Part I -- FINANCIAL INFORMATION

Item 1Financial Statements

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

See accompanying notes to condensed consolidated financial statements.

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSOPERATIONS

(Unaudited)

See accompanying notes to condensed consolidated financial statements.

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

(Unaudited)

GEOVAX LABS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

(Unaudited)

See accompanying notes to consolidated financial statements.

Supplemental disclosure of cash flow information:non-cash financing activities:

During the nine months ended September 30, 2017, 178 shares of Series C Convertible Preferred Stock were converted into 11,862,000 shares of common stock. During the nine months ended September 30, 2016, 132 shares of Series C Convertible Preferred Stock were converted into 1,400,000 shares of common stock (Note 8).2021:

During the nine months ended September 30, 2020:

See accompanying notes to condensed consolidated financial statements.

GEOVAX LABS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30,, 2017 2021

(unaudited)

GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a clinical-stage biotechnology company developing humanimmunotherapies and vaccines against infectious diseases and cancers using our novel vector vaccine platform. Our currentplatforms. GeoVax’s Modified Vaccinia Ankara-Virus-Like Particle (MVA-VLP) based platform utilizes MVA, a large virus capable of carrying several vaccine antigens, to express proteins that assemble into highly effective virus-like particle (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

GeoVax’s MVA-VLP development programs are focused primarily on preventive vaccines against Human Immunodeficiency Virus (HIV),the SARS-CoV-2 virus (COVID-19) and immunotherapies for solid tumor cancers. Other development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), Human Immunodeficiency Virus (HIV), and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. We believe our technology and vaccine development expertise are well-suited for a variety of human infectious diseases and we intend to pursue further expansionmalaria. Certain of our product pipeline.

Certain of our vaccine development activities have been, and continue to be, financially supported by the U.S. government.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.

We operateOn September 28, 2021, GeoVax entered into an Assignment and License Agreement with PNP Therapeutics, Inc., 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 a highly regulatedpatients with recurrent head and competitive environment.neck squamous cell carcinoma (HNSCC), with tumors accessible for injection and no curable treatment options. The manufacturingFDA has granted Gedeptin Orphan Drug status for the treatment of HNSCC and marketingthe initial stage of pharmaceutical products require approval from, and are subject to,the ongoing oversightclinical trial is being funded by the Food and Drug Administration (FDA) in the United States, by the European Medicines Agency (EMA) in the European Union, and by comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, may take many years and often involves expenditure of substantial resources. Our goal isFDA pursuant to build a profitable company by generating income from products we develop and commercialize, either alone its Orphan Products Clinical Trials Grants Program. GeoVax’s license to Gedeptin includes rights to expand its use to all human diseases and/or with one or more potential strategic partners.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 Smyrna,the metropolitan Atlanta, Georgia (metropolitan Atlanta area).area.

The accompanying condensed consolidated financial statements at September 30, 2017 2021 and for the three-monththree-month and nine-monthnine-month periods ended September 30, 2017 2021 and 20162020 are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of the dates and periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K10-K for the year ended December 31, 2016. 2020. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.

We enacted reverse stock splits of our common stock on September 25, 2020 (1-for-20) and on January 21, 2020 (1-for-2,000). The accompanying financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock splits.

Our financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for at least the twelve-monthtwelve-month period following the issue date of thethese consolidated financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates. We have funded our activities to date from sales of our equity securities, government grants and clinical trial assistance, and from sales of our equity securities.corporate and academic collaborations. We will continueexpect to incur future net losses and require substantial funds toas we continue these activities.

We believe that our existing cash resources and government funding commitments will be sufficient to continue our planned operations into the first quarter of 2018. Due to our history of operating losses and our continuing need for capital to conduct our research and development activities, there is substantial doubt concerningactivities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our abilityproduct candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to operate as a going concern beyond that date.need to raise additional funding. We are currently exploring sourcesintend to fund future operations through additional private and/or public offerings of debt or equity securities. In addition, we may seek additional capital through additional government grants and contracts. We also intend to seek additional funds through sales of our equity securities, exercise of currently outstanding stock purchase warrants,arrangements with strategic partners or from other means. Management believessources. There can be no assurance that we will be successful in securing theable to raise 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. Additional funding may not be available on favorable termsfunds or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back,achieve or eliminate somesustain profitability or all of our research and development programs as well as reduce our general and administrative expenses.positive cash flows from operations. 

We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K10-K for the year ended December 31, 2016 2020 those accounting policies that we consider significant in determining our results of operations and financial position. ThereDuring the nine months ended September 30, 2021, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.

In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”), which amends Accounting Standards Codification Topic 718, Compensation – Stock Compensation. ASU 2016-09 is an attempt to simplify several aspects of the accounting for stock-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities,10-K, and classification on the statement of cash flows. We adopted ASU 2016-09 effective January 1, 2017; such adoption had no material impact on our financial statements.

In May 2017, the FASB issued Accounting Standards Update 2017-09, Scope of Modification Accounting (“ASU 2017-09”), which amends Accounting Standards Codification Topic 718, Compensation – Stock Compensation. ASU 2017-09 is an attempt to provide clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718 Compensation – Stock Compensation, to a change to the terms or conditions of a share-based payment award. ASU 2017-09 is effective for the Company beginning January 1, 2018. We are currently evaluating the impact of the adoption of ASU 2017-09 on our financial statements.

In July 2017, the FASB issued Accounting Standards Update 2017-11, (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”), which amends Accounting Standards Codification Topic 260, Earnings Per Share, Topic 480, Distinguishing Liabilities from Equity, and Topic 815, Derivatives and Hedging. ASU 2017-11 changes the classification of certain equity-linked financial instruments (or embedded features) with down round features, and clarifies existing disclosure requirements for equity-classified instruments. ASU 2017-11 is effective for the Company beginning January 1, 2019. We are currently evaluating the impact of the adoption of ASU 2017-11 on our financial statements.

Therethere have been no other recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2017, as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which we expect to have a material impact on our financial statements.

Basic netand diluted loss per common share isare computed usingbased on the weighted-averageweighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted-average number of common shares and potentially dilutive common share equivalents outstanding during the period. Potentially dilutive commonoutstanding. Common share equivalents consist of common shares issuable upon conversion of convertible preferred stock, and upon exercise of stock options and stock purchase warrants. CommonAll common share equivalents which potentially could dilute basic earningsare excluded from the computation of diluted loss per share insince the future, andeffect would be anti-dilutive. The weighted average number of common share equivalents which were excluded from the computation of diluted loss per share astotaled 2,965,451 and 2,550,184 shares for the effect would be anti-dilutive, totaled approximately 277.5 millionthree-month and 73.1 million shares at nine-month periods ended September 30, 20172021, respectively, as compared to 204,553 and 2016, 78,754 shares for the three-month and nine-month periods ended September 30, 2020, respectively.

Property and equipment as shown on the accompanying Condensed Consolidated Balance Sheets is composed of thethe following as of September 30, 2017 2021 and December 31, 2016:2020:

Accrued expenses as shown on the accompanying Condensed Consolidated Balance Sheets isare composed of the following as of September 30, 2017 2021 and December 31, 2016:2020:

7.Notes Payable

GRA Note – On February 28, 2018, we entered into a Senior Note Purchase Agreement with Georgia Research Alliance, Inc. (GRA) pursuant to which we issued a five-year Senior Promissory Note (the “GRA Note”) to GRA in exchange for $50,000. The GRA Note bore an annual interest rate of five percent. Interest expense related to the GRA Note for the three-month and nine-month periods ended September 30, 2021 was $-0- and $633, respectively, as compared to $411 and $1,344, respectively, for the same periods of 2020. During May 2021, we repaid the remaining principal balance of $22,737 and retired the GRA Note.

CARES Act Paycheck Protection Program Loan –On April 17, 2020, we received a $170,200 bank loan backed by the United States Small Business Administration (SBA) pursuant to the Paycheck Protection Program (PPP) provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan bore an annual interest rate of one percent. We recorded accrued interest expense related to the PPP Loan of $-0- and $653 for the three-month and nine-month periods ended September 30, 2021, respectively, as compared to $429 and $774, respectively, for the same periods of 2020. During May 2021, upon receiving payment from the SBA, the lender forgave the full principal balance of $170,200 together with $1,856 of accrued interest and extinguished the PPP Loan.

Lease Agreement

We lease approximately 8,4008,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2018, with an additional 12-month renewal option. As of 2022. Rent expense for the three-month and nine-month periods ended September 30, 2017, our future2021 was $42,803 and $128,410, respectively, as compared to $41,539 and $124,617, respectively, for the same periods of 2020. Future minimum lease payments total $194,543, $37,998$42,803 for the remainder of which will 2021 and $176,356 in 2022, although the lease may be payable during 2017 and $156,545 in 2018.terminated at any time by either party with ninety days’ written notice.

Other Commitments

In the normal course of business, we may enter into various firm purchase commitments related to production and testing of our vaccine, products, conduct of our clinical trials,research studies, and other research-related activities. As of September 30, 2017, we had2021, there are approximately $79,000$607,000 of unrecorded outstanding purchase commitments to our vendors and subcontractors, all of which we expect will be paid during 2017. We expect this entire amount to be reimbursable to us pursuant to currently outstanding government grants (See Note 10).due in 2021.

Series B Convertible Preferred Stock

As of September 30, 2017, there arePreferred Stock –On June 7, 2021, we repurchased the remaining 100 shares of our Series B Convertible Preferred Stock (“Series B Preferred Stock”)for a total price of $1,000. As of September 30, 2021, there are 0 shares of our preferred stock outstanding. The Series B Preferred Stock may be converted at any time at

Public Offering –On February 11, 2021, we closed an underwritten public offering of 1,644,000 shares of our common stock, including 204,000 shares sold pursuant to the optionfull exercise of the holder intounderwriter’s option to purchase additional shares, at a price to the public of $6.25 per share. Net proceeds after deducting underwriting discounts and commissions and other offering expenses were approximately $9.4 million. Additionally, we issued to the underwriter, as a portion of the underwriting compensation, warrants to purchase 72,000 shares of our common stock at a conversionan exercise price of $0.35$6.875 per share, or 285,714 shares. During the nine months ended September 30, 2017, there were no conversions or other transactions involving our Series B Preferred Stock.share.

Series C Convertible Preferred Stock

As Options –We have a stock-based incentive plan (the “2020 Plan”) pursuant to which our Board of September 30, 2017, there are 2,690Directors may grant stock options and other stock-based awards to our employees, directors and consultants. A total of 1,500,000 shares of our Series C Convertible Preferred common stock are reserved for issuance pursuant to the 2020 Plan. During the nine months ended September 30, 2021, there were no stock option transactions related to the 2020 Plan. As of September 30, 2021, there were 602,000 stock options outstanding, with a weighted-average exercise price of $2.79 per share and a weighted-average remaining term of 9.2 years.

Stock (“Series C Preferred Stock”) outstanding. The Series C Preferred Stock may be converted at any time atPurchase Warrants –During January and February 2021, 188,688 stock purchase warrants were exercised on a cashless basis, resulting in the optionissuance of 145,866 shares of our common stock, and 690,034 stock purchase warrants were exercised for cash, resulting in the holderissuance of 690,034 shares of our common stock for net proceeds to us of $3,174,156.

During August 2021, 27,004 stock purchase warrants were exercised on a cashless basis, resulting in the issuance of 3,839 shares of our common stock, and 50,000 stock purchase warrants were exercised for cash, resulting in the issuance of 50,000 shares of our common stock for net proceeds to us of $230,000.

On September 28, 2021, in connection with our entering into an Assignment and License Agreement with PNP Therapeutics, Inc. (PNP) we issued a five-year stock purchase warrant to PNP for 100,000 shares of our common stock at a conversionan exercise price of $0.015$13.00 per share, or 179,349,733 shares. In May 2017, in connection with the issuance of our Series D Convertible Preferred Stock discussed below, the conversion price of our Series C Preferred Stock was automatically reduced from $0.05 per share to $0.015 per share. During the nine months ended September 30, 2017, we issued an aggregate of 11,862,000 shares of our common stock related to conversion of 178 shares our Series C Preferred Stock.

Series D Convertible Preferred Stock

In May 2017, we issued 1,000 shares of our Series D Convertible Preferred Stock, $1,000 stated value (“Series D Preferred Stock”), for gross proceeds of $1.0 million. Net proceeds, after deduction of certain expenses, were $980,000.

Each share of Series D Preferred Stock is entitled to a liquidation preference equal to the initial purchase price, has no voting rights, and is not entitled to a dividend. The Series D Preferred Stock is convertible at any time at the option of the holders into shares of our common stock, with an initial conversion price of $0.015 per share. The Series D Preferred Shares contains price adjustment provisions, which may, under certain circumstances, reduce the conversion price on future dates according to a formula based on the then-current market price for our common stock.

We assessed the Series D Preferred Stock under ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”), ASC Topic 815, “Derivatives and Hedging” (“ASC 815”), and ASC Topic 470, “Debt” (“ASC 470”). The preferred stock contains an embedded feature allowing an optional conversion by the holder into common stock which meets the definition of a derivative. However, we determined that the preferred stock is an “equity host” (as described by ASC 815) for purposes of assessing the embedded derivative for potential bifurcation and that the optional conversion feature is clearly and closely associated to the preferred stock host; therefore, the embedded derivative does not require bifurcation and separate recognition under ASC 815. We determined there to be a beneficial conversion feature (“BCF”) requiring recognition at its intrinsic value. Since the conversion option of the preferred stock was immediately exercisable, the amount allocated to the BCF was immediately accreted to preferred dividends, resulting in an increase in the carrying value of the preferred stock.

Increase in Authorized Shares of Common Stock

At a special meeting of our stockholders held on August 4, 2017, our stockholders approved an amendment to our certificate of incorporation to increase our authorized shares of common stock from 300,000,000 to 600,000,000 shares. The amendment to our certificate of incorporation was filed with the Delaware Secretary of State on August 4, 2017.

Common Stock Transactions

As discussed above, duringof September 30, 2021, there are 2,816,631 stock purchase warrants outstanding, with a weighted-average exercise price of $5.35 per share and a weighted-average remaining term of 3.9 years.

Other Common Stock Transactions – During the nine months ended September 30, 2017, 2021, we issued 11,862,00013,707 shares of our common stock pursuant to the conversion of 178 shares of our Series C Preferred Stock. During the nine months ended September 30, 2017, we also issued 3,816,667 shares of our common stock related to the exercise of stock purchase warrants, resulting in net proceeds to us of $154,167.consulting agreements.

Stock Options

The following table presents a summary of our stock option transactions during the nine months ended September 30, 2017:

Stock Purchase Warrants

The following table presents a summary of stock purchase warrant transactions during the nine months ended September 30, 2017:

10.Stock-Based Compensation Expense

Stock-based compensation expense related to ouremployee and director stock option plansoptions was $14,433$56,190 and $43,535 for$168,570 during the three-monththree-month and nine-monthnine-month periods ended September 30, 2017, respectively, as compared to $13,686 and $41,058 for the three-month and nine-month periods ended September 30, 2016, respectively. Additionally, during the three-month and nine-month periods ended September 30, 2016, we recorded $15,030 and $484,829, respectively, of2021, respectively; there was 0 stock-based compensation expense related to modifications toemployee stock purchase warrants.

options during the comparable periods of 2020.Stock-based compensation expense forrelated to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the related employee classification. As of September 30, 2017,2021, there was $88,449is $486,940 of unrecognized compensation expense related to stock options, whichthat we expect to recognize over a weighted averageweighted-average period of 1.92.2 years.

Because of our historically significant net operating losses, we have not paid income taxes since inception. We maintain deferred tax assets that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. These deferred tax assets are comprised primarily of net operating loss carryforwards and also include amounts relating to nonqualified stock options and research and development credits. The net deferred tax asset has been fully offset by a valuation allowance because of the uncertainty of our future profitability and our ability to utilize the deferred tax assets. Utilization of operating losses and credits will be subject to substantial annual limitations due to ownership change provisions of Section 382 of the Internal Revenue Code. The annual limitation will may result in the expiration of net operating losses and credits before utilization.

Government Grants and ContractsCollaboration Revenue

We receive payments from government entities under our grants and contracts withfrom the National Institute of Allergy and Infectious Diseases (NIAID) and from the U.S. Department of Defense in support of certain of our vaccine research and development efforts. We record revenue associated with government grants and contracts as the reimbursable costs are incurred. During the three-monththree-month and nine-monthnine-month periods ended September 30, 2017, 2021, we recorded $247,994$30,414 and $800,866,$220,539, respectively, of revenues associated with these grants, and contracts, as compared to $440,106$231,330 and $653,986,$1,186,844, respectively, for the comparable periods of 2016.2020. During the three-month and nine-month periods ended September 30, 2020, we also recorded $184,128 and $385,193, respectively, of revenues associated with research collaboration agreements with third parties. As of September 30, 2017, 2021, there is an aggregate of $744,769$244,888 in approved grant and contract funds available for use.use through mid-2022.

13.Subsequent Event

On November 9, 2021, we entered into an Exclusive License Agreement the (“License Agreement”) with City of Hope (“COH”) under which we obtained exclusive worldwide rights to key patents, know-how, regulatory filings and clinical materials related to COH’s COVID-19 vaccine program, currently undergoing human clinical trials. We will pay an upfront fee to COH of $5,000,000 within 30 days of the effective date of the License Agreement and are obligated to pay additional fees of $3,000,000 and $2,000,000 on the first and second anniversaries, respectively, of the effective date of the License Agreement. We will also pay COH milestone fees based on achievement of success-based development and regulatory milestones, and annual royalties on net sales of products covered by the License Agreement.

Collaboration Revenue

In March 2017, we entered into a clinical trial collaboration agreement with American Gene Technologies International, Inc. (“AGT”) whereby AGT intends to conduct a phase 1 human clinical trial investigating our combined technologies as a functional cure for HIV infection. In connection with the agreement, during the second quarterItem 2Management’s Discussion and Analysis of 2017 AGT paid to us a non-refundable feeFinancial Condition and Results of $95,000, which we recorded as collaboration revenue during the nine-month period ended September 30, 2017.

During October 2017, we issued 8,000,000 shares of our common stock pursuant to the conversion of 120 shares of our Series C Preferred Stock. During October and November 2017 we issued 5,000,000 shares of our common stock pursuant to the exercise of stock purchase warrants for net proceeds of $75,000.

FORWARD LOOKING STATEMENTS

In additionThe following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to historical information,help the informationreader understand our results of operations and financial condition. This MD&A is provided as a supplement to, and should be read in conjunction with, our condensed consolidated financial statements and the accompanying notes thereto and other disclosures included in this Quarterly Report on Form 10-Q contains forward-looking statements. Forward-looking(this “Report”), and our audited financial statements involve numerous risks and uncertainties, including but not limited to the risk factors set forth under the heading “Risk Factors”accompanying notes thereto included in theour Annual Report on Form 10-K for the year ended December 31, 2016,2020, which was filed with the Securities and should not be relied upon as predictions of future events. Certain suchExchange Commission on March 23, 2021.

Forward-Looking Statements

Information included in this Report contains forward-looking statements canwithin the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. All statements in this Report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, expectations and objectives could be identified by the use of forward-looking terminology such as ‘‘believes,’’ ‘‘expects,’’ ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘seeks,’’ ‘‘approximately,” ‘‘intends,’’ ‘‘plans,’’ ‘‘pro forma,’’ ‘‘estimates,’’ or ‘‘anticipates’’ or other variations thereof or comparable terminology, or by discussions of strategy, plans, or intentions.statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are necessarily dependent on assumptions, data, or methods thatbeyond our control, which may be incorrect or imprecise and may be incapable of being realized. The following factors, among others, could cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and future eventsfactors include, but are not limited to, differ materially from those factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020. We operate in a highly competitive, highly regulated and rapidly changing environment and our business is constantly evolving. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not possible for management to predict all such risk factors or contemplated inchanges therein, or to assess either the forward-looking statements:

Readers are cautioned not to place undue relianceimpact of all such risk factors on forward-looking statements, which reflect our management’s analysis only.business. We assume no obligation to publicly update or revise any forward-looking statements.statements, whether as a result of new information, future events or otherwise. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.

Overview

GeoVax is a clinical-stage biotechnology company developing humanimmunotherapies and vaccines against infectious diseases and cancercancers using a novel patentedvector vaccine platforms. GeoVax’s Modified Vaccinia Ankara-Virus LikeAnkara-Virus-Like Particle (MVA-VLP) vector vaccine platform. In thisbased platform utilizes MVA, a large virus capable of carrying several vaccine antigens, expressesto express proteins that assemble into highly effective VLPvirus-like particle (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated.vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The platform elicitsMVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

Our currentGeoVax’s MVA-VLP development programs are focused primarily on preventive vaccines against HIV,the SARS-CoV-2 virus (COVID-19) and immunotherapies for solid tumor cancers. Other development programs include preventive vaccines against Zika Virus, hemorrhagichemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), Human Immunodeficiency Virus (HIV), and malaria,malaria. 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 therapeutic vaccinesindirect support for chronic Hepatitis B infectionsthe conduct of preclinical animal studies and cancers. Allhuman clinical trials.

On September 28, 2021, we entered into an Assignment and License Agreement with PNP Therapeutics, Inc., whereby we expanded our immuno-oncology pipeline and added a new technology platform through the acquisition of exclusive worldwide 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. GeoVax’s license to Gedeptin includes rights to expand its use to all human diseases and/or conditions including, but not limited to, cancers.

On November 9, 2021, we entered into an Exclusive License Agreement with City of Hope, whereby we obtained exclusive worldwide rights to develop and commercialize COH04S1, a multi-antigenic COVID-19 vaccine currently undergoing Phase 2 human clinical trials. This program is supplemental to, and synergistic with, our potential productsexisting pan coronavirus vaccine (GEO-CM02), currently in preclinical testing.

Our programs are in preclinical research and development phases, with the exceptionvarious stages of our preventive HIV vaccine, which is currently in human clinical trials.development:

Our corporate strategy is to advance, protect and protectexploit our vaccinedifferentiated vaccine/immunotherapy platform leading to the successful development of preventive and use its capabilities totherapeutic vaccines against infectious diseases and various cancers. With our design and developdevelopment capabilities, we are progressing and validating an array of products. We aimcancer and infectious disease immunotherapy and vaccine product candidates. Our goal is to advance products successfully through to human clinical testing and to seekregistration, while considering partnership or licensing arrangements for achieving regulatory approval and commercialization. We will also leverage third partythird-party resources through collaborations and partnerships for preclinical and clinical testing. Our current collaborators include National Institute of Allergytesting, and Infectious Diseases (NIAID), HIV Vaccines Trial Network (HVTN), Centers for Disease Controlmanufacturing with multiple government, academic and Prevention (CDC), United States Army Research Institute of Infectious Disease (USAMRIID), University of Pittsburgh, Georgia State University Research Foundation, University of Maryland, Peking University, Burnet Institute, American Gene Technologies International, Inc., and ViaMune, Inc.corporate entities.

We have not generated any revenues from the sale of any of ourthe 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.

Results of Operations

The following tables summarize our results of operations for the three-month and nine-month periods ended September 30, 2021 and 2020: