booster to mRNA vaccines)

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Preclinical/IND-Enabling

Cancer Immunotherapy

COVID-19 (Booster for Chronic Lymphocytic Leukemia patients)

Clinical – Phase 2 (Investigator Initiated Trial)

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Ebola, Marburg, Sudan**

Hemorrhagic Fever Viruses

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Preclinical/IND-Enabling

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COVID-19, caused by SARS-CoV-2, has rapidly swept throughout the world. The World Health Organization (WHO) declared COVID-19 a public health emergency of international concern and, as of early March 2022, has reported more than 425 million cases and nearly 6 million deaths worldwide.

GEO-CM04S1 as a Booster Vaccine – In December 2021, patient enrollment began for the Phase 2 portion of a Phase 1/2 trial (NCT04639466) of GEO-CM0461, evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. The clinical trial, titled "Phase 1/2 Dose Escalation Study to Evaluate the Safety and Biologically Effective Dose of COH04S1, a Synthetic MVA-based SARS-CoV-2 Vaccine, Administered as One or Two Injections or as a Booster to Healthy Adult Volunteers" is being conducted at COH.

Our Cancer Immunotherapy Programs

Severe respiratory illnesses caused by the SARS-CoV-2 virus, remain a serious public health issue of international concern. SARS-CoV-2 is an enveloped, single-stranded, positive-sense RNA virus belonging to the family Coronavidae within the genus beta-coronavirus. The genome of SARS-CoV-2 encodes one large Spike ("S") protein that plays a pivotal role during viral attachment to the host receptor and entry into host cells. The S protein is the major principal target basis for most approved vaccines used to protect against human coronavirus, including SARS-CoV-2. Neutralizing antibodies targeting the receptor binding domain ("RBD") subunit of the S protein block the virus from binding to host cells. Over 90% of all neutralizing antibodies produced in response to infection are directed to the RBD subunit. and mAbs that have shown therapeutic activity target epitopes on the RBD.

Based on our research, there are currently twenty-four forty vaccines authorized for use in one or more countries around the world, including three 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. Antiviral drugs and mAbs currently have limited availability and effectiveness. According to Unfortunately, the U.S. Centers for Disease Control continued adaptation and Prevention (CDC), estimates mutation of COVID-19 mRNA vaccine effectiveness have declined SARS-CoV-2 has resulted in recent months because the emergence of waning vaccine induced immunity over time, possible increased immune evasion by SARS-CoV-2 variants or a combination that are not optimally neutralized by vaccine-induced antibodies, reducing vaccine efficacy. This has required the adjustment of these vaccine composition and other factors. the administration of booster doses. Recently, the FDA indicated the likely need for continued vaccine adjustments and yearly boosters, similar to the approach used for influenza virus vaccines.

Modified Vaccinia Ankara (MVA) is the viral vaccine vector platform utilized in a number of our vaccine candidates, including our next generation SARS-CoV-2 product, GEO-CM04S1. There are several potential advantages to SARS-CoV-2 vaccines based on MVA vectors:

MVA has a large genetic coding capacity which provides the foundation for vaccines based on multiple SARS-CoV-2 proteins, instead of the singular focus on the S protein. This approach induces immune responses with greater breadth of specificity.

MVA is known to effectively induce T-cell responses in addition to antibodies and the responses are durable.

MVA does not replicate in human cells which contributes to it being an extremely safe vaccine platform for human vaccines.

As a result of the combination of these properties, MVA is an ideal vaccine vector platform for the design of the next generation COVID-19 vaccines. This is especially true when the need to correct for suboptimal vaccine-induced immune responses of certain patient populations with compromised immune systems is considered, including patients suffering from and/or being treated for a variety of cancers, organ transplant patients, and renal dialysis patients.

GEO-CM04S1 for Immunocompromised Patients – The CDC lists and other global public health agencies identify immunocompromised patients, including patients who have received therapeutic procedures for hematologic malignancy, as high highest risk for SARS-CoV-2 disease. SARS-CoV-2 infection is expected to can be very serious in this vulnerable population of hematology patients, including autologous (auto) and allogeneic (allo) hematopoietic cell transplant (HCT), and recipients of chimeric antigen receptor (CAR)-T cell therapies. 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 the therapy outcomes, such as morbidity and survival. There is very limited data and multiple critical gaps in our knowledge of the epidemiology and clinical manifestations of SARS-CoV-2in hematology patients as no clinical trial of an approved vaccine has focused on immunocompromised patients. Thus, the efficacy and safety of a SARS-CoV-2 vaccine has not been established in the different immunocompromised patient populations and it is possible that candidate SARS-CoV-2 vaccines may differ in their efficacy and safety for these patients.

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 the therapy outcomes, such as 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.

Our vaccine candidate, GEO-CM04S1, (formerly referred to as COH04S1), is based on a synthetic, attenuated Modified Vaccinia Ankara (sMVA) vector expressing both spike (S) and nucleocapsid (N) antigens of the SARS-CoV-2 virus and was initially developed at City of Hope (COH) for immunocompromised patients. In a placebo-controlled Phase 1 clinical trial of healthy adults conducted by COH, GEO-CM04S1 was shown to be safe and immunogenic. In November 2021, GeoVax entered into a license agreement with COH, granting GeoVax exclusive worldwide rights to further develop and commercialize the vaccine.

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 patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. GEO-CM04S1 is the only SARS-CoV-2vaccine that includes both S and Nproteins to advance to a Phase 2 trial in cancer patients. 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-2vaccine SARS-CoV-2 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccine vaccines from Pfizer/BioNTech and Moderna in people who are immunocompromised. Such patients have often shown a weak antibody 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 ), in 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 inadequate antibody responses being generated against COVID infections or vaccinations. 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 against the loss of efficacy associated with the reduced 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.

GEO-CM04S1 as a Booster Vaccine – GEO-CM04S1 is also being studied in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna.

Because GEO-CM04S1 is designed to stimulate potent humoral and cellular immune responses against both the S and N proteins of SARS-CoV-2, GeoVax believes its administration as a booster will provide additional antigenic targets to the immune system resulting in induce a broader immune response. The GEO-CM0461 GEO-CM04S1 vaccine's MVA backbone may also be more effective at inducing immunity since MVA is known to strongly induce T cell responses. even In a background of immunosuppression. In addition, GEO-CM04S1 may offer greater protection against the significant sequence variation observed with the S antigen and durability of immunity, which because the N antigen is well established for MVA. not variable amongst evolving variants.

The Phase 1 portion of the trial 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 in healthy volunteers who were administered the vaccine at three different dose levels by intramuscular (IM) injection. Follow-up studies of the volunteers are continuing in order to better assess duration of immune responses. Scientific presentations and publications of the Phase 1 trial results are planned for early 2022.

The Phase 2 booster study, for which vaccination is ongoing, will include 60 patient enrollment was completed in October 2023, includes 63 healthy individuals, 18 years of age and older, adults who were previously vaccinated with the two-dose regimen of one of the FDA-approved SARS-CoV-2 mRNA vaccines, manufactured by either Pfizer/BioNTech or Moderna. The study is designed as a dose-escalation comparison trial to specifically evaluate the safety profile and immunogenicity of COH04S1 as a booster. The immunological responses measured throughout the study will include the level of SARS-CoV-2 neutralizing antibodies against SARS-CoV-2 variants of concern (VOC), including the Omicron VOC, and Delta VOCs, as well as specific T-cell responses.

GEO-CM02 as a Pan-Coronavirus Vaccine – First-generation SARS-CoV-2 vaccines were rapidly developed and have proven highly efficacious in the human population. As noted, most of these the first-generation SARS-CoV-2 vaccines were designed to encode the S protein of the SARS-CoV-2 virus with the goal of inducing high levels of neutralizing antibodies. However, potential limitations of narrowly focusing on the S protein are becoming apparent with emerging variants capable limitations of partially escaping neutralization by vaccine induced antibodies, as has been seen with the Omicron variant. Thus, this approach in the effectiveness face of these vaccines against new SARS-CoV-2 continually emerging variants is now obvious and future coronavirus spillover events remains of immense concern. alternative vaccine designs are being developed.

Using its novel Modified Virus Ankara - Virus Like Particle (GV-MVA-VLP TM ) platform, GeoVax has developed a design strategy for vaccines expected to induce broader immunity through inclusion of multiple, genetically conserved structural and nonstructural proteins from the target pathogen. SARS-CoV-2 and other beta-coronaviruses with the GV-MVA-VLP TM platform is known potential to induce a balanced antibody and cellular (T-cells) response against infect humans. This is possible, through the multiple encoded immunogens, potentially limiting immune escape by emerging variants. Expression use of the SARS-CoV-2 spike (S), membrane (M) and envelope (E) proteins by our MVA supports the in vivo formation of virus like particles (VLPs), which induce both antibody and T-cell responses. Incorporation of platform to incorporate other sequence-conserved structural and nonstructural proteins will provide as targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses. This strategy provides the basis for generating a universal vaccine with augmented potential to alleviate the burden of disease caused by circulating coronaviruses. Unique when compared to other vaccines approved or under development, the GeoVax vaccine candidates are therefore specifically designed to provide a broader and more long-lived level of protective immunity against SARS-CoV-2 which should protect against emerging variants while avoiding the potential side effects that can limit vaccine utility and acceptance.

GeoVax's lead vaccine candidate (GEO-CM02) encodes the S protein as the antibody target and the M and E proteins as T-cell targets. The combination of S, M and E protein expression supports In vivo VLP formation and optimal immunogenicity. In small animal studies, the Company measured functional immune responses after a single dose that mediated protection from infection and pathogenesis, including protection against the more virulent Beta variant In January 2021, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), awarded the GeoVax a Small Business Innovative Research (SBIR) grant in support of the Company's vaccine development efforts. The Phase 1 grant, titled, " Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19, " is supporting supported the ongoing design, construction and preclinical testing of our MVA-vectored vaccine candidates. evaluation, in preparation This program currently is serving as the foundation for human clinical trials. Scientific presentations further internal experimental design and publications small animal model testing focusing on the use of highly conserved viral nonstructural proteins as additional T-cell immunogens to further increase the experimental results were delivered at multiple international vaccine conferences during 2021 functional and publication is planned for 2022. specificity of induced immune responses.

In September 2023, data for GEO-CM02, which contains S, membrane (M) and envelope (E) proteins, were presented during the Keystone Symposia on Molecular and Cellular Biology held in Atlanta, Georgia. The presentation highlighted the following data: (i) the GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose, (ii) animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution, and (iii) GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals. Together, these data indicate that immunization with the multi-antigen MVA-vectored vaccine can protect against severe disease and death induced by SARS-CoV-2 infection, regardless of the variant.

Our Cancer Therapy Programs

Gedeptin ® – Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In September 2021, GeoVax entered into an assignment and license agreement with PNP Therapeutics, Inc. ("PNP"), granting GeoVax exclusive worldwide rights to develop and commercialize Gedeptin. The Gedeptin technology was developed with funding support from the National Cancer Institute (NCI), part of the NIH. GeoVax's license to Gedeptin includes the rights to expand the use of Gedeptin to all human diseases and/or conditions including, but not limited to, other cancers. solid tumors.

In GDEPT, a an adenovirus vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic inactive prodrug into a very toxic an active antitumor compound, in situ . A cycle of Gedeptin therapy consists of three intra-tumoral injections of Gedeptin over a two-day period followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. 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.

A multi-site Phase 1/2 trial (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 currently enrolling at Stanford University in collaboration with Emory University. ongoing. The trial design involves repeat administration using Gedeptin followed by systemic fludarabine as a way phosphate, in order to gain additional 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. In January 2022, we engaged CATO SMS, a global provider of clinical research solutions, to manage the ongoing Phase 1/2 This trial will guide the design of a larger study that also may involve patients with other anatomically accessible oral and pharyngeal cancers and, may lead to assist labeling discussions with the expansion of clinical sites FDA and acceleration initiation of patient enrollment further Gedeptin investigations including in combination with immune checkpoint inhibitors for additional cancerous and evaluation. non-cancerous tumor indications.

MUC1-based Immunotherapy – Tumors are often able to inhibit the body's natural immune system by producing inhibitory factors as a mechanism of immune resistance, especially against the T cells that are specific for tumor antigens and can kill cancer cells. The field of immuno-oncology has received new momentum with the discovery and commercial launch of immune checkpoint inhibitors (ICIs), a type of monoclonal antibodies (Mabs). ICIs block the naturally occurring and tumor-induced immune checkpoints, thus allowing functional T cells to more fully restore cellular proliferation, cytokine production function and killing of respond against tumor cells.

Unlike conventional therapies (e.g. radiation, chemotherapy, antibody, etc.), therapeutic cancer vaccines have the potential to induce responses that not only result in contribute to the control and even clearance of tumors but also establish immunological memory that can suppress and prevent tumor recurrence. Convenience, safety, and low toxicity of cancer vaccines could make them invaluable tools to be included in future immunotherapy approaches in combination with ICIs for treating tumors. Currently, there are only a few vectored cancer vaccines being tested in combination with ICIs, all of which are in early clinical stages.

We are developing our GV-MVA-VLP™ vaccine platform, that which is based on the aberrantly glycosylated forms of the cell surface-associated MUC1 protein, that and is expressed on a wide range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung, with the goal of raising therapeutic anti-tumor antibodies and T cell responses in cancer patients.

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We previously collaborated with ViaMune, Inc., which has developed a fully synthetic MUC1 vaccine candidate (MTI), with the goal of developing a MUC1-based vaccine that can produce a broad spectrum of anti-tumor antibody and T cell responses. The resulting MUC1 vaccine could be combined with ICIs as a novel vaccination strategy for cancer patients with advanced MUC1+ tumors. Preclinical studies of the combined MTI and MVA-VLP-MUC1 vaccines conducted by Dr. Pinku Mukherjee have shown the combination of our vaccine with MTI and ICI have significantly reduced the tumor burden in a mouse model for colorectal cancer.

MUC1-based cancer immunotherapy is a multi-pronged effort comprised of combinations of novel technologies and products. GeoVax believes our approach holds significant promise to be part of the continually expanding cancer treatment options in the future.

We collaborated with Dr. Olivera Finn, a leading expert in cancer immunotherapy at the University of Pittsburgh, who was one of the first medical researchers to show that many tumors express an abnormal form of MUC1 that is recognized by the immune system as foreign. Our collaboration with Dr. Finn has shown that a combination of our MVA-VLP-MUC1 vaccine candidate with a MUC1 synthetic peptide was capable of breaking tolerance to human MUC1 in transgenic mice and inducing immune responses with efficacy against challenge in a lymphoma tumor model.

In 2022, we initiated an potential IND enabling small animal study studies with Dr. Pinku Mukherjee at the University of North Carolina at Charlotte to define the optimal course and schedule of vaccination to define a protocol that can be evaluated in a Phase 1 clinical trial. These studies, which are ongoing, include assessment of the therapeutic benefit the vaccine in combination with a synthetic peptide, adjuvant and immune checkpoint inhibitor using a human MUC1 transgenic mouse model to optimally match existing and previously tested cancer treatment regimens.

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"). 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 protection against Mpox and smallpox.

MVA is the vaccine currently used and stockpiled in the US Strategic National Stockpile for immunization against the MPox and smallpox viruses. GeoVax previously demonstrated that an experimental HIV vaccine, utilizing NIH-MVA as the vaccine vector, protected non-human primates challenged with a lethal dose of the Mpox virus. Further, in August 2022, the City of Hope team, which originally developed GEO-CM04S1, published results demonstrating that both their proprietary sMVA (synthetic MVA) and GEO-CM04S1 (referred to as "COH04S1" in the publication) elicited robust orthopoxvirus-specific binding and neutralizing antibody responses. The authors concluded that GEO-CM04S1 and sMVA prepresent unique vaccine candidates to control the unforeseen global Mpox outbreak.

In response to the global need to address the continued emerging threat from Mpox and the unique opportunity offered by MVA-based vaccines, in November 2022, GeoVax secured rights from the NIH covering preclinical, clinical and commercial uses of the NIH-MVA against Mpox or smallpox viruses. The Company is now evaluating development and regulatory pathways towards expanding the public health options available to reduce and manage the risk of Mpox worldwide. The Company intends to successfully develop and commercialize GEO-MVA, becoming the first U.S.-based supplier of MVA as a vaccine against Mpox and smallpox.

Our Hemorrhagic Fever Virus Vaccines (Ebola Zaire, Ebola Sudan, Marburg) and Lassa) Ebola (EBOV, formerly designated as Zaire ebolavirus), Sudan (SUDV), and Marburg viruses (MARV) are the most virulent species of the Filoviridae family, causing hemorrhagic fever illnesses with up to a 90% fatality rate in humans. Lassa fever virus (LASV), a member of the Arenaviridae family, also causes severe and often fatal hemorrhagic illnesses in an overlapping region with Ebola. In December 2019, FDA approved the first live recombinant Ebola vaccine for prevention of Ebola disease by Zaire virus. This rVSV-ZEBOV showed safety concerns in Phase 1 trials and by virtue of being replication competent could pose threats to immunocompromised individuals, such as those infected with HIV living in West Africa where recent Ebola epidemics started.

To address the unmet need for a product that can respond to future hemorrhagic fever outbreaks, we are developing vaccines utilizing our GV-MVA-VLP™ platform. As previously noted, the MVA vector itself is considered safe, having originally been developed for use in immunocompromised individuals as a smallpox vaccine. We expect our vaccines may not only protect at-risk individuals against EBOV, SUDV MARV and LASV, MARV, but also potentially reduce or modify the severity of other re-emerging pathogens such as Bundibugyo, Ivory Coast, and Reston viruses, based on antigenic cross reactivity and the elicitation of T cells to the more conserved matrix proteins (e.g. VP40 or Z) in addition to standard GP proteins used by us and other manufacturers. Thus, the GeoVax GV-MVA-VLP™ approach could offer a unique combination of advantages to achieve breadth and safety of a pan-filo vaccine. In addition to protecting people historically higher-risk populations in Africa, it is also intended to prevent the spread of disease to the US and globally, and for preparedness against terrorist release of any of bio-threat pathogens in the US and globally.

Our initial preclinical studies in rodents and nonhuman primates for our MVA-VLP-EBOV vaccine candidate have shown 100% significant levels of protection against a lethal dose doses of EBOV. upon a single immunization. Recent studies in lethal challenge guinea pig models demonstrated that GeoVax vaccines MVA-VLP-SUDV and MVA-VLP-MARV 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. Likewise, our initial preclinical studies in rodents for our LASV vaccine candidate have shown 100% single-dose protection against a lethal dose of LASV challenge composed of multiple strains delivered directly into The brain. The nonhuman primate studies are ongoing conducted in collaboration with NIAID and the U.S. Department of Defense (DoD) have been completed and clinical development programs will be are being defined based with these same partners with a focus on efficacy data and global priorities as potentially dangerous outbreaks occur. developing products for the US Strategic National Stockpile.

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In January 2023, GeoVax announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, " Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein ." Preclinical studies demonstrated a single dose of GEO-ZM02 provided 100% protection against a lethal dose of Zika virus.

GEO-MM02 for Malaria – According to recent data from the World Health Organization, globally, malaria causes 228 227 million infections and 405,000 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. (e.g. >50%). 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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HIV – Due to our corporate refocusing of development efforts prioritizing our SARS-CoV-2 and cancer immunotherapy programs, and to a lack of continuing government support for our HIV vaccine development efforts, in early 2022 we recently decided to discontinue suspend active development of these programs. Our technology and intellectual property in this will remain available for out-license or partnering, but we will are no longer devote devoting any significant corporate resources to the programs. this program.

Of interest, recent results from a clinical study of a combinational HIV therapy that included GeoVax's HIV booster vaccine candidate, MVA62B were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held February 19-22, 2023 in Seattle, Washington. The data presented were part of an effort led by researchers at the University of California, San Francisco (UCSF), to develop a combinational therapy aimed at inducing remission in HIV-positive individuals (a "functional cure"). The primary objectives of the proof-of-concept trial were to assess the safety and tolerability of the combinational therapy and to determine the viral load "set-point" during antiviral treatment interruption. Secondary objectives were to assess immune responses and changes in viral reservoir status. The clinical trial was led by Steven Deeks, M.D. of UCSF, a world leader in therapeutic approaches to HIV infections, and was one of the most comprehensive tests to date for the ability of synergistic approaches to control HIV infection. The studies were conducted with funding from amfAR, The Foundation for AIDS Research. The overall goal of this trial was to induce immune responses that could potentially control HIV replication in patients in the absence of antiviral drugs. The data presented by the UCSF researchers indicated very high levels of immunogenicity (particularly T cell immunity), despite the fact these occurred in technically immunocompromised patients. These results further validate the ability of the MVA-VLP platform to stimulate a robust T-cell response to various diseases.

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VLPs mimic authentic viruses in form but are not infectious or capable of replicating and can cause the body's immune system to recognize and kill targeted viruses to prevent an infection. VLPs can also train the immune system to recognize and kill virus-infected cells to control infection and reduce the length and severity of disease. One of the biggest challenges with VLP-based vaccines is to design the vaccines in such a way that the VLPs will be recognized by the immune system in the same way as the authentic virus would be. We design our vaccines such that, when VLPs for enveloped viruses like HIV, Ebola Marburg or Lassa fever Marburg are produced in vivo (in the cells of the recipient), they include not only the protein antigens, but also an envelope consisting of membranes from the vaccinated individual's cells. In this way, they are highly similar to the virus generated in a person's body during a natural infection. VLPs produced in vitro (in a pharmaceutical plant), by contrast, have no envelope or, envelopes from the cultured cells (typically hamster or insect cells) used to produce them. We believe our technology therefore provides distinct advantages by producing VLPs that more closely resemble the authentic viruses. We believe this feature of our immunogens allows the body's immune system to more readily recognize the virus. By producing VLPs in vivo , we believe we also avoid potential purification issues associated with in vitro production of VLPs.

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In the MVA-VLP platform, we take advantage of MVA's large "coding capacity" to insert genes that encode multiple proteins, the combination of which is adequate to support the generation of VLPs by the MVA infected cells. Utility has been demonstrated for multiple vaccine candidates wherein the MVA-encoded viral matrix proteins and glycoproteins assemble into VLPs. MVA was originally developed as a safer smallpox vaccine for use in immune-compromised individuals. It was developed by attenuating the standard smallpox vaccine by passaging it (over 500 passages) in chicken embryos or chicken embryo fibroblasts, resulting in a virus with limited ability to replicate in human cells (thus safe) but with high replication capability in avian cells (thus cost effective for manufacturing). The deletions modifications also resulted in the loss of immune evasion genes which assist the spread of wild type smallpox infections, even in the presence of human immune responses.

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Protection against Mpox and Smallpox : MVA vectored vaccines have been previously shown to provide potential protection against Mpox and Smallpox.

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Support from the United States Government

Grants and Contracts

We have been the recipient of multiple federal grants and contracts in support of our vaccine development programs. Our most recent awards are as follows:

Lassa DoD Grant. In September 2018, the U.S. Department of Defense (DoD) awarded us a $2,442,307 cooperative agreement in support of our LASV vaccine development program. The grant was awarded by the U.S. Army Medical Research Acquisition Activity pursuant to the Peer Reviewed Medical Research Program (PRMRP), part of the Congressionally Directed Medical Research Programs (CDMRP). In addition to the grant funds provided directly to GeoVax, DoD also funded testing of our vaccine by U.S. Army scientists under a separate subaward. The award, entitled " Advanced Preclinical Development and Production of Master Seed Virus of GEO-LM01, a Novel MVA-VLP Vaccine Against Lassa Fev er", supports generation of immunogenicity and efficacy data for our vaccine candidate in both rodent and nonhuman primate models, as well as manufacturing process development and cGMP production of vaccine seed stock.

COVID-19 SBIR Grant. In January 2021, NIAID awarded us a $299,927 Phase I SBIR grant in support of our development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The grant, titled, " Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19, " has supported the ongoing design, construction and preclinical testing of our vaccine candidates.

Other Federal Support

We have been the recipient of additional in-kind federal support through collaborative and intramural arrangements with CDC for our Zika vaccine program, the Rocky Mountain Laboratory facility of NIAID for our hemorrhagic fever virus vaccine program, and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for our hemorrhagic fever virus vaccine program. This support generally has been for the conduct or support of preclinical animal studies on our behalf.

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Recent Government Initiatives

US Regulators and Senior White House and Congressional Leaders have recently announced multiple objectives and initiatives that may impact GeoVax. These include:

Project NextGen and the Rapid Response Partnership Vehicle (RRPV) -- Supporting the Biomedical Advanced Research and Development Authority (BARDA) in its objective to develop innovative vaccine platforms facilitating the production of a next generation broader performing COVID vaccines – GeoVax's MVA-vectored COVID-19 vaccine candidates (e.g., GEO-CM04S1) is a logical candidate given the features and benefits noted throughout this report.

The reshoring and protection of the domestic biotech ecosystem – GeoVax represents the first domestic source for Smallpox and Mpox production which is currently controlled by a single foreign entity.

Replenishing the US stockpile with additional vaccines addressing Mpox and Hemorrhagic Fevers – GeoVax has multiple products in advanced stages of development.

Assisting African countries in their quest to prevent an array of debilitating illnesses including those caused by hemorrhagic fever viruses Fevers – GeoVax has multiple products in advanced stages of development.

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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.

The PRV may be sold. For example, a small company might win a voucher for developing a drug for a neglected disease and sell the voucher to a large company for use on a commercial disease. The price of the voucher depends on supply and demand. The voucher's value derives from three factors: shifting sales earlier, longer effective patent life due to earlier entry, and competitive benefits from earlier entry relative to competitors. Top-selling treatments can yield billions in sales each year, so being approved months earlier can be worth hundreds of millions of dollars to the voucher. Since the first voucher sale in 2014, the price of the vouchers has ranged from $68 million to $350 million. 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 MVA component of our vaccine is currently manufactured in cells that are cultured from embryonated eggs. We are exploring a number of approaches to growing MVA in continuous cell lines that can be grown in bioreactors more suitable for commercial-scale manufacturing.

We do not currently have Rather than establishing the necessary facilities or internal expertise to manufacture any of the clinical or commercial supplies of any of our product. Rather, products, our strategy is to rely on established, recognized third-party contract manufacturers to produce vaccines materials needed for research and clinical trials. We have arrangements with third party manufacturers for the supply of our DNA and MVA vaccines products for use in our planned clinical trials. These suppliers operate under the FDA's Good Manufacturing Practices and (in the case of European manufacturers) similar regulations of the European Medicines Agency. We anticipate that these suppliers will be able to provide sufficient vaccine supplies to complete our currently planned clinical trials. Various contractors are generally available in the United States and Europe for manufacture of vaccines materials for clinical trial evaluation, however, it may be difficult to replace existing contractors for certain manufacturing and testing activities and costs for contracted services may increase substantially if we switch to other contractors. Furthermore, there is currently a shortage of vaccine manufacturing capability due to demand for potential COVID-19 vaccines, which could affect our ability to have our vaccine candidates manufactured.

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Transition to high-yield, scalable MVA manufacturing process – Currently, MVA vaccines are manufactured in cells cultured from chicken embryonic fibroblasts (CEF), a suboptimal and time-consuming process useful primarily for niche markets and stockpile reserves. After exploring various approaches to growing MVA, utilizing continuous avian cell lines in bioreactors more suitable for high-yield, commercial-scale manufacturing, we have accelerated activities towards fully implementing a proprietary, continuous avian cell line manufacturing system that will provide lower-cost, scalable versatility for broad MVA vaccine and immunotherapy applications. To this end, in September 2023, we announced the signing of a commercial multi-product license agreement for ProBioGen's AGE1.CR.pIX ® suspension cell line, an innovative and proven platform that enables high-yield and scalable production, ensuring efficient industrial manufacturing processes. The AGE1.CR.pIX cell line's versatility allows it to support a wide range of viruses and vaccine types, enhancing its suitability for various vaccines in development and as a replacement for traditional production systems. MVA grows particularly well on this cell line, making it even more advantageous for vaccine development.

Developing a high-yield, high-capacity process to produce MVA-based vaccines and immunotherapies constitutes a transformational development – for GeoVax, biomedicine, and the public's health. By advancing our MVA manufacturing to a modern, interchangeable process, we are on course to expand MVA applications from stockpile-based solutions for niche medical markets to respond to world needs on a timely basis, whenever and wherever they arise. We believe that this capability puts us in the position to be the first supplier of MVA-based vaccines to implement such a transformative manufacturing process and becoming the first U.S.-based supplier of the MVA vaccine to prevent Mpox, Smallpox and other pox-related viruses.

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We face general market competition from several subsectors of the vaccine development field, including large, multinational pharmaceutical companies including Sanofi, GSK, Merck, Janssen, Mitsubishi Tanabe, Takeda, and Pfizer; Inc.; mid-size pharmaceutical companies and emerging biotechnology companies including Dynavax, Novavax Inc., Moderna, BioNTech and Hookipa; Bavarian Nordic; and academic and not-for-profit vaccine researchers and developers including the NIH. The industry is typified by extensive collaboration, licensing, and merger and acquisition activity despite the intense competition.

More than twenty forty COVID-19 vaccines are currently authorized for use in one or more countries around the world, including three in the United States (from Pfizer/BioNTech, Moderna, and Janssen). All these vaccines are based on the S protein of the SARS-CoV-2 virus but rely on different mechanisms for presentation or expression of the S antigen, including whole, inactivated virus, defective adenovirus vectors (three different types) or mRNA. Key companies in The space with late-stage World Health Organization reports that there are 180 COVID products in clinical or pre-approval vaccine candidates include, Novavax, Inc., AstraZeneca PLC, CureVac N.V., Medicago Inc., GSK, Sanofi S.A., Dynavax, and Valneva SE. development.

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There are currently no FDA licensed and commercialized Zika vaccines, or hemorrhagic fever virus vaccines (other than for Ebola Zaire) available in the world market. We are aware of several development-stage and established enterprises, including major pharmaceutical and biotechnology firms, which are actively engaged in vaccine research and development in these areas. For hemorrhagic fever viruses, these include NewLink Genetics and Merck, Johnson & Johnson, Novavax, Inovio and GlaxoSmithKline. For Zika, these include NewLink Genetics, Inovio, Merck, Butantan Institute and NIH (NIAID). In December 2019, the FDA approved the first vaccine (ERVEBO®) for prevention of Ebola Zaire, developed by Merck.

There are currently no commercialized vaccines to prevent malaria infection. A first-generation infection-blocking In October 2021, the WHO approved the first malaria vaccine, RTS, S. is under regulatory review. It requires 4 doses and has been recommended by the WHO for pilot implementation studies. Since this vaccine is based on a single antigen and has modest efficacy (30-40%, (approximately 50%, depending on the age of subjects), the WHO has defined a Road Map for developing and licensing of next generation malaria vaccines. These vaccines are expected to contain multiple antigens designed More recently, a vaccine, R21/Matrix-M™️, jointly developed by Oxford University and the Serum Institute of India has met the WHO targeted efficacy to block both infection and transmission of malaria with at least a 75% efficacy rate.

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and 24 more changes in the filing

MD&A 139 changes

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Our pan coronavirus vaccine (GEO-CM02) has shown promising results in preclinical studies to date and with additional studies planned for 2022 to prepare for IND (Investigational New Drug) filing and subsequent human clinical trials.

Our additional research programs for treatment of solid tumors, and vaccines against Zika virus, malaria and hemorrhagic fever viruses are at various stages of preclinical development.

On May 25, 2022, we entered into a Securities Purchase Agreement (the "PIPE Securities Purchase Agreement") with Armistice providing for the issuance and sale to Armistice in a private placement offering of 9,090,910 shares of our common stock issuable upon exercise of a pre-funded warrant and a preferred investment option to purchase up to 9,090,910 shares of common stock. Concurrently with the entrance into the PIPE Securities Purchase Agreement, we entered into another Securities Purchase Agreement (the "RD Securities Purchase Agreement") with Armistice providing for the issuance and sale to Armistice in a registered direct offering of 1,050,000 shares of our common stock, a pre-funded warrant to purchase up to 1,980,304 shares of our common stock and a preferred investment option to purchase up to 3,030,304 shares of common stock. Aggregate gross proceeds from the private placement and registered direct offerings to the Company were approximately $20.0 million.

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 in 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 HIV, Zika Virus, Mpox and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan Marburg, and Lassa) Marburg), Zika virus and malaria, as well as immunotherapies for multiple solid tumors.

Our programs are in various stages of development, the most significant of which are summarized below along with recent developments:

GEO-CM04S1 – Immunocompromised Trial

GEO-CM04S1 is currently undergoing a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy, as a preventive COVID-19 vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in blood cancer high-risk immunocompromised patients (e.g. patients who have previously received a bone marrow either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor therapy (CAR) T cell therapy).

In September 2023, the journal, Vaccines, published data from the open-label safety portion of the trial indicating that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including neutralizing antibodies, and T cell responses.

In September 2023, preclinical vaccine efficacy data for GEO-CM02 were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, demonstrating that our multi-antigen SARS-CoV-2 vaccine, GEO-CM02, induced efficacious immune responses against the original Wuhan strain and BA.1 Omicron variant with a single dose. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines such as GEO-CM04S1, which are designed to induce both antibodies and T-cells to multiple viral structural proteins, can address the issue of viral variation and escape from the immune system.

In October 2023, we announced commencement of the planned site expansion for this trial to accelerate patient enrollment. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial is now open to eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and the Fred Hutchinson Cancer Center (Seattle, Washington).

GEO-CM04S1 – Healthy Booster Trial

In December 2021, patient enrollment began for GEO-CM04S1 is undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), of GEO-CM04S1, evaluating its use as a universal COVID-19 booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna.

In September 2023, we announced the completion of patient enrollment for this trial.

GEO-CM04S1 – CLL Trial

In July 2023, an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 began, evaluating its use as a COVID-19 booster vaccine in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine.

Gedeptin ® – Advanced Head and Neck Cancer Trial

Gedeptin® is currently undergoing a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck cancer, which squamous cell carcinoma (HNSCC). This trial is being conducted with funding support from 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.

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

Advanced Vaccine Manufacturing Process Development

In September 2023, GeoVax and ProBioGen AG announced the signing of a commercial license agreement for ProBioGen's AGE1.CR.pIX® suspension cell line. The agreement enhances our manufacturing capabilities for our entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio. This follows the May 2023 execution of a Master Services Agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of our vaccine candidates through late-stage development toward eventual commercialization. These agreements move the Company toward fully implementing a continuous cell line manufacturing system that will provide lower-cost, scalable versatility for our entire MVA-based vaccine portfolio.

Intellectual Property Development

In October 2023, the U.S. Patent and Trademark Office issued a Notice of Allowance to GeoVax for 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 October 2023, the U.S Patent and Trademark Office issued a Notice of Allowance to GeoVax for 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 August 2023, the U.S. Patent and Trademark Office issued a Notice of Allowance to GeoVax for 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 July 2023, the U.S. Patent and Trademark Office issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company's patent application No. 15/543,139 titled "Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40), covering GeoVax's vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus.

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 $3.26 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $1.65 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 10,567,484 shares of the Company's common stock, at a reduced exercised price of $0.414 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 21,134,968 Common Shares with an exercise price of $0.414 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.

On December 6, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market, LLC ("Nasdaq") stating that Nasdaq has determined to delist the Company's securities from the Nasdaq Capital Market for failure to maintain a minimum bid price of $1.00 per share in accordance with Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Requirement").

The Company has appealed the Nasdaq determination and has requested a hearing (the "Hearing") before a Nasdaq Hearings Panel (the "Panel") to seek continued listing pending its return to compliance with the Bid Price Requirement. The Hearing request will stay the delisting of the Company's securities pending the Panel's decision.

At the Hearing, which is scheduled for March 5, 2024, the Company intends to discuss the events that it believes will enable it to regain compliance, including a commitment to effect a reverse stock split, as soon as reasonably practicable, subject to applicable law and Nasdaq rules. In this regard, the Company plans to hold a Special Stockholders meeting on January 16, 2024 for the purpose of seeking stockholder approval for such reverse stock split.

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We have not generated any revenues from product sales to date. 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. Our grant revenues relate to grants and contracts from agencies of the U.S. government in support of our vaccine development activities. We record revenue associated with these grants as the related costs and expenses are incurred.

Research and development expenses

Since our inception, we have focused and we continue to focus significant resources on our research and development activities, including developing our vector platform and analytical testing methods, conducting preclinical studies, developing manufacturing processes, and conducting clinical trials. Research and development costs are expensed as incurred and consist primarily of the following:

personnel costs in our research, development and regulatory functions, which include salaries, benefits and stock-based compensation;

expenses incurred under agreements with contract research organizations ("CROs"), that conduct clinical trials on our behalf;

expenses incurred under agreements with contract manufacturing organizations ("CMOs"), that manufacture product used in the clinical trials;

expenses incurred in procuring materials and for analytical and release testing services required to produce vaccine candidates used in clinical trials;

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

laboratory supplies, vendor expenses and other third-party contract expenses related to preclinical research activities;

technology license fees;

consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and facilities, depreciation and other general overhead expenses.

We expect our research and development expenditures to increase during 2024 and beyond as we advance our existing and future product candidates into and through clinical trials and pursue regulatory approval, especially with regard to the Gedeptin and GEO-CM04S1 clinical programs. We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with biotechnology research and development. Due to these uncertainties, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. As we obtain data from preclinical studies and clinical trials, we may elect to discontinue or delay certain development programs to focus our resources on more promising product candidates. Completion of preclinical studies and human clinical trials may take several years or more, but the length of time can vary substantially depending upon several factors. The duration and the cost of future clinical trials may vary significantly over the life of the project because of differences arising during development of the human clinical trial protocols, including the length of time required to enroll suitable patient subjects, the number of patients that ultimately participate in the clinical trial, the duration of patient follow-up, and the number of clinical sites included in the clinical trials.

General and administrative expenses

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, and other general corporate activities.

Critical Accounting Policies and Estimates

This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates and adjusts them as necessary. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Our significant accounting policies are summarized in Note 2 to our consolidated financial statements for the year ended December 31, 2022, which are included in this prospectus. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements:

We recognize revenue in accordance with FASB Accounting Standards Update 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which created a new Topic, Accounting Standards Codification Topic 606. The standard is principle-based and provides a five-step model to determine when and how revenue is recognized. The core principle is that an entity should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.

We receive payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds. From time to time, we may enter into collaborative research and development agreements for specific vaccine development approaches and/or disease indications whereby we receive third-party funding for preclinical research under certain of these arrangements. Each agreement is evaluated in accordance with the process defined by ASU 2014-09 and revenue is recognized accordingly.

Stock-Based Compensation

We account for stock-based transactions in which the Company receives services from employees, directors or others in exchange for equity instruments based on the fair value of the award at the grant date. Stock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Stock-based compensation cost for stock options or warrants is estimated at the grant date based on each instrument's fair value as calculated by using the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award. See Note 6 to our financial statements for additional stock-based compensation information.

Research and Development Expense

Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates. These expenses consist primarily of (i) salaries, benefits, and stock-based compensation for personnel, (ii) laboratory supplies and facility-related expenses to conduct development, (iii) fees paid to third-party service providers to perform, monitor and accumulate data related to our preclinical studies and clinical trials, (iv) costs related to sponsored research agreements, (v) costs to procure and manufacture materials used in clinical trials, and (vi) license fees and other expenses associated with technology license agreements.

The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or trials, including clinical trial participant enrollment, completion of events, invoices received and other events. Advance payments for research and development activities are deferred and included in prepaid expenses and other assets. The deferred amounts are expensed as the related goods are delivered or the services are performed.

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Our operating results typically fluctuate due to the timing of activities and related costs associated with our research and development activities and our general and administrative costs, as described below. The following tables summarize our results of operations for the years ended December 31, 2021 and 2020 and the three-month periods ended March 31, 2022 and 2021:

The following table summarizes our results of operations for the years ended December 31, 2022 and 2021 and for the three-month and nine-month periods ended September 30, 2023 and 2022:

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Grant and collaboration revenue

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Three Months Ended March 31, September 30,

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Total other income (expense)

Grant and Collaboration Revenues

Our grant and collaboration revenues relate to grants and contracts from agencies of the U.S. government and collaborative arrangements with other third parties in support of our vaccine development activities. Detail concerning our grant and collaboration revenues during the years ended December 31, 2021 and 2020, the three-month periods ended March 31, 2022 and 2021, are presented in the tables below.

Year Ended December 31,

Lassa Fever – U.S. Army Grant

Covid-19 – NIH SBIR Grant

Malaria – Collaboration Revenue

Three Months Ended March 31,

Lassa Fever – U.S. Army Grant

Covid-19 – NIH SBIR Grant

Grant and collaboration revenues decreased by $1,438,157 (79%) for the year ended December 30, 2021 compared to 2020, and by $28,891 (26%) for the three-month period ended March 31, 2022 compared to the three-month period ended March 31, 2021, attributable to the differing mix of active grants and collaborations as shown in the tables above, as well as the timing of expenditures related to such grants and collaborations. As of March 31, 2022, all approved grant funds have been utilized.

Nine Months Ended September 30,

Research and development

General and administrative

Total operating expenses

Loss from operations

Grant revenues decreased by $303,975 (79%) for the year ended December 30, 2022 compared to 2021, attributable to the differing mix of active grants as well as the timing of grant-related expenditures.

There were no grant revenues during either of the three-month periods ended September 30, 2023 and 2022. Grant revenue decreased by $81,526 (100%) for the nine-month period ended September 30, 2023 compared to the nine-month period ended September 30, 2022, reflective of the wind-down of the Company's grant from the U.S. Department of Defense for our Lassa Fever vaccine program. As of September 30, 2023, all approved grant funds have been utilized.

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Our research and development expenses can fluctuate considerably on a period-to-period basis, depending on the timing of expenditures related to our government grants and other research projects, and other factors. We do not disclose our research and development expenses by project, since our employees' time is spread across multiple programs and our laboratory facility is used for multiple vaccine candidates. We track the direct cost of research and development expenses related to government grant revenue by the percentage of assigned employees' time spent on each grant and other direct costs associated with each grant. Indirect costs associated with grants are not tracked separately but are applied based on a contracted overhead rate negotiated with the NIH. Therefore, the recorded revenues associated with government grants approximate the costs incurred.

Our research and development expenses were $15,554,171 for the year ended December 31, 2021, as compared to $2,444,459 for 2020, representing an increase of $13,109,712 (536%). Of this increase, $10,000,000 relates to upfront license fees pursuant to the COH License ($5,000,000 paid during 2021 and $5,000,000 payable in future years), $1,864,300 relates to clinical trial expense and patent cost reimbursements pursuant to the COH License, and $459,825 relates to upfront license fees (inclusive of $209,825 of stock-based expense) associated with the Gedeptin License. Research and development expense for 2021 and 2020 includes stock-based compensation expense of $96,814 and $7,156, respectively associated with employee stock options, reflecting a $89,658 increase (see discussion under "Stock-Based Compensation Expense" below). The remaining $695,929 increase in research and development expense from 2020 to 2021 relates primarily due to expenditures related to our COVID-19 vaccine program, manufacturing process development, and a generally higher level of activity, offset in part by lower external expenditures related to our government grants.

Research and development expenses increased by $727,761 (121%) for the three-month period ended March 31, 2022 versus the 2021 comparable period. Research and development expense for the three-month periods ended March 31, 2022 and 2021 includes stock-based compensation expense of $54,292 and $21,468, respectively, associated with employee stock options, reflecting an increase of $32,824 (see discussion under "Stock-Based Compensation Expense" below). The remaining increase of $694,937 relates primarily to higher personnel costs (including the use of external consultants), costs of manufacturing materials for use in clinical trials, and a generally higher level of activity.

Our research and development expenses were $9,123,479 for the year ended December 31, 2022, as compared to $15,554,171 for 2021, representing a decrease of $6,430,692 (41%). Research and development expense for 2021 includes $12,324,125 of upfront license fees and other costs related to our licenses of GEO-CM04S1 and Gedeptin; excluding these costs, research and development expense increased by $5,893,433 (182%) from 2021 to 2022. The increase during 2022 relates primarily to higher personnel costs (including the use of external consultants), costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, and a generally higher level of activity. Research and development expense for 2022 and 2021 includes stock-based compensation expense of $225,031 and $96,814, respectively, associated with employee stock options.

For the three-month and nine-month periods ending September 30, 2023, research and development expenses increased by $4,226,783 (155%) and $9,127,979 (170%), respectively, versus the comparable 2022 periods. The overall increase during the 2023 periods relates primarily to costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs. Research and development expense for the three-month and nine-month periods of 2023 included stock-based compensation expense of $77,873 and $232,516, respectively; as compared to $54,293 and $162,878 respectively, for the comparable 2022 periods.

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and 59 more changes in the filing

Management 20 changes

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Kelly T. McKee, M.D.

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Robert T. McNally Ph.D.(1)(2)

Independent Director

John W. Sharkey, Ph.D.

Vice President, Business Development

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Independent Director

Robert T. McNally Ph.D. (1)(2)

Independent Director

Jayne Morgan, M.D. (2)

Independent Director

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Robert T. McNally, Ph.D . Dr. McNally joined the Board of Directors in December 2006 and was appointed as our President and Chief Executive Officer effective April 1, 2008, a position he held until his retirement in September 2018. From 2000 to March 2008, Dr. McNally served as Chief Executive Officer of Cell Dynamics LLC, a cGMP laboratory services company. Previously, Dr. McNally was a co-founder and Senior Vice President of Clinical Research for CryoLife, Inc., a pioneering company in transplantable human tissues. He has over 35 years of experience in academic and corporate clinical investigations, management, research, business, quality and regulatory affairs. Dr. McNally is a Fellow of the American Institute for Medical and Biological Engineering, served on the advisory boards of the Petit Institute for Bioengineering and Dupree College of Management at the Georgia Institute of Technology, and is a former Chairman of Georgia Bio, a state trade association. Dr. McNally holds a Bachelor of Science in engineering from Villanova University and his Ph.D. in biomedical engineering from the University of Pennsylvania. The Board of Directors has concluded that Dr. McNally should serve on its Board of Directors by virtue of his prior business and scientific experience, including his experience as Chief Executive Officer of Cell Dynamics, LLC and as Senior Vice President of Clinical Research for CryoLife, Inc., and due to his involvement with the Company as its former President and Chief Executive Officer.

Mark J. Newman, Ph.D . Dr. Newman became employed 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.

Kelly T. McKee, M.D . Dr. McKee was appointed as our Chief Medical Officer effective January 6, 2022 and serves served in that role on a part-time consulting basis pursuant to until becoming a consulting agreement. full-time employee effective March 1, 2023. Dr. McKee has over 30 years of experience in research and development, with specific expertise in vaccines, emerging diseases, biodefense, and respiratory viral infections. His progressive clinical research experience began in 1981 at Fort Detrick, Frederick, MD., United States, where he held a variety of leadership positions in virology, immunology, preventive medicine, and clinical research and development with the U.S. Army, retiring as a Colonel in 2001. Dr. McKee subsequently served as State Epidemiologist in North Carolina, and as Senior Director of Clinical Research at DynPort Vaccine Company. He then held multiple leadership roles, including Vice President and Managing Director of Public Health and Government Services, and Vice President for Vaccines and Public Health in the Infectious Diseases and Vaccines Center of Excellence, at Quintiles/QuintilesIMS (now IQVIA) for more than 10 years. Since 2017 he has provided contract clinical development and medical advisory services to biopharmaceutical industry in infectious diseases and related areas. Dr. McKee earned an M.D. from the University of Virginia School of Medicine, and a Master of Public Health from Johns Hopkins University School of Hygiene and Public Health in Baltimore, MD. He has authored or co-authored more than 100 peer-reviewed publications and book chapters.

John W. Sharkey, Ph.D . Dr. Sharkey joined the Company as our Vice President, Business Development, effective June 13, 2022. Prior to his current appointment, he served as our part-time Head of Business Development pursuant to a consulting agreement. Previously, as CEO of Largent Health, LLC, he oversaw the development strategy for three 510(k) medical devices incorporating a proprietary antimicrobial technology, eventually leading to the registration and commercial launch of the 1st FDA cleared dental cavity cleanser with antimicrobial claims. In 2010, Dr. Sharkey founded Cogas Consulting, LLC, a consultancy providing executive management, technical development, regulatory and business development services to small and mid-size pharma and medical device companies. He has also assisted several companies in their financing activities. Prior to the above, he held senior executive positions within both Novartis and Shionogi and was involved in several notable partnering transactions including Novartis obtaining European rights to Lucentis® as well obtaining global rights to Focalin® and Focalin® XR and Shionogi's global license for Osphena®. Dr. Sharkey holds a Ph.D. in Chemistry from the University of Buffalo and a B.S. in Chemistry from the State University of New York at Oneonta.

Randal D. Chase, Ph.D. Dr. Chase joined the Board of Directors in March 2015. Dr. Chase is an experienced pharmaceutical and biotechnology executive who currently serves as a business advisor and consultant to companies in the life science sector. He also serves as a director for Mirexus Biotechnologies, Inc., a biomaterials company, and as Chairman of the Board for Glysantis, Inc. a biotechnology company. From February 2017 to April 2018, Dr. Chase was President and Chief Executive Officer of Advanced Proteome Therapeutics Corporation, a publicly-held biopharmaceutical company; he served as a member of that company's board of directors from 2015 to April 2018. He served as Chairman of the Board for Medicago, Inc. until its sale to Mitsubishi Tanabe Pharma Corporation in 2013. From 2006 to 2011, he served as President and Chief Executive Officer of Immunovaccine, Inc., a clinical-stage biotechnology company developing vaccines against cancer and infectious diseases. Dr. Chase is also a former president of Shire Biologics, North American Vaccine, Pasteur Merieux Connaught, and Quadra Logic Technologies, Inc. His early career was at Bristol Myers and Glaxo Pharmaceuticals. Dr. Chase holds a Bachelor of Sciences degree in biochemistry from Bishop's University and a Ph.D. in biochemistry from the University of British Columbia. Dr. Chase completed a post-doctoral fellowship at the McArdle Cancer Institute of the University of Wisconsin. He also attended the Senior Executive Program of the London Business School in the United Kingdom. The Board of Directors has concluded that Dr. Chase should serve on the Board of Directors due to his extensive leadership experience in the pharmaceutical industry, and the vaccine industry in particular.

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Nicole Lemerond. Ms. Lemerond joined the Board of Directors in August 2022. Ms. Lemerond is a financial executive with over 25 years of experience in investment management, private equity, investment banking, mergers/acquisitions, and leveraged finance, most recently serving as Managing Partner of NV Capital from February 2010 to August 2022. She has significant experience executing complex transactions, investing in healthcare companies, raising capital and structuring balance sheets. Her breadth of industry expertise includes providers, payors, medical device manufacturers, HCIT providers, pharmaceutical and life sciences companies. Ms. Lemerond also serves as a director for InMed Pharmaceuticals, Inc. Throughout her career, she established and led healthcare groups at leading investment firms and has also worked at several large financial institutions, including Lehman Brothers and The Carlyle Group. Ms. Lemerond holds a Bachelor of Science degree from Cornell University and is a CFA charter holder. The Board of Directors has concluded that Ms. Lemerond should serve on the Board of Directors due to her extensive experience in investment management and her experience working with management teams to increase stakeholder value.

Robert T. McNally, Ph.D . Dr. McNally joined the Board of Directors in December 2006 and was appointed as our President and Chief Executive Officer effective April 1, 2008, a position he held until his retirement in September 2018. From 2000 to March 2008, Dr. McNally served as Chief Executive Officer of Cell Dynamics LLC, a cGMP laboratory services company. Previously, Dr. McNally was a co-founder and Senior Vice President of Clinical Research for CryoLife, Inc., a pioneering company in transplantable human tissues. He has over 35 years of experience in academic and corporate clinical investigations, management, research, business, quality and regulatory affairs. Dr. McNally is a Fellow of the American Institute for Medical and Biological Engineering, served on the advisory boards of the Petit Institute for Bioengineering and Dupree College of Management at the Georgia Institute of Technology, and is a former Chairman of Georgia Bio, a state trade association. Dr. McNally holds a Bachelor of Science in engineering from Villanova University and his Ph.D. in biomedical engineering from the University of Pennsylvania. The Board of Directors has concluded that Dr. McNally should serve on its Board of Directors by virtue of his prior business and scientific experience, including his experience as Chief Executive Officer of Cell Dynamics, LLC and as Senior Vice President of Clinical Research for CryoLife, Inc., and due to his involvement with the Company as its former President and Chief Executive Officer.

Jayne Morgan, M.D. Dr. Morgan joined the Board of Directors in December 2022. She is a Cardiologist and the Executive Director of Health and Community Education at the Piedmont Healthcare Corporation in Atlanta, GA, the largest healthcare system in Georgia. Within this role she serves to address health literacy and information both internally to the 35,000 employee system, as well as to external stakeholders. Previously she served as the system Covid vaccine expert as the Executive Director of the Covid Task Force, analyzing the science and data from Piedmont and nationally, publishing 5 scientific articles, and driving efforts at addressing vaccine hesitancy and increasing vaccine uptake. In doing so, she created a social media series called The Stairwell Chronicles , providing up to date medical and scientific information in an easy to understand format. Dr. Morgan is the recipient of several awards acknowledging her work in providing accurate science and medicine to all communities including the NAACP Award, the National Women's Empowerment Award, the Atlanta Business Chronicle Award, and the Medical Association of GA Humanitarian Award. Further she serves as a CNN medical expert, holds an appointment as an Adjunct Assistant Professor of Medicine at The Morehouse School of Medicine, was selected to support the Department of Health in its series of "Ask The Experts", and has been a diligent and long-time advocate for health equity for all communities via access to clinical trials. Dr. Morgan further serves on the Board of Georgia Bio, the Medical Association of Atlanta, and the National Board of the American Heart Association Diversity and Inclusion. Dr. Morgan is published in the areas of Congenital Heart Disease, Interventional Cardiology, and Covid19; serves as the Health Equity Advisor for Moderna, and is on Steering Committees of both Pfizer, and Novartis, where she also serves as the National Lead of the Horizon trial (Novartis). Previously she served as the Chief Medical Officer of the American Chemistry Council, Cardiology advisor to the MitraClip Team at Abbott Labs, the Global Director of the Cardiorenal Division of Solvay Pharmaceuticals, the Assistant Professor of Medicine at the Cleveland Clinic, and the first African American President of the Southeast Life Sciences Association (single largest biotech association in the Southeast). Dr. Morgan completed her B.S. degree at Spelman College, Medical Degree at Michigan State University, Internal Medicine Residency at George Washington University and her Cardiology and Pacemaker Fellowships at Mount Sinai Medical Center. The Board of Directors has concluded that Dr. Morgan should serve on the Board of Directors due to her medical background and experience.

John N. (Jack) Spencer, Jr., CPA. Mr. Spencer joined the Board of Directors in September 2006. Mr. Spencer is a certified public accountant and was a partner of Ernst & Young LLP where he spent more than 38 years until he retired in 2000. Mr. Spencer holds a Bachelor of Science degree from Syracuse University, and MBA from Babson College. He also attended the Harvard Business School Advanced Management Program. The Board of Directors has concluded that Mr. Spencer should serve on the Board of Directors by virtue of his experience at Ernst & Young LLP where he was the partner in charge of that firm's life sciences practice for the southeastern United States, and his clients included a large number of publicly-owned and privately-held medical technology companies.

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The Board of Directors has determined that Messrs. Directors Chase, Kollintzas, Lemerand, McNally, Morgan and Spencer are the members of our Board of Directors who are "independent," as that term is defined by Section 301(3)(B) of the Sarbanes-Oxley Act of 2002. The Board of Directors has also determined that these individuals meet the definition of "independent director" set forth in Rule 5605(a)(2) of the Nasdaq Listing Rules and that Mr. Spencer is the qualified "financial expert" on the Audit Committee. As independent directors, Messrs. Chase, Kollintzas, McNally and Spencer these individuals serve as the members of our Audit Committee, our Compensation Committee, and our Nominating and Governance Committee.

Executive compensation 31 changes

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Chief Financial Officer

The following table sets forth all compensation awarded or earned for employment services during 2021 2023 and 2020 2022 by (i) each person who served as our chief executive officer, during 2021, and (ii) our two other most highly compensated executive officers (collectively referred to as the "Named Executive Officers").

Kelly T. McKee, MD (2)

Chief Medical Officer

Mark J. Newman, PhD (2) (3)

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Represents the grant date fair value for stock options granted on December 7, 2021 for 48,200 shares with an exercise price of $3.82 per share, vesting over a three-year period (5) Represents the grant date fair value for stock options granted on December 7, 2021 for 25,700 shares with an exercise price of $3.82 per share, vesting over a three-year period.

Represents the grant date fair value for stock options granted on December 2, 2020 for 128,000 shares with an exercise price of $2.79 per share, vesting over a three-year period.

Represents the grant date fair value for stock options granted on December 2, 2020 for 35,000 shares with an exercise price of $2.79 per share, vesting over a three-year period.

Represents the grant date fair value of the stock options for financial statement reporting purposes. See footnotes 2 and 7 6 to our consolidated financial statements for the year ended December 31, 2021 2022 for a discussion of the assumptions made and methods used for determining stock compensation values.

Dr. McKee became our Chief Medical Officer effective January 15, 2022 on a part-time consulting basis, becoming a full-time employee effective March 1, 2023. The amounts reported in the table above include payments made to Dr. McKee pursuant to his consulting agreement as well as pursuant to his employment.

Dr. Newman became our Chief Scientific Officer effective August 25, 2020 on a part-time basis, becoming a full-time employee effective March 1, 2022.

Represents the grant date fair value for stock options granted on December 7, 2021 2022 for 103,000 250,000 shares with an exercise price of $3.82 $0.755 per share, vesting over a three-year period.

Represents the grant date fair value for stock options granted on December 2, 2020 7, 2022 for 273,000 15,000 shares with an exercise price of $2.79 $0.755 per share, vesting over a three-year period (6) Represents the grant date fair value for stock options granted on December 7, 2022 for 100,000 shares with an exercise price of $0.755 per share, vesting over a three-year period.

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David A. Dodd . Mr. Dodd serves as our President and Chief Executive Officer under an employment agreement dated September 1, 2018. The employment agreement has no specified term. The employment agreement provides for an initial annual base salary of $250,000 to Mr. Dodd (currently $371,000), subject to periodic increases as determined by the Board. Mr. Dodd is also eligible for an annual bonus, as determined by the Board. Mr. Dodd is eligible for annual grants of awards from our equity incentive plans as determined by the Board. Mr. Dodd also is eligible for health insurance and 401(k) benefits at the same level and subject to the same conditions as provided to all other employees.

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Mark J. Newman, PhD . Dr. Newman serves as our Chief Scientific Officer under an employment agreement dated August 25, 2020, which was amended and restated effective March 1, 2022. The employment agreement has no specified term. The employment agreement, as amended, provides for an annual base salary of $275,000, to Dr. Newman (currently $291,500), subject to periodic increases as determined by the Compensation Committee. The Board of Directors may also approve the payment of a discretionary bonus annually. Dr. Newman is eligible for annual grants of awards from our equity incentive plans as determined by the Board. Dr. Newman is eligible for health insurance and 401(k) benefits at the same level and subject to the same conditions as provided to all other employees.

Our employment agreement with Mr. Reynolds Dr. Newman provides that, if we terminate his employment without cause, we will pay a severance payment in the form of monthly payments of base salary for a period equal to one week for each full year of service. Additionally, if we terminate Mr. Reynolds' Dr. Newman's employment at any time during the three month period which immediately precedes a change in control (as defined in the amended employment agreement) or during the one year period following a change in control, then we would pay an amount in cash equal to (a) two times his then base salary and target annual bonus, (b) two times the cost to provide 401(k) or other deferred compensation or health and welfare benefits to him, (c) full, complete vesting of all stock options, restricted stock grants or other equity or equity-type grants, and (d) a tax gross-up payment (if an excise tax is imposed by §4999 of the Internal Revenue Code or any related interest or penalties are incurred by him). The change of control provision also provides for full and complete vesting of all stock option grants held by him.

Mark W. Reynolds. Mr. Reynolds Kelly T. McKee, MD. Dr. McKee serves as our Chief Financial Medical Officer under an employment agreement dated January March 1, 2010 and amended on October 22, 2013. 2023. The employment agreement has no specified term. The employment agreement, as amended, provides for an initial annual base salary of $212,600 to Mr. Reynolds, Dr. McKee (currently $350,000), subject to periodic increases as determined by the Compensation Committee. The Board of Directors may also approve the payment of a discretionary bonus annually. Mr. Reynolds Dr. McKee is eligible for annual grants of awards from our equity incentive plans as determined by the Board. Mr. Reynolds Dr. McKee is eligible for health insurance and 401(k) benefits at the same level and subject to the same conditions as provided to all other employees.

Our employment agreement with Dr. McKee provides that, if we terminate his employment without cause, we will pay a severance payment in the form of monthly payments of base salary for a period equal to one week for each full year of service. Additionally, if we terminate Dr. McKee's employment at any time during the three month period which immediately precedes a change in control (as defined in the amended employment agreement) or during the one year period following a change in control, then we would pay an amount in cash equal to (a) two times his then base salary and target annual bonus, (b) two times the cost to provide 401(k) or other deferred compensation or health and welfare benefits to him, (c) full, complete vesting of all stock options, restricted stock grants or other equity or equity-type grants, and (d) a tax gross-up payment (if an excise tax is imposed by §4999 of the Internal Revenue Code or any related interest or penalties are incurred by him). The change of control provision also provides for full and complete vesting of all stock option grants held by him.

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GeoVax has awarded stock options to its senior management and other employees, pursuant to the GeoVax Labs, Inc. 2020 Stock Incentive Plan (the "2020 Plan") and the 2023 Stock Incentive Plan (the "2023 Plan"). Each of the 2020 Plan was and 2023 Plan were adopted by the Board on June 19, 2020 and December 7, 2022, respectively, to provide equity-based and/or incentive awards to selected employees, directors, and independent contractors of the Company or its affiliates. The terms of these awards typically provide for vesting over a defined period of time and the options expire if not exercised within ten years from the date of grant. The Company does not have a formula for determining stock option awards. Awards are generally based on the subjective judgment of the President and Chief Executive Officer and on the Compensation Committee's subjective judgment. The following table sets forth certain information with respect to unexercised options previously awarded to our Named Executive Officers that were outstanding as of December 31, 2021. 2023. The table also includes warrants, if any, granted to our Named Executive Officers upon payment of deferred compensation.

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The unexercisable portion of these stock options will vest and become exercisable in equal installments on December 7, 2022, 2023 and 2024 and 2025.

The unexercisable portion of these stock options will vest and become exercisable in equal installments on December 2, 2022 and 2023. 7, 2024.

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Each of the 2020 Plan and 2023 Plan contains provisions that could lead to an accelerated vesting of options or other awards. In the event of certain change-in-control transactions described in the 2020 Plan, such plans, (i) outstanding options or other awards may be assumed, converted or replaced; (ii) the successor corporation may substitute equivalent options or other awards or provide substantially similar consideration to the 2020 Plan or 2023 Plan, as applicable, participants as were provided to stockholders (after taking into account the existing provisions of the options or other awards); or (iii) the successor corporation may replace options or awards with substantially similar shares or other property. In the event the successor corporation (if any) refuses to assume or substitute options or other awards as described (i) the vesting of any or all options or awards granted pursuant to the 2020 Plan or 2023 Plan, as applicable, will accelerate upon the change-in-control transaction, and (ii) any or all options granted pursuant to the Plans will become exercisable in full prior to the consummation of the change-in-control transaction at such time and on such conditions as the Compensation Committee determines. If the options are not exercised prior to the consummation of the change-in-control transaction, they shall terminate at such time as determined by the Compensation Committee. Subject to any greater rights granted to 2020 Plan participants under the 2020 Plan or 2023 Plan participants under the 2023 Plan, as applicable, in the event of the occurrence of a change-in-control transaction any outstanding options or other awards will be treated as provided in the applicable agreement or plan of merger, consolidation, dissolution, liquidation, or sale of assets. If the Company had experienced a change-in-control event as described in each of the 2020 Plan and 2023 Plan on December 31, 2021, 2022, the value of accelerated options the Named Executive Officers, based on the difference between the closing price of our common stock on the Nasdaq Stock Market on December 31, 2021, 2022, and, if lower, the exercise price per share of each option for which vesting would be accelerated for each Named Executive Officer, would be an aggregate of $241,254. $-0-.

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The following table sets forth information concerning the compensation earned for service on our Board of Directors during the fiscal year ending December 31, 2021 2023 by each individual who served as a director at any time during the fiscal year.

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Represents the grant date fair value of stock options granted on December 7, 2021 to each non-employee director for 25,000 shares with an exercise price of $3.82 per share, vesting over a one-year period.

The table below shows the aggregate numbers of warrants and number option awards and warrants outstanding for each non-employee director as of December 31, 2021. 2023. The table includes warrants granted issued to certain of our directors upon payment of deferred compensation occurring on September 29, 2020.

1 unchanged paragraph

and Warrants Outstanding

as of December 31, 2021 2023

1 unchanged paragraph

Cash Fees – For 2021, each non-employee director earned an annual retainer (paid quarterly) of $10,000 ($30,000 for a non-employee Chairperson) for service as a member of the Board, $5,000 ($9,000 for the Chairperson) for service as a member of the Audit Committee. and $3,300 ($6,000 for the Chairperson) for service as a member of the Compensation Committee or the Nominating and Corporate Governance Committee. Non-employee directors also earned fees for each Board of Directors or Committee meeting attended as follows: $3,000 for in person Board of Directors meetings ($1,500 for telephonic meetings), $1,000 for in person Committee meeting chaired ($750 for telephonic meetings), and $500 for in person Committee meeting attended as a non-chair member ($400 for telephonic meetings).

Director Compensation Plan. In December 2020, 2021, the Board of Directors approved a recommendation from the Compensation Committee for director compensation, which we refer to as the "Director Compensation Plan." The Director Compensation Plan applies only to non-employee directors. Directors who are employees of the Company receive no compensation for their service as directors or as members of committees.

In December 2021, the Board of Directors approved a recommendation from the Compensation Committee to amend Cash Fees – Under the Director Compensation Plan, effective January 1, 2022, such that each non-employee director will receive receives an annual retainer (paid quarterly) of $25,000 ($50,000 for a non-employee Chairperson) for service as a member of the Board. In the absence of a non-employee Chairperson of the Board, a non-employee director designated as the Lead Director shall receive (currently Dr. McNally) receives an annual cash retainer of $35,000. Each non-employee director will also receive receives an annual retainer of $7,500 ($15,000 for the Chairperson) for service as a member of the Audit Committee, $5,000 ($10,000 for the Chairperson) for service as a member of the Compensation Committee, and $5,000 ($7,500 for the Chairperson) for service as a member of the Nominating and Corporate Governance Committee. No additional fees will be are paid for meetings attended.

Stock Option Grants – We currently do not have a formula for determining stock option grants to directors (upon their election to the Board of Directors, or otherwise). Such option grants are currently determined by the Board of Directors, upon recommendation by the Compensation Committee based on the Compensation Committee's annual deliberations and review of the director compensation structure of similar companies. At its meeting in December 2021, 2022, upon a recommendation of the Compensation Committee, the Board of Directors approved an annual stock option grant of 25,000 50,000 shares to each of its non-employee members for ongoing service as members of the Board of Directors. At its meeting in December 2023, the Board of Directors determined to adjust the calendar cycle of all stock option grants to employees as well as the Board of Director, such that no stock options were granted during 2023 and that annual grants would be considered in early 2024.

1 unchanged paragraph

Certain relationships and related person transactions 10 changes

On February 25, 2019, we entered into a Securities Purchase Agreement with the Sabby Healthcare Master Fund, Ltd. and Sabby Volatility Warrant Master Fund, Ltd. (collectively, "Sabby") providing for the issuance and sale to Sabby of an aggregate of up to 1,000 shares of our Series G Convertible Preferred Stock and related warrants ("Series I Warrants") for gross proceeds of up to $1.0 million. In January 2021, all of the remaining Series I Warrants were converted into 20,196 shares of our common stock pursuant to the cashless exercise provisions of the warrants.

June 2020 Bridge Financing

On June 26, 2020, we entered into a Securities Purchase Agreement with Cavalry Fund I LP and Cavalry Special Ops Fund, LLC, pursuant to which the Company received aggregate gross proceeds of $1,050,000 in exchange for the issuance of 5% Original Issue Senior Secured Convertible Debentures in the aggregate principal amount of $1,200,000 and five-year warrants to purchase an aggregate of 2,400,000 shares of our common stock at an exercise price of $0.50 per share, subject to adjustment. On September 29, 2020, the June 26, 2020 5% Original Issue Senior Secured Convertible Debentures mandatorily converted into 303,667 conversion units, of which 177,625 include shares of common stock and 126,042 include pre-funded warrants (the "Conversion Units"). The Conversion Units provide substantially the same terms as the Units issued in September 2020. The pre-funded warrants provide the holder the right to purchase one share of common stock at an exercise price of $0.01 per share, are immediately exercisable and will not expire until exercised in full. These pre-funded warrants were exercised on January 13, 2021. The Company also issued these investors five-year warrants to acquire an additional 303,668 shares of common stock, in the aggregate, at $5.00 per share.

January 2022 Private Placement

On January 14, 2022, we entered into a Securities Purchase Agreement with Armistice providing for the issuance and sale to Armistice of 707,484 shares of common stock, 2,360,000 shares of common stock issuable upon the exercise of a pre-funded warrant (the "January Pre-Funded Warrant") and 3,067,484 shares of common stock issuable upon the exercise of a warrant (the "Common Warrant" and together with the January Pre-Funded Warrant, the "January Warrants"). The January Warrants are exercisable immediately and contain price adjustment provisions which may, under certain circumstances, reduce the applicable exercise price; the January Pre-Funded Warrant shall terminate when fully exercised and the Common Warrant shall terminate on the fifth anniversary of the effective date of the Resale Registration Statement. The Private Placement closed on January 20, 2022. The January Pre-Funded Warrant was exercised during the first quarter of 2022.

May 2022 Registered Direct and Private Placement

On May 25, 2022, we entered into a Securities Purchase Agreement (the "PIPE Securities Purchase Agreement") with Armistice providing for the issuance and sale to Armistice in a private placement offering of 9,090,910 shares of our common stock issuable upon exercise of a pre-funded warrant and a preferred investment option to purchase up to 9,090,910 shares of common stock. Concurrently with the entrance into the PIPE Securities Purchase Agreement, we entered into another Securities Purchase Agreement (the "RD Securities Purchase Agreement") with Armistice providing for the issuance and sale to Armistice in a registered direct offering of 1,050,000 shares of our common stock, a pre-funded warrant to purchase up to 1,980,304 shares of our common stock and a preferred investment option to purchase up to 3,030,304 shares of common stock. Aggregate gross proceeds from the private placement and registered direct offerings to the Company were approximately $20.0 million.

Other than compensation arrangements for our Named Executive Officers and directors, we describe below each transaction there were no transactions since January 1, 2021, 2022, to which we were a party or will be a party, in which the amount exceeds $120,000 and in which any "related person" (as defined in paragraph (a) of Item 404 of Regulation S-K) had or will have a direct or indirect material interest. Compensation arrangements for our named executive officers and directors are described above under "Executive Compensation."

December 2023 Private Placement

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 $3.26 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $1.65 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 10,567,484 shares of the Company's common stock, at a reduced exercised price of $0.414 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 21,134,968 shares of Common Stock with an exercise price of $0.414 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.

Security ownership of principal stockholders, directors and officers 18 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 10, 2022 December 31, 2023 by (i) each director; principal stockholder, (ii) each director; (iii) each of the executive officers named in the summary compensation table; and (iii) (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 10, 2022. December 31, 2023. 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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Mark W. Reynolds (9)

The shares are directly held by Armistice 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.

Robert T. McNally (7) (9)

John N. Spencer, Jr. (10) (12)

All executive officers and directors as a group (8 persons) (11 persons) (13)

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 12,547,829 29,657,287 shares of Common Stock outstanding as of June 10, 2022. December 31, 2023. 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 10, 2022 December 31, 2023 (subject to specified limits), at any time at the option of the holder, are deemed outstanding.

These shares are directly held by Armistice 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) 9,090,910 7,605,484 shares of common stock issuable upon the exercise of the pre-funded warrants (ii) 12,121,214 shares of common stock issuable upon exercise of the Preferred Investment Options, and (iii) 3,067,484 (ii) 21,134,968 shares of common stock issuable upon the exercise of common warrants, each of which are subject to beneficial ownership limitations that prohibit Armistice from exercising any portion of a warrant and/or preferred investment option that would result in Armistice owning a percentage of our outstanding common stock exceeding the ownership limitations contained within each instrument (9.99% 4.99% 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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Includes 16,613 36,613 shares of Common Stock and stock options/warrants to purchase 24,946 116,613 shares of common stock exercisable within 60 days.

Includes 81,870 148,957 shares of Common Stock and stock options/warrants to purchase 172,870 506,869 shares of common stock exercisable within 60 days.

Includes 11,987 shares of Common Stock and stock options/warrants to purchase 20,320 111,987 shares of common stock exercisable within 60 days.

Includes stock options to purchase 11,666 50,000 shares of common stock exercisable within 60 days.

Includes 53,925 28,838 shares of Common Stock and stock options/warrants options to purchase 62,258 5,000 shares of common stock exercisable within 60 days.

Includes 60,184 53,925 shares of Common Stock and stock options/warrants to purchase 102,850 153,925 shares of common stock exercisable within 60 days.

Includes 21,024 shares of Common stock and stock options/warrants options to purchase 29,357 50,000 shares of common stock exercisable within 60 days.

Includes 260,324 shares of Common stock and stock options/warrants options to purchase 424,267 85,466 shares of common stock exercisable within 60 days.

Includes 21,024 shares of Common Stock and stock options/warrants to purchase 121,024 shares of common stock exercisable within 60 days.

Includes 382,388 shares of Common Stock and stock options/warrants to purchase 1,494,533 shares of common stock exercisable within 60 days.

Description of the securities 5 changes

4 unchanged paragraphs

As of June 10, 2022, December 31, 2023, there were 12,547,829 26,695,287 shares of common stock outstanding and no shares of preferred stock outstanding. As 7,605,484 shares of June 10, 2022, there were 9,090,910 common stock are issuable upon the exercise of pre-funded warrants pursuant to the Private Placement, together with an exercise price of $0.0001 per share, Preferred Investment Options the 2023 Common Warrant to purchase 12,121,214 up to 21,134,968 shares of common stock with an exercise prices price of $1.65 $0.414 per share, and other outstanding warrants to purchase 5,884,115 up to 2,816,631 shares of common stock with a weighted average exercise price of $4.19 $5.16 per share. An additional 1,500,000 5,018,800 shares of common stock are reserved for issuance under our 2020 and 2023 Stock Incentive Plan, Plans, of which 962,300 2,018,800 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $3.18 $1.89 per share.

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We will not offer preferred stock unless the offering is approved by a majority of our independent directors. The independent directors will have access, at our expense, to our counsel or independent counsel.

Our Board of Directors has the authority to issue up to 10,000,000 shares of preferred stock in one or more series and fix the number of shares constituting any such series, the voting powers, designations, preferences and relative, participating, optional or other special rights and qualifications, limitations or restrictions thereof, including the dividend rights, dividend rate, terms of redemption (including sinking fund provisions), redemption price or prices, conversion rights and liquidation preferences of the shares constituting any series, without any further vote or action by the stockholders. For example, the Board of Directors is authorized to issue preferred stock that would have the right to vote, separately or with any other stockholder of preferred stock, on any proposed amendment to our certificate of incorporation, or on any other proposed corporate action, including business combinations and other transactions. We will not offer preferred stock unless the offering is approved by a majority of our independent directors. The independent directors will have access, at our expense, to our counsel or independent counsel.

22 unchanged paragraphs

The transfer agent and registrar for our common stock and warrant agent for our September Warrants is American Stock Transfer & Trust Company, LLC, 6201 15th Avenue, Brooklyn, NY 11219, telephone (718) 921-8200.

The transfer agent and registrar for our common stock is Equiniti Trust Company, LLC, 48 Wall Street, New York, NY 10005, telephone (800) 468-9716.

1 unchanged paragraph

Plan of distribution 5 changes

Each The Selling Stockholder and any of their its respective pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their the securities covered hereby on the Nasdaq or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. Each The Selling Stockholder may use any one or more of the following methods when selling securities:

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Each The Selling Stockholder may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.

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Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, each Selling Stockholder will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by such Selling Stockholder or any other person. We will make copies of this prospectus available to a Selling Stockholder and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

We are required to pay certain fees and expenses incurred by us incident to the registration of the securities. We have agreed to indemnify each the Selling Stockholder against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.

We agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by a Selling Stockholder without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for us to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with. Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, each Selling Stockholder will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by such Selling Stockholder or any other person. We will make copies of this prospectus available to a Selling Stockholder and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

Experts 1 change

Our consolidated financial statements as of and for the years ended December 31, 2021 2022 and 2020 2021 included in this prospectus and elsewhere in the registration statement have been audited by Wipfli LLP, an independent registered public accounting firm, as indicated in their report with respect thereto, and are included herein in reliance upon the authority of said firm as experts in auditing and accounting in giving said report.

Financial statements 1 change

Condensed Consolidated Balance Sheets as of March 31, 2022 September 30, 2023 (unaudited) and December 31, 2021 2022 Condensed Consolidated Statements of Operations for the three-month periods ended March 31, 2022 and 2021 September 30, 2023 (unaudited) and 2022 Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficiency) for the three-month periods ended March September 30, 2023 (unaudited) and December 31, 2022 and 2021 (unaudited) Condensed Consolidated Statements of Cash Flows for the three-month periods ended March September 30, 2023 (unaudited) and December 31, 2022 and 2021 (unaudited)

Notes to the financial statements 128 changes

Years Ended December 31, 2021 2022 and 2020 2021

1 unchanged paragraph

GEO- CM04S1 License -- In November 2021, GeoVax entered into a license agreement with City of Hope (the "COH License"), granting GeoVax exclusive rights to further develop and commercialize GEO- CM04S1 (formerly referred to as COH04S1 ). GEO- CM04S1, a synthetic, attenuated modified vaccinia Ankara (sMVA) vector expressing Spike and Nucleocapsid antigens of the SARS-CoV- 2 virus, was initially developed at COH for immunocompromised patients.

GEO- CM04S1 is being studied in an ongoing Phase 2 clinical trial to evaluate its safety and immunogenicity, compared to the Pfizer mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. GEO- CM04S1 is the only COVID- 19 vaccine that includes both SARS-CoV- 2 spike and nucleocapsid proteins to advance to a Phase 2 trial in cancer patients. Such vaccines also 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 COVID- 19 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccine from Pfizer/BioNTech in people who are immunocompromised. Such patients have often shown a weak antibody response after receiving currently available COVID- 19 vaccines.

In December 2021, patient enrollment began for the Phase 2 portion of a Phase 1/2 trial of GEO- CM04S1, to study its use as a universal booster vaccine to current FDA-approved vaccines. GeoVax believes that the GEO- CM04S1 vaccine, when administered as a heterologous booster, will provide additional recognition elements to the immune system over a homologous boost from mRNA vaccines such as those developed by Moderna or Pfizer, which are directed only toward SARS-CoV- 2 Spike protein. The COH04S1 vaccine's MVA backbone may be more effective at inducing COVID- 19 immunity since MVA strongly induces T cell responses even in a background of immunosuppression. In addition, GEO- CM04S1 targeting of both Spike and Nucleocapsid antigens, may offer greater protection against the significant sequence variation observed with the Spike antigen.

Gedeptin ® License -- In September 2021, GeoVax entered into an Assignment and License Agreement with PNP Therapeutics, Inc. (the "PNP License), whereby GeoVax expanded its immuno-oncology pipeline and added a new technology platform through the acquisition of exclusive rights to Gedeptin®, a novel patented product for the treatment of solid tumors through a gene therapy strategy known as GDEPT (Gene-Directed Enzyme Prodrug Therapy). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a potent antitumor compound. A Phase 1/2 clinical trial is currently enrolling to evaluate the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumors accessible for injection and no curable treatment options. The FDA has granted Gedeptin Orphan Drug status for the treatment of HNSCC and the initial stage of the ongoing clinical trial is being funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. GeoVax's license to Gedeptin includes rights to expand its use to all human diseases and/or conditions including, but not limited to, cancers.

GeoVax is incorporated under the laws of the State of Delaware and our principal offices are located in the metropolitan Atlanta, Georgia area.

GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as "GeoVax" or the "Company".

GeoVax Labs, Inc. ("GeoVax" or The Company is a clinical-stage biotechnology company focused on developing immunotherapies and vaccines against infectious diseases and cancers using novel vector vaccine platforms. GeoVax's product pipeline includes ongoing human clinical trials in COVID- 19 for vaccines against COVID-19 and a therapy for advanced head and neck cancer. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever) Zika virus, and malaria, as well as immunotherapies for solid tumors. Certain of our vaccine development activities have been, and continue to be, financially supported by the U.S. Government. This support has been both in the form of research grants and contracts awarded directly to us, as well as indirect support for the conduct of preclinical animal studies and human clinical trials.

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The accompanying consolidated financial statements include the accounts of GeoVax Labs, Inc. together with those of our wholly-owned subsidiary, GeoVax, Inc. All intercompany transactions have been eliminated in consolidation.

1 unchanged paragraph

On January 21, 2020, we effected a 1 -for- 2000 reverse split of our common stock and on September 25, 2020, we effected a 1 -for- 20 reverse split of our common stock. Unless otherwise noted, the accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock splits.

1 unchanged paragraph

We have funded our activities to date from sales of our equity securities, government grants and clinical trial assistance, and corporate and academic collaborations. We believe that our existing cash resources will be sufficient to continue our planned operations into the second quarter of 2023. We intend to fund future operations through additional private and/or public offerings of debt or equity securities. In addition, we may seek additional capital through arrangements with strategic partners or from other sources. There can be no assurance that we will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations.

Since inception, the Company's activities have consisted primarily of performing research and development to advance its technologies. We expect to continue to generate operating losses in the foreseeable future and will require additional funding to continue our research and development activities. We believe that our existing cash resources will be sufficient to continue our planned operations into the fourth quarter of 2023. Due to our history of operating losses and our continuing need for capital to conduct our research and development activities, there is substantial doubt concerning our ability to operate as a going concern beyond that date. We are currently exploring sources of capital and intend to fund our future operations through additional private and/or public offerings of debt or equity securities. We also intend to seek additional capital through government grants, arrangements with strategic partners or from other sources. 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. There can be no assurance that additional funding will be available on favorable terms or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back, or eliminate some or all of our research and development programs as well as reduce our general and administrative expenses.

4 unchanged paragraphs

Financial instruments that subject us to concentration of credit risk consist primarily of cash and cash equivalents, which are maintained by a high credit quality financial institution. institutions. The carrying values reported in the balance sheets for cash and cash equivalents approximate fair values.

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Property and equipment are stated at cost, less accumulated depreciation and amortization. Expenditures for maintenance and repairs are charged to operations as incurred, while additions and improvements are capitalized. We calculate depreciation using the straight-line method over the estimated useful lives of the assets which range from three to five (generally 5 years). We amortize leasehold improvements using the straight-line method over the term of the related lease.

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Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. Common share equivalents consist of common shares issuable upon conversion of convertible preferred stock, and upon exercise of stock options and stock purchase warrants. All common share equivalents are excluded from the computation of diluted loss per share since the effect would be anti-dilutive. The weighted average number of common share equivalents which were excluded from the computation of diluted loss per share, calculated using the treasury stock method, totaled 213,831 and 1,001,948 shares at December 31, 2021 and 2020, respectively.

Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company's additional 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 15,442,915 and 3,778,931 shares at December 31, 2022 and 2021, respectively.

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Grant revenue – We receive payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds.

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and 111 more changes in the filing

Recent Sales of Unregistered Securities 17 changes

and 17 more changes in the filing

Exhibits 19 changes

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and 19 more changes in the filing

Undertakings 4 changes

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and 4 more changes in the filing