As Filedfiled with the Securities and Exchange Commission onDecember 15, 2015. June 14, 2022
Registration No. 333-_______
333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
GEOVAX LABS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 2834 | 87-0455038 | ||
(State or other jurisdiction of incorporation or organization) | (Primary Standard Industrial Classification Code Number) | (I.R.S. Employer Identification Number) |
1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080
Tel: (678) 384-7220
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
David A. Dodd President & Chief Executive Officer GeoVax Labs, Inc. 1900 Lake Park Drive, Suite 380 Smyrna, Georgia 30080 Tel: (678) 384-7220
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(Name, address, including zip code, and telephone number, including area code, of agent for service) |
Copies to:
F. Reid Avett, Esq.
Womble Bond Dickinson (US) LLP
2001 K Street, NW, Suite 400 South
Washington, D.C. 20006
Tel: (202) 857-4425
Approximate date of commencement of proposed sale to the public:publicFrom time to time: As soon as practicable after the effective date of this registration statement.statement is declared effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box.box: ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer☐ Accelerated filer☐ Non-accelerated filer☐ Smaller reporting company☒
Calculation of Registration Fee
Title of Each Class Of Securities To Be Registered | Amount To Be Registered (1) | Proposed Maximum Offering Price Per Unit | Proposed Maximum Aggregate Offering Price | Amount of Registration Fee | ||||
Common stock, $0.001 par value per share underlying Series C convertible preferred stock, $0.001 par value per share | 10,733,902 (2) | $0.102 (3) | $1,094,858 (3) | $110.25 | ||||
TOTAL | 10,733,902 |
| $1,094,858 | $110.25 |
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Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
Title of Each Class of Security Being Registered | Amount Being Registered(1) | Proposed Maximum Offering Price per Security(2) | Proposed Maximum Aggregate Offering Price(2) | Amount of Registration | ||||||||||||
Common Stock, $0.001 par value per share (3) | 21,412,124 | $ | 1.47 | �� | $ | 31,457,822.28 | $ | 2,917.81 | ||||||||
Total | 21,412,124 | $ | 1.47 | $ | 31,457,822.28 | $ | 2,917.81 |
(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.
The Registrantregistrant hereby amends this Registration Statementregistration statement on such date or dates as may be necessary to delay its effective date until the Registrantregistrant shall file a further amendment which specifically states that this Registration Statementregistration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statementregistration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
EXPLANATORY NOTE
The Registrant previously registered 67,999,997 shares of its common stock on a Registration Statement on Form S-1 (File No. 333-202897) filed by the Registrant on March 20, 2015, and declared effective by the Securities and Exchange Commission on April 8, 2015. The Registrant registered an additional 4,460,094 shares of its common stock which became available to the selling stockholders no extra cost to them due to anti-dilution provisions on a Registration Statement on Form S-1 (File No. 333-206617) on August 27, 2015, which was immediately effective pursuant to Rule 462(b).
The shares of common stock being registered pursuant to this Registration Statement have become available to the selling stockholders at no cost to them due to certain anti-dilution provisions in the terms of the Series C Preferred Stock.
The information in this preliminary prospectus is not complete and may be changed. The selling stockholders may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it iswe are not soliciting offersan offer to buy these securities in any state or jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED DECEMBER 15, 2015June 14, 2022
PRELIMINARY PROSPECTUS
PROSPECTUSGEOVAX LABS, INC.
GEOVAX LABS, INC.
Up to 10,733,90221,412,124 Shares of Common Stock
This prospectus relates to the resale of up to 10,733,902an 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, $0.001 par value,Common Stock issuable upon the exercise of GeoVax Labs, Inc.pre-funded warrants issued in the Private Placement (the “Pre-Funded Warrant”), or(ii) 12,121,214 shares of Common Stock issuable upon the “Company,” that may be sold from timeexercise 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 time by the selling stockholders named in this prospectus, which includesresale of up to:
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The prices at whichto an aggregate of 21,212,124 Common Shares issuable upon the selling stockholders may sell the shares will be determined by the prevailing market price for the shares or in negotiated transactions. The shares included in this prospectus may be reoffered and sold directly by the selling stockholders in accordance with one or moreexercise of the methods described inPre-Funded Warrant and the planPreferred Investment Option by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (“Armistice”), 128,000 Common Shares issuable upon the exercise of distribution, which begins on page 3the 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 this prospectus. the 2021 Common Warrant by Maxim Partners.
We will not receive any proceeds from the salessale of outstandingthe Common Shares covered by this prospectus by the Selling Stockholders. All net proceeds from the sale of the Common Shares covered by this prospectus will go to the Selling Stockholders. However, we may receive the proceeds from any exercise of each of the Preferred Investment Option, the 2020 Common Warrant or the 2021 Common Warrant. See “Use of Proceeds.”
The Selling Stockholders may sell all or a portion of the Common 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 selling stockholders.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 is registered under Section 12(g) ofand the Securities Exchange Act of 1934 and quotedwarrants we issued to investors in a September 2020 public offering (the “September 2020 Warrants”) are listed on the over-the-counter marketNasdaq Capital Market under the symbol “GOVX.symbols “GOVX” and “GOVXW,” respectively. On December 11, 2015,June 10, 2022, the last reported sale price forof our common stock aswas $1.42 per share and the last reported onsale price of the over-the-counter marketSeptember 2020 Warrants was $0.11$0.56 per share.warrant.
This prospectus may only be used where it is legal to offer and sell the shares covered by this prospectus. We have not taken any action to register or obtain permission for this offering or the distribution of this prospectus in any country other than the United States.
Investing in theour shares of common stock involves a high degree of risk. See “Risk Factors”The risks are described in the “Risk Factors” section beginning on page 3 for a discussion6 of this prospectus. You should also consider the risk factors described or referred to in any applicable prospectus supplement before investing in these risks.securities.
Neither the Securities and Exchange Commission (“SEC”) nor any state securities commissionother regulatory body has approved or disapproved of these securities or determined ifpassed upon the accuracy or adequacy of this prospectus is truthful or complete.prospectus. Any representation to the contrary is a criminal offense.
The date of this Prospectusprospectus is December __, 2015, 2022.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS | ii |
PROSPECTUS SUMMARY |
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RISK FACTORS |
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USE OF PROCEEDS |
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DIVIDEND POLICY | 15 |
CAPITALIZATION | 16 |
BUSINESS |
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF |
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MANAGEMENT | 42 |
EXECUTIVE COMPENSATION | 45 |
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS | 49 |
SECURITY OWNERSHIP OF PRINCIPAL STOCKHOLDERS, DIRECTORS AND OFFICERS |
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SELLING STOCKHOLDERS |
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DESCRIPTION OF |
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PLAN OF DISTRIBUTION | 56 |
LEGAL MATTERS | 57 |
EXPERTS | 57 |
WHERE YOU CAN FIND MORE INFORMATION | 57 |
INDEX TO FINANCIAL STATEMENTS | F-1 |
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the SEC. As permitted by the rules and regulations of the SEC, the registration statement filed by us includes additional information not contained in this prospectus. You should rely onlymay read the registration statement and the other reports we file with the SEC at the SEC’s website described below under the heading “Where You Can Find More Information.”
Neither we nor the Selling Stockholders 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 take any responsibility for, or can provide any assurance as to the reliability of, any information other than the information contained in this prospectus, and any free-writingamendment or supplement to this prospectus or any free writing prospectus prepared by us or on behalfour behalf. We and the Selling Stockholders are offering to sell, and seeking offers to buy, shares of us or to which we have referred you. We have not authorized anyone to provide you with additional or different information. Theour common stock only in jurisdictions where offers and sales are permitted. You should assume that the information containedappearing 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 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 regardless ofin any jurisdiction where action for that purpose is required, other than in the time of deliveryUnited States. Persons outside the United States who come into possession of this prospectus ormust inform themselves about, and observe any restrictions relating to, the offering of any salethe securities as to distribution of our securities. the prospectus outside of the United States.
Unless the context otherwise requires, references to “GeoVax,” “we,” “our,” “us,”“us” or the “Company” in this prospectus mean GeoVax Labs, Inc.
We obtained industry and market data used throughoutits consolidated subsidiaries. Solely for convenience, trademarks and tradenames referred to in this prospectus throughmay appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our research, surveysrights, or that the applicable owner will not assert its rights, to these trademarks and studies conducted by third parties and industry and general publications. We have not independently verified market and industry data from third-party sources.tradenames.
PROSPECTUS SUMMARY
The following summary highlights certain information contained elsewhere in this prospectus. Because this is only a summary. We urgesummary, however, it does not contain all the information you toshould consider before investing in our securities and it is qualified in its entirety by, and should be read the entire prospectus, includingin conjunction with, the more detailed consolidated financial statements, notes toinformation included elsewhere in this prospectus. Before you make an investment decision, you should read this entire prospectus carefully, including the consolidated financial statements and other information included. Investingrisks of investing in our securities involves risks. Therefore, please carefully consider the information provideddiscussed under the heading “Risk Factors” starting on page 3.section of this prospectus entitled “Risk Factors.” You should not invest unless you can affordalso carefully read the exhibits to lose your entire investment.the registration statement of which this prospectus is a part.
COMPANY OVERVIEWOverview
GeoVax Labs, Inc. (“GeoVax” or the “Company”) is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using our novel vaccine platform. Our platform supports production of non-infectious virus-like particles (VLPs) from the cells of the person receiving the vaccine. Producing non-infectious VLPsproprietary platforms. GeoVax’s product pipeline includes ongoing human clinical trials in the person being vaccinated circumvents the need to purify virus-like particles for inoculation. The production of VLPs in the person being vaccinated mimics a natural infection, stimulating both the humoralCOVID-19 and cellular arms of the immune system to recognize, preventhead and control the target infection should it appear.
Our currentneck cancer. Additional research and development programs are focused oninclude preventive vaccines against Human ImmunodeficiencyZika Virus, (HIV) and hemorrhagic fever viruses (Ebola, Marburg). Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors. Our portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 70 granted or pending patent applications spread over 20 patent families.
Our Product Development Pipeline
We believe our technologyare currently developing a number of vaccines and vaccine development expertise is well-suitedimmunotherapies for a varietyprevention or treatment of human infectious diseases and potentially, cancer immunotherapy. We intend to pursue expansioncancers. The table below summarizes the status of our product pipeline.development programs, which are discussed in greater detail under the heading “Business” below.
Indication | Product Candidate | Current Status |
Coronavirus Vaccines | ||
COVID-19 (Booster to mRNA) | GEO-CM04S1 | Clinical - Phase 2 |
COVID-19 (Primary vaccine for immunocompromised patients) | GEO-CM04S1 | Clinical - Phase 2 |
Pan Coronavirus | GEO-CM02 | Preclinical/IND-Enabling |
Cancer Immunotherapy | ||
Solid Tumors (Advanced Head and Neck Cancer)* | Gedeptin® | Clinical - Phase 1/2 |
Solid Tumors (MUC1) | MVA-VLP-MUC1 | Preclinical/IND-Enabling |
Other Infectious Disease Vaccines | ||
Zika** | GEO-ZM02 | Preclinical/IND-Enabling |
Ebola, Marburg, Sudan** | GEO-EM01 | Preclinical/IND-Enabling |
Lassa Fever** | GEO-LM01 | Exploratory |
Malaria** | GEO-MM02 | Exploratory |
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* Orphan Drug status granted
** Indication within FDA Priority Review Voucher program
Our programs are in various stages of development, the most advanced HIV vaccine programsignificant of which are summarized below:
● | GEO-CM04S1 is currently undergoing a Phase 2 clinical trial (NCT04977024), evaluating its safety and efficacy as a preventive COVID-19 vaccine, compared to the Pfizer/BioNTech mRNA-based vaccine, in blood cancer patients who have received a bone marrow transplant or chimeric antigen receptor therapy (CAR T). |
● | In December 2021, patient enrollment began for the Phase 2 portion of a Phase 1/2 trial (NCT04639466) of GEO-CM04S1, evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. |
● | Gedeptin® is currently undergoing a Phase 1/2 clinical trial (NCT03754933) for treatment of patients with advanced head and neck cancer, which is being conducted with funding support from the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Grants Program. |
● | 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 focused onto advance, protect and exploit our differentiated vaccine/immunotherapy technologies leading to the clade B subtypesuccessful development of HIV prevalent in the Americaspreventive and Western Europe.therapeutic vaccines and immunotherapies against infectious diseases and various cancers. Our preventive clade B HIV vaccine has successfully completed Phase 2agoal is to advance products through to human clinical testing, and is targeted to enter a follow-onseek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical trial in early 2016. It has shown outstanding safetytesting with multiple government, academic and excellent and highly reproducible immunogenicity (Journal of Infectious Diseases volume 203, pg 610 and volume 210 pg 99). corporate entities.
We are also extending our HIV vaccine effort to the most common virus subtype affecting sub-Saharan Africa, clade C and are conducting preclinical studies pursuant to a granthave not generated any revenues from the National Institutessale of Health (NIH). Additionally,the products we are investigatingdeveloping, 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 HIV vaccines for their potentialresearch and development efforts, and we may never generate sufficient product revenue to contribute to combination therapies for therapeutic treatment leading to a cure for HIV infections.be profitable.
Our hemorrhagic fever vaccine program was initiated during 2014 with the objective of developing both monovalent vaccines and tetravalent vaccines designed to protect not only against current strains for filoviruses such as Ebola and Marburg, but also against other major hemorrhagic fever viruses endemic in African countries. Studies of our first Ebola vaccine candidate have demonstrated 100 percent protection in rodent models. We plan to conduct additional animal challenge studies during 2016 with the goal of beginning human clinical trials during the first half of 2017.Private Placement
In December 2015,On May 25, 2022, we entered into a Collaborative ResearchSecurities 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 Universityentrance 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 Pittsburgh1,050,000 shares of our common stock, a pre-funded warrant to evaluatepurchase up to 1,980,304 shares of our VLP vaccine platform for use in cancer immunotherapy, includingcommon stock and a preferred investment option to purchase up to 3,030,304 shares of common stock. Aggregate gross proceeds from the selectionprivate placement and testingregistered direct offerings to the Company were approximately $20.0 million.
Summary of vaccine candidates.Risk Factors
Our vaccine development activities have been,business is subject to numerous risks and continue to be, financially supported by the U.S. government. This support has been both in the form of research grants awarded directly to us, as well as indirect support for the conduct of our human clinical trials. This is discussed further under “Support from the United States Government” below.
Our HIV vaccine technology was developed in collaboration with researchers at Emory University, the NIH, and the Centers for Disease Control and Prevention (CDC). The technology developed by the collaboration is exclusively licensed to us from Emory University. We also have nonexclusive licenses to certain patents owned by the NIH. Our hemorrhagic fever virus vaccines have been developed with technology licensed from, and in collaboration with, the NIH.
Each of our vaccine development programs isuncertainties, discussed in greatermore detail in the sections that follow below.following section. These risks include, among others, the following key risks:
Company BackgroundRisks Related to Our Business and Capital Requirements
● | We have a history of operating losses, and we expect losses to continue for the foreseeable future. |
● | Our business will require continued funding. If we do not receive adequate funding, we may not be able to continue our operations. |
● | Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business. |
● | Our business could be adversely affected by widespread public health epidemics or other catastrophic events beyond our control. |
Risks Related to Development and Commercialization of Product Candidates and Dependence on Third Parties
● | Our products are still being developed and are unproven. These products may not be successful. |
● | We depend upon key personnel who may terminate their employment with us at any time. If we were to lose the services of any of these individuals, our business and operations may be adversely affected. |
● | Regulatory and legal uncertainties could result in significant costs or otherwise harm our business. |
● | We face intense competition and rapid technological change that could result in products that are superior to the products we will be commercializing or developing. |
● | Our product candidates are based on new medical technology and, consequently, are inherently risky. Concerns about the safety and efficacy of our products could limit our future success. |
● | We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects. |
● | Failure to obtain timely regulatory approvals required to exploit the commercial potential of our products could increase our future development costs or impair our future sales. |
● | State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities. |
● | Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations. |
● | We may not be successful in establishing collaborations for product candidates we seek to commercialize, which could adversely affect our ability to discover, develop, and commercialize products. |
● | We do not have manufacturing, sales or marketing experience. |
● | Our products under development may not gain market acceptance. |
● | We may be required to defend lawsuits or pay damages for product liability claims. |
● | Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that they will be widely used. |
Risks Related to Our Intellectual Property
● | We could lose our license rights to our important intellectual property if we do not fulfill our contractual obligations to our licensors. |
● | Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products. |
● | Any inability to protect intellectual property rights in the United States and foreign countries could limit our ability to manufacture or sell products. |
Risks Related to Our Common Stock
● | The market price of our common stock is highly volatile. |
● | The sale or issuance of additional shares of our common stock or other equity securities could result in additional dilution to our stockholders. |
● | Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control. |
● | We have never paid dividends and have no plans to do so. |
● | Public company compliance may make it more difficult for us to attract and retain officers and directors. |
● | Our Certificate of Incorporation and Bylaws may be amended by the affirmative vote of a majority of our stockholders. |
● | Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules. |
Corporate Information
We are incorporated under the laws of the State of Delaware. Our principal corporate offices are located at 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080 (metropolitan Atlanta). Our telephone number is (678) 384-7220. The address of our website is www.geovax.com. Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports, are available to you free of charge through the “Investors” section of our web site as soon as reasonably practicable after such materials have been electronically filed with, or furnished to, the Securities and Exchange Commission. Information contained on our website does not form a part of this prospectus.
The Offering
Shares offered |
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Shares of common stock outstanding prior to this offering | 12,547,829 shares of Common Stock. | ||
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| proceeds | We will not receive any proceeds from the sale of the shares of common stock by the Selling Stockholders. All net proceeds from the sale of the shares of common stock covered by this | |
Nasdaq Capital Markets symbols | Our common stock and the warrants we issued to investors in a September 2020 public offering (the “September 2020 Warrants”) are listed on the Nasdaq Capital Market under the symbols “GOVX” and “GOVXW,” respectively. | ||
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Risk factors | |||
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(1) The
Unless otherwise indicated, the number of shares of our common stock to be outstanding afterprior to this offering is based on 31,950,81312,547,829 shares of common stock outstanding as of December 11, 2015June 10, 2022, and excludes:exclude as of such date:
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● | 5,884,115 shares of common stock issuable upon the exercise of other outstanding | |
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RISK FACTORS
InvestingAn investment in our securities involves a high degree of risk. YouBefore making an investment decision, you should carefully review and consider the risks, uncertainties andfollowing risk factors as well as other factors described below before you decide whether to purchase our securities. Any of these factors could materially and adversely affect our business, financial condition, operating results and prospects and could negatively impact the market price of our common stock, and you may lose some or all of your investment.information we include in this prospectus. The risks and uncertainties described below are not the only ones facing our Company. Additional risks and uncertainties that we are unaware of,presently known to us or that we currently deem immaterial may also impairmaterially harm our business, operations. You should also refer to the information containedoperating results and financial condition and could result in this prospectus, including our financial statements and the related notes.a complete loss of your investment.
Risks Related to Our Business and Capital Requirements
We have a history of operating losses, and we expect losses to continue for the foreseeable future.
WeAs a research and development-focused company, we have had no product revenue to date and there can be no assurance thatrevenues from our government grants and other collaborations have not generated sufficient cash flows to cover operating expenses. Since our inception, we will ever generate any product revenue. We have experiencedincurred operating losses since we began operationseach year due to costs incurred in 2001. Asconnection with research and development activities and general and administrative expenses associated with our operations. We incurred a net loss of September 30, 2015, we had an accumulated deficit of approximately $31.8 million.$18.6 million, $3.0 million, $2.4 million, and $1.6 million for the years ended December 31, 2021 and 2020 and the three months ended March 31, 2022 and 2021, respectively. We expect to incur additional operating losses and expect cumulative losses to increase as our research and development, pre-clinical,preclinical, clinical, manufacturing and marketingmanufacturing efforts expand. Our ability to generate revenue and achieve profitability depends on our ability to successfully complete the development of our product candidates, conduct pre-clinicalpreclinical tests and clinical trials, obtain the necessary regulatory approvals, and manufacture and market the resultingor otherwise commercialize our products. Unless we are able to successfully meet these challenges, we will not be profitable and may not remain in business.
Our business will require continued funding. If we do not receive adequate funding, we willmay not be able to continue our operations.
To date, we have financed our operations principally through the private placementsale of our equity securities and through NIH grants.government grants and clinical trial support. We will require substantial additional financing at various intervals for our operations, including clinical trials, operating expenses, intellectual property protection and enforcement, for pursuit of regulatory approvals, and for establishing or contracting out manufacturing, marketing and sales functions. There is no assurance that such additional funding will be available on terms acceptable to us or at all. If we are not able to secure the significant funding that is required to maintain and continue our operations at current levels, or at levels that may be required in the future, we may be required to delay clinical studies or clinical trials, curtail operations, or obtain funds through collaborative arrangements that may require us to relinquish rights to some of our products or potential markets.
The costs of conducting all of our human clinical trials to date for our preventive HIV vaccine have been borne by the HIV Vaccine Trials Network (HVTN), with funding by the NIH, and we expect NIHWe may pursue additional support for additional clinical trials. GeoVax incurs costs associated with manufacturing the clinical vaccine supplies and other study support. We cannot predict the level of support we will receive from the HVTN or the NIH for any additional clinical trials of our HIV vaccines.
Our operations are also partially supported by the NIH grants awarded to us to support our HIV/AIDS vaccine program. As of September 30, 2015, there was approximately $261,000 of unused grant funds remaining and available for use during the remainder of 2015 and the first half of 2016. We are pursuing additional grants from the federal government for both our HIVvaccine and Ebola/Marburg vaccine programs. However,immunotherapy development programs; however, as we progress to the later stages of our vaccine development activities, government financial support may be more difficult to obtain, or may not be available at all. Furthermore, there is some risk that actual funding for grants could be delayed, cut back, or eliminated due to government budget constraints. Therefore, it will be necessary for us to look to other sources of funding in order to finance our development activities.
We expect that our current working capital combined with proceeds from the grants awarded to us from the NIH will be sufficient to support our planned level of operations through the first quarter of 2016.into early 2024. We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations beyond the first quarter of 2016.operations. In order to meet our operating cash flow requirementsneeds 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.
Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business.
We rely upon a combination of information technology systems and traditional recordkeeping to operate our business. In the ordinary course of business, we collect, store, and transmit confidential information (including, but not limited to, personal information and intellectual property). We have also outsourced elements of our operations to third parties, including elements of our information technology systems and, as a result, we manage a number of independent vendor relationships with third parties who may or could have access to our confidential information. Our information technology and information security systems and records are potentially vulnerable to security breaches, service interruptions, or data loss from inadvertent or intentional actions by our employees or vendors. Our information technology and information security systems and records are also potentially vulnerable to malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of expertise and motives (including, but not limited to, financial crime, industrial espionage, and market manipulation).
While we have invested, and continue to invest, a portion of our limited funds in our information technology and information security systems, there can be no assurance that our efforts will prevent security breaches, service interruptions, or data losses. Any security breaches, service interruptions, or data losses could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business, and reputational harm to us or allow third parties to gain material, inside information that they may use to trade in our securities.
Our business could be adversely affected by widespread public health epidemics or other catastrophic events beyond our control.
In addition to our reliance on our own employees and facilities, we depend on our collaborators, laboratories and other facilities for the continued operation of our business. Despite any precautions we take, public health epidemics, such as COVID-19, or other catastrophic events, such as natural disasters, terrorist attacks, hurricanes, fire, floods and ice and snowstorms, may result in interruptions in our business.
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.
Risks Related to Development and Commercialization of Product Candidates and Dependence on Third Parties
Our products are still being developed and are unproven. These products may not be successfulsuccessful.
To become profitable, we must generate revenue through sales of our products. However, our products are in varying stages of development and testing. Our products have not been proven in human clinical trials and have not been approved by any government agency for sale. If we cannot successfully develop and prove our products and processes, or if we do not develop other sources of revenue, we will not become profitable and at some point, we would discontinue operations.
Whether we are successful will be dependent, in part,We depend upon the leadership provided by our management.key personnel who may terminate their employment with us at any time. If we were to lose the services of any of these individuals, our business and operations may be adversely affected. Further, we may not carry key man life insurance on certain
The success of our executive officers or directors.business strategy will depend to a significant degree upon the continued services of key management, technical and scientific personnel and our ability to attract and retain additional qualified personnel and managers. Competition for qualified personnel is intense among companies, academic institutions and other organizations. The ability to attract and retain personnel is adversely affected by our financial challenges. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.
Whether our business will be successful will be dependent, in part, upon the leadership provided by our officers, particularly our President and Chief Executive Officer and our Chief Scientific Officer. The loss of the services of these individuals may have an adverse effect on our operations. Although we carry some key man life insurance on Dr. Harriet L. Robinson, the amount of such coverage may not be sufficient to offset any adverse economic effects on our operations and we do not carry key man insurance on any of our other executive officers or directors. Further, our employees, including our executive officers and directors, are not subject to any covenants not to compete against the Company, and our business could be adversely affected if any of our employees or directors engaged in an enterprise competitive with the Company.
Regulatory and legal uncertainties could result in significant costs or otherwise harm our business.
To manufacture and sell our products, we must comply with extensive domestic and international regulation. In order to sell our products in the United States, approval from the FDAU.S. Food and Drug Administration (the “FDA”) is required. Satisfaction of regulatory requirements, including FDA requirements, typically takes many years, and if approval is obtained at all, it is dependent upon the type, complexity and novelty of the product, and requires the expenditure of substantial resources. We cannot predict whether our products will be approved by the FDA. Even if they are approved, we cannot predict the time frame for approval. Foreign regulatory requirements differ from jurisdiction to jurisdiction and may, in some cases, be more stringent or difficult to meet than FDA requirements. As with the FDA, we cannot predict if or when we may obtain these regulatory approvals. If we cannot demonstrate that our products can be used safely and successfully in a broad segment of the patient population on a long-term basis, our products would likely be denied approval by the FDA and the regulatory agencies of foreign governments.
We face intense competition and rapid technological change that could result in products that are superior to the products we will be commercializing or developing.
The market for vaccines that protect against or treat human infectious diseases is intensely competitive and is subject to rapid and significant technological change. We have numerous competitors in the United States and abroad, including, among others, large companies with substantially greater resources than us. These competitors may develop technologies and products that are more effective or less costly thanIf any of our future technologycompetitors develop products with efficacy or products or that could rendersafety profiles significantly better than our technology or products, obsolete or noncompetitive. If our technology or products are not competitive, we may not be able to commercialize our products, and sales of any of our commercialized products could be harmed. Some of our competitors and potential competitors have substantially greater product development capabilities and financial, scientific, marketing and human resources than we do. Competitors may develop products earlier, obtain FDA approvals for products more rapidly, or develop products that are more effective than those under development by us. We will seek to expand our technological capabilities to remain competitive; however, research and development by others may render our technologies or products obsolete or noncompetitive or result in business.treatments or cures superior to ours.
Our product candidates are based on new medical technology and, consequently, are inherently risky. Concerns about the safety and efficacy of our products could limit our future success.
We are subject to the risks of failure inherent in the development of product candidates based on new medical technologies. These risks include the possibility that the products we create will not be effective, that our product candidates will be unsafe or otherwise fail to receive the necessary regulatory approvals, and that our product candidates will be harddifficult to manufacture on a large scale or will be uneconomical to market.
Many pharmaceutical products cause multiple potential complications and side effects, not all of which can be predicted with accuracy and many of which may vary from patient to patient. Long term follow-up data may reveal additionalpreviously unidentified complications associated with our products. The responses of potential physicians and others to information about complications could materially adversely affect the market acceptance of our products, which in turn would materially harm our business.
We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects.
We do not know whether planned pre-clinical and clinical trials will begin on time or whether we will complete any of our clinical trials on schedule, if at all. Product development costs will increase if we have delays in testing or approvals, or if we need to perform more or larger clinical trials than planned. Significant delays may adversely affect our financial results and the commercial prospects for our products and delay our ability to become profitable.
We rely heavily on the HVTN, independent clinical investigators, vaccine manufacturers, and other third partythird-party service providers for successful execution of our clinical trials, but do not control many aspects of their activities. We are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or our stated protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates. There is also a risk of changes in clinical trial strategy and timelines due to the HVTN and the NIH altering their trial strategy.
Failure to obtain timely regulatory approvals required to exploit the commercial potential of our products could increase our future development costs or impair our future sales.
None of our vaccines are approved by the FDA for sale in the United States or by other regulatory authorities for sale in foreign countries. To exploit the commercial potential of our technologies, we are conducting and planning to conduct additional pre-clinical studies and clinical trials. This process is expensive and can require a significant amount of time. Failure can occur at any stage of testing, even if the results are favorable. Failure to adequately demonstrate safety and efficacy in clinical trials could delay or preclude regulatory approval and restrict our ability to commercialize our technology or products. Any such failure may severely harm our business. In addition, any approvals we obtain may not cover all of the clinical indications for which approval is sought or may contain significant limitations in the form of narrow indications, warnings, precautions or contraindications with respect to conditions of use, or in the form of onerous risk management plans, restrictions on distribution, or post-approval study requirements.
State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities.
In recent years, severalSeveral states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs and file periodic reports on sales, marketing, pricing and other activities. Similar legislation is being considered in other states. Many of these requirements are new and uncertain, and available guidance is limited. Unless we are in full compliance with these laws, we could face enforcement action, fines, and other penalties and could receive adverse publicity, all of which could harm our business.
We may be subject to new federalChanges in healthcare law and state legislation to submit information on our open and completed clinical trials to public registries and databases.
In 1997, a public registry of open clinical trials involving drugs intended to treat serious or life-threatening diseases or conditions was established under the FDA Modernization Act (FDMA), to promote public awareness of and access to these clinical trials. Under the FDMA, pharmaceutical manufacturers and other trial sponsors are required to post the general purpose of these trials,implementing regulations, as well as the eligibility criteria, locationchanges in healthcare policy, may impact our business in ways that we cannot currently predict, and contact informationmay have a significant adverse effect on our business and results of the trials. Since the establishment of this registry, there has been significant public debate focused on broadening the types of trials included in this or other registries, as well as providing for public access to clinical trial results. A voluntary coalition of medical journal editors has adopted a resolution to publish results only from those trials that have been registered with a no-cost, publicly accessible database, such as www.clinicaltrials.gov. Federal legislation was introduced in the fall of 2004 to expand www.clinicaltrials.gov and to require the inclusion of trial results in this registry. The Pharmaceutical Research and Manufacturers of America also issued voluntary principles for its members to make results from certain clinical trials publicly available and established a website for this purpose. Other groups have adopted or are considering similar proposals for clinical trial registration and the posting of clinical trial results. Failure to comply with any clinical trial posting requirements could expose us to negative publicity, fines and other penalties, all of which could materially harm our business.
Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain.operations.
In the United States and some foreign jurisdictions, there have been, a number ofand continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our drugproduct candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any drugproduct candidates for which we obtain marketing approval.
Among policy makers and payors in the United States and elsewhere, including in the European Union, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality andand/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. In March 2010, President Obama signed into law the
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act or collectivelyof 2010 (collectively, the PPACA,“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 sweeping lawnumber of provisions that are intended to broaden accesslower healthcare costs, including provisions relating to health insurance, reduce or constrain the growth of healthcareprescription drug prices and government spending enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.medical products.
Among the provisionsSince its enactment, there have also been judicial and Congressional challenges to certain aspects of the PPACAAffordable Care Act, as well as efforts by the former Trump administration to repeal or replace certain aspects of importancethe statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our potential drug candidates are:business. It is uncertain the extent to which any such changes may impact our business or financial condition.
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In addition, other legislative changesThere 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 and adopted since the PPACA was enacted. These changes include aggregate reductionsbills, as well as state efforts, designed to, Medicare payments to providers of up to 2% per fiscal year, starting in 2013. On March 1, 2013, the President signed an executive order implementing the 2% Medicare payment reductions, and on April 1, 2013, these reductions went into effect. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare paymentsbring more transparency to several providersproduct pricing, review the relationship between pricing and increasedmanufacturer patient programs, and reform government program reimbursement methodologies for drug products. In June 2017, the statuteFDA issued a Drug Competition Action plan intended to lower prescription drug prices by encouraging competition from generic versions of limitationsexisting products. In July 2018, the FDA issued a Biosimilar Action Plan, intended to similarly promote competition to prescription biologics from biosimilars.
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. Effective in 2016, Vermont passed a law requiring certain manufacturers identified by the governmentstate to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and, accordingly, our financial operations.justify their price increases.
We expect that the PPACA, as well asthese, and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that we receive for any approved drug.product. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payers.payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs.drugs, once marketing approval is obtained.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
We may not be successful in establishing collaborations for product candidates we may seek to commercialize, which could adversely affect our ability to discover, develop, and commercialize products.
We expect to seek collaborations for the development and commercialization of product candidates in the future. The timing and terms of any collaboration will depend on the evaluation by prospective collaborators of the clinical trial results and other aspects of our vaccine’sa product’s safety and efficacy profile. If we are unable to reach agreements with suitable collaborators for any product candidate, we will be forced to fund the entire development and commercialization of such product candidates, ourselves, and we may not have the resources to do so. If resource constraints require us to enter into a collaboration agreement early in the development of a product candidate, we may be forced to accept a more limited share of any revenues thisthe product may eventually generate. We face significant competition in seeking appropriate collaborators. Moreover, these collaboration arrangements are complex and time-consuming to negotiate and document. We may not be successful in our efforts to establish collaborations or other alternative arrangements for any product candidate. Even if we are successful in establishing collaborations, we may not be able to ensure fulfillment by collaborators of their obligations or our expectations.
We do not have manufacturing, sales or marketing experience.
We do not have experience in manufacturing, selling, or marketing vaccines.marketing. To obtain the expertise necessary to successfully manufacture, market, and sell our vaccines,products, we will require the development ofmust develop our own commercial infrastructure and/or collaborative commercial arrangements and partnerships. Our ability to execute our current operating plan is dependent on numerous factors, including, the performance of third partythird-party collaborators with whom we may contract.
Our vaccinesproducts under development may not gain market acceptance.
Our vaccinesproducts may not gain market acceptance among physicians, patients, healthcare payers and the medical community. Significant factors in determining whether we will be able to compete successfully include:
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We may be required to defend lawsuits or pay damages for product liability claims.
Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and for products that we sell after regulatory approval. We carry product liability insurance and we expect to continue such policies. However, product liability claims, regardless of their merits, could exceed policy limits, divert management’s attention, and adversely affect our reputation and the demand for our products.
Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that they will be widely used.
Market acceptance of products we develop, if approved, will depend on reimbursement policies and may be affected by, among other things, future healthcare reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for any products that we may develop. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for our products. If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize products that we develop.
Risks Related to Our Intellectual Property
We could lose our license rights to our important intellectual property if we do not fulfill our contractual obligations to our licensors.
Our rights to significant parts of the technology we use in our vaccinesproducts are licensed from third parties and are subject to termination if we do not fulfill our contractual obligations to our licensors. Termination of intellectual property rights under any of our license agreements could adversely impact our ability to produce or protect our vaccines.products. Our obligations under our license agreements include requirements that we make milestone payments to our licensors upon the achievement of clinical development and regulatory approval milestones, royalties as we sell commercial products, and reimbursement of patent filing and maintenance expenses. Should we become bankrupt or otherwise unable to fulfill our contractual obligations, our licensors could terminate our rights to critical technology that we rely upon.
Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products.
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 products have been subject to substantial patent rights litigation in the pharmaceutical industry. These lawsuits generally relate to the validity and infringement of patents or 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 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:
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Any litigation or interference proceedings, regardless of their outcome, would likely delay the regulatory approval process, be costly and require significant time and attention of our key management and technical personnel.
Any inability to protect intellectual property rights in the United States and foreign countries could limit our ability to manufacture or sell products.
We will rely on trade secrets, unpatented proprietary know-how, continuing technological innovation and, in some cases, patent protection to preserve our competitive position. Our patents and licensed patent rights may be challenged, invalidated, infringed or circumvented, and the rights granted in those patents may not provide proprietary protection or competitive advantages to us. We and our licensors may not be able to develop patentable products.products with acceptable patent protection. Even if patent claims are allowed, the claims may not issue, or in the event of issuance, may not be sufficient to protect the technology owned by or licensed to us. If patents containing competitive or conflicting claims are issued to third parties, we may be prevented from commercializing the products covered by such patents or may be required to obtain or develop alternate technology. In addition, other parties may duplicate, design around or independently develop similar or alternative technologies.
We may not be able to prevent third parties from infringing or using our intellectual property, and the parties from whom we may license intellectual property may not be able to prevent third parties from infringing or using the licensed intellectual property. We generally will attempt to control and limit access to, and the distribution of, our product documentation and other proprietary information. Despite efforts to protect this proprietary information, unauthorized parties may obtain and use information that we may regard as proprietary. Other parties may independently develop similar know-how or may even obtain access to these technologies.
The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries.
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.
Risks Related To This Offering andto Our SecuritiesCommon Stock
The market price of our common stock is highly volatile.
The market price of our common stock has been, and is expected to continue to be, highly volatile. Certain factors, including announcements of new developments by us or other companies, regulatory matters, new or existing medicines or procedures, concerns about our financial position, operating results, litigation, government regulation, developments or disputes relating to agreements, patents or proprietary rights, may have a significant impact on the market price of our stock. In addition, potential dilutive effects of future sales of shares of common stock by us, and subsequent sales of common stock by the holders of warrantsour options and optionswarrants could have an adverse effect on the market price of our shares.
OurIn addition, the securities markets from time-to-time experience significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock does not have a vigorous trading market and investors may not be able to sell their securities when desired.stock.
We have a limited active public market for our common shares. A more active public market, allowing investors to buy and sell large quantitiesThe sale or issuance of additional shares of our common stock or other equity securities could result in additional dilution to our stockholders.
In order to meet our operating cash flow needs, we may never develop. Consequently,plan additional offerings of our equity securities, debt, or convertible debt instruments. The sale of additional equity securities could result in significant additional dilution to our stockholders. The incurrence of indebtedness could result in debt service obligations and operating and financing covenants that would restrict our operations. We cannot assure investors that financing will be available in amounts or on terms acceptable to us, if at all.
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 shares at a nominal exercise price, and other outstanding warrants are exercisable for 18,005,329 shares at exercise prices ranging from $1.65 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.
Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may notmake it more difficult for a third party to effect a change in control.
Our certificate of incorporation authorizes our Board of Directors to issue up to 10,000,000 shares of preferred stock. The shares of preferred stock may be ableissued in one or more series, the terms of which may be determined at the time of issuance by our Board of Directors without further action by the stockholders. These terms may include voting rights, including the right to liquidate their investmentsvote as a series on particular matters, preferences as to dividends and liquidation, conversion rights, redemption rights and sinking fund provisions. The issuance of any newly issued preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of our common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell assets to, a third party. The ability of our Board of Directors to issue preferred stock could make it more difficult, delay, discourage, prevent or make it costlier to acquire or effect a change-in-control, which in turn could prevent the stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of an emergency or for any other reason.our common stock.
We have never paid dividends and have no plans to do so.
Holders of shares of our common stock are entitled to receive such dividends as may be declared by our Board of Directors. To date, we have paid no cash dividends on our shares of common stock and we do not expect to pay cash dividends on our common stock in the foreseeable future. We intend to retain future earnings, if any, to provide funds for operations of our business. Therefore, any potential return investors may have in our common stock will be in the form of appreciation, if any, in the market value of their shares of common stock.
If we fail to maintain an effective system of internal controls, wePublic company compliance may not be able to accurately report our financial results or prevent fraud.
We are subject to reporting obligations under the United States securities laws. The Securities and Exchange Commission (SEC) as required by the Sarbanes-Oxley Act of 2002, adopted rules requiring every public company to include a management report on such company’s internal controls over financial reporting in its annual report. Effective internal controls are necessarymake it more difficult for us to produce reliable financial reportsattract and are importantretain officers and directors.
The Sarbanes-Oxley Act, the Dodd-Frank Act, the JOBS Act, the FAST Act, and rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies. As a public company, we expect these rules and regulations, and amendments to help prevent fraud.them, to contribute to our compliance costs and to make certain activities more time consuming and costly. As a public company, we also expect that these rules and regulations may make it difficult and expensive for us to obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be difficult for us to attract and retain qualified persons to serve on our failureboard of directors or as executive officers.
Our Certificate of Incorporation and Bylaws may be amended by the affirmative vote of a majority of our stockholders.
Under the Delaware General Corporation Law, a corporation’s certificate of incorporation may be amended by the affirmative vote of the holders of a majority of the outstanding shares entitled to achievevote, and maintain effective internal controls over financial reporting could resulta majority of the outstanding shares of each class entitled to vote as a class, unless the articles require the vote of a larger percentage of shares. Our Certificate of Incorporation, as amended, does not require the vote of a larger percentage of shares. As permitted under the Delaware General Corporation Law, our Bylaws give our board of directors the power to adopt, amend, or repeal our Bylaws. Our stockholders entitled to vote have concurrent power to adopt, amend, or repeal our Bylaws.
Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules.
The SEC has adopted a number of rules to regulate “penny stocks” that restrict transactions involving stock which is deemed to be penny stock. Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may have the effect of reducing the liquidity of penny stocks. “Penny stocks” generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on Nasdaq if current price and volume information with respect to transactions in such securities is provided by the exchange or system). Our securities have in the loss of investor confidencepast constituted, and may again in the reliabilityfuture, if we are delisted from Nasdaq, constitute, “penny stock” within the meaning of the rules. The additional sales practice and disclosure requirements imposed upon U.S. broker-dealers may discourage broker-dealers from effecting transactions in shares of our financial statements,common stock, which in turn could negatively impact the trading price of our stock.
If we fail to remain current in our reporting requirements, our securities could be removed from the OTC Market, which wouldseverely limit the ability of broker-dealers to sell our securities and the ability of stockholders to sell their securities in the secondary market.
United States companies trading on the OTC Market must be reporting issuers under Section 12 of the Exchange Act, and must be current in their reports under Section 13. If we fail to remain current on our reporting requirements, we could be removed from the OTC Market. As a result, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securitiessuch shares and the ability of stockholders to sellimpede their securitiessale in the secondary market.
We expectA U.S. broker-dealer selling penny stock to need additional capital, and the sale of additional shares or other equity securities could result in additional dilution to our stockholders.
We believe that our current cash and cash equivalents, combined with anticipated cash flow from our NIH grants will be sufficient to meet our anticipated cash needs through the first quarter of 2016. In order to meet our operating cash flow requirements we plan additional offerings of our equity securities, debt, or convertible debt instruments. The sale of additional equity securities could result in additional dilution to our stockholders. Certain equity securities, such as convertible preferred stock or warrants, may contain anti-dilution provisions which could result in the issuance of additional shares at lower prices if we sell other shares below specified prices. The incurrence of indebtedness would result in debt service obligations and could result in operating and financing covenants that would restrict our operations. We cannot assure investors that financing will be available in amounts or on terms acceptable to us, if at all.
Our directors and executive officers beneficially own a significant amount of our common stock and will be able to exercise significant influence on matters requiring stockholder approval.
As of December 11, 2015, our directors and executive officers collectively beneficially own approximately 8.7% of our common stock and Emory University beneficially owns 14.5%. If our directors and executive officers move to act in concert with Emory University, they may be able to exert significant influence over the election of directors and the outcome of most corporate actions requiring stockholder approval and our business, which may have the effect of delaying or precluding a third party from acquiring control of us.
The exercise of options or warrants or conversion of our Series B or Series C Preferred Stock may depress our stock price and may result in significant dilution to our common stockholders.
There are a significant number of outstanding warrants and options to purchase our stock and we have issued Series B and Series C Convertible Preferred Stock that is convertible into our Common Stock. If the market price of our Common Stock exceeds the exercise price of outstanding warrants and options or the conversion prices of the Series B or Series C Convertible Preferred Stock, holders of those securities may be likely to exercise their warrants and options or convert their preferred shares and sell the Common Stock acquired upon exercise or conversion of such securities, as applicable, in the open market. Sales of a substantial number of shares of our Common Stock in the public market by holders of warrants, options, or preferred shares may depress the prevailing market price for our Common Stock and could impair our ability to raise capital through the future sale of our equity securities. Additionally, if the holders of outstanding options, warrants, or preferred shares exercise those options or warrants or convert those preferred shares, as applicable, our common stockholders will incur dilution in their relative percentage ownership. The prospect of this possible dilution may also impact the price of our Common Stock.
Our outstanding options and warrants include warrants to purchase up to 34,666,665 shares with an exercise price of $0.11299 per share, and warrants to purchase up to 19,357,332 shares with an exercise price of $0.09416 per share.These warrants contain anti-dilution provisions, which may, under certain circumstances, reduce the exercise price (but have no effect on the number of shares subject to the warrants) to match if we sell or grant options to purchase, including rights to reprice, our common stock or common stock equivalents at a price lower than the exercise price of the warrants, or if we announce plans to do so. This potential reduction in exercise price could reduce the funds the Company receives upon exercise of the warrants, and increase the likelihood that a dilutive issuance will occur.
Our common stock is and likely will remain subject to the SEC’s “penny stock” rules, which make it more difficult to sell.
Our common stock is currently and may remain classified as a “penny stock.” The SEC rules regarding penny stocks may have the effect of reducing trading activity in our shares, making it more difficult for investors to sell. Under these rules, broker-dealers who recommend such securities to personsanyone other than institutional accredited investors must:
an established customer or “accredited investor” (generally, an individual with net worth in excess of $1,000,000 (exclusive of personal residence) or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special written suitability determination for the purchaser;
purchaser and must receive the purchaser’s written agreementconsent to athe transaction prior to sale;
providesale, unless the purchaserbroker-dealer or the transaction is otherwise exempt. In addition, the “penny stock” regulations require the U.S. broker-dealer to deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in accordance with risk disclosure documents which identify certain risks associatedSEC standards relating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt. A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price information with investingrespect to the “penny stock” held in a customer’s account and information with respect to the limited market in “penny stocks” and which describe.
Stockholders should be aware that, according to the SEC, the market for these “penny stocks” as well ashas suffered in recent years from patterns of fraud and abuse. Such patterns include (i) control of the market for the security by one or a purchaser’s legal remedies;
obtainfew broker-dealers that are often related to the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) “boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a signed and dated acknowledgment fromdesired level, resulting in investor losses. Our management is aware of the purchaser demonstratingabuses that have occurred historically in the purchaser has received the required risk disclosure document before a transactionpenny stock market. Although we do not expect to be in a “penny stock” can be completed; and
give bid and offer quotations and broker and salesperson compensation informationposition to dictate the customer orallybehavior of the market or of broker-dealers who participate in writing before or with the confirmation.
These rules make it more difficult for broker-dealersmarket, management will strive within the confines of practical limitations to effectuate customer transactions and trading activity in our securities and may result in a lower trading volume of our common stock and lower trading prices.
Certain provisions of our certificate of incorporation which authorize the issuance of additional shares of preferred stock may make it more difficult for a third party to effect a change in control.
Our certificate of incorporation authorizes our Board of Directors to issue up to 10,000,000 shares of preferred stock. We have issued 100 shares of Series B Convertible Preferred Stock and 3,000 shares of our Series C Convertible Preferred Stock. We believe the terms of these preferred shares would not have a substantial impact on the ability of a third party to effect a change in control. The remaining shares of preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our Board of Directors without further action by the stockholders. These terms may include voting rights including the right to vote as a series on particular matters, preferences as to dividends and liquidation, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of our common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell assets to, a third party. The ability of our Board of Directors to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a change-in-control, which in turn could prevent the stockholdersdescribed patterns from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price ofbeing established with respect to our common stock.securities.
Provisionscontained in certain of our outstanding warrants may make it more difficult for a third party to effect a change in control.CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Our outstanding warrants include warrants to purchase up to 54,023,997 shareswhich contain provisions permitting the holders to require the payment to them of an amount of cash equal to the value (based on a Black-Scholes computation)Some of the remaining unexercised portionstatements in this prospectus contain forward-looking statements within the meaning of Section 27A of the warrants on the dateSecurities Act of 1933, as amended (the “Securities Act”), and Section 21E of the consummationSecurities Exchange Act of a fundamental transaction (as defined, but generally a change in control of the Company) that is (i) an all cash transaction, (ii) a “going private” transaction, or (ii) a transaction involving a person or entity not traded on a national securities exchange. The prospect of making such payments may discourage a potential third party acquirer.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements. Forward-looking1934, as amended (the “Exchange Act”). These statements relate to future events or our future financial performance.performance and involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our ability to control or predict and that may cause actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by forward-looking statements. These factors include but are not limited to those described under “Risk Factors” herein, as well as the other information contained in this prospectus. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this prospectus. Readers are cautioned not to place undue reliance on forward-looking statements. We generallyundertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.
In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or“potential,” “continue” or the negative of these terms or other similar words,comparable terminology, although not all forward-looking statements contain these identifying words. Forward-lookingOur forward-looking statements may include, but are not limited to,among other things, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating losses, future performance, future revenues and projected expenses; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current executive officers, directors and principal consultants; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into any collaboration with respect to product candidates; the performance of our third-party manufacturers; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; our reliance on key scientific management or personnel; the payment and reimbursement methods used by private or governmental third-party payers; and other factors discussed elsewhere in this prospectus or any document incorporated by reference herein or therein.about:
The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this prospectus are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section titled “Risk Factors.” Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. “Risk Factors” and “Business,” as well as other sections in this prospectus or incorporated by reference into this prospectus, discuss some of the factors that could contribute to these differences.
● | our ability to continue as a going concern and our history of losses; |
● | our ability to obtain additional financing; |
The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Other factors besides those described in this prospectus could also affect our actual results.
● | our use of the net proceeds from this offering; |
● | our ability to prosecute, maintain or enforce our intellectual property rights; |
● | the accuracy of our estimates regarding expenses, future revenues and capital requirements; |
● | the implementation of our business model and strategic plans for our business and technology; |
● | the successful development and regulatory approval of our technologies and products; |
● | the potential markets for our products and our ability to serve those markets; |
● | the rate and degree of market acceptance of our products and any future products; |
● | our ability to retain key management personnel; and |
● | regulatory developments and our compliance with applicable laws. |
This prospectus also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. While we believe these assumptions to be reasonable and sound as of the date of this prospectus, if these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may have a material adverse effect on our business, results of operations, financial condition and the market price of our common stock.
USE OF PROCEEDS
We will not receive any proceeds from the salessale of the shares of common stock by the selling stockholders.
MARKET FOR OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
Market Information
OurSelling Stockholders. All net proceeds from the sale of the shares of common stock is currently traded oncovered by this prospectus will go to the OTCQB Market underSelling Stockholders. We expect that the symbol “GOVX”. The following table sets forth the high and low bid prices for our common stock for the periods indicated. The prices represent quotations between dealers and do not include retail mark-up, markdown, or commission, and do not necessarily represent actual transactions. On December 11, 2015, the last reported sale price for ourSelling Stockholder will sell their shares of common stock as reporteddescribed under “Plan of Distribution.”
We may receive proceeds from each of the exercise of the Preferred Investment Option, the 2020 Common Warrant and the 2021 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 Common Warrant is exercised for cash in full, the gross proceeds would be approximately $21.2 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 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 Common Warrant will be exercised, or if exercised, that it will be exercised for cash, the quantity which will be exercised or in the OTCQB Market was $0.11 per share.
High | Low | |||||||
2015 | ||||||||
Fourth Quarter (through December 11, 2015) | $ | 0.14 | $ | 0.09 | ||||
Third Quarter | 0.18 | 0.12 | ||||||
Second Quarter | 0.20 | 0.15 | ||||||
First Quarter | 0.24 | 0.14 | ||||||
2014 | ||||||||
Fourth Quarter | $ | 0.51 | $ | 0.13 | ||||
Third Quarter | $ | 0.26 | $ | 0.19 | ||||
Second Quarter | $ | 0.37 | $ | 0.21 | ||||
First Quarter | $ | 0.60 | $ | 0.34 | ||||
2013 | ||||||||
Fourth Quarter | $ | 0.97 | $ | 0.36 | ||||
Third Quarter | $ | 0.51 | $ | 0.36 | ||||
Second Quarter | $ | 0.63 | $ | 0.43 | ||||
First Quarter | $ | 0.85 | $ | 0.55 |
Holdersperiod in which it will be exercised.
On December 11, 2015, there were approximately 630 holdersDETERMINATION OF OFFERING PRICE
Each 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 recordthe sale, varying prices determined at the time of our common stock. Because manysale, or negotiated prices. For more information, see “Plan of Distribution.”
DIVIDEND POLICY
To date, we have paid no cash dividends on our shares of common stock are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these record holders.
Dividends
We have not paid any dividends since our inception and do not contemplate payingexpect to pay cash dividends on our common stock in the foreseeable future. We intend to retain future earnings, if any, to provide funds for operations of our business. Therefore, any potential return investors may have in our common stock will be in the form of appreciation, if any, in the market value of their shares of common stock. We are not subject to any legal restrictions respecting the payment of dividends, except that we may not pay dividends if the payment would render us insolvent. Any future determination as to the declaration and payment of cash dividends if any,on our common stock will be at the discretion of our Board of Directors and will depend on then existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our Board of Directors may deem relevant.Directors.
Securities Authorized for Issuance Under Equity Compensation PlansCAPITALIZATION
The following table sets forth certain informationour capitalization as of DecemberMarch 31, 2014 with respect to compensation plans under which our equity securities are authorized for issuance.2022:
Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-averageexercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) |
Equity compensation plans approved by stockholders (1) | 720,000 | $5.51 | -0- |
Equity compensation plans not approved by stockholders (2) | 463,100 | $0.38 | 16,900 |
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You should read this table together with our financial statements and the related notes, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
As of March 31, 2022 (unaudited) | ||||||||
Actual | As Adjusted | |||||||
Cash and cash equivalents | $ | 16,257,716 | $ | 34,742,719 | ||||
Total liabilities | 5,501,103 | 5,501,103 | ||||||
Stockholder’s equity: | ||||||||
Common stock | 9,449 | 21,570 | ||||||
Additional paid-in capital | 78,147,616 | 96,620,498 | ||||||
Accumulated deficit | (66,803,413 | ) | (66,803,413 | ) | ||||
Total stockholders’ equity | $ | 16,854,755 | $ | 35,339,758 |
The table and discussion above are based on 9,449,025 shares of common stock outstanding as of March 31, 2022, and 21,570,239 shares as adjusted, and do not include, as of that date:
● | 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; | |
● | 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 602,000 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $2.79 per share. |
BUSINESS
Overview
GeoVax Labs, Inc. (“GeoVax” or the “Company”) is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. GeoVax’s product pipeline includes ongoing human clinical trials in COVID-19 and head and neck cancer. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors. Our portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 70 granted or pending patent applications spread over 20 patent families.
Our Product Development Pipeline
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.
Indication | Product Candidate | Current Status |
Coronavirus Vaccines | ||
COVID-19 (Booster to mRNA) | GEO-CM04S1 | Clinical - Phase 2 |
COVID-19 (Primary vaccine for immunocompromised patients) | GEO-CM04S1 | Clinical - Phase 2 |
Pan Coronavirus | GEO-CM02 | Preclinical/IND-Enabling |
Cancer Immunotherapy | ||
Solid Tumors (Advanced Head and Neck Cancer)* | Gedeptin® | Clinical - Phase 1/2 |
Solid Tumors (MUC1) | MVA-VLP-MUC1 | Preclinical/IND-Enabling |
Other Infectious Disease Vaccines | ||
Zika** | GEO-ZM02 | Preclinical/IND-Enabling |
Ebola, Marburg, Sudan** | GEO-EM01 | Preclinical/IND-Enabling |
Lassa Fever** | GEO-LM01 | Exploratory |
Malaria** | GEO-MM02 | Exploratory |
---------------
* Orphan Drug status granted
** Indication within FDA Priority Review Voucher program
Our Coronavirus Vaccine Programs
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.
There are currently twenty-four vaccines authorized for use in one or more countries around the world, including three 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 the U.S. Centers for Disease Control and Prevention (CDC), estimates of COVID-19 mRNA vaccine effectiveness have declined in recent months because of waning vaccine induced immunity over time, possible increased immune evasion by SARS-CoV-2 variants, or a combination of these and other factors.
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 for vaccines 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.
GEO-CM04S1 for Immunocompromised Patients –The CDC lists immunocompromised patients, including patients who have received therapeutic procedures for hematologic malignancy, as high risk for SARS-CoV-2 disease. SARS-CoV-2 infection is expected to 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.
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 (NCT04977024) to evaluate its safety and immunogenicity, compared to the Pfizer/BioNTech 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 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.
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.
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 a broader immune response. The GEO-CM0461 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 is well established for MVA.
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 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 healthy individuals, 18 years of age and older, 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 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, 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. Most of these first-generation 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 of partially escaping neutralization by vaccine induced antibodies, as has been seen with the Omicron variant. Thus, the effectiveness of these vaccines against new SARS-CoV-2 variants and future coronavirus spillover events remains of immense concern.
Using its novel Modified Virus Ankara - Virus Like Particle (GV-MVA-VLPTM) 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. The GV-MVA-VLPTM platform is known to induce a balanced antibody and cellular (T-cells) response against the multiple encoded immunogens, potentially limiting immune escape by emerging variants. Expression of the SARS-CoV-2 spike (S), membrane (M) and envelope (E) proteins by MVA supports the in vivo formation of virus like particles (VLPs), which induce both antibody and T-cell responses. Incorporation of other sequence-conserved structural and nonstructural proteins will provide 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 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 the ongoing design, construction and preclinical testing of our vaccine candidate’s evaluation, in preparation for human clinical trials. Scientific presentations and publications of the experimental results were delivered at multiple international vaccine conferences during 2021 and publication is planned for 2022.
Our Cancer Immunotherapy 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 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.
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 very toxic antitumor compound, in situ. A cycle of Gedeptintherapy 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 Phase 1/2 trial (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. The trial design involves repeat administration using Gedeptin followed by systemic fludarabine, as a way to gain additional information 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 Gedeptinorphan 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 trial, and to assist with the expansion of clinical sites and acceleration of patient enrollment and evaluation.
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 and killing of 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 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 is based on the aberrantly glycosylated forms of the cell surface-associated MUC1 protein that 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.
● | We have produced a MVA-VLP-MUC1 vaccine candidate, demonstrated VLP production by electron microscopy using MUC1 immunogold staining, and showed that the VLPs express a hypo-glycosylated form of MUC1 in human cell lines. |
● | We collaborated with Dr. Olivera Finn, a leading expert in cancer immunotherapy at the University of Pittsburgh, who was one of the first 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 IND enabling animal study 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. |
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.
Our Hemorrhagic Fever Virus Vaccines (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. 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, 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 in Africa, it is intended to prevent the spread of disease to the US, and for preparedness against terrorist release of any of bio-threat pathogens.
Our initial preclinical studies in rodents and nonhuman primates for our MVA-VLP-EBOV vaccine candidate have shown 100% protection against a lethal dose 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 in collaboration with NIAID and DoD and clinical development programs will be defined based on efficacy data and global priorities as potentially dangerous outbreaks occur.
Other Infectious Disease Programs
GEO-ZM02 for Zika – Zika disease is an emerging infectious disease caused by the Zika virus (ZIKV) and has been linked to an increase in microcephaly in infants and Guillain-Barre syndrome (a neurodegenerative disease) in adults. ZIKV is a member of the Flaviviridae family, which includes medically important pathogens such as dengue fever, yellow fever, Japanese encephalitis, tick-borne encephalitis, and West Nile viruses. Public health officials recommend avoiding exposure to ZIKV, delaying pregnancy, and following basic supportive care (fluids, rest, and acetaminophen) after infection.
To address the unmet need for a ZIKV vaccine, we are developing novel vaccine candidates constructed using our novelGV-MVA-VLP platform. MVA has an outstanding safety record, which is particularly important given the need to include women of child-bearing age and newborns among those being vaccinated. Our Zika vaccine platform. is designed based on the NS1 gene product to eliminate the risk of Antibody Dependent Enhancement (ADE), which is a serious side effect observed when a vaccinated individual doesn’t have a fully protective immune response which actually causes a more virulent reaction if infected.
Our initial preclinical studies in rodents using our GEO-ZM02 vaccine candidate demonstrated 100% single-dose protection against a lethal dose of ZIKV delivered directly into the brain. In rhesus macaques, vaccination with GEO-ZM02 induced immune responses that effectively controlled the virus replication despite the fact the vaccine is not designed to induce ZIKV neutralizing antibodies. Further development of GEO-ZM02 will be dependent upon partnering support.
GEO-MM02 for Malaria – Globally, malaria causes 228 million infections and 405,000 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.
We have collaborated with the Burnet Institute, a leading infectious diseases research institute in Australia, for the development of a vaccine to prevent malaria infection. The project included the design, construction, and characterization of multiple malaria vaccine candidates using GeoVax’s GV-MVA-VLP™ vaccine platform supports productioncombined with malaria Plasmodium falciparum and Plasmodium vivax sequences identified by the Burnet Institute. The vaccine design, construction, and characterization were performed at GeoVax with immunogenicity and challenge studies in animal models conducted at Burnet Institute using their unique functional assays. Further development of non-infectiousGEO-MM02 will be dependent upon additional funding support via federal grants or other sources.
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, we recently decided to discontinue active development of these programs. Our technology and intellectual property in this will remain available for out-license or partnering, but we will no longer devote any corporate resources to the programs.
Our GV-MVA-VLP™ Platform
GeoVax’s GV-MVA-VLP™ vaccine platform utilizes Modified Vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLPs) from the cells of(VLP) immunogens in the person receiving the vaccine. Producing non-infectious virus-like particlesThe production of VLPs in the person being vaccinated circumventscan mimic the need to purify virus-like particles for inoculation. Thevirus production of virus-like particlesthat occurs in the person being vaccinated mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection should it appear.
Our current development programs are focused oninfection. The MVA-VLP derived vaccines against Human Immunodeficiency Virus (HIV) and hemorrhagic fever viruses (Ebola, Marburg). We believe our technology and vaccine development expertise is well-suited for a variety of human infectious diseases and, potentially, cancer immunotherapy. We intend to pursue expansion of our product pipeline.
Our most advanced HIV vaccine program is focused on the clade B subtype of HIV prevalentcan elicit durable immune responses in the Americas and Western Europe. Our preventive clade B HIV vaccine has successfully completed Phase 2a human clinical testing and is targeted to enter a follow-on clinical trial in early 2016. It has shown outstanding safety and excellent and highly reproducible immunogenicity (Journal of Infectious Diseases volume 203, pg 610 and volume 210 pg 99). We are also extending our HIV vaccine effort to the most common virus subtype affecting sub-Saharan Africa, clade C and are conducting preclinical studies pursuanthost similar to a grant fromlive-attenuated virus, while providing the National Institutessafety characteristics of Health (NIH). Additionally, we are investigating our HIV vaccines for their potential to contribute to combination therapies for therapeutic treatment leading to a cure for HIV infections.
Our hemorrhagic fever vaccine program was initiated during 2014 with the objective of developing both monovalent vaccines and tetravalent vaccines designed to protect not only against current strains for filoviruses such as Ebola and Marburg, but also against other major hemorrhagic fever viruses endemic in African countries. Studies of our first Ebola vaccine candidate have demonstrated 100 percent protection in rodent models. We plan to conduct additional animal challenge studies during 2016 with the goal of beginning human clinical trials during the first half of 2017.
In December 2015, we entered into a Collaborative Research Agreement with the University of Pittsburgh to evaluate our VLP vaccine platform for use in cancer immunotherapy, including the selection and testing of vaccine candidates.
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 awarded directly to us, as well as indirect support for the conduct of our human clinical trials. This is discussed further under “Support from the United States Government” below.
Our HIV vaccine technology was developed in collaboration with researchers at Emory University, the NIH, and the Centers for Disease Control and Prevention (CDC). The technology developed by the collaboration is exclusively licensed to us from Emory University. We also have nonexclusive licenses to certain patents owned by the NIH. Our Ebola/Marburg vaccines have been developed with technology licensed from, and in collaboration with, the NIH.
Each of our vaccine development programs is discussed in greater detail in the sections that follow below.
We are incorporated in Delaware, and our offices and laboratory facilities are located in Smyrna, Georgia (metropolitan Atlanta).
Our Technologyreplication-defective vector.
Vaccines typically contain agents (antigens) that resemble disease-causing microorganisms. Traditional vaccines are often made from weakened or killed forms of the virus or from its surface proteins. ManySome newer vaccines use recombinant DNA (deoxyribonucleic acid) technology to generate vaccine antigens in bacteria or cultured cells from specific portions of the DNA sequence of the target pathogen. The generated antigens are then purified and formulated for use in a vaccine. TheWe believe the most successful of these purified antigens have been non-infectious virus-like particles (VLPs) as exemplified by vaccines for hepatitis B (Merck’s Recombivax® and GSK’s Engerix®) and Papilloma viruses (GSK’s Cervarix®, and Merck’s Gardasil®). Our approach uses recombinant DNA and/or recombinant virusesMVA to produce VLPs in the person being vaccinated.vaccinated (in vivo) reducing complexity and costs of manufacturing. In human clinical trials of our HIV vaccines, we believe we have demonstrated that our VLPs, expressed infrom within the cells of the person being vaccinated, arecan be safe, yet elicit both strong and durable humoral and cellular immune response.
AllVLPs mimic authentic viruses in form but are not infectious or capable of our vaccines are designed to produce self-assembling non-infectious VLPs in the cells of the person being vaccinated. VLPs trainreplicating and can cause the body’s immune system to recognize and kill the authentic virus should it appear.targeted viruses to prevent an infection. VLPs can also train the immune system to recognize and kill infectedvirus-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. WhenWe design our vaccines such that, when VLPs for enveloped viruses like HIV, Ebola, and Marburg or Lassa fever are producedin 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 externally,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 virus, which in turn,viruses. We believe this feature of our immunogens allows the body’s immune system to more readily recognize the authentic virus. By producing VLPsin vivo, we believe we also avoid potential purification issues associated within vitro production of VLPs.
Figure 1 below shows examples of thin section electron micrographs of actual viruses and VLPs for these viruses expressed by GeoVax MVA-VLP vaccines.
Figure 1. Comparison of MVA-VLPs and native virus structures
DNA and MVA as Vaccine Vectors.Our HIV vaccines incorporate two delivery components (or vectors): a recombinant plasmid DNA vaccine, and a recombinant MVA (modified vaccinia Ankara) vaccine. Our Ebola and Marburg vaccines use onlyIn the MVA vector. Both our DNA and MVA vaccines express sufficient vaccineMVA-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 productiongeneration of non-infectious VLPs. The VLPs cannot cause disease because they contain mutated or deleted enzymatic functions that are essential for virus replication. The virus-like particles display trimeric membrane bound forms of the viral envelope glycoprotein (Env for HIV or GP for Ebola or Marburg). This is important because the natural form of the envelope glycoprotein elicits multi-target antibody capable of recognizing incoming virus and blocking infections. Expression of multiple proteins by the vaccines is essentialMVA infected cells. Utility has been demonstrated for multiple vaccine candidates wherein the formation ofMVA-encoded viral matrix proteins and glycoproteins assemble into VLPs. The multiple proteins also provide more targets for immune responses such as cytotoxic T-cells. Elicitation of multi-target humoral and cellular responses limits immune escape, just as multi-drug therapies limit drug escape.
Ebola VLPs HIV VLPs
Figure 1. Electron micrographs showing the virus-likeparticles (VLPs) elicited by GeoVax vaccines from human cells. Note that the Ebola VLPs on the left self-assemble into the rod-like shape of the authentic Ebola virus, while the HIV VLPs shown on the right take on the spherical shape of the authentic HIV virus. While below the resolution of these micrographs, both types of VLPs display what we believe to be the native form of their respective viral envelope glycoproteins which we believe is key to generating an effective immune humoral response.
We selected MVA for use as the live viral component of our vaccines because of its well-established safety record and because of the ability of this vector to carry sufficient viral proteins to produce virus-like particles. MVA was originally developed as a safer smallpox vaccine for use in immune compromised humans.immune-compromised individuals. It was developed by attenuating the standard smallpox vaccine by making overpassaging it (over 500 passages of the viruspassages) in chicken embryos or chickchicken embryo fibroblasts, which resultedresulting in a virus with limited ability to replicate in human cells (thus safe) but did not compromise the ability of MVA to grow onwith high replication capability in avian cells which are used(thus cost effective for manufacturing the virus.manufacturing). The deletions 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.
We collaborated with the laboratory of Dr. Bernard Moss at NIH/NIAID on four different generations of MVA was safely administeredvectors, spanning over 15 years of collaboration, to over 120,000 peopleeffectively express vaccine proteins that assemble into VLPs. These efforts led to the development of different shuttle vectors and the identification of multiple insertion sites for introducing foreign genes encoding the vaccine target proteins into MVA in a manner that optimizes each product for manufacturing stability. Each MVA-VLP vaccine has up to two expression cassettes, each encoding one or more antigens selected from pathogens of interest. At a minimum, each vaccine expresses two antigens required for VLP formation; in the 1970s ascase of HIV and hemorrhagic fever vaccines for example, a smallpox vaccine.viral matrix protein and an envelope glycoprotein. We use a synthetic early late promoter that provides high, yet not lethal, levels of insert expression, which is initiated immediately after infection in cells of the vaccinated individual.
Induction of T-cell and Antibody Immune Responses.In both preclinical and clinical trials, our HIV vaccines have been shown to induce both humoral (antibody) and cellular (T-cell) responses against HIV. The induction of both antibodies and T-cells is beneficial because these immune responses work through different mechanisms. Antibodies prevent infection by blocking viruses from infecting cells. In preclinical simianOur GV-MVA-VLP™ vaccine studies using repeated rectal challenges with moderate doses of virus, the avidity, or tightness, of antibody binding to the surface envelope glycoprotein of HIV correlates with the prevention of infection (The Journal of Infectious Diseases,204:164 (2011)). In high dose challenges that infect all animals at the first exposure, the avidity of the antibody for envelope glycoprotein correlates with reduced levels of virus replication (Journal of Virology, 83:4102 (2009)). Similarly, antibody responses are believed to be critical for vaccine-elicited protection against Ebola and Marburg infection (Expert Review of Vaccines, 10:63 (2011)). These results likely reflect the tightly binding antibody both blocking infection as well as tagging virus and infected cells for destruction, by white blood cells such as macrophages, neutrophils and natural killer cells. Our vaccines elicit CD8+ T-cells, a type of T-cell that can recognize and kill cells that become infected by virus (without antibody tagging). For HIV, CD8+ T-cells are important for the control of the virus that has established an infection. For Ebola and Marburg, antibodies can stop or slow the progress of infection, but T cells are important for clearing the infection by killing remaining infected cells.
Background – Viruses and Vaccines
What are Viruses? Viruses are microscopic organisms consisting of genetic material comprised of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid), surrounded by a protein, lipid (fat), or glycoprotein coat. Viruses invade healthy, living host cells in order to replicate and spread. In many cases, the body’s immune system can recognize and effectively combat an infection caused by a virus. However, with certain viral infections, the body’s immune system is unable to fully destroy or inhibit the replication of the virus, which results in persistent and ongoing viral replication resulting in disease.
Infections caused by viruses can be chronic or acute. Chronic infections, such as those caused by HIV, do not typically self-resolve with time and can cause chronic disease. Acute infections associated with viruses, such as influenza, generally last for a relatively short period of time, and self-resolve in most immunocompetent individuals. However, certain acute infections, such as those caused by Ebola and Marburg, can overwhelm the immune system, resulting in serious disease and death.
Viruses can also be characterized as either active or latent. An active virus can cause a persistent infection or disease over an extended period of time. A latent virus will remain in the body for very long periods of time after the initial infection and generally will only cause disease when the body’s immune system weakens, fails or is suppressed, allowing the virus to once again replicate. Vaccines have been widely used to prevent active viral infections from occurring. Latent infections are more difficult to address with vaccines. A latent virus does not replicate actively and can “fly below the radar” of the immune system in that it does not provide the immune system with targets for antibody and T-cell responses.
Viruses that develop resistance to antiviral drugs are increasingly becoming a challenge in the treatment of viral infections, particularly those that are chronic in nature. The ability of viruses to mutate spontaneously during replication allows drug-resistant strains to emerge when patients are using drugs that are not potent enough to quickly and completely inhibit viral replication. Drug-resistant mutant viruses, while initially low in number, eventually become the predominant strain in an infected patient as those strains that remain susceptible to the drug are inhibited from replicating. Once this occurs, the treatment benefit of that particular antiviral drug diminishes, resulting in treatment failure and the need for an alternate therapy with different or possibly new drugs, or classes of drugs. In general, viruses that cause chronic infections, such as HIV, are more likely to develop drug resistance due to the long-term and persistent exposure of the virus to the antiviral therapy.
What are Vaccines? Vaccines represent an approach to broaden the ability to prevent serious infectious diseases caused by both viruses and bacteria.A vaccine is a substance introduced into the human body that teaches the immune system to detect and destroy a pathogen (a virus orplatform affords other pathogen that causes disease). All vaccines contain some harmless form or part of the pathogen they target or of a highly similar pathogen. They exert their effects through the adaptive immune response, an arm of the immune system that learns to recognize and control specific pathogens.
There are several types of vaccines:advantages:
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Our Ebola & Marburg Vaccine Program
About Ebola and Marburg. Ebola Hemorrhagic Fever (EHF) and the related disease Marburg Virus Disease (MVD) are highly contagious, extremely deadly diseases that, if not contained by quarantine, are capable of threatening populations worldwide. Since 1976, when Ebola was first discovered, at least 28 outbreaks have occurred. The 2014 Ebola outbreak in West Africa was significantly larger than any previous epidemic, the first to reach urban areas and the first to lead to person-to-person transmission in the United States. This outbreak resulted in approximately 28,600 infections with over 11,000 deaths (40% fatality rate). No approved preventive or therapeutic products exist for EHF or MVD.
Ebola and Marburg naturally infect animals including bats, creating reservoirs of Ebola and Marburg that, like rabies, cannot be completely eradicated. The rapid urbanization of many areas of Sub-Saharan Africa and the ease of modern air travel create conditions that facilitate the epidemic spread of EHF and MVD, which previously had been limited to localized outbreaks in villages. EHF is caused by ebolaviruses (Ebola), and MVD is caused by marburgviruses (Marburg). Ebola and Marburg are members of the familyFiloviridae. Ebolaviruses are more diverse than marburgviruses and are divided into five subtypes: Zaire, Sudan, Bundibugyo, Tai Forest, and Reston. Zaire is the most lethal of the strains and is responsible for the current epidemic. Sudan and Bundibugyo are also lethal but have caused fewer and less severe outbreaks.
A challenge in Ebola and Marburg vaccine development is the need to create products that are effective both in containing an epidemic (in which rapid responses are critical) and in routine immunization (in which the duration of immunity is important). Ideal countermeasures to Ebola and Marburg would include a single-shot strain-specific epidemic vaccine capable of rapidly producing protective antibodies and T cells, and a routine vaccine capable of eliciting durable immunity to the lethal strains of Ebola (Zaire, Sudan and Bundibugyo) as well as Marburg. An effective vaccine against Ebola and/or Marburg would dramatically reduce the epidemic spread of infections as well as the transmission of Ebola and/or Marburg from natural animal hosts to humans.
Research on Ebola vaccines is progressing rapidly amongst a number of different pharmaceutical companies, with recombinant chimpanzee adenovirus (ChAd3), rare-serotype adenovirus (Ad26) and vesicular stomatitis virus (VSV) candidates already in clinical trials and several other vaccines scheduled to begin clinical trials. However, none of these vaccines has an ideal design, nor are any of them well suited for use in proactive immunization of populations to prevent future epidemics. The adenovirus vaccines require boosting with MVA to raise protective immune responses, and the two-product regimen (adenovirus and MVA) dramatically raises manufacturing costs and the complexity of vaccination. The replication competent VSV recombinants have already shown risk signals in the current trial, necessitating a temporary halt to the trial followed by resumption at a lower vaccine dose. The potential dose-limiting toxicity of the VSV vaccines raises safety concerns for large-scale vaccinations and also could pose threats to immunocompromised people, such as those infected with HIV. None of the competitors’ vaccines produce virus-like particles, a desirable characteristic, which is discussed in detail elsewhere in this document. To the best of our knowledge, no non-GeoVax vaccine candidates share this characteristic. One or more of the current candidates may well show success in stemming the current epidemic. However, the world must be prepared with the optimal vaccine for the next epidemic when it occurs. All of the vaccines currently in clinical trials are designed to protect against one, or at most two, strains of Ebola. To be successful, an optimal vaccine should be safe, effective, and long lasting, all at a reasonable cost. Our analysis suggests that the GeoVax designs are well suited to achieve this aim.
Our Vaccines. To address the unmet need for a product to prevent hemorrhagic fever viruses, we are developing a series of vaccines, which combine our proven MVA technology with advanced vaccine design. We are developing individual vaccines (monovalent) that will address each of the lethal strains of Ebola virus (Zaire, Sudan and Bundibugyo), as well as Marburg virus. We also are developing a multivalent vaccine, which will incorporate multiple monovalent vaccines to protect not only against current strains of filoviruses such as Ebola and Marburg, but also against other major hemorrhagic fever viruses endemic in African countries.
In April 2015, we entered into a Research Collaboration Agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, for development of our vaccines against Ebola and Marburg viruses. Under this agreement, NIAID is contributing materials, reagents, and scientific advice for vaccine construction, and has conducted animal protection studies in guinea pigs, and hamsters. In September, studies of our first Ebola vaccine candidate conducted pursuant to this collaboration demonstrated 100 percent protection in these small animal models. We plan to conduct additional animal challenge studies during 2016 with the goal of beginning human clinical trials during the first half of 2017. We intend to seek additional funding from U.S. government agencies and/or world health organizations to assist us in this regard.
We believe our Ebola/Marburg vaccines will demonstrate a unique combination of advantages that set them apart from any other products in development for prevention of EHF.
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Our HIV/AIDS Vaccine Program
About HIV/AIDS.HIV is a retrovirus that carries its genetic code in the form of RNA. Retroviruses use RNA and the reverse transcriptase enzyme to create DNA from the RNA template. The HIV-1 virus enters human cells and copies its viral RNA to produce complementary DNA (cDNA) that is subsequently inserted into the chromosomes, which are the genetic material of a cell. HIV preferentially infects and replicates in T-cells, which are a type of white blood cell. Infection of T-cells alters them from immunity mediating cells to cells that produce and release HIV. This process results in the destruction of the immune defenses of infected individuals and ultimately, the development of AIDS.
There are several AIDS-causing HIV virus subtypes, or clades, that are found in different regions of the world. These clades are identified as clade A, clade B and so on. The predominant clade found in Europe, North America, parts of South America, Japan and Australia is clade B, whereas the predominant clades in Africa are clades A and C. In India, the predominant clade is clade C. Each clade differs by at least 20% with respect to its genetic sequence from other clades. These differences may mean that vaccines or treatments developed against HIV of one clade may only be partially effective or ineffective against HIV of other clades. Thus, there is often a geographical focus to designing and developing HIV vaccines.
HIV, even within clades, has a high rate of mutation that supports a significant level of genetic variation. In drug treatment programs, virus mutation can result in the development of drug resistance, referred to as virus drug escape, thereby rendering drug therapy ineffective. Hence, we believe that multi-drug therapy is very important. If several drugs are active against virus replication, the virus must undergo multiple simultaneous mutations to escape, which is less likely. The same is true for immune responses. HIV can escape single targeted immune responses. However, our scientists believe if an immune response is directed against multiple targets, which are referred to as epitopes, virus escape is much less frequent. Vaccination against more than one of the proteins found in HIV increases the number of targets for the immune response as well as the chance that HIV will not escape the vaccine-stimulated immune response, thus resulting in protection against infection or the development of clinical AIDS if infection occurs.
HIV infects and gradually destroys T-cells and macrophages, which are white blood cells that play key roles in protecting humans against infectious disease caused by viruses, bacteria, fungi and other micro-organisms. Opportunistic infections by organisms, normally posing no problem for control by a healthy immune system, can ravage persons with immune systems damaged by HIV infections. Destruction of the immune system occurs over years. The average onset of the clinical disease recognized as AIDS occurs after three to ten years of HIV infection if the virus is not treated effectively with drugs, but the time to developing AIDS is highly variable.
AIDS is considered by many in the scientific and medical community to be the most lethal infectious disease in the world. An estimated 37 million people are living with HIV worldwide, with approximately 2.5 million newly infected in 2012 alone. Approximately 39 million people infected with HIV have died since the 1981 start of the HIV pandemic. The United States currently has an estimated 1.2 million HIV-infected individuals, with approximately 50,000 new infections per year.
At present, the standard approach to treating HIV infection is to inhibit viral replication through the use of combinations of drugs. Available drugs include reverse transcriptase inhibitors, protease inhibitors, integration inhibitors and inhibitors of cell entry to block multiple essential steps in virus replication. However, HIV is prone to genetic changes that can produce strains that are resistant to currently approved drugs. When HIV acquires resistance to one drug within a class, it can often become resistant to the entire class, meaning that it may be impossible to re-establish control of a genetically altered strain by substituting different drugs in the same class. Furthermore, these treatments continue to have significant limitations which include toxicity, patient non-adherence to the treatment regimens and cost. As a result, over time, viruses acquire drug-resistant mutations, and many patients develop intolerance to the medications or simply give up taking the medications due to the side effects.
According to the International AIDS Vaccine Initiative (IAVI), the cost and complexity of new treatment advances for AIDS puts them out of reach for most people in the countries where treatment is most needed. As noted above, in industrialized nations, where drugs are more readily available, side effects and increased rates of viral resistance have raised concerns about their long term use. AIDS vaccines, therefore, are seen by many as the most promising way to end the HIV/AIDS pandemic. It is expected that vaccines for HIV/AIDS, once developed, will be used universally and administered worldwide by organizations that provide health care services, including hospitals, medical clinics, the military, prisons and schools.
Our Preventive HIV Vaccine Program
Prevention of HIV infection remains a worldwide unmet medical need, even in the United States and other first world countries where effective antiretroviral therapies are available. There is no approved HIV vaccine. Current antiretroviral therapies do not eliminate HIV infection, requiring individuals to remain on antiretroviral drugs for their entire lives. In the United States, it is estimated that of the 1.2 million infected individuals, for various reasons (lack of diagnosis, linkage to care, patient compliance, etc.) only 25% ultimately remain in HIV care with their viral load sufficiently suppressed to prevent spread of HIV. As a result, the annual incidence of new HIV infections has remained virtually unchanged for the past 20 years. Furthermore, the annual financial burden to the U.S. taxpayer for HIV education, prevention, and treatment costs borne through multiple federal agencies is more than $20 billion annually.
Work on our HIV vaccines began during the 1990s at Emory University in Atlanta, Georgia, under the direction of Dr. Harriet L. Robinson, who is now our Chief Scientific Officer. The vaccine technology was developed in collaboration with researchers at the NIH and the CDC.
Our most clinically advanced vaccine development program is a DNA/MVA vaccine regimen designed to protect against the clade B subtype of the HIV virus. Clade B is prevalent in the Americas and Western Europe. An estimated 3.3 million people are infected with clade B HIV virus worldwide, with 187,000 new infections in 2012.
We have two HIV vaccine components under development: a recombinant DNA vaccine, and a recombinant MVA vaccine. Both the DNA and MVA vaccines contain sufficient HIV genes to support the production of non-infectious virus-like particles. These VLPs display the native trimeric membrane-bound form of the HIV envelope glycoprotein (Env) that mediates entry into cells and is the target for protective antibody. When used together, the recombinant DNA component primes immune responses, which are boosted by administration of the recombinant MVA component. This prime-boost strategy elicits high avidity antibodies (tightly binding antibodies) and cytotoxic T cells. The antibodies can block infections and initiate the killing of virus and infected cells by bound antibody signaling destruction by virion capture, antibody-dependent cellular cytotoxicity, phagocytosis and complement mediated lysis. We may also pursue development of our MVA vaccine component as a standalone HIV vaccine, or in combination with other vaccine components.
Clinical trials of our preventive HIV vaccine have been conducted by the HIV Vaccine Trials Network (HVTN). The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The HVTN’s HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents.
We have completed multiple Phase 1 trials and a Phase 2a trial (HVTN 205) of various dosing regimens and formulations of our vaccines. These vaccines have been evaluated in nearly 500 humans. All of the clinical trials of our preventive vaccines have been conducted by the HVTN, and fully funded by the NIH.
We also expect the NIH to fully fund the cost of another Phase 1 trial (HVTN 114) of our preventive HIV vaccine to begin in early 2016, which will investigate the effect of adding a “protein boost” component to our vaccine. Protein boosts may augment antibody responses that can block virus infections (neutralizing antibody) and cause antibody dependent cellular cytotoxicity (ADCC antibody). Proteins added to HIV vaccines have shown some success in other trials. The HVTN believes this “dual-action” approach will be a prudent and cost-effective path forward for supporting large clinical trials. Information from this trial would then inform the design of future, larger clinical trials. While efforts are underway to evaluate the protein boost concept, we also intend to seek funding to expedite our vaccine (without the additional protein boost) directly into pivotal Phase 2b efficacy trials.
The HVTN is continuing to consider future efficacy studies, and members are working to develop collaborative clinical development plans, as well as initiating regulatory planning. The plans for large-scale clinical trials may change as researchers continue to gather information from our earlier studies and are influenced by results from other vaccine trials. Trial start dates are dependent on many factors and are likely to change.
Preventive HIV Vaccine Program – Clade C. We also plan to develop vaccines designed for use to combat the subtypes of HIV that predominate in the developing countries. We have licensed from the U.S. National Institutes of Health (NIH) the modified vaccine Ankara (MVA) construct for the clade C subtype of HIV prevalent in South Africa and India, and we have completed lead discovery using a novel approach to vaccination against clade C. We have performed initial process development studies for the NIH-developed vaccine and initiated early development work on the other, newer clade C vaccine. Depending on the results of animal studies and the focus of future government support, we may advance either or both of the clade C vaccines into the clinic. In June 2015, the NIH awarded us a Small Business Innovative Research (SBIR) grant entitled “Directed Lineage Immunizations for Eliciting Broadly Neutralizing Antibody” toward this effort. The initial grant award of $299,585 is for the first year of a two year project period beginning July 1, 2015.
Preclinical Studies.We conducted preclinical efficacy trials of our preventive HIV vaccines by vaccinating non-human primates with simian immunodeficiency virus prototypes of our HIV vaccines and then testing them for resistance to simian immunodeficiency virus infection. The experimental data produced by these trials documented the ability of the simian prototypes of our vaccines to induce immune responses that can prevent infection as well as reduce the levels of viral replication in those animals that become infected.
Completed Human Clinical Trials -- Preventive HIV Vaccine
Phase 1 Human Clinical Trials.All of our preventive vaccination trials in humans have been conducted by the HVTN, a network that is funded and supported by the NIH. The HVTN is the largest worldwide clinical trials network focused on the development and testing of HIV/AIDS vaccines. The results of a two group, 30 participant, Phase 1 trial (designated HVTN 045) are published inAIDS RESEARCH AND HUMAN RETROVIRUSES22:678 (2006) and of a four group 120 participant trial (HVTN 065) inThe Journal of Infectious Diseases 203:610 (2011). Our Phase 1 trials have tested both safety and dosing regimens.
In our first Phase 1 clinical trial, HVTN 045, our DNA vaccine was tested without MVA boosting to document the safety of the DNA. Our second Phase 1 clinical trial, HVTN 065, was designed to test the combined use of DNA and MVA and consisted of a dose escalation as well as regimen studies. The low dose consisted of 0.3 mg of DNA and 1x107 tissue culture infectious doses (TCID50) of MVA. Once safety was demonstrated for the low dose in 10 participants, the full dose (3 mg of DNA and 1x108 TCID50 of MVA) was administered to 30 participants. A single dose of DNA at time 0 followed by MVA at weeks 8 and 24, a DMM regimen, and three doses of MVA administered at weeks 0, 8 and 24, an MMM regimen, were also tested in 30 participants each. Participants were followed for 12 months to assess vaccine safety and to measure vaccine-induced immune responses.
Data from the HVTN 065 trial again documented the safety of the vaccine products but also showed that the DDMM and MMM regimens induced different patterns of immune responses. The full dose DDMM regimen induced higher response rates of CD4++ T-cells (77%) and CD8++ T-cells (42%) compared to the MMM regimen (43% CD4+ and 17% CD8+ response rates). In contrast, the highest response rates and highest titers of antibodies to the HIV Env protein were induced in the group that received only the MVA using the MMM regimen. Antibody response rates were documented to be higher for the MMM group using three different assays designed to measure total binding antibody levels for an immune dominant portion of the Env protein (27% for DDMM and 75% for MMM), binding of antibodies to the gp120 subunit of the envelope glycoprotein (81% for DDMM and 86% for MMM) and neutralizing antibodies (7% for DDMM and 30% for MMM). The 1/10th dose DDMM regimen induced overall similar T-cell responses but reduced antibody responses while the response rates were intermediate in the DMM group.
The HVTN also sponsored and conducted a Phase 1 clinical trial in humans (HVTN 094) of the adjuvanted form of our vaccine that co-expresses GM-CSF in the DNA priming vaccine. We have designated the GM-CSF-adjuvanted version of our DNA/MVA vaccine regimen as GOVX-B21, and the unadjuvanted version as GOVX-B11. During December 2013, we reviewed preliminary results from HVTN 094. Based on excellent preclinical non-human primate data, this trial was originally initiated with the expectation that GOVX-B21 would be carried forward into Phase 2 testing by the HVTN, with support by the NIH. However, comparison of data between HVTN 094 and the Phase 2a trial, HVTN 205 (see below) did not show a significant benefit from adding the adjuvant to the vaccine for preventive use; therefore GOVX-B21 was not advanced in further clinical testing (results to be published).
Phase 2 Human Clinical Trials.Based on the safety and the immunogenicity results in the HVTN 045 and HVTN 065 trials, the full dose DNA/MVA and MVA-only regimens were selected for testing by the HVTN in a Phase 2a trial (designated HVTN 205) which was completed in 2012 and the subject of an oral presentation at theAIDS Vaccine 2012 Conference in September 2012, with further analysis presented at theAIDS Vaccine Meeting in Barcelona, Spain, in October 2013 and a publication in theJournal of Infectious Diseases (volume 210, pg 99)in 2014. HVTN 205 was designed to evaluate the safety and immunogenicity of our vaccines in healthy, HIV-uninfected adults. In HVTN 205, 299 participants were randomly assigned to three study arms: 149 participants received two injections of our DNA vaccine followed by two injections of our MVA vaccine (DDMM arm), 75 participants received three MVA injections and one placebo injection (MMPM arm), and 75 participants received four injections of placebo. After the final vaccination, antibody responses against the HIV Envelope protein (Env), the target for protective antibody, were detected in 93.2% of the DDMM arm (the vaccination regimen selected for further clinical study). At six months after final vaccination (the latest time point tested), gp140 IgG antibody response titers in the DDMM arm had declined by less than 3-fold, with response rates only declining from 100% to 84%, indicating significant durability of the antibody response. Additionally, HVTN 205 also showed that the antibody responses after vaccination had high affinity binding, a characteristic which has been associated with prevention of HIV infection in preclinical models. The study also showed low response rates for serum IgA, a desirable characteristic because serum IgA competed with serum IgG for reducing the risk of infection in the one partially protective (31%) AIDS vaccine trial in Thailand. Response rates for serum IgG3, an isotype associated with activating innate methods of protection such as complement (C’)-mediated lysis and antibody-dependent cellular cytotoxicity were excellent (91%).
HIV Immunotherapy Program
Current antiretroviral therapies, though highly effective at suppressing HIV viral load, are unable to eliminate HIV infection entirely. A major challenge in the development of HIV therapeutics is the ability of HIV to persist in host cells in a latent proviral form, invisible to the immune system and inaccessible to antiretroviral drugs. In response to this problem, the NIH and other leaders in the HIV field have developed a new concept: the “shock and kill” strategy, in which patients remain on standard-of-care anti-retroviral drug therapy while a second drug (“shock agent”) is used to activate latent HIV and a third drug (“kill agent”) is used to recognize and eliminate cells that harbor the latent HIV reservoir. A shock and kill therapy could potentially contribute to a cure for HIV.
Observations from a pilot Phase 1 clinical trial of our HIV vaccines (GV-TH-01 – discussed below) have led us to postulate that our DNA vaccines may be effective as a shock agent and that a subsequent, precisely timed MVA inoculation may reduce viral reservoirs. The Company is currently considering the best course of action for advancing its HIV immunotherapy program. Future therapeutic studies of GeoVax’s vaccine may investigate vaccine’s ability to act as a “shock agent” in a shock and kill therapy in combination with standard of care antiretroviral drug therapy to seek a cure. The timetable and specific clinical plans will be dependent upon the Company’s ability to secure external funding for the program, and on the nature of any potential collaborations GeoVax may establish.
Preclinical Studies – Therapeutic Vaccine. In 2007-2008, data were generated in three pilot studies on therapeutic vaccination in simian immunodeficiency virus-infected non-human primates. The vaccine used in these pilot studies was specific for simian immunodeficiency virus but with the design features of our HIV/AIDS vaccine. In these pilot studies, conducted at Yerkes National Primate Research Center of Emory University, non-human primates were infected, drug-treated, vaccinated and then drug-interrupted. Following treatment interruption, median levels of virus in blood, measured as viral RNA, were 10 to 1000-times lower than those measured prior to drug and vaccine treatment. The therapeutic reductions in virus levels were best for animals placed on drugs within 12 weeks of infection with lower levels of protection being achieved in animals that were placed on drugs at 3 months or later after infection.
Phase 1 Trial (Treatment Interruption). In early 2014, we completed a Phase 1 clinical trial (GV-TH-01) investigating the therapeutic use of our vaccines in HIV-infected patients. GV-TH-01 is an open label Phase 1 treatment interruption trial investigating the safety and immunogenicity of our DNA/MVA vaccine regimen in 9 HIV-infected patients who initiated drug treatment within 18 months of seroconversion and had stably controlled virus for at least 6 months. Patients were vaccinated with two DNA inoculations followed by two MVA inoculations at intervals of two months. Eight weeks following the last inoculation, patients suspended drug therapy for a 12-week period. Vaccinated patients’ ability to control the time and temporal height of re-emergent virus in the absence of drugs was then observed. Drug treatment was re-instituted after 12 weeks, and trial participants were observed for an additional 6 months. The primary endpoint of this study was to evaluate the safety of our vaccine in HIV-positive patients with well-controlled infections who are being treated with oral HIV medications. An exploratory objective of the study was to evaluate the ability of the vaccinated patient to control re-emergent virus during the drug treatment interruption period.
Analysis of GV-TH-01 data indicates that, during the vaccination phase of the trial, enhanced CD8++ T cells were elicited in 8 of 9 participants and enhanced CD4++ T cell in 5 of 9 participants. Antibody responses were boosted in 4 of 9 participants. Analyses during the treatment interruption phase of the trial suggested that individuals with the best immune responses had lower levels of re-emergent virus. These levels however were not sufficiently low to prevent immune escape and the reinstitution of progression towards AIDS. Excellent safety was observed throughout the trial, with none of the participants needing to reinstate antiretroviral drugs during the treatment interruption phase of the trial (data being compiled for publication).
Support from the United States Government
WithGrants and Contracts
We have been the exceptionrecipient 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 GV-TH-01 Phase 1 therapeutic trial (treatment interruption protocol), all of our human clinical trials to date have been conducted by the HVTN and funded by NIH. This financial support has been provided by the NIH directly to the HVTN, so has not been recognized in our financial statements. Our responsibility for these clinical trials has been to provide sufficient supplies of vaccine materials and technical expertise when necessary.
Congressionally Directed Medical Research Programs (CDMRP). In addition to clinical trialthe 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 Fever”, 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 fromof our development of a vaccine against SARS-CoV-2, the NIH,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 operationsvaccine candidates.
Other Federal Support
We have been partially funded by NIH research grants. Refer tothe recipient of additional in-kind federal support through collaborative and intramural arrangements with CDC for our Financial Statements beginningZika 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 page F-1 of this Prospectus, and to “Management's Discussion and Analysis of Financial Condition and Results of Operations”, for additional information regarding revenue and funds availability from these grants.our behalf.
RegulationsGovernment Regulation
Regulation by governmental authorities in the United States and other countries is a significant factor in our ongoing research and development activities and in the manufacture of our products under development.products. Complying with these regulations involves considerable expertise, time and expense.
In the United States, drugs and biologics are subject to rigorous federal and state regulation. Our products are regulated under the Federal Food, Drug and Cosmetic Act as amended (FD&C Act), the Public Health Service Act, and the regulations promulgated thereunder,under these statutes, and other federal and state statutes and regulations. These laws govern, among other things, the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of medications and medical devices. Product development and approval within this regulatory framework is difficult to predict, takes a number ofseveral years and involves great expense. The steps required before a human vaccine may be marketed in the United States include:
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Each of these steps is described further below. Before marketing any drug or biologic for human use in the United States, the product sponsor must obtain FDA approval. In addition, each manufacturing establishment must be registered with the FDA and must pass a Pre-Approval Inspection (PAI)pre-approval inspection before introducing any new drug or biological productbiologic into commercial distribution.
The Emergency Use Authorization (EUA) authority granted to the FDA allows the FDA to help strengthen the nation’s public health protections against certain threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under section 564 of the FD&C Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents when there are no adequate, approved, and available alternatives. This potentially may provide a faster pathway to market for our COVID-19 or other infectious disease vaccine candidates. This was the approval pathway followed by Pfizer-BioNTech and Moderna for their respective COVID-19 vaccines.
Because GeoVax does not manufacture vaccines for human use within our own facilities, we must ensure compliance both in our own operations and in the outsourced manufacturing operations. All FDA-regulated manufacturing establishments (both domestic establishments and foreign establishments that export products to the United States) are subject to inspections by the FDA and must comply with the FDA’s Good Manufacturing PracticescGMP regulations for products, drugs and devices.
The FDA determines compliance with applicable statutes and regulations through documentation review, investigations, and inspections. Several enforcement mechanisms are available to the FDA, ranging from a simple demand to correct a minor deficiency to mandatory recalls, closure of facilities, and even criminal charges for the most serious violations.
Preclinical Testing.Preclinical testing includes laboratory evaluationEven if FDA regulatory clearances are obtained, a marketed product is subject to continual review, and later discovery of chemistry and formulation,previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as cell culture and animal studies to assess the safety and potential efficacy of the product. Preclinical safety tests and certain other pivotal preclinical studies must be conducted by laboratories that comply with the FDA’s Good Laboratory Practices,possible civil or GLP. The results of pre-clinical testing are submitted to the FDA as part of the IND application and are reviewed by the FDA prior to the commencement of human clinical trials. Unless the FDA objects to an IND, the IND becomes effective 30 days following its receipt by the FDA.
cGMP-Compliant Manufacturing and Testing.FDA has issued, and frequently updates, extensive regulations on current Good Manufacturing Practice (cGMP). Any drug, biologic, or device for human use, whether commercial or investigational, must be manufactured under these regulations. cGMP regulations include a wide variety of requirements covering personnel, documentation, facilities, equipment, testing procedures, and many other aspects of manufacturing and testing.criminal sanctions.
Clinical Trials.Clinical trials involve the administration of investigational drugs to volunteers or to patients under the supervision of a qualified, medically trained clinical investigator. Clinical trials are conducted in accordance with Good Clinical Practices under protocols that detail the objectives of the trial, the parameters to be used to monitor safety and the efficacy criteria to be evaluated. Each protocol and the qualifications of the investigators who plan to carry it out must be submitted to the FDA as part of the IND. Further, each clinical trial must be conducted under the auspices of an independent institutional review board at the institution where the trial will be conducted. The institutional review board will consider, among other things, ethical factors, the safety of human subjects and the possible liability of the institution.
Clinical trials are typically conducted in three sequential phases, but the phases may overlap. In the Phase 1 clinical trial, the initial introduction of the product into healthy human subjects, the vaccine is tested for safety (including adverse side effects) and dosage tolerance. The Phase 2 clinical trial is the proof of principal stage and involves trials in a limited patient population to determine whether the product induces the desired effect (for our vaccines this means immune responses) and to better determine optimal dosage. The continued identification of possible safety risks is also a focus. When there is evidence that the product may be effective and has an acceptable safety profile in Phase 2 clinical trials, Phase 3 clinical trials are undertaken to evaluate clinical efficacy and to test for safety within an expanded patient population. Phase 3 trials are completed using multiple clinical study sites which are geographically dispersed. The manufacturer or the FDA may suspend clinical trials at any time if either believes that the individuals participating in the trials are being exposed to unacceptable health risks.
Biologics License Application and FDA Approval Process.The results and details of the pre-clinical studies and clinical trials are submitted to the FDA in the form of a Biologics License Application (BLA), which is equivalent to the New Drug Application (NDA) submitted by companies seeking to market new drugs. If the BLA is approved, the manufacturer may market the product in the United States. Under the Prescription Drug User Fee Act (PDUFA), FDA charges user fees to applicants to offset the costs of its operations. The PDUFA user fee for a new vaccine is over $2 million, unless the applicant obtains a waiver or reduction through certain programs designed to encourage development of certain types of products.
Postmarketing Requirements. FDA frequently imposes postmarketing requirements as a condition of NDA or BLA approval. Common postmarketing requirements include additional clinical trials (Phase 4 trials) or observational studies. Postmarketing requirements are especially relevant to our Ebola and Marburg vaccines. We intend to pursue approval of these vaccines using the accelerated approval process, in which FDA grants approval based on performance against a criterion other than actual protection against the disease but requires the manufacturer to monitor and submit data on efficacy of the approved product. Unlike pathogens such as human papillomavirus, Ebola and Marburg are not constantly in circulation; instead, they occur in sporadic but extremely deadly outbreaks. For this reason, it would be impractical and potentially unethical to attempt to perform a traditional Phase 3 trial in which vaccinated participants are compared against unvaccinated participants to determine the efficacy of the vaccine in preventing infection with Ebola or Marburg. The accelerated approval process allows FDA to approve a new medicine based on its performance against a surrogate endpoint (in the case of Ebola or Marburg, its performance in raising immune responses). We anticipate that, as a condition of receiving accelerated approval, GeoVax would agree to monitor the real-world performance of our Ebola and Marburg vaccines.
International Approval.Whether or not the FDA has approved the drug, approval of a product by regulatory authorities in foreign countries must be obtained prior to the commencement of commercial sales of the drug in such countries. The requirements governing the conduct of clinical trials and drug approvals vary widely from country to country, and the time required for approval may be longer or shorter than that required for FDA approval.
Other Regulations.In addition to FDA regulations, our business activities may also be regulated by the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential future federal, state or local regulations. Violations of regulatory requirements at any stage may result in various adverse consequences, including regulatory delay in approving or refusal to approve a product, enforcement actions, including withdrawal of approval, labeling restrictions, seizure of products, fines, injunctions and/or civil or criminal penalties. Any product that we develop must receive all relevant regulatory approvals or clearances before it may be marketed.
Manufacturing
We do not havealso are subject to various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory and manufacturing practices, the facilitiesexperimental use of animals, and the use and disposal of hazardous or expertise to manufacturepotentially hazardous substances used in connection with our research. The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted.
FDA Tropical Disease Priority Review Voucher Program
Section 524 of the clinicalFD&C Act authorizes the FDA to award priority review vouchers (PRVs) to sponsors of approved tropical disease product applications that meet certain criteria. To qualify for a PRV, a sponsor’s application must be for a drug or biological product for the prevention or treatment of a “tropical disease,” must otherwise qualify for priority review, and must contain no active ingredient (including any salt or ester of an active ingredient) that has been approved in any other application under Section 505(b)(1) of the FD&C Act or section 351 of the Public Health Services Act. Priority review means that the FDA aims to render a decision in 6 months.
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 suppliesdisease. The price of anythe 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 our products. 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.
Manufacturing
To be successful, our products must be manufactured in commercial quantities in compliance with regulatory requirements and at an acceptable cost. To date, we have not commercialized any products, nor have we demonstrated that we can manufacture commercial quantities of our product candidates in accordance with regulatory requirements. If we cannot manufacture products in suitable quantities and in accordance with regulatory standards, either on our own or through contracts with third parties, it may delay clinical trials, regulatory approvals and marketing efforts for such products. Such delays could adversely affect our competitive position and our chances of achieving profitability. We cannot be sure that we can manufacture, either on our own or through contracts with third parties, such products at a cost or in quantities that are commercially viable.
We do not currently rely and intendhave the facilities or internal expertise to continuemanufacture any of the clinical or commercial supplies of any of our product. Rather, our strategy is to rely on third-party contract manufacturers to produce vaccines needed for research and clinical trials. We have entered into arrangements with third party manufacturers for the supply of our DNA and MVA vaccines 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 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.
Development of Improved Manufacturing Techniques for MVA –The MVA component of our vaccine is currently manufactured in cells that are cultured from embryonated chicken eggs, which is a reliable method to manufacture large quantities of vaccine. In an attempt to find a means to reduce costs for large-scale manufacturing, we have exploredeggs. We are exploring a number of approaches to producinggrowing MVA in continuous cell lines that can be grown in bioreactors. In this process we have identified a duck stem-cell-derived line (termed EB66), that is proprietary to Valneva S.E., France. We are currently working with Valneva on the use of EB66 cellsbioreactors more suitable for the growth of our MVA vaccines. We are hopeful that upon completion of this alternative process we will have the option of producing vaccine at significantly higher titers in a much more advanced and scalable process, allowing for quality improvements over the current process as well as meaningful cost reductions.
Competitioncommercial-scale manufacturing.
The biopharmaceutical industryraw materials and the vaccine market is competitive and subject to rapid and substantial technological change. Developments by others may render our proposed vaccination technologies noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological competitionsupplies that are used in the industryproduction process for our vaccines and that we use in our research activities are generally available from a number of commercial suppliers and we believe we will be able to obtain sufficient quantities of such materials and supplies for all foreseeable clinical investigations.
Competition
Our product candidates face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology companies universities, governmental entitiesas well as academic and others diversifying into the fieldresearch institutions. We compete in an industry that is intensecharacterized by rapid technological change; evolving industry standards; emerging competition; and is expected to increase. Many of the pharmaceutical companiesnew product introductions. Competitors have existing products and technologies that will compete with our pipeline candidates and technologies and may develop and commercialize additional products and technologies that will compete with our pipeline candidates and technologies. Because competing companies and institutions may have greater financial resources than us, have significantlythey may be able to provide broader services and product lines; and make greater investments in research and development. Competitors may also have greater development capabilities than we do and have as well as substantially more marketing,greater experience in undertaking nonclinical and clinical testing of products, obtaining regulatory approvals and manufacturing and financial resources. In addition, acquisitionsmarketing pharmaceutical products. They may also have greater name recognition and better access to customers.
We face general market competition from several subsectors of or investments in, smallthe vaccine development field, including large, multinational pharmaceutical orcompanies 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; and academic and not-for-profit vaccine researchers and developers including the NIH. The industry is typified by such large corporations could increase their research, financial, marketing, manufacturingextensive collaboration, licensing, and merger and acquisition activity despite the intense competition.
More than twenty 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 clinical or pre-approval vaccine candidates include, Novavax, Inc., AstraZeneca PLC, CureVac N.V., Medicago Inc., GSK, Sanofi S.A., Dynavax, and Valneva SE.
A number of companies are developing various types of therapeutic vaccines or other resources. Competitive technologies may ultimately proveimmunotherapy approaches to be safer, more effective or less costly than any vaccine that we develop.treat cancer including Advaxis, Immune Design, Oncothyreon, Bavarian Nordic, Roche Pharmaceuticals, Merck & Co, Bristol Myers Squibb, and AstraZeneca plc.
There are currently no FDA licensed and commercialized Ebola vaccines, MarburgZika vaccines, or HIVhemorrhagic fever virus vaccines (other than for Ebola) 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 Ebola,hemorrhagic fever viruses, these include NewLink Genetics and Merck, Johnson & Johnson, GlaxoSmithKline,Novavax, Inovio and Merck.GlaxoSmithKline. For HIV,Zika, these include Novartis, Sanofi-AventisNewLink Genetics, Inovio, Merck, Butantan Institute and GlaxoSmithKline. Other HIVNIH (NIAID). In December 2019, the FDA approved the first vaccine (ERVEBO®) for prevention of Ebola, developed by Merck.
There are currently no commercialized vaccines to prevent malaria infection. A first-generation infection-blocking 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%, 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 in varying stagesexpected to contain multiple antigens designed to block both infection and transmission of research, testing and clinical trials including those supported by the NIH Vaccine Research Center, the U.S. Military, IAVI, the European Vaccine Initiative, and the South African AIDS Vaccine Initiative. We may also experience competition from companies that have acquired or may acquire technologies from companies, universities and other research institutions. As these companies develop their technologies, they may develop proprietary technologies which may materially and adversely affect our business.
If any of our competitors develop productsmalaria with at least a 75% efficacy or safety profiles significantly better than our products, we may not be able to commercialize our products, and sales of any of our commercialized products could be harmed. Some of our competitors and potential competitors have substantially greater product development capabilities and financial, scientific, marketing and human resources than we do. Competitors may develop products earlier, obtain FDA approvals for products more rapidly, or develop products that are more effective than those under development by us. We will seek to expand our technological capabilities to remain competitive; however, research and development by others may render our technologies or products obsolete or noncompetitive, or result in treatments or cures superior to ours.rate.
Our competitive position will be affected by the disease indications addressed byIntellectual Property
Our commercial success depends in part on our product candidates and those of our competitors, the timing of market introduction for these products and the stage of development of other technologies to address these disease indications. For usability, and our competitors, proprietary technologies, the ability to complete clinical trials on a timely basis and with the desired results, and thelicensors’ ability, to obtain timely regulatory approvals to market theseand maintain proprietary protection for our clinical product candidates, are likely to be significant competitive factors. Other important competitive factors will includeincluding our Modified Vaccinia Ankara-Virus-Like Particle (MVA-VLP) based vaccines, our in-licensed synthetic MVA Covid-19 vaccine candidate, and our in-licensed Gedeptin gene-directed enzyme prodrug therapy, and methods of treatment using the efficacy, safety, ease of use, reliability, availability and price of products and the ability to fund operations during the period between technological conception and commercial sales.
Our Intellectual Propertysame.
We, will be ableand in collaboration with our licensors for our in-licensed assets, seek patent protection on each of our product and developmental candidates and, where applicable, on combinations with other therapeutic and/or antigenic agents and dosing schedules. Our success also depends on our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary rights from unauthorized useposition by, third parties onlyamong other methods, filing U.S. patent applications and, where appropriate, foreign patent applications covering our proprietary technology, inventions, and improvements that are important to the extentdevelopment and implementation of our business. We collaborate with our licensors to ensure the filing of U.S. patent applications and, where appropriate, foreign patent applications covering our in-licensed technology, inventions, and improvements that are important to the development and implementation of our business. We also rely on trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary rights are described by validposition. Additionally, we expect to benefit, where appropriate, from statutory frameworks in the United States, Europe, and enforceable patentsother countries that provide a period of clinical data exclusivity to compensate for the time required for regulatory approval of our clinical product candidates.
We continually assess and refine our intellectual property strategies as we develop new technologies and product candidates. We plan to file additional patent applications based on our intellectual property strategies where appropriate, including where we seek to improve our basic technology, adapt to competition, or are effectively maintainedto improve business opportunities. Further, we plan to file patent applications, as trade secrets. Accordingly, we are pursuing and will continueconsider appropriate under the circumstances, to pursueprotect new technologies that we develop. Our patent filing strategy typically includes seeking patent protection in the United States and, wherein appropriate, in additional countries where we believe such protection is likely to be useful.
As of December 31, 2021, our owned, co-owned, and in-licensed patent estate, on a worldwide basis, includes 19 granted U.S. patents, 3 allowed U.S. patent applications, 10 pending U.S. patent applications; 56 granted foreign patents, 20 pending foreign patent applications, 4 Patent Cooperation Treaty (PCT) applications, and 4 U.S. provisional applications spread over 25 patent families. The term of individual patents depends upon the laws of the countries in which they are obtained. In the countries in which we currently file, the patent term is 20 years from the earliest date of filing of a non-provisional patent application which serves as a priority application. In addition, we plan to seek patent term adjustments, restorations, and/or patent term extensions where applicable in the United States and other jurisdictions. For example, depending upon the timing, duration, and specifics of FDA approval of our vaccine products, some of our U.S. patents may be eligible for our proprietary technologies obtained or developed through our collaborations with Emory University,a patent term extension under the NIH,Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the “Hatch-Waxman Amendments,” and codified as 35 U.S.C. § 156. 35 U.S.C. § 156 permits restoration of the patent term of up to five years as compensation for patent term lost during product development and FDA regulatory review process. Patent term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one half the time between the effective date of an IND and the CDC,submission date of a Biologics License Application (BLA), plus the time between the submission date of a BLA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved vaccine product is eligible for such an extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or developedrestoration. A similar kind of patent extension, referred to as a Supplementary Protection Certificate, is available in Europe. Legal frameworks are also available in certain other jurisdictions to extend the term of a patent. We currently intend to seek patent term extensions on any of our, or our exclusively licensed, issued patents in any jurisdiction where we have a qualifying patent and the extension is available; however, there is no guarantee that the applicable regulatory authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions. Further, even if our patent is extended, the patent, including the extended portion of the patent, may be held invalid or unenforceable by us alone. a court of final jurisdiction in the United States or a foreign country.
Our current patent portfolio described more fully below, includes claims5 patent families directed to various aspects of our DNA and MVA basedMVA-based HIV vaccines, their genetic inserts expressing multiple HIV protein components, composition, structure, claim of immunization against multiple subtypes of HIV, routes of administration, safety and other related factors and methods of therapeutic and prophylactic use thereof including administration regimes. Also included are claimsWe have in-licensed patents from Emory University and the U.S. National Institutes of Health (NIH) relevant to our HIV-vaccine program. These patents will expire between 2022 and 2028, exclusive of any patent term adjustments or extensions. We wholly own one patent family, including one granted U.S. patent (US 11,098,086), directed to specific vaccine administration methods which, where issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments or extensions.
We wholly own one allowed U.S. patent application directed to preventive vaccines against Ebola virus, and one pending U.S. patent application directed to Marburg virusesvirus and uses thereof. These applications, where issued, valid, and enforceable, will expire in 2036, exclusive of any patent term adjustments or extensions.
We wholly own one U.S. patent application directed to preventive vaccines against Zika virus and uses thereof. This application, if issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments or extensions.
We co-own one patent family with Georgia State University directed to preventive vaccines against hepatitis B virus (HBV), and uses thereof, including one granted U.S. patent (US 11,052,148). These applications, where issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments or extensions.
We wholly own one allowed U.S. patent application directed to preventive vaccines against malaria and use thereof. AsThis application, where issued, valid, and enforceable, will expire in 2038, exclusive of January 1, 2015, we are the licensee of at least eight issuedany patent term adjustments or extensions.
We wholly own 3 patent families, which includes one allowed U.S. patents and at least 12 issued or allowed non-U.S. patents. We are actively pursuing one U.S. provisionalpatent application and one international patentgranted foreign application as the owner(AU 2017206102), directed to our immuno-oncology vaccine compositions and methods of record, in addition to at least six U.S.use thereof. The patent applications of these families, where issued, valid, and at least 15 non-U.S.enforceable, will expire between 2037-2040, exclusive of any patent term adjustments or extensions.
We wholly own two pending patent families directed to various MVA-based vaccines for the treatment of SARS CoV-2. The patent applications in six jurisdictions under license.these families, if issued, valid, and enforceable, will expire between 2041-2042, exclusive of any patent term adjustments or extensions. We have non-exclusively in-licensed from the U.S. National Institutes of Health (NIH) 3 patent families directed to certain aspects of our MVA-viral backbone used in our SARS-CoV2 vaccine, which will expire between 2023 and 2032, exclusive of any patent term adjustments or extensions. We have non-exclusively in-licensed from the NIH 2 patent families relating to coronavirus spike protein compositions relevant to our MVA SARS-CoV2 vaccine candidates. The patent applications for these families, if issued, valid, and enforceable, will expire between 2037 and 2041, exclusive of any patent term adjustments or extensions.
We wholly one pending U.S. application directed to MVA-based vaccines for the treatment of Zika virus. The patent application, if issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments or extensions.
We co-own one patent family with Leidos, Inc. directed to viral constructs for use in enhancing T-cell priming during vaccination. The patent applications in this patent family, if issued, valid, and enforceable, will expire in 2042, exclusive of any patent term adjustments or extensions.
We are the exclusive, worldwide licensee of a number ofseveral patents and patent applications, which we refer to as the Emory Technology, owned, licensed or otherwise controlled by Emory University for HIV or smallpox vaccines pursuant to a License Agreementlicense agreement originally entered into on August 23, 2002 and restated on June 23, 2004 which we refer to as the(the “Emory License”). The in-licensed Emory License.University patents will expire between 2022 and 2028, exclusive of any patent term extensions. Through the Emory License we are also a non-exclusive licensee of four issued United States patents owned by the NIH related to the ability of our MVA vector vaccine to operate as a vehicle to deliver HIV virus antigens, and also to induce an immune response in humans. The four issued United StatesThese in-licensed NIH patents owned by the NIHwill expire in 2023. All2023, exclusive of our obligations with respect to the HIV NIH-owned MVA patents are covered by the Emory License. The Emory License expires on the expiration date of the last to expire of the patents licensed thereunder including those that are issued on patents currently pending. We will not know the final termination date of the Emory License until such patents are issued. The Company may terminate the Emory University License upon 90 days’ written notice. The Emory License also contains standard provisions allowing Emory University to terminate upon breach of contract by the Company or upon the Company’s bankruptcy.any patent term extensions.
The EmoryMVA backbone that we have been using in our vaccines was provided to us by the laboratory of Dr. Bernard Moss of the NIAID, Laboratory of Viral Diseases (LVD). We have a non-exclusive commercial license to the NIH MVA backbone for our SARS CoV-2 vaccine with the NIAID of the National Institutes of Health NIH on behalf of the United States, which includes the use of certain patents and patent applications arising from the Moss laboratory and the provided materials. We also have a non-exclusive research and development license to use the MVA backbone for our other vaccine candidates. If we later decide to commercialize vaccine candidates that are under the research and development license, we will need to negotiate appropriate commercialization licenses. These in-licensed NIH patents and patent applications, if and where issued, valid, and enforceable, will expire between 2023 and 2032, exclusive of any patent term adjustments or extensions.
We have exclusively in-licensed three patent families from the City of Hope in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of COVID-19 pursuant to an Exclusive License among other contractual obligations, requires payments basedAgreement entered into on the following:November 9, 2021. The in-licensed patent families are directed to synthetic MVA vectors, including synthetic MVA vaccines encoding one or more SARS-CoV-2 antigens, and their methods of production and use, and encompass COH04S1, a multi-antigenic SARS-CoV-2 vaccine currently undergoing Phase 2 human clinical trials. These in-licensed City of Hope patent families, if issued, valid, and enforceable, will expire in 2041, exclusive of any patent term adjustments or extensions.
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We may only usehave exclusively in-licensed two patent families from the Emory Technology for therapeutic or prophylactic HIV or smallpox vaccines. Emory University also reservedof Alabama and the rightSouthern Research Institute pursuant to use the Emory Technology for research, educationalan Assignment and non-commercial clinical purposes. DueLicense Agreement with PNP Therapeutics, Inc. entered into on September 28, 2021. The two patent families are directed to the use of federal funds intail-mutant purine nucleoside phosphorylase enzymes and fludarabine for the developmenttreatment of cancer, and cover aspects of the Emory Technology, the U.S. Government has the irrevocable, royalty-free, paid-up right to practice and have practiced certain patents throughout the world, should it choose to exercise such rights.
We are not a party to any litigation, opposition, interference, or other potentially adverse proceeding with regard to our patent positions. However, if we become involved in litigation, interference proceedings, oppositions or other intellectual property proceedings, for example as a result of an alleged infringement or a third-party alleging an earlier date of invention, we may have to spend significant amounts of money and time and, in the event of an adverse ruling, we could be subject to liability for damages, invalidationuse of our intellectual propertyGedeptin clinical product candidate. These in-licensed patent families, where issued, valid, and injunctive relief that could prevent us from using technologiesenforceable, will expire between 2029 and 2032, exclusive of any patent term adjustments or developing products, any of which could have a significant adverse effect on our business, financial conditions or results of operations. In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous if available at all.
In addition to patent protection, we also attempt to protect our proprietary products, processes and other information by relying on trade secrets and non-disclosure agreements with our employees, consultants and certain other persons who have access to such products, processes and information. Under these agreements, all inventions conceived by employees are our exclusive property. Nevertheless, there can be no assurance that these agreements will afford significant protection against misappropriation or unauthorized disclosure of our trade secrets and confidential information.extensions.
We cannot be certain that any of the current pending patent applications we have or have licensed, or any new patent applications we may file or license, will ever be issued in the United States or any other country. Even if issued, there can be no assurance that those patents will be sufficiently broad to prevent others from using our products or processes. Furthermore, our patents, as well as those we have licensed or may license in the future, may be held invalid or unenforceable by a court, or third parties could obtain patents that we would need to either license or to design around, which we may be unable to do. Current and future competitors may have licensed or filed patent applications or received patents and may acquire additional patents or proprietary rights relating to products or processes competitive to ours. In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous to us, if available at all.
We also expect to benefit, where appropriate, from statutory frameworks in the United States, Europe, and other countries that provide a period of regulatory exclusivity to compensate for the time and cost required in securing regulatory approval of our clinical products. For example, in 2010, the United States enacted the Biologics Price Competition and Innovation Act (BPCIA). Under the BPCIA, innovator manufacturers of biological products may be granted 12 years of exclusive use before biosimilar versions of such products can be licensed for marketing in the U.S. This means that the FDA may not approve an application for a biosimilar version of our products until 12 years after the date the product is approved for sale (with a potential six-month extension of exclusivity if certain pediatric studies are conducted and the results accepted by the FDA), although a biosimilar application may be submitted four years after the date we receive approval from the FDA to sell our product. Additionally, the BPCIA establishes procedures by which potentially relevant patents may be shared and litigation over patents may proceed in advance of approval. The BPCIA also provides incentives to biosimilar applicants by providing a period of exclusivity to the first biosimilar of a product approved by the FDA. The 12-year data exclusivity provision of the BPCIA does not prevent a competitor from seeking marketing approval of one of our products, or a product similar thereto, by submitting its own, original Biologics License Application (BLA).
We intend to benefit, where applicable, from additional market exclusivity provisions in various jurisdictions that reward the treatments of rare diseases. For example, in the United States under the Orphan Drug Act of 1983, the FDA may grant orphan designation to a vaccine product intended to prevent or treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making the product available in the United States for this type of disease or condition will be recovered from sales of the product. Orphan designation must be requested before submitting a BLA. After the FDA grants orphan designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety, or providing a major contribution to patient care, or in instances of drug supply issues. Competitors, however, may receive approval of either a different product for the same indication or the same product for a different indication; in the latter case, because health care professionals are free to prescribe products for off-label uses, the competitor’s product could be used for the orphan indication despite our orphan exclusivity.
We are not a party to any litigation, opposition, interference, or other potentially adverse proceeding with regard to our patent positions. However, if we become involved in litigation, interference proceedings, oppositions or other intellectual property proceedings, for example as a result of an alleged infringement or a third-party alleging an earlier date of invention, we may have to spend significant amounts of money and time and, in the event of an adverse ruling, we could be subject to liability for damages, invalidation of our intellectual property and injunctive relief that could prevent us from using technologies or developing products, any of which could have a significant adverse effect on our business, financial conditions or results of operations. In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous if available at all.
In addition to patents, we rely upon unpatented, proprietary trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with our commercial partners, collaborators, employees, and consultants, and invention assignment agreements with our employees. These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party. These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our commercial partners, collaborators, employees, and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
License Agreements
City of Hope License – On November 9, 2021, we entered into an Exclusive License Agreement (COH License) with City of Hope (COH), a California nonprofit public benefit corporation, under which the Company obtained exclusive worldwide rights to further develop and commercialize COH04S1, a multi-antigenic SARS-CoV-2 vaccine currently undergoing Phase 2 human clinical trials. The COH License grants GeoVax exclusive rights to key patents, know-how, regulatory filings and clinical materials for use against COVID-19. The terms of the COH License, include an upfront fee consisting of an initial payment to COH of $5,000,000 within 30 days of the effective date of the COH License, and additional payments of $3,000,000 and $2,000,000 on the first and second anniversaries, respectively, of the effective date of the COH License. The terms also include milestone payments due upon the achievement of selected development, regulatory and sales events. The Company will also pay COH an annual royalty on net sales of products covered by the patents licensed from COH on a country-by-country and licensed product-by-licensed product basis, subject to specified reductions.
Gedeptin License – On September 28, 2021, we entered into an Assignment and License Agreement (the “Gedeptin License”) with PNP Therapeutics, Inc. (“PNP”) under which the Company obtained exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials, and trademarks. The Gedeptin patent portfolio was originally licensed from the University of Alabama at Birmingham (“UAB”) and Southern Research Institute (“SRI”) by PNP. Under the terms of the Gedeptin License, the Company is the successor to PNP under the Exclusive License Agreement between UAB, SRI and PNP, and has acquired the exclusive rights to develop and commercialize Gedeptin, a novel patented product for the treatment of solid tumors.
The terms of the Gedeptin License, include (i) an upfront payment at closing, (ii) milestone payments due upon the achievement of selected development and regulatory events, and (iii) quarterly support payments for the lesser period of three years or the Company’s filing for FDA approval of its Biologics License Application on the use of Gedeptin for the treatment of head and neck cancer in humans. The Company will also pay tiered percentage annual royalties in the low-to-mid teens on Net Sales (as defined in the Gedeptin License) of products covered under the Gedeptin License on a country-by-country and product-by-product basis, subject to specified reductions. The Company also issued a warrant to PNP, exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 100,000 shares of the Company’s common stock at an exercise price of $13.00 per share. The Gedeptin License will remain in effect during the original term, which concludes upon FDA approval of a generic or biosimilar product, and then will automatically renew for 5-year additional terms, subject to customary termination rights.
NIH Licenses –On November 25, 2020, the Company entered into a Patent and Biological Materials License Agreement for Internal Research Use (the “Research License”) with the U.S. Department of Health and Human Services (HHS), as represented by NIAID, in support of the Company’s non-clinical development of vaccines against numerous pathogens. The Research License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of preventive and/or therapeutic Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccines against Ebola-Zaire virus, Ebola-Sudan virus, Lassa virus, Marburg virus, Zika virus and malaria. The agreement also extends to the Company’s research and development efforts in certain oncology areas. The agreement provides GeoVax with nonexclusive rights for the nonclinical development and manufacturing of its vaccine and immunotherapy candidates using HHS patents and materials.
On October 22, 2020, the Company entered into a Patent and Biological Materials License Agreement (the “COVID License”) with HHS, as represented by NIAID, in support of the Company’s development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The COVID License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of a preventive Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccine that primes and/or boosts the immune system against COVID-19. The COVID License provides GeoVax with nonexclusive rights to develop, manufacture and commercialize its COVID-19 vaccine and includes access to NIAID’s patent rights in the stabilized SPIKE protein, which is the protein that SARS-CoV-2 uses to gain entry into human tissue.
Research and Development
Our expenditures for research and development activities were $1,812,969, $2,914,878,$15.6 million, $2.4 million, $1.3 million and $3,043,522$0.6 million during the years ended December 31, 2014, 20132021 and 2012, respectively;2020 and $1,166,803the three months ended March 31, 2022 and $1,344,560 for the nine month periods ended September 30, 2015 and 2014,2021, respectively. As our vaccines continue to go through the process to obtain regulatory approval, we expect our research and development costs to continue to increase as human clinical trials proceed.increase. We have not yet formulated any plans for marketing and sales of any vaccine candidate we may successfully develop. Compliance with environmental protection laws and regulations has not had a material effect on our capital expenditures, earnings or competitive position to date.
Properties and EmployeesScientific Advisors
We seek advice from our Scientific Advisory Board, which consists of a number of leading scientists, on scientific and medical matters. The current members of our Scientific Advisory Board are:
Name | Position/Institutional Affiliation | |
Harriet L. Robinson, PhD. | Chief Scientific Officer Emeritus, GeoVax | |
Stanley A. Plotkin, MD | Professor Emeritus, University of Pennsylvania, Adjunct Professor, Johns Hopkins University | |
Barney S. Graham, MD, PhD | Senior Investigator, Vaccine Research Center, NIAID | |
Scott C. Weaver, PhD | Director, University of Texas Medical Branch Institute for Human Infections and Immunity | |
Olivera J. Finn, PhD | Distinguished Professor of Immunology and Surgery, University of Pittsburgh |
Properties
Our principal executive offices are located in Smyrna, Georgia, where we lease approximately 8,400 square feet of office and laboratory space located at 1900 Lake Park Drive, Suite 380, Smyrna, Georgia under aspace. Our lease agreement which began November 1, 2009, with an original expiration date offor the premises is currently scheduled to terminate on December 31, 2014.2022. We have renewed the lease through December 31, 2016, with a 12-month renewal option.do not currently own any real property. We believe this space is adequate forthat our current needs. As of December 8, 2015,facilities are adequate to meet our immediate needs and believe that we had sixshould be able to renew our lease without an adverse impact on our operations. In addition, we believe that if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.
Human Capital Resources
We currently have twelve full-time and three part-time employees. None of our employees are covered by collective bargaining agreements and we believe that our employee relations are good. We also engage consultants and independent contractors to fulfill key roles and/or provide expert services on both an ongoing and short-term basis.
We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees. We provide our employees with competitive compensation, opportunity for equity ownership, and a robust employment package that promotes wellness across all aspects of their lives, including healthcare, retirement planning, and paid time off.
CorporateCorporate Background
Our primary business is conducted by our wholly owned subsidiary, GeoVax, Inc., which was incorporated under the laws of Georgia in June 2001. Our address is 1900 Lake Park Drive, Smyrna, Georgia 30080, and our telephone number at that address is 678-384-7220. The predecessor of our parent company, GeoVax Labs, Inc. (the reporting entity) was originally incorporated in June 1988 under the laws of Illinois as Dauphin Technology, Inc. (“Dauphin”). In September 2006, Dauphin completed a merger with GeoVax, Inc. As a result of the merger, GeoVax, Inc. became a wholly-ownedwholly owned subsidiary of Dauphin, and Dauphin changed its name to GeoVax Labs, Inc. In June 2008, the Company was reincorporated under the laws of Delaware. We currently do not conduct any business other than GeoVax, Inc.’s business of developing new products for the treatment or prevention of human diseases. Our principal offices are located in Smyrna, Georgia (metropolitan Atlanta).
AVAILABLE INFORMATION
Our website address is www.geovax.com. We make available on this website under “Investors – SEC Reports,” free of charge, our proxy statements, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports as soon as reasonably practicable after we electronically file or furnish such materials to the SEC. We also make available our Code of Ethics on this website under the heading “Investors – Corporate Governance”. Information contained on our website is not incorporated into this prospectus.
SELECTED FINANCIAL DATA
The following selected financial data as of and for each of the five years ended December 31, 2014 are derived from our audited consolidated financial statements. The selected financial data as of and for the nine months ended September 30, 2015 and 2014 is unaudited. The historical results presented below are not necessarily indicative of the results to be expected for any future period. The information set forth below should be read in conjunction with the information contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, and our consolidated financial statements and the related notes, beginning on page F-1 of this prospectus.
Years Ended December 31, | ||||||||||||||||||||
2014 | 2013 | 2012 | 2011 | 2010 | ||||||||||||||||
Statement of Operations Data: | ||||||||||||||||||||
Total revenues (grant income) | $ | 882,956 | $ | 2,417,550 | $ | 2,657,327 | $ | 4,899,885 | $ | 5,185,257 | ||||||||||
Net loss | (2,733,555 | ) | (2,284,943 | ) | (2,135,140 | ) | (2,346,826 | ) | (2,474,328 | ) | ||||||||||
Basic and diluted net loss per common share | (0.10 | ) | (0.11 | ) | (0.12 | ) | (0.15 | ) | (0.18 | ) |
As of December 31, | ||||||||||||||||||||
2014 | 2013 | 2012 | 2011 | 2010 | ||||||||||||||||
Balance Sheet Data: | ||||||||||||||||||||
Total assets | 1,333,198 | 2,839,576 | 1,477,970 | 1,645,142 | 2,357,834 | |||||||||||||||
Total stockholders’ equity | 1,146,175 | 2,527,227 | 1,150,935 | 703,607 | 1,836,226 |
Nine Months Ended September 30, | ||||||||
2015 | 2014 | |||||||
(unaudited) | ||||||||
Statement of Operations Data: | ||||||||
Total revenues (grant income) | $ | 268,028 | $ | 659,867 | ||||
Net loss | (1,996,556 | ) | (1,809,970 | ) | ||||
Basic and diluted net loss per common share | (0.06 | ) | (0.07 | ) |
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MANAGEMENT’SMANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONSOPERATION
The following discussion and analysis of our financial condition and results of operations should be read together with “Selected Financial Data” and our consolidated financial statements and the related notes beginning on page F-1 ofincluded in this prospectus. This discussion contains forward-looking statements that involve risks and uncertainties because they are based on current expectations and relate to future events and our future financial performance. Our actual results may differ materially from those anticipated in these forward-looking statements as a resultbecause of many important factors, including those set forth under “Risk Factors”“Risk Factors” and elsewhere in this prospectus.
Overview and Recent Developments
GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and cancers using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human vaccines using our novel platform technology. Our currentclinical trials in COVID-19 and head and neck cancer. Additional research and development programs are focused on Ebolainclude preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Marburg viruses,Lassa) and HIV. Our HIV vaccine technology was developed in collaboration with researchers at Emory University, the NIH, and the CDC, and is exclusively licensed to us from Emory University. We also have nonexclusive licenses to certain patents owned by the NIH. Our Ebola and Marburg vaccines are being developed with technology licensed to us from the NIH.malaria, as well as immunotherapies for solid tumors.
Our programs are in various stages of development, the most advanced HIV vaccine development effortssignificant of which are focused on a preventive vaccine to address the clade B subtype of the HIV virus that is most prevalent in the developed world (primarily North America and Western Europe). All of the clinical trials for our preventive HIV vaccine (through Phase 2a) have beensummarized below:
● | GEO-CM04S1 is currently undergoing a Phase 2 clinical trial (NCT04977024), evaluating its safety and efficacy as a preventive COVID-19 vaccine, compared to the Pfizer/BioNTech mRNA-based vaccine, in blood cancer patients who have received a bone marrow transplant or chimeric antigen receptor therapy (CAR T). |
● | In December 2021, patient enrollment began for the Phase 2 portion of a Phase 1/2 trial (NCT04639466) of GEO-CM04S1, evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. |
● | Gedeptin® is currently undergoing a Phase 1/2 clinical trial (NCT03754933) for treatment of patients with advanced head and neck cancer, which is being conducted |
● | 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 NIH. Through a continued collaboration withprivate placement and registered direct offerings to the NIH and HVTN, in early 2016 we expect to initiate a Phase 1 clinical trial investigating the effect of a “protein boost” to increase the antibody responses elicited by our vaccine. While this effort continues, we are also exploring our options to secure fundingCompany were approximately $20.0 million.
Our corporate strategy is to advance, protect and exploit our vaccine (withoutdifferentiated vaccine/immunotherapy technologies leading to the additional protein boost) directly into pivotal Phase 2b efficacy trials.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 have also begunleverage third party resources through collaborations and partnerships for preclinical studies to develop an HIV vaccine candidate for the clade C subtype of HIV prevalent in the developing world (primarily sub-Saharan Africa and India); these studies are currently being supported by NIH grants. Our Ebola vaccine development efforts were initiated in 2014clinical testing with multiple government, academic and we are currently conducting preclinical animal studies through a collaboration with the NIH.corporate entities.
We have neither receivednot 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 anycommercialization. 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
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:
Year Ended December 31, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Grant and collaboration revenue | $ | 385,501 | $ | 1,823,658 | $ | (1,438,157 | ) | |||||
Operating expenses: | ||||||||||||
Research and development | 15,554,171 | 2,444,459 | 13,109,712 | |||||||||
General and administrative | 3,577,153 | 2,196,014 | 1,381,139 | |||||||||
Total operating expenses | 19,131,324 | 4,640,473 | 14,490,851 | |||||||||
Loss from operations | (18,745,823 | ) | (2,816,815 | ) | (15,929,008 | ) | ||||||
Total other income (expense) | 175,506 | (141,253 | ) | 316,759 | ||||||||
Net loss | $ | (18,570,317 | ) | $ | (2,958,068 | ) | $ | (15,612,249 | ) |
Three Months Ended March 31, | ||||||||||||
2022 | 2021 | Change | ||||||||||
Grant revenue | $ | 81,526 | $ | 110,417 | $ | (28,891 | ) | |||||
Operating expenses: | ||||||||||||
Research and development | 1,330,544 | 602,783 | 727,761 | |||||||||
General and administrative | 1,179,024 | 1,071,710 | 107,314 | |||||||||
Total operating expenses | 2,509,568 | 1,674,493 | 835,075 | |||||||||
Loss from operations | (2,428,042 | ) | (1,564,076 | ) | (863,966 | ) | ||||||
Total other income (expense) | 527 | 1,298 | (771 | ) | ||||||||
Net loss | $ | (2,427,515 | ) | $ | (1,562,778 | ) | $ | (864,737 | ) |
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 candidates, nordevelopment 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, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Lassa Fever – U.S. Army Grant | $ | 85,574 | $ | 1,438,465 | $ | (1,352,891 | ) | |||||
Covid-19 – NIH SBIR Grant | 299,927 | - | 299,927 | |||||||||
Malaria – Collaboration Revenue | - | 385,193 | (385,193 | ) | ||||||||
Total | $ | 385,501 | $ | 1,823,658 | $ | (1,438,157 | ) |
Three Months Ended March 31, | ||||||||||||
2022 | 2021 | Change | ||||||||||
Lassa Fever – U.S. Army Grant | $ | 81,526 | $ | - | $ | 81,526 | ||||||
Covid-19 – NIH SBIR Grant | - | 110,417 | (110,417 | ) | ||||||||
Total | 81,526 | 110,417 | (28,891 | ) |
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.
Research and Development Expenses
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.
General and Administrative Expenses
Our general and administrative expenses were $3,577,153 for the year ended December 31, 2021, as compared to $2,196,014 for 2020, representing an increase of $1,381,139 (63%). General and administrative expense for these periods includes stock-based compensation expense of $273,173 and $57,307, respectively (see discussion under “Stock-Based Compensation Expense” below). Excluding stock-based compensation expense, general and administrative expenses were $3,303,979 and $2,138,707 for 2021 and 2020, respectively, representing an increase of $1,165,272 (54%). Approximately $360,000 of this increase is attributable to higher Delaware franchise taxes (which we expect will be no more than $200,000 in future years) with the remainder primarily due to higher legal, accounting and patent costs; insurance costs; consulting fees; and investor relations costs.
For the three-month periods ended March 31, 2022, general and administrative expenses increased by $107,314 (10%) versus the 2021 comparable period. General and administrative expense for the three-month periods ended March 31, 2022 and 2021 included stock-based compensation expense of $150,859 and $55,322, respectively, reflecting an increase of $95,537 (see discussion under “Stock-Based Compensation Expense” below).
Stock-Based Compensation Expense
The table below shows the components of stock-based compensation expense for the years ended December 31, 2021 and 2020 and three-month periods ended March 31, 2022 and 2021.
Year Ended December 31, | Three Months Ended March 31, | |||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Stock option expense | $ | 269,427 | $ | 18,730 | $ | 190,191 | $ | 56,190 | ||||||||
Stock issued for consulting services | 100,560 | 45,733 | 14,960 | 20,600 | ||||||||||||
Total stock-based compensation expense | $ | 369,987 | $ | 64,463 | $ | 205,151 | $ | 76,790 |
Our stock option grants to employees generally vest over a three-year period from the date of grant. For members of our Board of Directors the vesting period is one year, effective with grants made during 2021. Stock-based compensation expense is recognized on a straight-line basis over the requisite vesting period for stock option grants or service period for stock awards to consultants. Such expense is allocated to research and development expense or general and administrative expense according to the classification the employee, consultant or director to whom the stock compensation was granted.
As a result of the reverse stock splits enacted in April 2019 and in January 2020, we made adjustments and retroactive restatements to all of our outstanding stock options such that the balances in January 2020 were negligible. We therefore recorded no stock-based compensation expense related to our stock option plan for the majority of 2020. We re-initiated employee stock option grants in December 2020 and recorded a proportionate amount of expense for the year ended December 31, 2020.
Stock option expense increased by $134,001 for the three-month period ended March 31, 2022 versus the 2021 comparable period. The increase is primarily due to the prorated expense associated with the 2021 year-end stock option grants. As of March 31, 2022, there is $1,229,953 of unrecognized expense related to stock options that we expect to recognize over a weighted-average period of 2.1 years.
Other Income (Expense)
Interest income was $4,736 and $2,271 for the years ended December 31, 2021 and 2020, respectively. Interest income for the three-month periods ended March 31, 2022 and 2021 was $527 and $2,053, respectively. The variances between years are primarily attributable to the cash available for investment and to interest rate fluctuations.
Interest expense was $1,286 and $143,524 for the years ended December 31, 2021 and 2020, respectively. Interest expense for 2021 relates to the GRA Note and PPP Loan, and for 2020 relates to the GRA Note, PPP loan, financing costs associated with insurance premiums, and convertible debentures which were retired during 2020. Interest expense for the three-month periods ended March 31, 2022 and 2021 was $-0- and $755, respectively.
During 2021, we recorded a $172,056 gain on debt extinguishment associated with the forgiveness of the PPP loan principal and accrued interest.
Liquidity and Capital Resources
From inception through March 31, 2022, we have accumulated net losses of approximately $66.8 million and we expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. We have funded our operations to date primarily from sales of our equity securities and from government grants and clinical trial assistance.
The following tables summarize our liquidity and capital resources as of March 31, 2022 and December 31, 2021 and 2020, and our cash flows for the years ended December 31, 2021 and 2020 and the three-month periods ended March 31, 2022 and 2021:
Liquidity and Capital Resources | March 31, 2022 | December 31, 2021 | December 31, 2020 | |||||||||
Cash and cash equivalents | $ | 16,527,716 | $ | 11,423,870 | $ | 9,883,796 | ||||||
Working Capital | 13,135,787 | 6,193,756 | 9,424,839 |
Year Ended December 31, | ||||||||
Cash Flow Data | 2021 | 2020 | ||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (11,196,420 | ) | $ | (2,750,570 | ) | ||
Investing activities | (47,718 | ) | (156,791 | ) | ||||
Financing activities | 12,784,212 | 12,507,816 | ||||||
Net increase in cash and cash equivalents | $ | 1,540,074 | $ | 9,600,455 |
Three Months Ended March 31, | ||||||||
Cash Flow Data | 2022 | 2021 | ||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (4,333,240 | ) | $ | (1,621,027 | ) | ||
Investing activities | (62,186 | ) | - | |||||
Financing activities | 9,229,272 | 12,580,013 | ||||||
Net increase in cash and cash equivalents | $ | 4,833,846 | $ | 10,958,986 |
Operating Activities – Net cash used in operating activities of $11,196,420 for the year ended December 31, 2021 was primarily due to our net loss of $18,570,317, offset by non-cash items such as depreciation expense, stock-based compensation expense and the gain recognized on extinguishment of our PPP loan, and by changes in our working capital accounts. Net cash used in operating activities of $2,750,570 for the year ended December 31, 2020 was primarily due to our net loss of $2,958,068, offset by non-cash charges such as depreciation and stock-based compensation expense, and by changes in our working capital accounts.
Net cash used in operating activities of $4,333,240 for the three months ended March 31, 2022, was primarily due to our net loss of $2,427,515, offset by non-cash items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts. Net cash used in operating activities of $1,621,027 for the three months ended March 31, 2021, was primarily due to our net loss of $1,562,778, offset by non-cash charges such as depreciation and stock-based compensation expense, and by changes in our working capital accounts.
Investing Activities – Net cash used in investing activities was $47,718 and $156,791 for the years ended December 31, 2021 and 2020, respectively, and relates to purchases of property and equipment.
Net cash used in investing activities was $62,186 and $-0- for the three-month periods ended March 31, 2022 and 2021, respectively, and relates to purchases of laboratory equipment.
Financing Activities – Net cash provided by financing activities was $12,784,212 for the year ended December 31, 2021, consisting of (i) net proceeds of $9,408,920 from a public offering of our common stock, (ii) $3,404,156 of net proceeds from the exercise of warrants, (iii) $1,000 expended for the repurchase of outstanding convertible preferred stock, and (iv) $27,864 in principal repayments toward a note payable to the Georgia Research Alliance, Inc. (the “GRA Note”); the GRA Note was fully repaid during 2021. Additionally, during May 2021 our PPP loan of $170,200, together with $1,856 of accrued interest, was forgiven by the lender and extinguished. Net cash provided by financing activities was $12,507,816 for the year ended December 31, 2020, consisting of (i) net proceeds of $11,158,496 from a public offering of our common stock and warrants, (ii) net proceeds of $300,000 from the sale of our convertible preferred stock, (iii) $170,200 of PPP loan proceeds, (iv) $888,500 of net proceeds from issuance of a note payable, (v) $2,500 in proceeds from warrant exercises, and (vi) $11,880 in principal repayments toward the GRA Note.
Net cash provided by financing activities was $9,229,272 for the three-month period ended March 31, 2022, consisting of net proceeds from a private placement of our common stock and warrants. Net cash provided by financing activities was $12,580,013 for the three-month period ended March 31, 2021, consisting of (i) net proceeds of $9,408,920 from a public offering of our common stock, (ii) $3,174,156 of net proceeds from the exercise of warrants, and (iii) $3,063 in principal repayments toward a note payable to the Georgia Research Alliance, Inc. (the “GRA Note”); the GRA Note has now been fully repaid.
Funding Requirements and Sources of Capital
Our primary uses of capital are for personnel costs, costs of conducting clinical trials, manufacturing costs for materials used in clinical trials, third-party research services, laboratory and related supplies, technology license fees, legal and other regulatory expenses, and general overhead costs. We expect these costs will continue to be the primary operating capital requirements for the near future.
We expect our research and development costs to increase as we continue development of our various programs and as we move toward later stages of development, especially with regard to clinical trials. We have entered into license agreements with City of Hope, PNP Therapeutics, Inc., University of Alabama at Birmingham, Southern Research Institute, Emory University, and with the U.S. Department of Health and Human Services (HHS), as represented by National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Aggregate unrecorded future minimum payments under these agreements (excluding milestone and royalty payments due upon contingent future events) are approximately $149,000 in 2022, $128,000 in 2023, $128,000 in 2024, $28,000 in 2025 and $28,000 in 2026.
Our research and development expenditures during 2022 and beyond will increase significantly as a result of 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 pre-clinical 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.
Gedeptin is currently undergoing a Phase 1/2 clinical trial (NCT03754933) for treatment of patients with advanced head and neck cancer. The initial stage of the study (10 patients) is being funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. We may seek additional sources of capital through government and quasi-government grant programs and clinical trial support, although there can be no assurance any commercialization capabilities; therefore, itsuch funds will be obtained.
We expect that our general and administrative costs may increase during the remainder of 2022 and beyond in support of expanded research and development activities and other general corporate activities.
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.
We believe our existing cash and cash equivalents will be sufficient to meet our anticipated cash requirements into the first quarter of 2024. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is possiblea forward-looking statement that involves risks and uncertainties and is based on assumptions that may prove to be wrong; actual results could vary materially. We may need to obtain additional funds sooner than planned or in greater amounts than we currently anticipate. The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control. These factors include the progress of our research activities; the number and scope of our research programs; the progress and success of our pre-clinical and clinical development activities; the progress of the development efforts of parties with whom we have entered into research and development agreements; the costs of manufacturing our product candidates, and the progress of efforts with parties with whom we may enter into commercial manufacturing agreements; our ability to maintain current research and development programs and to establish new research and development and licensing arrangements; the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; the impact of any natural disasters or public health crises, such as the COVID-19 pandemic; the costs associated with any products or technologies that we may never successfully derive significant product revenues from anyin-license or acquire; and the costs and timing of regulatory approvals.
We will need to continue to raise additional capital to support our future operating activities, including progression of our existing or future development programs, preparation for commercialization, and other operating costs. Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding, collaborations, strategic alliances or licensing arrangements with third parties. There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates.
We expect for the foreseeable future our operations will result in a net loss on a quarterly and annual basis. As of September 30, 2015, we had an accumulated deficit of $31.8 million.Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that are likely or reasonably likely to have a material effect on our financial condition or results of operations.
Quantitative and Qualitative Disclosures about Market Risk
Our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in the general level of United States interest rates, particularly because a significant portion of our investments are in institutional money market funds. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income received without significantly increasing risk. Due to the nature of our short-term investments, we believe that we are not subject to any material market risk exposure. We do not have any derivative financial instruments or foreign currency instruments.
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 the estimatesthem 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, 2014.2021, which are included in this Form 10-K. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements:
Revenue Recognition
We recognize revenue in accordance with the SEC’s Staff Accounting Bulletin No. 101,Revenue Recognition in Financial Statements,as amended by Staff Accounting Bulletin No. 104,Revenue Recognition,(“SAB 104”). SAB 104 provides guidance in applying U.S. generally accepted accounting principles (“GAAP”) to revenue recognition issues, and specifically addresses revenue recognition for upfront, nonrefundable fees received in connection with research collaboration agreements. During the years ended 2014, 2013 and 2012, and the nine months ended September 30, 2015, our revenue consisted of grant funding received from the NIH. Revenue from these arrangements is approximately equal to the costs incurred and is recorded as income as the related costs are incurred.
In May 2014, the Financial Accounting Standards Board (“FASB”) issuedFASB Accounting Standards Update 2014-09,Revenue from Contracts with Customers (“ASU 2014-09”)(ASU 2014-09), which createscreated 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.
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.
Research collaborations – 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 effective for the Company beginning in 2017 and allows for either full retrospective adoption or modified retrospective adoption. We are currently evaluating the impact of the adoption of ASU 2014-09 on our financial statements.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. CompensationStock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. CompensationStock-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.
Liquidity and Capital Resources
At September 30, 2015, we had cash and cash equivalents of $1,821,037 and total assets of $1,998,165, as compared to $1,101,651 and $1,333,198, respectively, at December 31, 2014, and $2,513,861 and $2,839,576, respectively, at December 31, 2013. Working capital totaled $1,778,092 at September 30, 2015, as compared to $1,038,472 at December 31, 2014 and $2,385,990 at December 31, 2013.
Sources and Uses of Cash
Historically, our primary uses of cash have been to finance our research and development activities. We have funded our activities to date primarily from government grants and clinical trial assistance, and from sales of our equity securities. Due See Note 7 to our significant research and development expenditures, we have not been profitable and have generated operating losses since our inception in 2001.
We believe that our existing cash resources will be sufficient to fund our planned operations through the first quarter of 2016. We will requirefinancial statements for additional funds to continue our planned operations beyond that date. We are currently seeking sources of non-dilutive capital through government grant programs and clinical trial support, and we may also conduct additional offerings of our equity securities. However, additional funding may not be available on favorable terms or at all and if we fail to obtain additional capital when needed, we may 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.
Cash Flows from Operating Activities
Net cash used in operating activities was $1,944,573 and $1,616,167 for the nine-month periods ended September 30, 2015 and 2014, respectively. Net cash used in operating activities was $2,250,107, $1,694,592, and $2,441,247 for the years ended December 31, 2014, 2013 and 2012, respectively. Generally, the differences between periods are due to fluctuations in our net losses, offset by non-cash charges such as depreciation and stock-based compensation expense, and by net changes in our assets and liabilities. Our net losses generally fluctuate based on expenditures for our research activities, offset by government grant revenues. As we expand our product development pipeline and move into the later stages of development, we anticipate that our cash expenditures and net losses will increase.information.
The NIH has funded the costs of conducting all of our human clinical trials (Phase 1 and Phase 2a) to date for our preventive HIV vaccines, with GeoVax incurring certain costs associated with manufacturing the clinical vaccine supplies and other study support. We also expect the NIH to fully fund the cost of another Phase 1 trial (HVTN 114) of our preventive HIV vaccine to begin in early 2016, which will investigate the effect of adding a “protein boost” component to our vaccine. While efforts are underway to evaluate the protein boost concept, we also intend to seek funding to expedite our vaccine (without the additional protein boost) directly into pivotal Phase 2b efficacy trials.
During 2014, we completed a Phase 1 clinical trial (GV-TH-01) investigating the therapeutic use of our GOVX-B11 vaccine in HIV-infected patients. Future therapeutic studies of our vaccine may investigate the vaccine’s ability to act as a “shock agent” in a shock and kill therapy in combination with standard of care antiretroviral drug therapy to seek a cure for HIV infection. We are currently not contemplating the use of any of our existing cash resources for this program. The timetable and specific plans for additional clinical studies will be dependent upon our ability to secure external funding for the program, and on the nature of any potential collaborations we may establish.
Our Ebola/Marburg vaccine program began in late 2014, and our primary activities during 2015 are focused on constructing the vaccines and conducting preclinical animal studies. During April 2015, we entered into a Research Collaboration Agreement with the National Institute of Allergy and Infectious Disease (NIAID), part of NIH, pursuant to which NIAID is contributing certain materials and carrying out animal protection studies in small animals. The initial animal studies are ongoing, and we our goal is to begin human clinical trials in early 2017.
In addition to clinical trial support from the NIH for our preventive HIV vaccines and collaborative research support from NIAID for our Ebola vaccine program, our operations have been partially funded by NIH research grants for our HIV program. As of September 30, 2015, there was $260,522 of unused grant funds available for use during the remainder of 2015 and the first half of 2016. We intend to pursue additional grants from the federal government for our HIV and Ebola programs but cannot be assured of success.
Cash Flows from Investing Activities
Our investing activities have consisted predominantly of capital expenditures. Capital expenditures were $15,850 and $35,503 for the nine month periods ended September 30, 2015 and 2014, respectively. Capital expenditures for the years ended December 31, 2014, 2013 and 2012, were $35,503, $86,603, and $-0-, respectively.
Cash Flows from Financing Activities
Net cash provided by financing activities was $2,679,809 and $-0- for the nine month periods ended September 30, 2015 and 2014, respectively. Net cash provided by financing activities was $873,400, $3,259,131, and $2,309,192 for the years ended December 31, 2014, 2013 and 2012, respectively.
During January 2012, we received $310,160 from stock sales to individual accredited investors (including $36,800 received in payment of a stock subscription receivable from December 2011).
In March 2012, we sold 2,200 shares of our Series A Convertible Preferred Stock, as well as accompanying warrants to purchase 8,799,999 shares of common stock, to a group of institutional investors for an aggregate purchase price of $2.2 million. Net proceeds to the Company, after deduction of placement agent fees and other expenses, were approximately $2.0 million. The cash generated by our financing activities during 2012 also includes $310,160 received in January 2012 related to the sale of our common stock to individual accredited investors in a private placement offering which was initiated during December 2011.
In January 2013, we reduced the exercise price of 2,933,333 of certain stock purchase warrants from $0.75 to $0.60 per share. In consideration for the reduction of the exercise price, the holders of the warrants immediately exercised 1,766,667 of the warrants for cash, resulting in total proceeds to the Company of $1,060,000. We also extended the expiration date of the 1,166,666 unexercised warrants from March 21, 2013 to May 21, 2013. In May 2013, we reduced the exercise price of the 1,166,666 remaining warrants from $0.60 to $0.50 per share. In consideration for the reduction of the exercise price, the holders of the warrants immediately exercised all of the remaining warrants for cash, resulting in total proceeds to the Company of $583,333.
In December 2013, we sold 1,650 shares of our Series B Convertible Preferred Stock to a group of institutional investors for an aggregate purchase price of $1.65 million. Net proceeds to the Company, after deduction of transaction expenses, were approximately $1.6 million. No warrants were issued in connection with the transaction.
In October 2014, we entered into an agreement with certain warrant holders to purchase shares of our common stock with respect to the payment to them of a warrant exercise fee of $0.075 per share for each share purchased upon exercise of warrants held by them. In exchange for the fee, they immediately exercised warrants for an aggregate of 3,176,000 shares of our common stock, resulting in proceeds to us of $873,400 (net of the exercise fee).
In February 2015, we sold shares of Series C convertible preferred stock to certain institutional investors for an aggregate purchase price of $3.0 million, and five-year Series D warrants to purchase an aggregate of 16,666,666 shares of our common stock with a current exercise price of $0.11299 per share.Net proceeds to the Company, after deduction of placement agent fees and other expenses, were approximately $2.7 million. The preferred stock is convertible at any time into shares of our common stock at $0.09416 per share, subject to adjustment as provided in the certificate of designation. We also granted to the investors an additional purchase right, evidenced in the form of one-year Series E warrants to purchase up to 16,666,666 of our common stock with a current exercise price of $0.09416 per share, and five-year Series F warrants to purchase up to 16,666,666 shares of our common stock with a current exercise price of $0.11299 per share. The Series E warrants are immediately exercisable. The Series F warrants only become exercisable at the time, and to the extent, that the Series E warrants are exercised.
Our capital requirements, particularly as they relate to our research and development activities, have been and will continue to be significant. We anticipate incurring additional losses for several years as we expand our clinical programs and proceed into higher cost human clinical trials. Conducting clinical trials for our vaccine candidates in development is a lengthy, time-consuming and expensive process. We will not generate revenues from the sale of our technology or products for at least several years, if at all. For the foreseeable future, we will be dependent on obtaining financing from third parties in order to maintain our operations, including our clinical program. Such capital may not be available on terms acceptable to the Company or at all. If we fail to obtain additional funding when needed, we would be forced to scale back or terminate our operations, or to seek to merge with or to be acquired by another company.
We expect that our current working capital (including the net proceeds from the February 2015 financing event discussed above) combined with the remaining available funds from the NIH grants will be sufficient to support our planned level of operations through the first quarter of 2016. We will require additional funds to continue our planned operations beyond that date. We are currently seeking sources of non-dilutive capital through government grant programs and clinical trial support, and we may also conduct additional offerings of our equity securities, although there can be no assurance that we will be able to do so. While we believe that we will be successful in obtaining the necessary financing to fund our operations through government grants and clinical trial support, exercise of stock purchase warrants, or other sources, there can be no assurances that such additional funding will be available to us on reasonable terms or at all. 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.
We have no off-balance sheet arrangements that are likely or reasonably likely to have a material effect on our financial condition or results of operations.
Contractual Obligations
Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contingent liabilities for which we cannot reasonably predict future payment. Additionally, the expected timing of payment of the obligations presented below is estimated based on current information. Timing of payments and actual amounts paid may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations.
As of September 30, 2015, we had noncancellable lease obligations and other firm purchase obligations totaling approximately $222,000, as compared to approximately $297,000 at December 31, 2014. We have no committed lines of credit and no other committed funding or long-term debt. We have employment agreements with our senior management team, each of which may be terminated with 30 days advance notice. The following table represents our contractual obligations as of December 31, 2014, aggregated by type (in thousands):
Payments Due by Period | ||||||||||||||||||||
Contractual Obligations | Total | Less than 1 Year | 1-3 Years | 4-5 Years | More than 5 years | |||||||||||||||
Operating Lease Obligations(1) | $ | 146 | $ | 146 | $ | -- | $ | -- | $ | -- | ||||||||||
Firm Purchase Commitments(2) | 151 | 151 | -- | -- | -- | |||||||||||||||
Emory University– License Agreement(3) | -- | -- | -- | -- | -- | |||||||||||||||
Total | $ | 297 | $ | 297 | $ | -- | $ | -- | $ | -- |
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Net Operating Loss Carryforwards
At December 31, 2014, we had consolidated net operating loss carryforwards for income tax purposes of $64.6 million, which will expire in 2019 through 2034 if not utilized. Approximately $42.6 million of our net operating loss carryforwards relate to the operations of our predecessor, Dauphin Technology, Inc. prior to the 2006 merger between Dauphin Technology, Inc. and GeoVax, Inc. We also have research and development tax credits of approximately $826,000 available to reduce income taxes, if any, which will expire in 2022 through 2034 if not utilized. The amount of net operating loss carryforwards and research tax credits available to reduce income taxes in any particular year may be limited in certain circumstances. Based on an assessment of all available evidence including, but not limited to, our limited operating history in our core business and lack of profitability, uncertainties of the commercial viability of our technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies, we have concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a 100% deferred tax valuation allowance has been recorded against these assets.
Results of Operations –Nine Months EndedSeptember 30, 2015 Compared toNine Months EndedSeptember 30, 2014
Net Loss
We recorded a net loss of $619,899 for the three-month period ended September 30, 2015, as compared to $514,515 for the three-month period ended September 30, 2014. For the nine-month period ended September 30, 2015, we recorded a net loss of $1,996,556, as compared to a net loss of $1,809,970 for nine-month period ended September 30, 2014. Our net losses will typically fluctuate due to the timing of activities and related costs associated with our vaccine research and development activities and our general and administrative costs, as described in more detail below.
Grant Revenue
During the three-month and nine-month periods ended September 30, 2015, we recorded grant revenue of $93,130 and $268,028, respectively, as compared to $322,086 and $659,867, respectively, during the comparable periods of 2014. Grant revenues for these periods relate to grants from the NIH in support of our HIV vaccine development activities. We record revenue associated with these grants as the related costs and expenses are incurred. The difference in our grant revenues from period to period is directly related to our expenditures for activities supported by the grants, and can fluctuate significantly based on the timing of the related expenditures.
In September 2007, the NIH awarded us a grant entitled “GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines”. The aggregate award (including subsequent amendments) totaled approximately $20.4 million. For this grant, we recorded revenues of $-0- and $75,464 for the three-month and nine-month periods ended September 30, 2015, respectively, as compared to $269,334 and $484,988, respectively during the comparable periods of 2014. There are no unrecognized grant funds remaining and available for use pursuant to this grant as of September 30, 2015.
In July 2013, the NIH awarded us a Small Business Innovative Research (SBIR) grant entitled “Enhancing Protective Antibody Responses for a GM-CSF Adjuvanted HIV Vaccine.” The initial grant award was $276,690 for the first year of a two year project period beginning August 1, 2013. In July 2014, the NIH awarded us $289,641 for the second year of the project period. For this grant, we recorded revenues of $54,067 and $153,501 for the three-month and nine-month periods ended September 30, 2015, respectively, as compared to $52,752 and $174,879, respectively during the comparable periods of 2014. There are no unrecognized grant funds remaining and available for use pursuant to this grant as of September 30, 2015.
In June 2015, the NIH awarded us a Small Business Innovative Research (SBIR) grant entitled “Directed Lineage Immunizations for Eliciting Broadly Neutralizing Antibody.” The initial grant award of $299,585 is for the first year of a two year project period beginning July 1, 2015. For this grant, we recorded revenues of $39,063 for the three-month and nine-month periods ended September 30, 2015; no revenues related to this grant were recorded during the comparable periods of 2014. There is $260,522 in approved grant funds remaining and available for use as of September 30, 2015, which we anticipate recognizing as revenue during the remainder of 2015 and through June 30, 2016.
Research and Development
During the three-month and nine-month periods ended September 30, 2015, we recorded $378,521 and $1,166,803, respectively, of research and development expense as compared to $425,498 and $1,344,560, respectively, during the three-month and nine-month periods ended September 30, 2014. Research and development expense for the three-month and nine-month periods of 2015 includes stock-based compensation expense of $5,340 and $15,972, respectively, while the comparable periods of 2014 include stock-based compensation expense of $7,404 and $24,420, respectively (see discussion under “Stock-Based Compensation Expense” below). Our research and development expenses can fluctuate considerably on a period-to-period basis, depending on our need for vaccine manufacturing by third parties, the timing of expenditures related to our grants from the NIH, the timing of costs associated with clinical trials being funding directly by us, and other factors.
We cannot predict the level of support we may receive from the HVTN, NIH, or other federal agencies (or divisions thereof) for our future research and development efforts. We expect that our research and development costs will increase in the future as we progress into the later stage human clinical trials for our HIV vaccines and as we expand our Ebola and Marburg vaccine development program.
Our vaccine candidates still require significant, time-consuming and costly research and development, testing and regulatory clearances. Completion of clinical development will take several years or more, but the length of time generally varies substantially according to the type, complexity, novelty and intended use of a product candidate. The NIH has funded the costs of conducting all of our human clinical trials to date for our preventive HIV vaccine, with GeoVax incurring costs associated with manufacturing the clinical vaccine supplies and other study support. We are having discussions with the HVTN and NIH with regard to the conduct of an additional trial of our preventive vaccine, and we expect the NIH will provide support for this trial as well. We intend to seek government and/or third party support for future clinical human trials and for production of our vaccine product for use in clinical trials, but there can be no assurance that we will be successful.
The duration and the cost of future clinical trials may vary significantly over the life of the project as a result of differences arising during development of the human clinical trial protocols, including, among others:
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Due to the uncertainty regarding the timing and regulatory approval of clinical trials and pre-clinical studies, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. From time to time, we will make determinations as to how much funding to direct to these programs in response to their scientific, clinical and regulatory success, anticipated market opportunity and the availability of capital to fund our programs.
In developing our product candidates, we are subject to a number of risks that are inherent in the development of products based on innovative technologies. For example, it is possible that our vaccines may be ineffective or toxic, or will otherwise fail to receive the necessary regulatory clearances, causing us to delay, extend or terminate our product development efforts. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could cause our research and development expenditures to increase which, in turn, could have a material adverse effect on our results of operations and cash flows. Because of the uncertainties of clinical trials, estimating the completion dates or cost to complete our research and development programs is highly speculative and subjective. As a result of these factors, we are unable to accurately estimate the nature, timing and future costs necessary to complete the development of our product candidates. In addition, we are unable to reasonably estimate the period when material net cash inflows could commence from the sale, licensing or commercialization of such product candidates, if ever.
General and Administrative Expense
During the three-month and nine-month periods ended September 30, 2015, we incurred general and administrative costs of $335,932 and $1,102,262, respectively, as compared to $411,814 and $1,128,478, respectively, during the comparable periods in 2014. General and administrative costs include officers’ salaries, legal and accounting costs, patent costs, amortization expense associated with intangible assets, and other general corporate expenses. General and administrative expense for the three-month and nine-month periods of 2015 include stock-based compensation expense of $11,586 and $34,544, respectively; while the comparable periods of 2014 include stock-based compensation expense of $106,880 and $141,218, respectively (see discussion under “Stock-Based Compensation Expense” below). We expect that our general and administrative costs may increase in the future in support of expanded research and development activities and other general corporate activities.
Stock-Based Compensation Expense
We recorded stock-based compensation expense of $16,926 and $50,516 during the three-month and nine-month periods ended September 30, 2015, respectively, as compared to $114,284 and $165,638, respectively, during the comparable periods of 2014. The expense for the 2014 periods includes $49,750 related to common stock issued for services and $39,711 related to the repricing and extension of certain stock purchase warrants. We allocate stock-based compensation expense to research and development expense or general and administrative expense according to the classification of cash compensation paid to the employee, consultant or director to whom the stock compensation was granted. For the three-month and nine-month periods ended September 30, 2015 and 2014, stock-based compensation expense was allocated as follows:
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
Expense Allocated to: | 2015 | 2014 | 2015 | 2014 | ||||||||||||
General and Administrative Expense | $ | 11,586 | $ | 106,880 | $ | 34,544 | $ | 141,218 | ||||||||
Research and Development Expense | 5,340 | 7,404 | 15,972 | 24,420 | ||||||||||||
Total Stock-Based Compensation Expense | $ | 16,926 | $ | 114,284 | $ | 50,516 | $ | 165,638 |
Other Income
Interest income for the three-month and nine-month periods ended September 30, 2015 was $1,424 and $4,481, respectively, as compared to $711 and $3,201, respectively, for comparable periods of 2014. The variances between periods are primarily attributable to cash available for investment and interest rate fluctuations.
Impact of Inflation
For the three-month and nine-month period ended September 30, 2015, we do not believe that inflation and changing prices had a material impact on our operations or on our financial results.
Results of Operations – Years Ended December 31, 2014, 2013 and 2012
Net Loss
We recorded net losses of $2,733,555, $2,284,943, and $2,135,140 for the years ended December 31, 2014, 2013 and 2012, respectively. Our operating results typically fluctuate due to the timing of activities and related costs associated with our vaccine research and development activities and our general and administrative costs, as described in more detail below.
Grant Revenue
We recorded grant revenues of $882,956, $2,417,550, and $2,657,327 for the years ended December 31, 2014, 2013 and 2012, respectively. Grant revenues relate to grants from the NIH in support of our HIV vaccine development activities. We record revenue associated with these grants as the related costs and expenses are incurred. The difference in our grant revenues from period to period is directly related to our expenditures for activities supported by the grants, and can fluctuate significantly based on the timing of the related expenditures. There is an aggregate of approximately $229,000 in approved grant funds remaining and available for use as of December 31, 2014. Additional detail concerning our grant revenues is discussed below.
In September 2007, the NIH awarded us a grant entitled “GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines”. The aggregate award (including subsequent amendments) totaled approximately $20.4 million. We recorded grant revenues of $624,689, $833,390, and $2,227,924 for the years ended December 31, 2014, 2013 and 2012, respectively, related to this grant, and there was $75,464 of unrecognized grant funds remaining and available for use pursuant to this grant as of December 31, 2014.
In September 2012, the NIH awarded us a grant entitled “Immunogens and Manufacturing” to support our HIV/AIDS vaccine development program. The grant award was for approximately $1.9 million. We recorded grant revenues of $-0-, $1,429,597, and $429,403 for the years ended December 31, 2014, 2013 and 2012, respectively, related to this grant, and all funding pursuant to this grant had been utilized as of December 31, 2014.
In July 2013, the NIH awarded us a Small Business Innovative Research (SBIR) grant entitled “Enhancing Protective Antibody Responses for a GM-CSF Adjuvanted HIV Vaccine.” The initial grant award was approximately $277,000 for the first year of a two year project period beginning August 1, 2013. In July 2014, the NIH awarded us approximately $290,000 for the second year of the project period. We recorded grant revenues of $258,267, $154,563, and $-0- for the years ended December 31, 2014, 2013 and 2012, respectively, related to this grant, and there was $153,501 of unrecognized grant funds remaining and available for use pursuant to this grant as of December 31, 2014.
Research and Development
Our research and development expenses were $1,812,969, $2,914,878, and $3,043,522 for the years ended December 31, 2014, 2013 and 2012, respectively. Research and development expense for these periods includes stock-based compensation expense of $32,134, $41,539, and $78,140 for 2014, 2013 and 2012, respectively (see discussion under “Stock-Based Compensation Expense” below). Since our inception, all of our research and development efforts have been focused on development of human vaccines – initially with a focus on HIV/AIDS vaccines, and with a recent expansion to vaccines for Ebola and Marburg. Our research activities conducted pursuant to our NIH grants are also focused solely on the development of human vaccines.
Our research and development expenses can fluctuate considerably on a period-to-period basis, depending on our need for vaccine manufacturing by third parties, the timing of expenditures related to our grants from the NIH, the timing of costs associated with clinical trials being funding directly by us, and other factors. The overall decrease in research and development expense from 2013 to 2014 can mostly be attributed to lower expenditures related to the activities supported by our grants from the NIH, and lower expenditures associated with a Phase 1 trial of our therapeutic HIV vaccine, which was completed during the first quarter of 2014.We have not received any government support for clinical trials of our therapeutic vaccine. Our research and development costs do not include costs incurred by the HVTN in conducting clinical trials of our preventive HIV vaccines; those costs are funded directly to the HVTN by the NIH.
General and Administrative Expense
Our general and administrative expenses were $1,807,605, $1,792,160, and $1,752,765 for the years ended December 31, 2014, 2013 and 2012, respectively. General and administrative costs include officers’ salaries, legal and accounting costs, patent costs, amortization expense associated with intangible assets, and other general corporate expenses. General and administrative expense includes stock-based compensation expense of $446,969, $360,565, and $231,936 for 2014, 2013 and 2012, respectively (see discussion under “Stock-Based Compensation Expense” below). We expect that our general and administrative costs may increase in the future in support of expanded research and development activities and other general corporate activities.
Stock-Based Compensation Expense
We recorded total stock-based compensation expense of $479,103, $402,104, and $310,076 during the years ended December 31, 2014, 2013 and 2012, respectively, which was allocated to research and development expense or general and administrative expense according to the classification of cash compensation paid to the employee, consultant or director to whom the stock compensation was granted. In addition to amounts related to the issuance of stock options to employees, the figures include amounts related to common stock and stock purchase warrants issued to consultants and non-employee directors. For the three years ended December 31, 2014, stock-based compensation expense was allocated as follows:
2014 | 2013 | 2012 | ||||||||||
General and administrative expense | $ | 446,969 | $ | 360,565 | $ | 231,936 | ||||||
Research and development expense | 32,134 | 41,539 | 78,140 | |||||||||
Total stock option expense | $ | 479,103 | $ | 402,104 | $ | 310,076 |
Other Income
Interest income was $ 4,063, $4,545, and $3,820 for the years ended December 31, 2014, 2013 and 2012, respectively. The variances between years are primarily attributable to the cash available for investment and to interest rate fluctuations.
Impact of Inflation
For the three-year period ended December 31, 2014, we do not believe that inflation and changing prices had a material impact on our operations or on our financial results.
Off-Balance Sheet Arrangements
We have not entered into off-balance sheet financing arrangements, other than operating leases.
SECURITY OWNERSHIP OFPRINCIPAL STOCKHOLDERS, DIRECTORS AND OFFICERS
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 December 11, 2015 by (1) each director; (2) each of our Named Executive Officers; (3) all executive officers and directors as a group; and (4) each additional person who is known by us to beneficially own more than 5% of our common stock. Except as otherwise indicated, the holders listed below have sole voting and investment power with respect to all shares of common stock beneficially owned by them.
Amount and Nature | ||||||||
of Beneficial | Percent | |||||||
Name of Beneficial Owner (1) | Ownership (2) | of Class (2) | ||||||
Directors and Executive Officers: | ||||||||
Randal Chase | 40,000 | * | ||||||
David A. Dodd (3) | 407,124 | 1.3 | % | |||||
Dean G. Kollintzas (4) | 178,712 | * | ||||||
Robert T. McNally (5) | 291,380 | * | ||||||
Mark W. Reynolds (6) | 267,000 | * | ||||||
Harriet L. Robinson (7) | 1,507,607 | 4.7 | % | |||||
John N. Spencer, Jr. (8) | 210,412 | * | ||||||
All executive officers and directors as a group (6 persons) (9) | 2,902,235 | 8.7 | % | |||||
Other 5% Stockholders: | ||||||||
Emory University (10) | 4,621,405 | 14.5 | % | |||||
Sabby Healthcare Master Fund, Ltd (11) | 3,509,500 | 9.99 | % | |||||
Sabby Volatility Warrant Master Fund, Ltd (12) | 3,533,000 | 9.99 | % | |||||
Welch & Forbes LLC (13) | 1,703,464 | 5.3 | % |
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*Less than 1%
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DIRECTORS AND EXECUTIVE OFFICERSMANAGEMENT
The following table sets forth certain information with respect to our directors and executive officers:officers as of the date hereof:
Name | Age | Current Position |
David A. Dodd |
| Chairman of the Board of Directors, |
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| President and Chief Executive Officer |
Mark W. Reynolds, CPA |
| Chief Financial Officer and Corporate Secretary |
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| Chief Scientific Officer |
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Robert T. McNally Ph.D.(1)(2) | 74 | Independent Director |
Randal D. Chase, Ph.D. (1)(2)(3) |
| Independent Director |
Dean G. Kollintzas (2)(3) |
| Independent Director |
John N. Spencer, Jr. (1) |
| Independent Director |
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______________________
(1) | Member of the Compensation Committee of the Board of Directors. |
(2) | Member of the Nominating and Governance Committee of the Board of Directors. |
(3) | Member of the Audit Committee of the |
David A. Dodd. Mr. Dodd joined the Board of Directors in March 2010, and becamebecoming Chairman of our Board of Directors on January 1, 2011. SinceEffective September 5, 2018, Mr. Dodd became our President and Chief Executive Officer, following Dr. McNally’s retirement. His executive management experience in the pharmaceutical and biotechnology industries spans more than 40 years. From September 2017 to April 2018, he served as Chief Executive Officer, and as a member of the Board of Directors of Medizone International, Inc. (“Medizone”), a developer and manufacturer of disinfectant systems. On April 20, 2018, Medizone announced that certain of its creditors had commenced an involuntary bankruptcy proceeding under Chapter 11 of the United States Bankruptcy Code against Medizone. The creditors included Medizone’s former Chairman and Chief Executive Officer and its former Director of Operations. From April 2013 he hasto July 2017, Mr. Dodd served as President and Chief Executive Officer, and as a member of the Board of Directors, of Aeterna Zentaris Inc., an oncology and endocrinologya drug development company. He is alsowas Chairman of the Chief Executive OfficerBoard of RiversEdge BioVentures, an investmentDirectors of Aeterna Zentaris, Inc. from May 2014 to May 2016, and advisory firm focused on the life sciences and pharmaceuticals industries, which he founded in 2009. He has more than 35 yearscontinued to serve as a member of executive experience in the healthcare industry.its Board of Directors until May 2018. From December 2007 to June 2009, Mr. Dodd was President, Chief Executive officer and Chairman of BioReliance Corporation, an organization that provideda leading provider of biological safety and related testing viral clearance testing, genetic and mammalian technology testing and laboratory animal diagnostic services testing.services. From October 2006 to April 2009, he served as non-executive chairmanChairman of Stem Cell Sciences Plc., where he oversaw the development and implementation of a strategic growth plan, implementation of an experienced executive team, and the sale of the company to Stem Cells, Inc. in April 2009. Before that, Mr. Dodd served as President, Chief Executive Officer and Director of Serologicals Corporation before it was sold to Millipore Corporation in July 2006 for $1.5 billion. For the five years prior, to his employment by Serologicals Corporation, Mr. Dodd served as President and Chief Executive Officer of Solvay Pharmaceuticals, Inc. and Chairman of its subsidiary Unimed Pharmaceuticals, Inc. He is also the Chief Executive Officer of RiversEdge BioVentures, an investment and advisory firm focused on the life sciences and pharmaceuticals industries, which he founded in 2009. Mr. Dodd holds Bachelor of Science and Master of Science degrees from Georgia State University and completed the Harvard Business School Advanced Management Program. The Board of Directors has concluded that Mr. Dodd should serve on the Board of Directors due to his experience in the pharmaceutical industry and his involvement as an officer and director of the Company, as well as his background in general management, business transformation, corporate partnering, and mergers and acquisitions.
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. 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 34 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, serves 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 trade association. Dr. McNally graduated with a 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 intimate involvement with the Company’s ongoing operations as its President and Chief Executive Officer.
Mark W. Reynolds, CPACPA. Mr. Reynolds joined the Company on a part-time basis in October 2006 as Chief Financial Officer and Corporate Secretary, becoming a full-time employee in January 2010. From 2003 to 2006, before being named Chief Financial Officer of GeoVax Labs, Inc., Mr. Reynolds provided financial and accounting services to GeoVax, Inc. as an independent contractor.Secretary. From 2004 to 2008, Mr. Reynolds served as Chief Financial Officer for HealthWatchSystems, Inc. a privately-held company in the consumer healthcare industry. From 2004 to 2006, he served as Chief Financial Officer for Duska Therapeutics, Inc., a publicly-held biotechnology company. From 1988 to 2002, Mr. Reynolds worked for CytRx Corporation, a publicly-held biopharmaceutical company, where he first served as Controller and then as Chief Financial Officer. Mr. Reynolds began his career as an auditor with Arthur Andersen & Co. from 1985 to 1988. He is a certified public accountant and earnedholds a Master’sMaster of Accountancy degree from the University of Georgia.
Mark J. Newman,Harriet L. Robinson, Ph.D. Dr. Robinson joinedNewman became employed as our Chief Scientific Officer on August 25, 2020. Dr. Newman, who previously served the Company as Senior Vice President, Researchvice president of research and Developmentdevelopment 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 November 2007peer 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 in that role on a full-timepart-time basis pursuant to a consulting agreement. 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 Chief Scientific Officera Colonel in February 2008,2001. Dr. McKee subsequently served as State Epidemiologist in North Carolina, and was electedas 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.
Robert T. McNally,Ph.D. Dr. McNally joined the Board of Directors in June 2008. SheDecember 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 co-founder of GeoVax, Inc. and has served as chief of its scientific advisory board since formationFellow of the company in 2001. From 1999 to February 2008, Dr. RobinsonAmerican Institute for Medical and Biological Engineering, served ason the Asa Griggs Candler Professoradvisory boards of Microbiologythe Petit Institute for Bioengineering and Immunology at Emory University in Atlanta, Georgia, and from 1998 to February 2008 as Chief, DivisionDupree College of Microbiology and Immunology, Yerkes National Primate Center and ProfessorManagement at the EmoryGeorgia 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 School of Medicine. She was Professor, Department of Microbiology & Immunology, atand his Ph.D. in biomedical engineering from the University of Massachusetts Medical Center from 1988 to 1997 and Staff, then Senior, then Principal Scientist at the University of Massachusetts Worcester Foundation for Experimental Biology from 1977 to 1987.Dr. Robinson received a Bachelor of Arts degree from Swarthmore College and M.S. and Ph.D. degrees from the Massachusetts Institute of Technology.Pennsylvania. The Board of Directors has concluded that Dr. RobinsonMcNally should serve on its Board of Directors by virtue of her extensive knowledgehis prior business and scientific experience, including his experience as Chief Executive Officer of the Company’s technology as its scientific founder.
Farshad Guirakhoo, Ph.D. Dr. Guirakhoo joined the CompanyCell Dynamics, LLC and as Senior Vice President of Clinical Research for CryoLife, Inc., and Development in October 2015. Dr. Guirakhoo has served in senior managementdue to his involvement with the Company as its former President and scientific roles within the biotechnology industry with Vaxess Technologies from 2014 to 2015, Hookipa Biotech from 2012 to 2014, Sanofi Pasteur from 2007 to 2012, Acambis, Inc. from 1999 to 2007 and OraVax, Inc from 1992 to 1999. He earned his Ph.D. in Virology at the Medical University of Vienna, Vienna, Austria, holds a M.Sc. degree in Genetics from the International Institute for Biophysics and Biochemistry of Tehran University, and a B.Sc. degree in Biology from the National University of Iran. He conducted his Post-Doctoral training at the Medical University of Vienna and at the National Centers for Disease Control and Prevention (CDC), Division of Vector-Borne Infectious Diseases. In his scientific career, Dr. Guirakhoo has filed over 90 patent applications and is author/co-author of more than 80 publications, including book chapters, in peer-reviewed journals. In 2014, he was named as one of the 50 Most Influential People in Vaccines.Chief Executive Officer.
Randal D. Chase, Ph.D. Dr. Chase joined the Board of Directors in March 2015. Since 2011, Dr. Chase has servedis 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 has also served as a member of the board of directors for numerous companies, and recently served as Chairman of the Board for Medicago, Inc. until its sale to Mitsubishi Tanabe Pharma Corporation in 2013. He currently serves as Chairman of the Board for Medimabs, Inc., a privately-held antibody company and as a member of the board of directors for Advanced Proteome Therapeutics Corporation. Dr. Chase attended the Senior Executive Program of the London Business School in the United Kingdom, holds a bachelorBachelor of sciencesSciences 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.
Dean G. Kollintzas. Mr. Kollintzas joined the Board of Directors upon consummation of the merger with GeoVax, Inc. in September 2006. Since 2001 Mr. Kollintzas has been an intellectual property attorney specializing in biotechnology and pharmaceutical licensing, FDA regulation, and corporate/international transactions. Mr. Kollintzas received a microbiology degree from the University of Illinois and a J.D. from Franklin Pierce Law Center. He is a member of the Wisconsin and American Bar Associations. Since 2004, Mr. Kollintzas has been in private practice. In 2014, he founded Procare Clinical, LLC, a clinical trial management company headquartered in Naperville, IL. Mr. Kollintzas holds a microbiology degree from the University of Illinois and a J.D. from the University of New Hampshire School of Law. The Board of Directors has concluded that Mr. Kollintzas should serve on the Board of Directors by virtue ofdue to his experience with intellectual property matters, biotechnology and pharmaceutical licensing, and FDA regulation.
John N. (Jack) Spencer,Jr., CPACPA. Mr. Spencer joined the Board of Directors upon consummation of the merger with GeoVax, Inc. 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 also serves as a director of MRI Interventions, Inc. (Nasdaq: MRIC), a medical device company, where he also chairs the audit committee and serves on the compensation committee. He served as the Temporary Chief Financial Officer of Applied Genetic Technologies Corporation from November 2013 until February 2014 while that company prepared its initial public offering. He also serves as a consultant to various companies primarily relating to financial accounting and reporting matters. Mr. Spencer receivedholds a Bachelor of Science degree from Syracuse University, and he earned an M.B.A. degree 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, together with his continuing expertise as a director of, and a consultant to, other publicly owned and privately held companies.
Family Relationships
EXECUTIVE COMPENSATION
There are no family relationships among any of our directors or executive officers.
Director Independence
The tablesBoard of Directors has determined that Messrs. Chase, Kollintzas, McNally and disclosuresSpencer are the members of our Board of Directors who are “independent,” as that followterm 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 serve as the members of our Audit Committee, our Compensation Committee, and our Nominating and Governance Committee.
EXECUTIVE COMPENSATION
Summary Compensation Table
The following table sets forth all compensation awarded or earned for employment services during 2021 and certain other information with respect to our “Named Executive Officers”. The Named Executive Officers for 2014 include2020 by (i) each person who served as our chief executive officer during 2021, and the(ii) our two other most highly compensated individuals who were serving as executive officers (collectively referred to as of December 31, 2014. Our Namedthe “Named Executive Officers for 2014 were:Officers”).
Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards (1) ($) | All Other Compensation ($) | Total ($) | |||||||||||||||
David A. Dodd | 2021 | $ | 250,000 | $ | 125,000 | $ | 295,610 | (3) | $ | 6,500 | (9) | $ | 677,110 | ||||||||
President and CEO | 2020 | 250,000 | 162,500 | 305,760 | (6) | 8,483 | (9) | 726,743 | |||||||||||||
Mark W. Reynolds | 2021 | 234,392 | 94,000 | 138,334 | (4) | 11,600 | (9) | 478,326 | |||||||||||||
Chief Financial Officer | 2020 | 234,392 | 117,196 | 143,360 | (7) | 5,803 | (9) | 500,751 | |||||||||||||
Mark J. Newman, PhD (2) | 2021 | 125,000 | 50,000 | 73,759 | (5) | - | 248,759 | ||||||||||||||
Chief Scientific Officer | 2020 | 41,667 | 18,750 | 39,200 | (8) | - | 99,617 |
(1) | Represents the grant date fair value of the stock options for financial statement reporting purposes. See footnotes 2 and 7 to our consolidated financial statements for the year ended December 31, 2021 for a discussion of the assumptions made and methods used for determining stock compensation values. |
(2) | Dr. Newman became our Chief Scientific Officer effective August 25, 2020. |
(3) | Represents the grant date fair value for stock options granted on December 7, 2021 for 103,000 shares with an exercise price of $3.82 per share, vesting over a three-year period. |
(4) | 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. |
(6) | Represents the grant date fair value for stock options granted on December 2, 2020 for 273,000 shares with an exercise price of $2.79 per share, vesting over a three-year period. |
(7) | 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. |
(8) | 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. |
(9) | Represents employer matching contributions to the Company’s 401(k) retirement plan. |
Employment Agreements
● Robert T. McNally, Ph.D., President and Chief Executive Officer
● Mark W. Reynolds, Chief Financial Officer
● Harriet L. Robinson, Ph.D., Chief Scientific Officer
Employment Agreements
Robert T. McNally.David A. Dodd On March 20, 2008, GeoVax entered into an employment agreement with Robert T. McNally, Ph.D. to become. Mr. Dodd serves as our President and Chief Executive Officer effective Aprilunder an employment agreement dated September 1, 2008.2018. The employment agreement has no specified term. The employment agreement providedprovides for an initial annual salary of $200,000$250,000 to Mr. Dodd, 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.
Our employment agreement with Mr. Dodd provides that we will pay severance compensation to Mr. Dodd in the event his employment is terminated by the Company without cause or by Mr. Dodd with good reason (as defined in the agreement). If we terminate Mr. Dodd’s employment not for cause or he resigns for good reason, then we would pay (a) an amount in cash equal to three times his then base salary and target annual bonus and (b) all stock option grants held by Mr. Dodd will be fully vested. The agreement also addresses his compensation upon termination if there is a change in control (as defined). If we terminate Mr. Dodd’s employment not for cause or he resigns for good reason at any time during the three month period which immediately precedes a change in control (as defined) or during the one year period following a change in control, then we would also pay Mr. Dodd an amount in cash equal to (x) three times the cost to provide 401(k) or other deferred compensation or health and welfare benefits to him, and (y) 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).
Mark W. Reynolds. Mr. Reynolds serves as our Chief Financial Officer under an employment agreement dated January 1, 2010 and amended on October 22, 2013. The employment agreement has no specified term. The employment agreement, as amended, provides for an initial annual salary of $212,600 to Mr. Reynolds, 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 is eligible for annual grants of awards from our equity incentive plans as determined by the Board. Mr. Reynolds 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 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’ 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 J. Newman, PhD. Dr. McNally,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 salary of $275,000, subject to periodic increases as determined by the Compensation Committee. The Board of Directors may also approve the payment of a discretionary bonus annually. Dr. McNallyNewman is eligible for annual grants of awards from our 2006equity 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.
Outstanding Equity Awards
GeoVax has awarded stock options to its senior management and other employees, pursuant to the GeoVax Labs, Inc. 2020 Stock Incentive Plan (the “Plan”“2020 Plan”) and is entitled to participate in any and all benefits in effect from time-to-time for employees generally. We may terminate. The 2020 Plan was adopted by the employment agreement, with or without cause. If we terminate the employment agreement without cause, we will be requiredBoard on June 19, 2020 to provide Dr. McNally at least 30 days prior noticeequity-based and/or incentive awards to selected employees, directors, and independent contractors of the terminationCompany or its affiliates. The terms of these awards typically provide for vesting over a defined period of time and one weekthe options expire if not exercised within ten years from the date of severance paygrant. The Company does not have a formula for each full yeardetermining stock option awards. Awards are generally based on the subjective judgment of service asthe President and Chief Executive Officer ($19,038and 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, 2014, paid as salary continuance). Dr. McNally may terminate the employment agreement at2021. The table also includes warrants, if any, time by giving us 60 days’ notice. In that event, he would not receive severance. In October 2013,granted to our Board of Directors approved an amendment to the employment agreement with Dr. McNally. The 2013 amendment includes severance provisions in the event of a change in control (as defined in the amendment) and a qualifying termination of employment. See the discussion under “Potential Payments Upon Change-in-Control” below. In February 2014, Dr. McNally reduced his time commitment to the company from 100% to 60%, and his base salary was adjusted proportionately from $275,000 to $165,000.
Mark W. Reynolds. On January 1, 2010, GeoVax entered into an amended and restated employment agreement with Mark W. Reynolds, our Chief Financial Officer. The employment agreement has no specified term. The employment agreement provides for an initial annual salary of $212,600 to Mr. Reynolds. The Board of Directors may also approve theNamed Executive Officers upon payment of a discretionary bonus annually. Mr. Reynolds is eligible for grants of awards from our Plan and is entitled to participate in any and all benefits in effect from time-to-time for employees generally. We may terminate the employment agreement, with or without cause. If we terminate the employment agreement without cause, we will be required to provide Mr. Reynolds at least 30 days prior notice of the termination and one week of severance pay for each full year of service as Chief Financial Officer ($32,708 as of December 31, 2014, paid as salary continuance). Mr. Reynolds may terminate the employment agreement at any time by giving us 60 days’ notice. In that event, he would not receive severance. In October 2013, our Board of Directors approved an amendment to the employment agreement with Mr. Reynolds. The 2013 amendment includes severance provisions in the event of a change in control (as defined in the amendment) and a qualifying termination of employment. See the discussion under “Potential Payments Upon Change-in-Control” below. In December 2014, the Compensation Committee awarded Mr. Reynolds a bonus of $2,000 and approved an increase to his base salary from $212,600 to $223,230, effective January 1, 2015.deferred compensation.
Harriet L. Robinson. On November 19, 2007, GeoVax entered into an employment agreement with Harriet L. Robinson, our Chief Scientific Officer. The employment agreement has no specified term. The employment agreement provided for an initial base salary of $250,000 to Dr. Robinson, subject to periodic increases as determined by the Compensation Committee. Dr. Robinson initially worked part-time for the Company, and became a full-time employee in February 2008. The Board of Directors may also approve the payment of a discretionary bonus annually. Dr. Robinson is eligible for grants of awards from our Plan and is entitled to participate in any and all benefits in effect from time-to-time for employees generally. We may terminate the employment agreement, with or without cause. If we terminate the employment agreement without cause, we will be required to provide Dr. Robinson at least 30 days prior notice of the termination and one week of severance pay for each full year of service ($28,619 as of December 31, 2014, paid as salary continuance). Dr. Robinson may terminate the employment agreement at any time by giving us 60 days’ notice. In that event, she would not receive severance. In April 2013, Dr. Robinson reduced her time commitment to the company to 80% in conjunction with a prorata reduction of her then annualized salary of $265,750 to $212,600. In October 2013, our Board of Directors approved an amendment to the employment agreement with Dr. Robinson. The 2013 amendment includes severance provisions in the event of a change in control (as defined in the amendment) and a qualifying termination of employment. See the discussion under “Potential Payments Upon Change-in-Control” below.
Option Awards | |||||||||||||
Number of Securities Underlying Unexercised Options | |||||||||||||
Name | (#) Exercisable | (#) Unexercisable | Option Exercise Price ($) | Option Expiration Date | |||||||||
David Dodd | - | 103,000 | (1) | $ | 3.82 | 12/7/31 | |||||||
91,000 | 182,000 | (2) | 2.79 | 12/2/30 | |||||||||
81,870 | (3) | - | 5.00 | 9/29/25 | |||||||||
Mark Reynolds | - | 48,200 | (1) | 3.82 | 12/7/31 | ||||||||
42,666 | 85,334 | (2) | 2.79 | 12/2/30 | |||||||||
60,184 | (3) | - | 5.00 | 9/29/25 | |||||||||
Mark Newman, PhD | - | 25,700 | (1) | 3.82 | 1287/31 | ||||||||
11,666 | 23,334 | (2) | 2.79 | 12/2/30 |
(1) | The unexercisable portion of these stock options vest and become exercisable in equal installments on December 7, 2022, 2023 and 2024. |
(2) | The unexercisable portion of these stock options vest and become exercisable in equal installments on December 2, 2022 and 2023. |
(3) | Warrants granted as partial payment of deferred compensation occurring on September 29, 2020. |
In October 2006 GeoVax Labs, Inc. and our subsidiary, GeoVax, Inc. entered into indemnification agreements with Messrs. McNally, Reynolds, Kollintzas and Spencer. Pursuant to these agreements, we have agreed to indemnify them to the full extent permitted by Illinois and Georgia law against certain liabilities incurred by these individuals in connection with specified proceedings if they acted in a manner they believed in good faith to be in or not opposed to the best interests of the Company and, with respect to any criminal proceeding, had no reasonable cause to believe that such conduct was unlawful. The agreements also provide for the advancement of expenses to these individuals subject to specified conditions.
Potential Payments Upon a Change-in-Control
Our 2006 Equity Incentive2020 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, (i) outstanding options or other awards under the Plan may be assumed, converted or replaced; (ii) the successor corporation may substitute equivalent options or other awards or provide substantially similar consideration to 2020 Plan 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 will accelerate upon the change-in-control transaction, and (ii) any or all options granted pursuant to the PlanPlans 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, 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 transactionevent as described in the 2020 Plan on December 31, 2014,2021, the value of accelerated options for eachthe Named Executive Officer,Officers, based on the difference between the closing price of our common stock on the OTCNasdaq Stock Market on December 31, 2014,2021, and, if lower, the exercise price per share of each option for which vesting would be accelerated for each Named Executive Officer, would be $0.
Our employment agreements with each Named Executive Officer provide for payment to each Named Executive Officer if we terminate such Named Executive Officer’s employment without cause. If each Named Executive Officer was terminated without cause on December 31, 2014, the following amounts, which represent one weekan aggregate of pay for each full year of service to the Company, would be payable to each Named Executive Officer as salary continuance under the terms of such Named Executive Officer’s employment agreement: Dr. McNally - $19,038; Mr. Reynolds - $32,708; and Dr. Robinson - $28,619.$241,254.
In October 2013, our Board of Directors approved amendments to the employment agreements with each Named Executive Officer These 2013 amendments include severance provisions in the event of a change in control and a qualifying termination of employment. Specifically, if a Named Executive Officer is terminated at any time during the three month period which immediately precedes a change in control (as defined in the amendment) or during the one year period following a change in control, then the Company would pay an amount in cash equal to (a) a multiple of the Named Executive Officer’s then base salary and target annual bonus (3x for Dr. McNally, 2x for Mr. Reynolds, and 2x for Dr. Robinson), (b) a multiple of the cost to provide 401(k) or other deferred compensation or health and welfare benefits to the Named Executive Officer (3x for Dr. McNally, 2x for Mr. Reynolds, and 2x for Dr. Robinson), and (c) 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 the officer) pursuant to the amendment. The amendments also provide for full and complete vesting of all stock option grants held by the Named Executive Officers.
SummaryDirector Compensation Table
The following narrative, table, and footnotes set forth information concerning the total compensation earned during the fiscal years ended December 31, 2014 and 2013 by our Named Executive Officers. The individual components of the total compensation reflected in the table are broken out as follows:
Salary. Base salary earned during 2014 and 2013. The terms of the Employment Agreements governed the base salaries for Dr. McNally, Mr. Reynolds, and Dr. Robinson.
Bonus. The amount of cash bonuses paid during 2014 and 2013.
Option Awards. The awards disclosed under the heading “Option Awards” consist of the aggregate grant date fair value of the stock option grants during 2014 and 2013 computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718,Compensation – Stock Compensation (“FASB ASC Topic 718”). For a discussion of the various assumptions made and methods used for determining such amounts, see footnotes 2 and 9 to our 2014 consolidated financial statements which begin at page F-10 of this prospectus.
All Other Compensation. The amounts include under “All Other Compensation” are described in the footnotes to the table.
Name and Principal Position | Year | Salary($) | Bonus ($) | Option Awards ($) | All Other Compensation ($)(3) | Total ($) | |||||||||||||||
Robert T. McNally | 2014 | $ | 174,167 | $ | - | $ | 4,080 | (1) | $ | 6,967 | $ | 185,214 | |||||||||
President andChief Executive Officer | 2013 | 275,000 | - | 12,930 | (2) | 10,200 | 298,130 | ||||||||||||||
Mark W. Reynolds | 2014 | 212,600 | 2,000 | 4,080 | (1) | 8,546 | 227,226 | ||||||||||||||
Chief Financial Officer | 2013 | 212,600 | - | 12,930 | (2) | 8,504 | 234,034 | ||||||||||||||
Harriet L. Robinson | 2014 | 212,600 | - | 4,080 | (1) | 8,504 | 225,184 | ||||||||||||||
Chief Scientific Officer | 2013 | 225,887 | - | 12,930 | (2) | 9,035 | 247,852 |
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Outstanding Equity Awards at Fiscal Year-End
GeoVax has awarded stock options to its senior management and other employees. The terms of these awards typically provide for vesting over a defined period of time, generally three years. 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, 2014.
Option Awards | |||||||||||||
Number of Securities Underlying Unexercised Options | |||||||||||||
Name | (#) Exercisable | (#) Unexercisable | Option Exercise Price ($) | Option Expiration Date | |||||||||
Robert McNally | - | 30,000 | (1) | $ | 0.17 | 12/9/2024 | |||||||
10,000 | 20,000 | (2) | 0.53 | 12/18/2023 | |||||||||
20,000 | 10,000 | (3) | 0.66 | 12/11/2022 | |||||||||
30,000 | - | 0.91 | 12/30/2021 | ||||||||||
10,000 | - | 1.98 | 12/10/2020 | ||||||||||
10,000 | - | 7 | 12/2/2019 | ||||||||||
10,000 | - | 5.5 | 12/11/2018 | ||||||||||
48,000 | - | 8.5 | 6/17/2018 | ||||||||||
10,000 | - | 8.05 | 12/5/2017 | ||||||||||
26,400 | - | 17.75 | 3/14/2017 | ||||||||||
Mark Reynolds | - | 30,000 | (1) | 0.17 | 12/9/2024 | ||||||||
10,000 | 20,000 | (2) | 0.53 | 12/18/2023 | |||||||||
16,666 | 8,334 | (3) | 0.66 | 12/11/2022 | |||||||||
25,000 | - | 0.91 | 12/30/2021 | ||||||||||
10,000 | - | 1.98 | 12/10/2020 | ||||||||||
10,000 | - | 7 | 12/2/2019 | ||||||||||
10,000 | - | 5.5 | 12/11/2018 | ||||||||||
10,000 | - | 8.05 | 12/5/2017 | ||||||||||
36,000 | - | 17.75 | 3/14/2017 | ||||||||||
Harriet Robinson | - | 30,000 | (1) | 0.17 | 12/9/2024 | ||||||||
10,000 | 20,000 | (2) | 0.53 | 12/18/2023 | |||||||||
16,666 | 8,334 | (3) | 0.66 | 12/11/2022 | |||||||||
25,000 | - | 0.91 | 12/30/2021 | ||||||||||
10,000 | - | 1.98 | 12/10/2020 | ||||||||||
10,000 | - | 7 | 12/2/2019 | ||||||||||
10,000 | - | 5.5 | 12/11/2018 |
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Other Benefits Provided to Executive Officers
Mr. Reynolds and Dr. Robinson are eligible for health insurance and 401(k) benefits at the same level and subject to the same conditions as provided to all other employees. Dr. McNally is eligible for 401(k) benefits at the same level and subject to the same conditions as provided to all other employees, but he is currently ineligible for health insurance due to his time commitment to the Company being less than the required 30 hours per week. GeoVax participates in a multi-employer defined contribution retirement plan (the “401k Plan”) administered by a third party service provider; and the Company contributes to the 401k Plan on behalf of all its eligible employees based upon the same matching formula. The amounts shown in the Summary Compensation Table under the heading “Other Compensation” represent the value of the Company’s matching contributions to the 401(k) accounts of these executive officers. Executive officers did not receive any other perquisites or other personal benefits or property from the Company or any other source.
DIRECTOR COMPENSATION
The following table sets forth information concerning the compensation earned for service on our Board of Directors during the fiscal year ending December 31, 20142021 by each individual who served as a director at any time during the fiscal year.
Name | Fees Earned or Paid in Cash ($) | Stock Awards ($) | (2)(3) Option Awards ($) | Non-Equity Incentive Plan Compensation ($) | Non-qualified Deferred Compensation Earnings ($) | All Other Compensation ($) | Total ($) | Fees Earned or Paid in Cash ($) | Option Awards ($) (2)(3) | Non-Equity Incentive Plan Compensation ($) | Non- qualified Deferred Compensation Earnings ($) | All Other Compensation ($) | Total ($) | |||||||||||||||||||||||||||||||||||||||
David A. Dodd | 48,550 | - | 3,400 | - | - | - | 51,950 | |||||||||||||||||||||||||||||||||||||||||||||
Randal D. Chase | 41,650 | 71,750 | 113,400 | |||||||||||||||||||||||||||||||||||||||||||||||||
David A. Dodd (1) | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
Dean G. Kollintzas | 28,500 | - | 3,400 | - | - | - | 31,900 | 35,975 | 71,750 | - | - | - | 107,725 | |||||||||||||||||||||||||||||||||||||||
Robert T. McNally (1) | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Harriet L. Robinson (1) | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Robert T. McNally | 27,000 | 71,750 | - | - | - | 98,750 | ||||||||||||||||||||||||||||||||||||||||||||||
John N. Spencer, Jr. | 37,450 | - | 3,400 | - | - | - | 40,850 | 47,000 | 71,750 | - | - | - | 118,750 |
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(3) | The table below shows the aggregate numbers of warrants and option awards outstanding for each non-employee director as of December 31, |
Name | Aggregate Option Awards Outstanding as of December 31, (#) | |||
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Dean G. Kollintzas | ||||
Robert T. McNally | 103,925 | |||
John N. Spencer, Jr. |
Director Compensation Plan
Plan.In March 2007,December 2020, the Board of Directors approved a recommendation from the Compensation Committee for director compensation, which we refer to as the “Director Compensation Plan.” It was subsequently amended in March 2008, December 2009, and in December 2010. 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.
Cash Fees
–For 2014,2021, each non-employee director receivedearned 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 CommitteeCommittee. and $3,300 ($6,000 for the Chairperson) for service as a member of the Compensation Committee or the Nominating and Corporate Governance Committee. The Chairman of the Audit Committee received an annual retainer of $9,000, and the Chairman of each of the Compensation Committee and the Nominating and Corporate Governance Committee received an annual retainer of $6,000. These retainers were also paid quarterly. Non-employee directors also receivedearned 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). Mr. Dodd,
In December 2021, the Board of Directors approved a recommendation from the Compensation Committee to amend the Director Compensation Plan, effective January 1, 2022, such that each non-employee Chairmandirector will receive 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, during 2013, receiveda non-employee director designated as the Lead Director shall receive an annual cash retainer of $35,000. Each non-employee director will also receive an annual retainer of $30,000 (paid quarterly)$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 was not entitled to$5,000 ($7,500 for the Chairperson) for service as a member of the Nominating and Corporate Governance Committee. No additional fees will be paid for Board meetings attended, but did receive additional fees for committees on which he serves. attended.
Stock Option Grants
Each of our current non-employee directors received a grant of options to purchase 26,400 shares of common stock on the date that such non-employee director was first elected or appointed. –We currently do not have a formula for determining annual stock option grants to directors (upon their re-electionelection 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 2015,2021, upon a recommendation of the Compensation Committee, the Board of Directors approved an annual stock option grant of 30,00025,000 shares to each of its non-employee members.members for ongoing service as members of the Board of Directors.
Expense Reimbursement
–All directors are reimbursed for expenses incurred in connection with attending meetings of the Board of Directors and committees.
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS
PoliciesOther than compensation arrangements for our Named Executive Officers and Proceduresdirectors, we describe below each transaction since January 1, 2021, 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 Approval of Related Party Transactionsour named executive officers and directors are described above under “Executive Compensation.”
Our Audit Committee is responsible for reviewing and approving all transactions or arrangements between the Company and any of our directors, officers, principal stockholders or any of their respective affiliates, associates or related parties, other than transactions with officers which are covered by the duties of the Compensation Committee. In determining whether to approve or ratify a related party transaction, the Audit Committee will discuss the transaction with management and will consider all relevant facts and circumstances available to it including:
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These policies are in writing and included in the Company’s minute book.
Our Board of Directors has made the following findings and adopted the following policies (in writing) regarding related party transactions:
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Transactions with Related Parties
Emory University is a significant stockholder of the Company, and our primary product candidates are based on technology rights subject to a license agreement with Emory University, which we refer to as the Emory License. The Emory License, among other contractual obligations, requires payments based on milestone achievements, royalties on sales by the Company or on payments to the Company by our sublicensees, and payment of maintenance fees in the event certain milestones are not met within the time periods specified in the Emory License. We may terminate the Emory License upon 90 days prior written notice. In any event, the Emory License expires on the date of the latest expiration date of the underlying patents. We are also obligated to reimburse Emory University for certain ongoing costs in connection with the filing, prosecution and maintenance of patent applications subject to the Emory License. The expense associated with these ongoing patent reimbursements to Emory University amounted to $179,958 for the year ended December 31, 2014 and $94,690 for the nine months ended September 30, 2015.
On October 14, 2014, we entered into a letter agreement with Sabby Healthcare Master Fund, Ltd. and Sabby Volatility Warrant Master Fund, Ltd. with respect to the payment to them of a warrant exercise fee of $0.075 per share for each share purchased upon exercise of Series A or Series C Common Stock PurchaseI Warrants (“Warrants”) held by them. Each of these parties at that time held Warrants to acquire an aggregate of 2,666,666 shares of our common stock. They agreed to exercise Warrants equal to 9.98% of the outstanding shares of GeoVax (3,176,000 shares in the aggregate) upon execution of the letter, and we paid the exercise fee of $238,200 subsequent to our receipt of the exercise price. See “Selling Stockholders” for information regarding the Purchasers’ current share ownership.
On February 25, 2015,2019, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with the Sabby Healthcare Master Fund, Ltd. and Sabby Volatility Warrant Master Fund, Ltd. (collectively, the “Purchasers”“Sabby”) providing for the issuance and sale to the PurchasersSabby of an aggregate of 3,000up to 1,000 shares of our Series CG Convertible Preferred Stock (the “Preferred Shares”) and related warrants (“Series I Warrants”) for gross proceeds of up to $1.0 million. In January 2021, all of the Company of $3.0 million. Each Preferred Share was initially convertibleremaining Series I Warrants were converted into approximately 5,555.5520,196 shares of our Common Stockcommon 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 total of 16,666,6662,400,000 shares of our Common Stockcommon 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 Shares”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 the Preferred Shares include anti-dilution provisions. Pursuantcommon 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 the Certificate of Designation which authorized the Series C Convertible Preferred Stock, the Preferred Shares could initially be converted at any time at the option of the Purchasers intoacquire an additional 303,668 shares of our Common Stockcommon stock, in the aggregate, at an initial conversion price$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 $0.18 per share707,484 shares of common stock, 2,360,000 shares of common stock issuable upon the exercise of a pre-funded warrant (the “Conversion Price”“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 Certificate of Designation containsJanuary Warrants are exercisable immediately and contain price adjustment provisions which may, under certain circumstances, (i) reduce the Conversion Priceapplicable exercise price; the January Pre-Funded Warrant shall terminate when fully exercised and the Common Warrant shall terminate on several future dates, includingthe fifth anniversary of the effective date of the registration statementResale 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 be filed to cover resale of the Conversion Shares, according to a formula based on the then-current market price for our common stock. We closed this transaction on February 27, 2015. On April 8, 2015 the Conversion Price was adjusted to $0.142 per share and on December 4, 2015 the Conversion Price was further adjusted to $0.9416 per share, resultingArmistice in a current aggregate totalprivate placement offering of 31,860,6629,090,910 shares of our common stock (“Conversion Shares”) into which the Series C Preferred Shares currently may be converted.
Pursuant to the Securities Purchase Agreement, each Purchaser was also issuedissuable upon exercise of a Series D Warrant, a Series E Warrantpre-funded warrant and a Series F Warrant (collectively, the “Warrants”), eachpreferred investment option to purchase up to a number of9,090,910 shares of common stock. Concurrently with the Company’s Common Stock equal to 100% ofentrance into the Conversion Shares underlying the Preferred Shares issued to such Purchaser pursuant to thePIPE Securities Purchase Agreement, (upwe entered into another Securities Purchase Agreement (the “RD Securities Purchase Agreement”) with Armistice providing for the issuance and sale to 16,666,666 sharesArmistice in the aggregate for eacha registered direct offering of the three series of warrants, or approximately 50,000,000 shares in total) (the “Warrant Shares”). The Series D Warrants had an initial exercise price of $0.22 per share, are exercisable immediately, and have a term of exercise equal to five years from the date of issuance. The Series E Warrants had an initial exercise price of $0.18 per share, are exercisable immediately, and have a term of exercise equal to one year from the date of issuance. The Series F Warrants had an initial exercise price of $0.22 per share and have a term of exercise equal to five years from the date of issuance, but only vest and become exercisable upon, and in proportion to, the exercise of the one-year Series E Warrants held by each Purchaser (or its assigns). The Warrants contain anti-dilution and price adjustment provisions, which may, under certain circumstances, (i) reduce the exercise price on several future dates, including the effective date of the registration statement to be filed to cover resale of the shares subject to the Warrants, according to a formula based on the then-current market price for our common stock and (ii) reduce the exercise price to match if we sell or grant options to purchase, including rights to reprice, our common stock or common stock equivalents at a price lower than the exercise price of the Warrants, or if we announce plans to do so. The number of shares subject to warrants will not increase due to such reductions in exercise price. We also issued the Maxim Warrant to our placement agent to acquire 1,333,3331,050,000 shares of our common stock, with an initial exercise price of $0.22 per share on substantially the same terms and conditions of the Series D warrants. On April 8, 2015 the exercise prices of the Series D and Series F Warrants were reduced to $0.1704 per share and the exercise prices of the Series E Warrants and the Maxim Warrant were reduced to $0.142 per share; and on December 4, 2015the exercise prices of the Series D, Series F and Maxim Warrants were reduced to $0.11299 per share and the exercise price of the Series E Warrants were reduced to $0.09416 per share. The Purchasers also received a price adjustment on Series A Warrantspre-funded warrant to purchase 1,207,332 common shares previously issued to them, resulting in a reduction of the exercise price from $0.142 to $0.09416. See “Selling Stockholders” for information regarding the Purchasers’ current share ownership.
The Purchasers also have the right to participate in certain future financings, subject to certain exceptions, and may invest up to 75% of the aggregate amount invested at that time. The Preferred Shares do not have voting rights except as required by law and are not entitled to a dividend. When issued, the Conversion Shares will have the voting rights afforded to all shares of Common Stock. The Preferred Shares have a liquidation preference equal to the initial purchase price.
On February 25, 2015, in connection with the closing of the private placement, we entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Purchasers. Under the Registration Rights Agreement, we are required to file a registration statement within 30 calendar days after signing the Registration Rights Agreement. Our failure to meet the filing deadlines and other requirements set forth in the Registration Rights Agreement may subject us to monetary penalties. Pursuant to the Registration Rights Agreement, we filed a registration statement with the Securities and Exchange Commission (“SEC”) on March 20, 2015. It was declared effective by the SEC on April 8, 2015, which triggered the price adjustment provisions of the Series C Preferred Shares and the related warrants. As of that date, the conversion price of the Series C Preferred Shares was reduced to $0.142, the exercise prices of the Series D Warrants, Series F Warrants and Maxim Warrants were reduced to $0.1704, and the exercise price of the Series E Warrants was reduced to $0.142. On November 27, 2015, in accordance with the terms of the Securities Purchase Agreement, additional price adjustment provisions of the Series C Preferred Shares and the related warrants were triggered. Five days subsequent to that date, on December 4, 2015, the conversion price of the Series C Preferred Shares was reduced to $0.09416, the exercise prices of the Series D Warrants, Series F Warrants and Maxim Warrants were reduced to $0.11299, and the exercise price of the Series E Warrants was reduced to $0.09416.
SELLING STOCKHOLDERS
This prospectus relates to the resale by the selling stockholders named below from time to time of up to a total of 10,733,902 shares that are owned by or issuable to the selling stockholders. The number of shares is subject to adjustment as described at “Description of Securities.” The common stock offered by this prospectus is being offered by the selling stockholders for their own accounts.
Private Placement Transaction
On February 27, 2015, we completed a private placement transaction and issued to a total of 3,000 shares of Series C Preferred Stock, with a stated value of $1,000 per share and an initial conversion price of $0.18, to two accredited investors. On April 8, 2015, pursuant to certain price adjustment provisions contained in the transaction documents, the conversion price was adjusted to $0.142, and further adjusted to $0.09416 on December 4, 2015. Each share of Series C Preferred Stock is currently convertible into 10,620.22 shares of our common stock. Each purchaser of a share of Series C Preferred Stock also acquired a Series D, a Series E, and a Series F Warrant (collectively, the “2015 Warrants”) to purchase a share of our common stock. See “Description of Securities” for details of the terms of these warrants. We also issued a warrant to Maxim Partners LLC to purchase 1,333,333 shares of our stock on substantially the same terms and conditions as the Series D warrants. The Series C Convertible Preferred Stock and the 2015 warrants were issued in reliance upon exemptions provided by Section 4(2) of the Securities Act for the offer and sale of securities not involving a public offering and Regulation D promulgated thereunder.
Selling Stockholders
The table below, which was prepared based on information supplied to us by the selling stockholders, sets forth information regarding the beneficial ownership of outstanding1,980,304 shares of our common stock owned byand a preferred investment option to purchase up to 3,030,304 shares of common stock. Aggregate gross proceeds from the selling stockholdersprivate placement and registered direct offerings to the shares that they may sell or otherwise dispose of from timeCompany were approximately $20.0 million.
SECURITY OWNERSHIP OF
PRINCIPAL STOCKHOLDERS, DIRECTORS AND OFFICERS
Based solely upon information made available to time under this prospectus. Each ofus, the selling stockholders, or their respective transferees, donees or their successors, may resell, from timefollowing table sets forth information with respect to time, all, some or none of the sharesbeneficial ownership of our common stock coveredas of June 10, 2022 by this prospectus,(i) each director; (ii) each of the executive officers named in the summary compensation table; and (iii) all executive officers and directors as provided in this prospectus under the section entitled “Plan of Distribution” and in any applicable prospectus supplement. However,a group. Other than Armistice, we do not know when, in what amount, or at what specific prices the selling stockholders may offer their shares for sale under this prospectus, if any.
The number of shares disclosed in the table below as “beneficially owned” are those beneficially owned as determined under the rules of the SEC. Such information is not necessarily indicative of ownership for any other purpose. Under the rules of the SEC, a person is deemed to be a “beneficial owner” of a security if that person has or shares “voting power,” which includes the power to vote or to direct the voting of such security, or “investment power,” which includes the power to dispose of or to direct the disposition of such security. In computing the number of shares beneficially owned by a selling stockholder and the percentage of ownership of that selling stockholder, shares of common stock underlying shares of Series C Preferred Stock, options or warrants held by that selling stockholder that are convertible or exercisable, as the case may be, within 60 days of December 8, 2015 are included, subject to the “Maximum Percentage” limitation described in footnote 1 to the table below. Those shares, however, are not deemed outstanding for the purpose of computing the percentage ownership of any other selling stockholder. Each selling stockholder’s percentage of ownership in the following table is based upon 31,950,813 sharesperson who beneficially owns more than 5% of our common stock outstanding as of December 8, 2015. Please note that the column titled “Total Shares that may be Offered and Sold Hereby” includes all shares that may be issued and sold pursuantJune 10, 2022. Except as otherwise indicated in footnotes to this prospectus.
Unless otherwise indicated and subjecttable or, where applicable, to the extent authority is shared by spouses under community property laws, where applicable, the selling stockholders named in the following table have, to our knowledge, the holders listed below have sole voting and investment power with respect to theall shares of common stock beneficially owned by them. In addition, none of the selling stockholders has any family relationships with our officers, directors or controlling stockholders. Furthermore, no selling stockholder is a registered broker-dealer or an affiliate of a registered broker-dealer.
Information concerning any of the selling stockholders may change from time to time, and any changed information will be presented in a prospectus supplement as necessary. Please carefully read the footnotes located below the table in conjunction with the information presented in the table.
Name of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percent of | ||||||
Principal Stockholders | ||||||||
Armistice Capital Master Fund Ltd. (2) | 1,253,500 | 9.99 | % | |||||
Directors and Executive Officers: (3) | ||||||||
Randal Chase (4) | 41,559 | * | ||||||
David A. Dodd (5) | 254,740 | 2.0 | % | |||||
Dean G. Kollintzas (6) | 32,307 | * | ||||||
Robert T. McNally (7) | 116,183 | * | ||||||
Kelly T. McKee | 14,721 | * | ||||||
Mark J. Newman (8) | 11,666 | * | ||||||
Mark W. Reynolds (9) | 163,034 | 1.3 | % | |||||
John N. Spencer, Jr. (10) | 50,381 | * | ||||||
All executive officers and directors as a group (8 persons) (11) | 684,591 | 5.3 | % |
Selling Stockholder Name | Beneficial Ownership Prior to this Offering (1) | Shares that may be Offered and Sold Hereby | Beneficial Ownership After this Offering (2) | % Holding After Completion of this Offering | ||||||||||||
Sabby Volatility Warrant Master Fund, Ltd. (3) | 3,533,000 | (4) | 5,366,951 | 4,264,400 | 9.99 | % | ||||||||||
Sabby Healthcare Master Fund, Ltd. (3) | 3,509,500 | (5) | 5,366,951 | 4,264,400 | 9.99 | % |
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* Less than 1%
(1) |
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(2) |
The number of shares beneficially owned includes (i) 9,090,910 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 |
(3) |
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(4) | Includes |
(5) | Includes 81,870 shares |
(6) | Includes 11,987 shares of Common Stock and stock options/warrants to purchase 20,320 shares of common stock exercisable within 60 days. |
(7) | Includes 53,925 shares of Common Stock and stock options/warrants to purchase 62,258 shares of common stock exercisable within 60 days. |
(8) | Includes stock options to purchase 11,666 shares of common stock exercisable within 60 days. |
(9) | Includes 60,184 shares of Common Stock and stock options/warrants to purchase 102,850 shares of common stock exercisable within 60 days. |
(10) | Includes 21,024 shares of Common Stock and stock options/warrants to purchase 29,357 shares of common stock exercisable within 60 days. |
(11) | Includes 260,324 shares of Common Stock and stock options/warrants to purchase 424,267 shares of common stock exercisable within 60 days. |
SELLING STOCKHOLDERS
The common stock being offered by each of the Selling Stockholders are those issuable to such Selling Stockholder, upon exercise of the Warrants, 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 Preferred Investment Options, 128,000 Common Shares issuable upon the exercise of the 2020 Common Warrant and 72,000 Common Shares issuable upon the exercise of the 2021 Common Warrant. For additional information regarding the issuances of those Warrants, see “Prospectus Summary–Recent Developments–Private Placement” above. We are registering the shares of common stock issuable upon exercise of the Warrants in order to permit the Selling Stockholders to offer the shares for resale from time to time. Except for as noted in this prospectus, neither Selling Stockholder has had any material relationship with us within the past three years.
The table below lists each of the Selling Stockholders and other information regarding the beneficial ownership of the shares of common stock by such Selling Stockholder. The second column lists the number of shares of common stock beneficially owned by each Selling Stockholder, based on its ownership of the Warrants, as of June 10, 2022, assuming exercise of the Warrants held by such Selling Stockholder on that date, without regard to any limitations on exercises. The third column lists the shares of common stock being offered by this prospectus by each of the Selling Stockholder.
In accordance with the terms of a registration rights agreement with Armistice or the terms of each of the 2020 Common Warrant and 2021 Common Warrant, this prospectus generally covers the resale of the maximum number of shares of common stock issuable upon exercise of the Warrants, determined as if the outstanding Warrants were exercised in full as of the trading day immediately preceding the date this registration statement was initially filed with the SEC, each as of the trading day immediately preceding the applicable date of determination and all subject to adjustment as provided in the registration right agreement, without regard to any limitations on the exercise of the Warrants. The fourth column assumes the sale of all of the shares offered by each Selling Stockholder pursuant to this prospectus.
Under the terms of the Warrants, each Selling Stockholder may not exercise the Warrants to the extent such exercise would cause such Selling Stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of common stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding common stock following such exercise, excluding for purposes of such determination shares of common stock issuable upon exercise of such Warrants which have not been exercised. The number of shares in the second and fourth columns do not reflect this limitation. Each Selling Stockholder may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
Selling Stockholder | Number of Shares of Common Stock Owned Prior to Offering | Maximum Number of Shares of Common Stock to be Sold Pursuant to this Prospectus | Number of Shares of Common Stock Owned After the Offering | |||||||||
Armistice Capital Master Fund Ltd. (1) | 24,279,608 | 21,412,124 | 3,067,484 | |||||||||
Maxim Partners LLC (2) | 200,000 | 200,000 | -0- |
(1) | The shares are directly held by Armistice and may be deemed to be indirectly beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the |
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(2) | The shares are directly held by Maxim Partners. The number of shares beneficially owned include 128,000 shares of common stock issuable upon exercise of |
DESCRIPTION OF SECURITIESCAPITAL STOCK
Capital Stock
The following description of our capital stock is summarized from, and qualified in its entirety by reference to, our certificate of incorporation, as amended, including the certificates of designation, as amended, setting forth the terms of our Series B Preferred Stock and Series C Preferred Stock, all of which have been previously filed with the SEC and are incorporated herein by reference.preferred stock. This summary is not intended to give full effect to provisions of statutory or common law. We urge you to review the following documents because they, and not this summary, define the rights of a holder of shares of common stock Series B and Series C Preferred Stock: preferred stock:
General
As of
Common Stock Our common stock is listed and traded on the Nasdaq Capital Market under the symbol “GOVX.” Holders of our common stock are entitled to one vote for each share held in the election of directors and in all other matters to be voted on by the stockholders. There is no cumulative voting in the election of directors. Holders of common stock are entitled to receive dividends as may be declared from time to time by our Board of Directors out of funds legally available
52 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.
Delaware Anti-Takeover Law
We have elected not to be subject to certain provisions of Delaware law that could make it more difficult to acquire us by means of a tender offer, a proxy contest, open market purchases, removal of incumbent directors and otherwise. These provisions, summarized below, are expected to discourage types of coercive takeover practices and inadequate takeover bids and to encourage persons seeking to acquire control of us to first negotiate with our Board of Directors.
In general, Section 203 of the DGCL prohibits a publicly held Delaware corporation from engaging in various “business combination” transactions with any interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:
A “business combination” is defined to include mergers, asset sales and other transactions resulting in financial benefit to a stockholder. In general, an “interested stockholder” is a person who, together with affiliates and associates, owns or within three years, did own, 15% or more of a corporation’s voting stock.
Section 203 applies to Delaware corporations that have a class of voting stock that is listed on a national securities exchange or held of record by more than 2,000 stockholders; provided, however, the restrictions of this statute will not apply to a corporation if:
53
Our certificate of incorporation includes a provision electing not to be governed by Section 203 of the DCGL. Accordingly, our board of directors does not have the power to reject certain business combinations with interested stockholders based on Section 203 of the DCGL.
Indemnification
Section 145 of the Our bylaws provide that we may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Company) by reason of the fact that the person is or was a director, officer, employee or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the person’s conduct was unlawful. Our bylaws also provide that we may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Company to procure a judgment in its favor by reason of the fact that the person is or was a director, officer, employee or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the Company and except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the Company unless and only to the extent that the Delaware Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Delaware Court of Chancery or such other court shall deem proper.
Under our bylaws, expenses (including attorneys’ fees) incurred by an officer or director in defending any civil, criminal, administrative or investigative action, suit or proceeding may be paid by the Company in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Company. Such expenses (including attorneys’ fees) incurred by former directors and officers or other employees and agents may be so paid upon such terms and conditions, if any, as we deem appropriate.
The indemnification and advancement of expenses provided by our bylaws is not exclusive, both as to action in such person’s official capacity and as to action in another capacity while holding such office. 54
Our bylaws also provide that we may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the Company would have the power to indemnify such person against such liability under our bylaws. The Company maintains an insurance policy providing for indemnification of its officers, directors and certain other persons against liabilities and expenses incurred by any of them in certain stated proceedings and under certain stated conditions.
In October 2006, GeoVax and our subsidiary, GeoVax, Inc. entered into indemnification agreements with Messrs. McNally, Reynolds, Kollintzas and Spencer. Pursuant to these agreements, we have agreed to hold harmless and indemnify these directors and officers to the full extent authorized or permitted by applicable Illinois and Georgia law against certain expenses and other liabilities actually and reasonably incurred by these individuals in connection with certain proceedings if they acted in a manner they believed in good faith to be in or not opposed to the best interests of the Company and, with respect to any criminal proceeding, had no reasonable cause to believe that such conduct was unlawful. The agreements also provide for the advancement of expenses to these individuals subject to specified conditions. Under these agreements, we will not indemnify these individuals for expenses or other amounts for which applicable Illinois and Georgia law prohibit indemnification. The obligations under these agreements continue during the period in which these individuals are our directors or officers and continue thereafter so long as these individuals shall be subject to any proceeding by reason of their service to the Company, whether or not they are serving in any such capacity at the time the liability or expense incurred for which indemnification can be provided under the agreements.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
In the event that a
Transfer Agent, Warrant Agent and Registrar 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. Listing Our common stock is listed on The Nasdaq Capital Market under the symbol “GOVX.” 55
PLAN OF DISTRIBUTION
Each
Broker-dealers engaged by
In connection with the sale of the securities or interests therein,
We agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by
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,
56 LEGAL MATTERS
The validity of the
EXPERTS
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC, under the Securities Act, a registration statement on Form S-1
We GeoVax Labs, Inc. 1900 Lake Park Drive, Suite 380 Smyrna, Georgia 30080 Tel: (678) 384-7220 Attention: Mark W. Reynolds, Chief Financial Officer Information contained on our website is not a prospectus and does not constitute a part of this prospectus. You
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INDEX TO FINANCIAL STATEMENTS
F-1
See accompanying notes to condensed consolidated financial statements.
F-2
GEOVAX LABS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
See accompanying notes to condensed consolidated financial statements.
F-3
GEOVAX LABS, INC. CONDENSED CONSOLIDATED STATEMENTS OF (Unaudited)
See accompanying notes to consolidated financial statements. F-4
Supplemental disclosure of non-cash financing activities: During the
See accompanying notes to condensed consolidated financial statements.
F-5
GEOVAX LABS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and cancers using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human GeoVax is incorporated under the laws of the State of Delaware and our principal offices are located in
The accompanying condensed consolidated financial statements at
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
We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form
Basic
F- 6
Property and equipment as shown on the accompanying Condensed Consolidated Balance Sheets is composed of the following as of
Operating Lease
We lease approximately 8,400 square feet of office and laboratory space
License Agreements We have entered into license agreements with City of Hope, PNP Therapeutics, Inc., University of Alabama at Birmingham, Southern Research Institute, Emory University, and with the U.S. Department of Health and Human Services (HHS), as represented by National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Aggregate unrecorded future minimum payments under these agreements (excluding milestone and royalty payments due upon contingent future events) are approximately $149,000 in 2022, $128,000 in 2023, $128,000 in 2024, $28,000 in 2025 and $28,000 in 2026. OtherCommitments
In the normal course of business, we
F- 7
Stock Purchase Warrants – As of
2021, respectively. Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the
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
We receive payments from government entities under grants from the National Institute of Allergy and Infectious Diseases (NIAID) and from the U.S. Department of Defense in support of our vaccine research and development efforts. We record revenue associated with government grants as the
grants.
F- 8
REPORTOF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of GeoVax Labs, Inc.
Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of GeoVax Labs, Inc. and subsidiary Basis for Opinion These financial statements
We conducted our audits in accordance with the standards of the Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the
F-9 Equity Transactions As described in Note 7 to the financial statements, the Company has multiple equity instruments with various levels of complexity and volumes including warrants and stock options. The principal considerations for our determination that the complexity of the Company’s equity structure should be a critical audit matter were based on the volume of equity transactions, including conversions to common stock, common stock issuance activity and warrant activity making it challenging to ensure adequate disclosure of all equity transactions. Auditing such estimates and activity required extensive audit effort due to the volume and complexity of these transactions and a high degree of auditor judgment when performing the requisite audit procedures and evaluating the results of those procedures. The primary audit procedures we performed to address this critical audit matter included:
/s/ We have served as the Company’s auditor since 2005.
Atlanta, Georgia March
F-10
See accompanying notes to consolidated financial statements.
F-11
F-12 GEOVAX CONSOLIDATED STATEMENTS OF
See accompanying notes to consolidated financial statements.
F-13
GEOVAX LABS. INC. CONSOLIDATED STATEMENTS OF CASH FLOWS Series A Convertible Series B Convertible Total Preferred Stock Preferred Stock Common Stock Paid-in Accumulated Stockholders’ Shares Amount Shares Amount Shares Amount Capital Deficit Equity Balance at December 31, 2011 Sale of common stock for cash Sale of convertible preferred stock andwarrants for cash Conversion of preferred stock to common stock Stock-based compensation expense Net loss for the year ended December 31, 2012 Balance at December 31, 2012 Sale of common stock for cash uponwarrant exercise Issuance of common stock for services Sale of convertible preferred stock for cash Conversion of preferred stock to common stock Stock-based compensation expense Net loss for the year ended December 31, 2013 Balance at December 31, 2013 Sale of common stock for cash uponwarrant exercise Issuance of common stock for services Conversion of preferred stock to common stock Stock-based compensation expense Net loss for the year ended December 31, 2014 Balance at December 31, 2014 Years Ended December 31, 2021 2020 Cash flows from operating activities: Net loss Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization Amortization of debt discount Stock-based compensation expense Warrant issued for technology license fee Gain on debt extinguishment Changes in assets and liabilities: Grant funds and other receivables Prepaid expenses and other current assets Accounts payable and accrued expenses Total adjustments Net cash used in operating activities Cash flows from investing activities: Purchase of property and equipment Net cash used in investing activities Cash flows from financing activities: Net proceeds from sale of common stock and warrants Net proceeds from warrant exercises Net proceeds from sale of preferred stock Net proceeds from issuance of note payable Net proceeds from bridge financing Repurchase of preferred stock Principal repayment of note payable Net cash provided by financing activities Net increase in cash and cash equivalents Cash and cash equivalents at beginning of period Cash and cash equivalents at end of period Supplemental disclosure of non-cash financing activities: During the year ended December 31, 2021: ● 149,705 shares of common stock were issued upon the cashless exercise of stock purchase warrants ● $172,056 of principal and accrued interest related to a note payable was extinguished upon the loan’s forgiveness During the year ended December 31, 2020: ● 716,790 shares of common stock were issued upon conversion of convertible preferred stock ● 36,902 shares of common stock were issued upon the cashless exercise of stock purchase warrants ● 300,001 shares of common stock and 300,001 stock purchase warrants were issued in exchange for cancellation of $1,500,000 owed to current and former employees and directors ● 177,626 shares of common stock, 126,042 pre-funded stock purchase warrants and 303,668 stock purchase warrants were issued upon conversion of $1,200,000 convertible debentures and $14,667 of related accrued interest See accompanying notes to consolidated financial statements. Years Ended December 31, 2014 2013 2012 Cash flows from operating activities: Net loss Adjustments to reconcile net loss to net cashused in operating activities: Depreciation and amortization Stock-based compensation expense,including common stock issued for services Changes in assets and liabilities: Grant funds receivable Prepaid expenses and other current assets Accounts payable and accrued expenses Total adjustments Net cash used in operating activities Cash flows from investing activities: Purchase of property and equipment Net cash used in investing activities Cash flows from financing activities: Proceeds from sale of common stock Proceeds from sale of preferred stock Net cash provided in financing activities Net increase (decrease) in cash and cash equivalents Cash and cash equivalents at beginning of period Cash and cash equivalents at end of period GEOVAX LABS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Years Ended December 31, 1. Description of Business and Recent Developments GeoVax Labs, Inc. (“GeoVax” or the “Company”), is a clinical-stage biotechnology company developing 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 In December 2021, patient enrollment began for the 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 GeoVax is incorporated under the laws of the State of Delaware and our principal offices are located in 2. Summary of Significant Accounting Policies Principles of Consolidation 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. Basis of Presentation 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. The accompanying consolidated 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 the We have funded our activities to date from sales of our equity securities, government grants and clinical trial assistance, and 2023.We Use of Estimates The preparation of financial statements in conformity with Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Our cash and cash equivalents consist primarily of bank deposits and money market accounts. The recorded values approximate fair market values due to the short maturities. Fair Value of Financial Instruments and Concentration of Credit Risk 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. The carrying values reported in the balance sheets for cash and cash equivalents approximate fair values. Property and Equipment 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 years. We amortize leasehold improvements using the straight-line method over the term of the related lease. We recognize leases in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No.2016-02,Leases (ASU 2016-02), which requires lessees to classify leases as either financing or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification determines whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. In the case of our facility lease agreement which has an effective term of less than 12 months, we made an accounting policy election to not recognize lease assets and liabilities and record lease expense on a straight-line basis over the lease term. Impairment of Long-Lived Assets We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future net cash flows expected to be generated by such assets. If we consider such assets to be impaired, the impairment to Accrued As part of the process of preparing our financial statements, we estimate expenses that we believe we have incurred, but have not yet been billed by our third Net Loss Per Share 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. Revenue Recognition We recognize revenue in accordance with 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. Research collaborations – 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. Research and Development Expense Research and development (R&D) expense primarily consists 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 Patent Costs Our expenditures relating to obtaining and protecting patents are charged to expense when incurred and are included in general and administrative expense. Our operating results are expected to fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results for future periods. Income Taxes We account for income taxes using the liability method. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance unless, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. 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. Other Recent Accounting Pronouncements Except as discussed above, there have been no recent accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements, nor do we believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on our financial statements. 3. Property and Equipment Property and equipment as shown on the accompanying Consolidated Balance Sheets is composed of the following as of December 31, 2014 2013 2021 2020 Laboratory equipment Equipment and furnishings Leasehold improvements Other furniture, fixtures & equipment Total property and equipment Accumulated depreciation and amortization Property and equipment, net Depreciation 4. 2014 2013 Technology licenses Deposits Accumulated amortization – technology licenses Total other assets 2021 2020 Accrued license fees – current Accrued license fees – noncurrent Accrued payroll Other accrued expenses Total accrued expenses 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 Convertible Debentures – On June 26 2020, we issued convertible debentures in 2021 2020 GRA Note PPP Loan Insurance premium financing costs Convertible debentures (including $124,185 of debt discount amortization) Total interest expense Commitments Operating Lease We lease approximately 8,400 square feet of office and laboratory space License Agreements We have entered into license agreements with City of Hope, PNP Therapeutics, Inc., University of Alabama at Birmingham, Southern Research Institute, Emory University, and with the U.S. Department of Health and Human Services (HHS), as represented by National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Aggregate unrecorded future minimum payments under these agreements (excluding milestone and royalty payments due upon contingent future events, and assuming neither party terminates the agreements) are approximately $174,000 in 2022, $128,000 in 2023, $128,000 in 2024, $28,000 in 2025 and $28,000 in 2026. Other Commitments In the normal course of business, we In Common Stock 2020 Public Offering –On September 29, 2020, we closed an underwritten public offering (the “2020 Offering”) From 2016 through August 2020, to help conserve the Company’s cash resources, our executive officers and non-employee directors agreed to defer receipt of all or a portion of their respective cash compensation. Upon consummation of the 2020 Offering, $1,500,000 of accumulated deferrals were converted at the $5.00 offering price, resulting in the issuance of 300,001 units substantially similar to the units sold in the public offering, with each unit consisting of 1 share of our common stock and 1 warrant substantially similar to a Unit Warrant. Upon consummation of the 2020 Offering, we issued an aggregate of 177,626 shares of our common stock, 2021 Public Offering –On February 11, 2021, we closed an underwritten public offering of 1,644,000 shares of our common stock, Other Common Stock Transactions – During 2021 and 2020 we Net proceeds Fair value of warrants (recorded to Additional Paid-in Capital) Beneficial conversion feature (recorded to Additional Paid-in Capital) Net proceeds allocated to preferred stock Accretion of beneficial conversion feature (deemed dividend) Initial carrying value of preferred stock Accretion of beneficial conversion feature (deemed dividend) related to issuanceof Series B Convertible Preferred Stock Conversions to common stock Carrying value at December 31, 2014 We have a stock-based incentive plan (the “2020 Plan”) pursuant to which our Board of Directors may grant stock options to our employees. A total of 1,500,000 shares of our common stock 2014 2013 2012 Conversion of Series A Preferred Shares Conversion of Series B Preferred Shares Expiration Date Number of Shares Weighted Average Exercise Price December 31, 2016 January 16, 2017 January 31, 2017 March 21, 2017 Total Outstanding at December 31, 2014 Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (yrs) Aggregate Intrinsic Value Outstanding at December 31, 2013 Granted Exercised Forfeited or expired Outstanding at December 31, 2014 Exercisable at December 31, 2014 2014 2013 2012 Weighted average fair value of options granted Intrinsic value of options exercised Total fair value of options vested We use the Black-Scholes model for determining the grant date fair value of our stock option grants. This model utilizes certain information, such as the interest rate on a risk-free security with a term generally equivalent to the expected life of the option being valued and requires certain other assumptions, such as the expected amount of time an option will be outstanding until it is exercised or expired, to calculate the fair value of stock options granted. The significant assumptions we used in our fair value calculations were as follows: 2014 2013 2012 2021 2020 Weighted average risk-free interest rates Expected dividend yield Expected life of option (years) Expected life of option (in years) Expected volatility A summary of stock option activity under the 2020 Plan as of December 31, 2021, and changes during the year then ended is presented below. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (yrs) Aggregate Intrinsic Value Outstanding at December 31, 2020 Granted Exercised Forfeited or expired Outstanding at December 31, 2021 Exercisable at December 31, 2021 The weighted-average grant date fair values of options granted during 2021 and 2020 were $2.87 and $1.12, respectively. Total stock option compensation expense recognized in the consolidated statement of operations for the years ended December 31, 2021 and 2020 was $269,427 and $18,730, respectively. As of December 31, 2021, there is $1,420,144 of unrecognized compensation expense that will be recognized over a weighted-average period of 2.2 years. Stock Purchase Warrants Warrant Description Number of Shares Exercise Price Expiration 2020 Warrants Jun 2025 2020 Unit Warrants Sep 2025 2020 Representative Warrants Mar 2024 2021 Representative Warrants Aug 2024 2021 Warrants Sep 2026 Total Warrants Outstanding at December 31, 2021 Weighted-Average Exercise Price Weighted-Average Remaining Life (in years) 2020 Warrants – In June 2020, in connection with the issuance of convertible debentures, we issued warrants to purchase 120,000 shares of common stock, with a five-year term and an exercise price of $10.00. As a result of the 2020 Public Offering, in September 2020 the exercise price was reduced to $5.00. 2020 Unit Warrants – In September 2020, in connection with the 2020 Public Offering, we issued 303,668 warrants upon the conversion of convertible debentures, 300,001 warrants upon the conversion of amounts owed to current and former executive officers and directors, and 2,560,000 warrants to other investors in the 2020 Public Offering, with each of the warrants having a five-year term and an exercise price of $5.00. During 2021, 740,034 of these warrants were exercised for cash and 27,004 were exercised using the cashless exercise feature of the warrant. 2020 Representative Warrants – In September 2020, we issued 128,000 warrants to the underwriter of the 2020 Public Offering, with a 42-month term and an exercise price of $5.50. 2021 Representative Warrants – In February 2021, we issued 72,000 warrants to the underwriter of the 2021 Public Offering, with a 42-month term and an exercise price of $6.875. 2021 Warrants – In September 2021, in connection with a technology licensing agreement, we issued 100,000 warrants, with a five-year term and an exercise price of $13.00. Additional Stock-Based Compensation Expense In addition to stock-based compensation expense related to the 2020 Plan (see Stock 2014 2013 2012 General and administrative expense Research and development expense Total stock option expense Retirement Plan We participate in a multi-employer defined contribution retirement plan (the Income Taxes At December 31, Section 382 of the Internal Revenue Code contains provisions that may limit our utilization of our NOL and R&D tax credit carryforwards in any given year as a result of significant changes in ownership interests that have occurred in past periods or may occur in future periods. Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets and liabilities included the following at December 31, 2014 2013 2021 2020 Deferred tax assets: Net operating loss carryforward Research and development tax credit carryforward Stock-based compensation expense Accrued salaries Total deferred tax assets Deferred tax liabilities Depreciation Total deferred tax liabilities Net deferred tax assets Valuation allowance Net deferred tax asset after reduction for valuation allowance We have established a full valuation allowance equal to the amount of our net deferred tax assets due to uncertainties with respect to our ability to generate sufficient taxable income to realize these assets in the 2014 2013 2012 2021 2020 U.S. federal statutory rate applied to pretax loss Permanent differences Research and development credits Change in valuation allowance Change in valuation allowance, net of expired items and other adjustments Reported income tax expense We 11. Subsequent Events 2014 Quarter Ended March 31 June 30 September 30 December 31 Revenue from grants Net loss Net loss per share 2013 Quarter Ended March 31 June 30 September 30 December 31 Revenue from grants Net loss Net loss per share GEOVAX LABS, INC. SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS For Additions (Reductions) Description Balance at Beginning Of Period Charged to Costs and Expenses Charged to Other Accounts Deductions Balance at End Of Period Reserve Deducted in the Balance Sheet From the Asset to Which it Applies: Allowance for Deferred Tax Assets Year ended December 31, 2021 Year ended December 31, 2020 Additions Description Balance at Beginning Of Period Charged to Costs and Expenses Charged to Other Accounts (1) Deductions Balance at End Of Period Reserve Deducted in the Balance SheetFrom the Asset to Which it Applies: Allowance for Deferred Tax Assets Year ended December 31, 2014 Year ended December 31, 2013 Year ended December 31, 2012 GEOVAX LABS, INC. 21,412,124 Shares of Common Stock PART II Item 13. Other Expenses of Issuance and The following table sets forth the Item Amount to be paid SEC registration fee Legal fees and expenses Accounting fees and expenses Printing and miscellaneous expenses Miscellaneous fees and expenses Total Item 14. Indemnification of Directors and Section 145 of the Our bylaws provide that we may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Company) by reason of the fact that the person is or was a director, officer, employee or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the person’s conduct was unlawful. Our bylaws also provide that we may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Company to procure a judgment in its favor by reason of the fact that the person is or was a director, officer, employee or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the Company and except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the Company unless and only to the extent that the Delaware Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Delaware Court of Chancery or such other court shall deem proper. Under our bylaws, expenses (including attorneys’ fees) incurred by an officer or director in defending any civil, criminal, administrative or investigative action, suit or proceeding may be paid by the Company in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Company. Such expenses (including attorneys’ fees) incurred by former directors and officers or other employees and agents may be so paid upon such terms and conditions, if any, as we deem appropriate. The indemnification and advancement of expenses provided by our bylaws is not exclusive, both as to action in such person’s official capacity and as to action in another capacity while holding such office. Our bylaws also provide that we may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the Company would have the power to indemnify such person against such liability under our bylaws. The Company maintains an insurance policy providing for indemnification of its officers, directors and certain other persons against liabilities and expenses incurred by any of them in certain stated proceedings and under certain stated conditions. In October 2006, GeoVax and our subsidiary, GeoVax, Inc. entered into indemnification agreements with Messrs. McNally, Reynolds, Kollintzas and Spencer. Pursuant to these agreements, we have agreed to hold harmless and indemnify these directors and officers to the full extent authorized or permitted by applicable Illinois and Georgia law against certain expenses and other liabilities actually and reasonably incurred by these individuals in connection with certain proceedings if they acted in a manner they believed in good faith to be in or not opposed to the best interests of the Company and, with respect to any criminal proceeding, had no reasonable cause to believe that such conduct was unlawful. The agreements also provide for the advancement of expenses to these individuals subject to specified conditions. Under these agreements, we will not indemnify these individuals for expenses or other amounts for which applicable Illinois and Georgia law prohibit indemnification. The obligations under these agreements continue during the period in which these individuals are our directors or officers and continue thereafter so long as these individuals shall be subject to any proceeding by reason of their service to the Company, whether or not they are serving in any such capacity at the time the liability or expense incurred for which indemnification can be provided under the agreements. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. Item 15. Recent The information provided below has been updated as noted to retroactively reflect the effect of the Company’s 1:500, 1:2000, and 1:20 reverse stock splits effected in April 2019, January 2020 and September 2020, respectively. On On February 25, 2019, we entered into a Securities Purchase Agreement with the Purchasers providing for the issuance and sale to the Purchasers of an aggregate of up to 1,000 shares of our Series G Convertible Preferred Stock (the “Series G Preferred Shares”) and Series I Warrants to purchase up to 16,666,666 shares (16.67 shares post-split) of our common stock at $0.015 per share ($15,000 per share post-split) at an initial aggregate exercise price of $250,000 for gross proceeds of up to $1.0 million, to be funded at up to three different closings. At the first closing on February 25, 2019, we issued 500 Series G Preferred Shares and Series I Warrants to purchase up to 16,666,666, shares (16.67 shares post-split) of our common stock in exchange for the payment by the Purchasers of $250,000 in the aggregate, plus the cancellation by them of Term Notes due to them from the Company in the aggregate amount of $250,000. At the second and third closings, which occurred on April 26 and June 19, 2019, we issued an aggregate of 500 additional shares of Series G Preferred Stock and Series I Warrants to purchase up to 33,333,333 shares (33.33 shares post-split) in exchange for the payment by the Purchasers of a total of $500,000. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. The accredited investors acquired the shares for investment for their own accounts in a transaction that did not involve a general solicitation. On July 17, 2019, we entered into Exchange Agreements with the Purchasers pursuant to which the Purchasers exchanged an aggregate of 2,256.5338 Series On July On January 24, 2020, we entered into a Securities Purchase Agreement (the “January Securities Purchase Agreement”) with the Purchasers providing for the issuance and sale to the Purchasers of an aggregate of 300 shares of our Series J Convertible Preferred Stock for gross proceeds of $300,000. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. The accredited investors acquired the shares for investment for their own accounts in a transaction that did not involve a general solicitation. Effective as of May 1, 2020, we entered into a Customer Agreement and Subscription Agreement with Content Carnivores, LLC, pursuant to which the Company receives services related to the management of our social media accounts in exchange for the issuance of shares of our common stock. As of the date hereof, we have issued 7,391 shares of our common stock to Content Carnivores, LLC at an aggregate value of $36,000 pursuant to this agreement. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. 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 our public offering 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 fully exercised on January 13, 2021. The Company also issued warrants to purchase 303,668 shares of common stock to the investors who provided us with bridge financing in June 2020 on terms which are substantially the same as the September 2020 Warrants. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. The accredited investors acquired the shares for investment for their own accounts in a transaction that did not involve a general solicitation. On September 29, 2020, the underwriters who conducted our public offering in September 2020 received warrants granted to them to purchase 128,000 shares of common (equal to five percent (5%) of the total number of shares of common stock sold in that offering) at an exercise price equal to $5.50 (110% of the public offering price in that offering), as a portion of the underwriting compensation payable to the underwriters in connection with this offering (the “Underwriters Warrants”). The Underwriters Warrants are initially exercisable March 29, 2021, and have a term of three years from their initial exercise date. Effective as of November 1, 2020, we entered into a Marketing and Consulting Agreement and Subscription Agreement with CorProminence, LLC, pursuant to which the Company is receiving services related to shareholder information and relations. In November 2020, we issued 20,000 shares of our common stock to CorProminence, LLC as a restricted stock award under our 2020 Stock Incentive Plan with a value at that date of $58,400. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a) (2) thereof and Rule 506 of Regulation D. On February 11, 2021, the Company issued to the Maxim Group LLC, as a portion of the underwriting compensation, warrants to purchase up to a total of 72,000 shares (equal to five percent (5%) of the shares of common stock sold in that offering) of common stock (the “Underwriter’s Warrant Agreement”). The shares subject to the Underwriter’s Warrant Agreement are exercisable at $6.875 per share, are initially exercisable August 10, 2021, and have a term of three years from their initial exercise date. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. On June 9, 2022, Maxim Group LLC assigned the 2020 Common Warrant to Maxim Partners. Effective as of May 1, 2021, we renewed our agreement with Content Carnivores, LLC for an additional one-year period. In connection with the renewal, in May 2021, we issued 11,000 shares of our common stock to Content Carnivores, LLC as a restricted stock award under our 2020 Stock Incentive Plan with a value at that date of $59,840. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a) (2) thereof and Rule 506 of Regulation D. On September 28, 2021, in connection with entering into an assignment and license agreement, the Company issued warrants to PNP Therapeutics, Inc. (“PNP”), exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 100,000 shares of the Company’s common stock at an exercise price of $13.00 per share. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. 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 Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. Armistice acquired the shares for investment for its own account in a transaction that did not involve a general solicitation. 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. The Private Placement closed on May 27, 2022. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D. Armistice acquired the shares for investment for its own account in a transaction that did not involve a general solicitation. Item 16. Exhibits and Financial Statement (a) Exhibit Index 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9 3.2 4.1 Form of Stock Certificate representing the Company’s Common Stock, par value $0.001 per share (21) 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 Form of Common Stock Purchase Warrant, dated June 26, 2020 (20) 4.1.6 Form of Underwriters Warrant Agreement dated February 11, 2021 (27) 4.1.7 Form of Common Stock Purchase Warrant, dated September 28, 2021 (29) 4.1.8 4.1.9 4.1.10 4.1.11 4.1.12 4.1.13 5.1 10.1 ** Employment Agreement between GeoVax Labs, Inc. and David A. Dodd (13) 10.2 ** Employment Agreement between GeoVax, Inc. and Mark W. Reynolds (4) 10.2.1 ** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Mark W. Reynolds (8) 10.2.2 10.2.3 10.5 ** GeoVax Labs, Inc. 2020 Stock Incentive Plan, as amended and restated August 11, 2021 (19) 10.5.1 10.6 License Agreement (as amended and restated) between GeoVax, Inc. and Emory University (2) 10.7 10.8 10.9 Office and Laboratory Lease between UCB, Inc. and GeoVax, Inc. (18) 10.10 Summary of the GeoVax Labs, Inc. Director Compensation Plan (32) 10.11 10.12 10.13 10.14 10.15 Form of PIPE Securities Purchase Agreement, dated May 25, 2022 (33) 10.16 Form of RD Securities Purchase Agreement, dated May 25, 2022 (33) 10.17 Form of Registration Rights Agreement, dated May 25, 2022 (33) 21.1 23.1 23.2 * Consent of Womble Bond Dickinson (US) LLP (included in Exhibit 5.1) 24.1 Power of Attorney (included in the signature page to this Registration Statement). 101.INS Inline XBRL Instance Document (the Instance Document does not appear in the Interactive Data Files because its XBRL tags are embedded with the Inline XBRL Document) (1) 101.SCH Inline XBRL Taxonomy Extension Schema Document (1) 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document (1) 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document (1) 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document (1) 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document (1) 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) 107 * Filed herewith. ** Indicates a management contract or compensatory plan or arrangement. (1) These interactive data files shall not be deemed filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under these sections. (2) Incorporated by reference from the registrant’s Current Report on Form 8-K filed October 4, 2006. (3) Incorporated by reference from the registrant’s Current Report on Form 8-K filed June 23, 2008. (4) Incorporated by reference from the registrant’s Annual Report on Form 10-K filed March 8, 2010. (5) Incorporated by reference from the registrant’s Current Report on Form 8-K filed April 14, 2010. (6) Incorporated by reference from the registrant’s Current Report on Form 8-K filed April 28, 2010. (7) Incorporated by reference from the registrant’s Current Report on Form 8-K filed August 2, 2013. (8) Incorporated by reference from the registrant’s Current Report on Form 8-K filed October 23, 2013. (9) [Not Used] (10) Incorporated by reference from the registrant’s Current Report on Form 8-K filed May 14, 2015. (11) Incorporated by reference from the registrant’s Current Report on Form 8-K filed June 16, 2016. (12) Incorporated by reference from the registrant’s Current Report on Form 8-K filed August 4, 2017. (13) Incorporated by reference from the registrant’s Current Report on Form 8-K filed September 7, 2018. (14) Incorporated by reference from the registrant’s Annual Report on Form 10-K filed March 26, 2019. (15) Incorporated by reference from the registrant’s Current Report on Form 8-K filed April 30, 2019 (16) Incorporated by reference from the registrant’s Quarterly Report on Form 10-Q filed November 7, 2019. (17) Incorporated by reference from the registrant’s Current Report on Form 8-K filed January 21, 2020. (18) Incorporated by reference from the registrant’s Annual Report on Form 10-K filed March 24, 2020. (19) Incorporated by reference from the registrant’s Quarterly Report on Form 10-Q filed November 12, 2021. (20) Incorporated by reference from the registrant’s Current Report on Form 8-K filed June 26, 2020. (21) Incorporated by reference from the Amendment No. 2 to registrant’s Registration Statement on Form S-1 (File No. 333-239958) filed August 26, 2020. (22) Incorporated by reference from the Amendment No. 3 to registrant’s Registration Statement on Form S-1 (File No. 333-239958) filed September 8, 2020 (23) Incorporated by reference from the Amendment No. 4 to registrant’s Registration Statement on Form S-1 (File No. 333-239958) filed September 23, 2020. (24) Incorporated by reference from the registrant’s Current Report on Form 8-K filed September 25, 2020. (25) Incorporated by reference from the registrant’s Current Report on Form 8-K filed October 26, 2020. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as the Company has determined (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the Company if publicly disclosed. (26) Incorporated by reference from the registrant’s Current Report on Form 8-K filed November 30, 2020. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as the Company has determined (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the Company if publicly disclosed. (27) Incorporated by reference from the registrant’s Current Report on Form 8-K filed February 11, 2021. (28) Incorporated by reference from the registrant’s Annual Report on Form 10-K filed March 23, 2021. (29) Incorporated by reference from the registrant’s Current Report on Form 8-K filed September 29, 2021. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and (ii) the Company customarily and actually treats the omitted information as private or confidential. (30) Incorporated by reference from the registrant’s Current Report on Form 8-K filed November 10, 2021. Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and (ii) the Company customarily and actually treats the omitted information as private or confidential. (31) Incorporated by reference from the registrant’s Current Report on Form 8-K filed January 20, 2022. (32) Incorporated by reference from the registrant’s Annual Report on Form 10-K filed March 9, 2022. (33) Incorporated by reference from the registrant’s Current Report on Form 8-K filed May 27, 2022. Item 17. Undertakings (a) The (1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration (i) To include any prospectus required by (ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent (iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; Provided, however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement. (2) That for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and this offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. (3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. (4) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: (i) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) (§ 230.424(b)(3) of this chapter) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and (ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any (5) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned Registrant undertakes that in a primary offering of securities of the undersigned Registrant pursuant to this registration statement, regardless of the method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned Registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: (i) Any preliminary prospectus or prospectus of the undersigned Registrant relating to the offering required to be filed pursuant to Rule 424; (ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned Registrant or used or referred to by the undersigned Registrant; (iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned Registrant or its securities provided by or on behalf of the undersigned Registrant; and (iv) Any other communication that is an offer in the offering made by the undersigned Registrant to the purchaser. (b) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each (c) Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Smyrna, State of Georgia, on GEOVAX LABS, INC. By: /s/ David A. Dodd Name: David A. Dodd Title: KNOW ALL Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed below by the following persons in the capacities and on the dates indicated. Name Position Date /s/ David A. Dodd Director President and Chief Executive Officer June 14, 2022 David A. Dodd (Principal Executive Officer) /s/ Chief Financial Officer June 14, 2022 Mark W. Reynolds (Principal Financial and Accounting Officer) /s/ Randal D. Chase Director /s/ Dean G. Kollintzas Director Dean G. Kollintzas /s/ Robert T. McNally Director /s/ John N. Spencer, Jr. Director John N. Spencer, Jr. |