GeoVax Labs GOVX
GeoVax Labs: securities offering
- Form
- S-1
- Filed
- Importance
- Notable
- Accession
- 0001437749-24-019645
- Document
- S-1
Not explained yet; the original is on EDGAR.
Securities offering
What changed since the last draft
32 changes since the S-1 filed Jan 2, 2024
Compared with the S-1 0001437749-24-000191, filed Jan 2, 2024.
Ticker reserved: GOVX
Ticker reserved now GOVX; the earlier draft had not stated.
From the filings
Now
Our Common Stock issued to investors is listed on the Nasdaq Capital Market LLC ("Nasdaq") under the symbol "GOVX". On June 5, 2024, the last reported sale price of our common stock was $1.80 per share.If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our…
Our common stock (GOVX) and related warrants (GOVXW) are currently listed on Nasdaq.
From the filings
Now
If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our Common Stock and related warrants could be delisted from the exchange. Our common stock (GOVX) and related warrants (GOVXW) are currently listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price, and certain corporate governance requirements. There can be no assurances that we will be able to continue to comply with the applicable listing standards. For example, on May 23, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq notifying the Company that it no longer complied with the $2,500,000 minimum stockholders' equity required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1) (the "Stockholders' Equity Requirement"), because the Company's stockholders' equity as reported in its Form 10-Q for the period ended March 31, 2024 did not meet the required minimum, and as of the date of the Notice, the Company did not meet the alternatives of market value of listed securities or net income from continuing operations (together with the Stockholders' Equity Requirement, the "Listing Rule"). We are currently reviewing potential transactions that, if implemented, could remedy the shortfall in our stockholders' equity. We do not know at this time, however, whether we will be able to remedy the non-compliance. If we are unable to maintain compliance with these Nasdaq requirements, our Common Stock and warrants will be delisted from Nasdaq. In that event, and if our Common Stock is not then eligible for quotation on another market or exchange, trading of our Common Stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as…Our business could be adversely affected by widespread public health epidemics or other catastrophic events…
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.
From the filings
Before
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. 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. 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. 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. The success of our 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…On December 6, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market, LLC…
The Company has appealed the Nasdaq determination and has requested a hearing (the "Hearing") before a Nasdaq Hearings Panel (the "Panel") to seek continued listing pending its return to compliance with the Bid Price…
From the filings
Before
On December 6, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market, LLC ("Nasdaq") stating that Nasdaq has determined to delist the Company's securities from the Nasdaq Capital Market for failure to maintain a minimum bid price of $1.00 per share in accordance with Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Requirement"). The Company has appealed the Nasdaq determination and has requested a hearing (the "Hearing") before a Nasdaq Hearings Panel (the "Panel") to seek continued listing pending its return to compliance with the Bid Price Requirement. The Hearing request will stay the delisting of the Company's securities pending the Panel's decision. At the Hearing, which is scheduled for March 5, 2024, the Company intends to discuss the events that it believes will enable it to regain compliance, including a commitment to effect a reverse stock split, as soon as reasonably practicable, subject to applicable law and Nasdaq rules. In this regard, the Company plans to hold a Special Stockholders meeting on January 16, 2024 for the purpose of seeking stockholder approval for such reverse stock split. Delisting from the Nasdaq Capital Market would cause us to pursue eligibility for trading of these securities on other markets or exchanges, or on the "pink sheets." In such case, our stockholders' ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices of these securities. There can be no assurance that our securities, if delisted from the Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the over-the-counter markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would also result in negative publicity, make…A portion of the 2023 Common Stock Purchase Warrant is not exercisable until stockholder approval and may…
Under Nasdaq Stock Market Rule 5635(d), the 2023 Common Warrant will only be exercisable up to 19.9% of the outstanding shares of our common stock until we obtain stockholder approval for the issuance of shares…
From the filings
Before
A portion of the 2023 Common Stock Purchase Warrant is not exercisable until stockholder approval and may have limited value. Under Nasdaq Stock Market Rule 5635(d), the 2023 Common Warrant will only be exercisable up to 19.9% of the outstanding shares of our common stock until we obtain stockholder approval for the issuance of shares issuable upon exercise of the 2023 Common Warrant in excess of 19.9%. While we intend to promptly seek stockholder approval at a special meeting, there is no guarantee that such approval will be obtained. In the event that the price of a share of our common stock does not exceed the exercise price of the common stock purchase warrants during the period when the common stock purchase warrants are exercisable, the common stock purchase warrants may not have any value. Until such time as we obtain the stockholder approval, the 2023 Common Warrant may have limited value.New period: year ended December 31, 2023
This draft adds figures for the year ended December 31, 2023.
From the filings
Now
Our significant accounting policies are summarized in Note 2 to our consolidated financial statements for the year ended December 31, 2023, which are included in this prospectus.New period: years ended December 31, 2023
This draft adds figures for the years ended December 31, 2023.
From the filings
Now
The following table summarizes our results of operations for the years ended December 31, 2023 and 2022 and for the three-month periods ended March 31, 2024 and 2023:New period: three months ended March 31, 2024
This draft adds figures for the three months ended March 31, 2024.
From the filings
Now
Net cash used in operating activities of $5,683,730 for the three months ended March 31, 2024 was primarily due to our net loss of $5,850,132, offset by non-cash charges such as depreciation and stock-based compensation expense, and by changes in our working capital accounts.We will receive proceeds from any cash exercise of the 2024 Common Warrant and related issuance of shares of…
Now "$2.7 million", was "$8.7 million".
From the filings
Before
We will receive proceeds from any cash exercise of the 2023 Common Warrant and related issuance of shares of common stock. If the 2023 Common Warrant is exercised for cash in full, the gross proceeds would be approximately $8.7 million. We intend to use the net proceeds from the exercise of the 2023 Common Warrant, if any, for general corporate purposes and working capital.Now
We will receive proceeds from any cash exercise of the 2024 Common Warrant and related issuance of shares of common stock. If the 2024 Common Warrant is exercised for cash in full, the gross proceeds would be approximately $2.7 million. We intend to use the net proceeds from the exercise of the 2024 Common Warrant, if any, for general corporate purposes and working capital.Significant disruptions of information technology systems or breaches of information security systems could…
Adds "Risks Related to Development and Commercialization of Product Candidates and Dependence…".
From the filings
Before
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.Now
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. Risks Related to Development…Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact…
Adds "The Patient Protection and Affordable Care Act, as amended by the Health Care and…"; drops "In August 2020, the Inflation Reduction Act included provisions to increase Medicare's…".
From the filings
Before
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. In the United States and foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product 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 and/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. There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products. There have been several Congressional inquiries and proposed bills, as well as state efforts, designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. In June 2017, the FDA issued a Drug Competition Action plan intended to lower prescription drug prices by encouraging competition from generic versions of existing products. In July 2018, the FDA issued a Biosimilar Action Plan, intended to similarly promote competition to prescription biologics from biosimilars. In August 2020, the Inflation Reduction Act included provisions to increase Medicare's ability to negotiate prescription drug…Now
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. In the United States and foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product 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 and/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. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "Affordable Care Act"), substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Affordable Care Act includes a number of provisions that are intended to lower healthcare costs, including provisions relating to prescription drug prices and government spending on medical products. Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts by the former Trump administration to repeal or replace certain aspects of the statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our business. It is uncertain the extent to…Our products under development may not gain market acceptance.
Drops "and the market demand is not readily known.".
From the filings
Before
Our products under development may not gain market acceptance. Our products 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: the price and cost-effectiveness of our products, especially as compared to any competitive products; and the ability to maintain patent protection; and the market demand is not readily known.Now
Our products under development may not gain market acceptance. Our products 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: the price and cost-effectiveness of our products, especially as compared to any competitive products; and the ability to maintain patent protection.
and 20 more, in the redline below
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Section by section. Added words and removed words against the earlier filing.
Cover page 9 changes
As filed with the Securities and Exchange Commission on January 2 , June 7, 2024
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SUBJECT TO COMPLETION, DATED JANUARY 2 , JUNE 7, 2024
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21,134,968 1,605,688 Shares of Common Stock
This prospectus relates to the resale of up to an aggregate of 21,134,968 1,605,688 shares (the "2023 "2024 Warrant Shares") of our common stock, par value $0.001 per share (the "Common Stock"), issuable upon the exercise of that certain common stock purchase warrant (the "2023 "2024 Common Warrant") issued in a private placement on December 2, 2023 May 21, 2024 by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company ("Armistice").
We will not receive any proceeds from the sale of the 2023 2024 Warrant Shares covered by this prospectus by the Selling Stockholder. All net proceeds from the sale of the 2023 2024 Warrant Shares covered by this prospectus will go to the Selling Stockholder. However, we will receive the proceeds from any cash exercise of the 2023 2024 Common Warrant. See "Use of Proceeds."
The Selling Stockholder may sell all or a portion of the 2023 2024 Warrant Shares stock covered by this prospectus from time to time in market transactions through any market on which our shares of our Common Stock are then traded, in negotiated transactions or otherwise, and at prices and on terms that will be determined by the then prevailing market price or at negotiated prices directly or through a broker or brokers, who may act as agent or as principal or by a combination of such methods of sale. See "Plan of Distribution."
Our Common Stock issued to investors is listed on the Nasdaq Capital Market LLC ("Nasdaq") under the symbols symbol "GOVX". On December 29, 2023, June 5, 2024, the last reported sale price of our common stock was $0.36 $1.80 per share.
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DESCRIPTION OF CAPITAL STOCK
DESCRIPTION OF SECURITIES
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Prospectus summary 45 changes
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GeoVax Labs, Inc. ("GeoVax" or "the Company") is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers using novel proprietary platforms. GeoVax's product pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancers. Additional research and development programs include preventive vaccines against Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), Zika virus and malaria, as well as immunotherapies for multiple solid tumors. The Company's portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 115 155 granted or pending patent applications spread over 24 patent families. which are discussed in greater detail in the "Our Intellectual Property" section.
17 unchanged paragraphs
Our programs are in various stages of development, the most significant of which are summarized below along with recent developments:
GEO-CM04S1 – Immunocompromised Trial
In September 2023, the journal, Vaccines, published data from the open-label safety portion of the trial indicating that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
In September 2023, preclinical vaccine efficacy data for GEO-CM02 were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, demonstrating that our multi-antigen SARS-CoV-2 vaccine, GEO-CM02, induced efficacious immune responses against the original Wuhan strain and BA.1 Omicron variant with a single dose. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines such as GEO-CM04S1, which are designed to induce both antibodies and T-cells to multiple viral structural proteins, can address the issue of viral variation and escape from the immune system.
In October 2023, we announced commencement of the planned site expansion for this trial to accelerate patient enrollment. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial is now open to eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and the Fred Hutchinson Cancer Center (Seattle, Washington).
In September 2023, we announced the completion of patient enrollment for this trial.
GEO-CM04S1 – CLL Trial
In September 2023, GeoVax and ProBioGen AG announced the signing of a commercial license agreement for ProBioGen's AGE1.CR.pIX® suspension cell line. The agreement enhances our manufacturing capabilities for our entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio. This follows the May 2023 execution of a Master Services Agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of our vaccine candidates through late-stage development toward eventual commercialization. These agreements move the Company toward implementing a continuous cell line manufacturing system to provide lower-cost, scalable versatility for our entire MVA-based vaccine portfolio.
Our programs are in various stages of development, the most significant of which are summarized below along with recent developments. We have not generated any revenues from the sale of the products we are developing, and we do not expect to generate any such revenues for at least the next several years. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.
Our corporate strategy is to advance, protect and exploit our differentiated vaccine/immunotherapy platform leading to the successful development of preventive and therapeutic vaccines against infectious diseases and various cancers. With our design and development capabilities, we are progressing and validating an array of cancer and infectious disease immunotherapy and vaccine product candidates. Our goal is to advance products through to human clinical testing, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.
GEO-CM04S1 – Immunocompromised/Cell Transplant Phase 2 Trial
GEO-CM04S1 is currently undergoing a Phase 2 multi-site clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in high-risk immunocompromised patients (e.g. patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy). Data published from the open-label safety portion of the trial indicating that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
GEO-CM04S1 – Healthy Booster Phase 2 Trial
GEO-CM04S1 is undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal COVID-19 booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. Patient enrollment was completed in September 2023.
In February 2024, we announced positive interim safety and immune responses findings following vaccine administration. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5.
GEO-CM04S1 – Immunocompromised/CLL Trial Phase 2 Trial
In July 2023, GEO-CM04S1 is undergoing an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355), of GEO-CM04S1 began, evaluating its use as a COVID-19 booster vaccine in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine.
Gedeptin ® – Advanced Head and Neck Cancer Phase 1/2 Trial
Gedeptin® is currently undergoing a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC). This trial is being funded in part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The trial is designed to inform the design of a larger patient trial that also may involve patients with other anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.
In July 2023, Interim data were presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference indicating in July 2023, indicated that administration of Gedeptin® is safe and feasible, with observation of tumor growth impairment in a majority of the patients.
In January 2024, we announced closure of patient enrollment for this trial. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of 2024. Our intent is to discuss a follow-on protocol with the FDA for a Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal, in conjunction with a complete review of the results of the current trial. We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.
Advanced MVA-Based Vaccine Manufacturing Process Development
In March 2024, we announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for our MVA-based vaccines, with the release of the first lot of GEO-CM04S1 produced with a commercial manufacturing platform. This marked the successful completion of the transfer and scale-up of manufacturing to Oxford Biomedica, the Company's cGMP (current Good Manufacturing Procedures) manufacturing partner.
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In July 2023, the U.S. Patent and Trademark Office issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company's patent application No. 15/543,139 titled "Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40), covering GeoVax's vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus.
On December 2, 2023, we entered into a common stock warrant exercise inducement offer letter (the "Inducement Letter") with the holder (the "Holder") of existing warrants to purchase shares of the Company's common stock at an exercise price of $3.26 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $1.65 per share issued on May 27, 2022 (together, the "Existing Warrants"), pursuant to which the Holder agreed to exercise for cash its Existing Warrants to purchase an aggregate of 10,567,484 shares of the Company's common stock, at a reduced exercised price of $0.414 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 21,134,968 Common Shares with an exercise price of $0.414 per share, exercisable at any on or after six months from the date of issuance and will expire five and one-half (5 ½) years following the date of issuance.
In August 2023, January 2024, the U.S. Patent and Trademark Office issued a Notice of Allowance Patent No. 11,857,611 to GeoVax, for pursuant to patent application No. 17/726,254 titled "Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria". The allowed claims cover compositions comprising GeoVax's modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the allowed claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.
In October 2023, February 2024, the U.S. Patent and Trademark Office issued a Notice of Allowance Patent No. 11,896,657 to GeoVax, for pursuant to patent application No. 17/584,231 titled "Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40)." The allowed claims generally cover GeoVax's vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
In October 2023, February 2024, the U.S Patent and Trademark Office issued a Notice of Allowance Patent No. 11,897,919 to GeoVax, for pursuant to patent application No. 17/409,574 titled "Multivalent HIV Vaccine Boost Compositions and Methods of Use." The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax's vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
In February 2024, the Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company's Patent Application No. 2022-153352 titled "Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen." The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax's MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims. This represents an extension of the GeoVax MVA-VLP platform that was originally developed for vaccines targeting infectious diseases.
On May 10, 2024, we conducted a bridge financing through the issuance and sale of 10% Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $150,000 to members of our Board of Directors and senior management. The Notes are unsecured, bear interest at a rate of 15% per annum, and mature upon the earlier of: (i) six months from the issue date; or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $5 million.
Registered Direct Offering
On May 16, 2024, the Company entered into a placement agency agreement (the "Placement Agency Agreement") with Roth Capital Partners, LLC ("Roth") and a securities purchase agreement (the "Purchase Agreement") with a purchaser pursuant to which the Company agreed to sell, in a registered direct offering (the "Registered Direct Offering"), an aggregate of (i) 220,000 shares of the Company's Common Stock, and (ii) pre-funded warrants to purchase up to an aggregate of 582,844 shares of Common Stock (the "Pre-Funded Warrants," and the Shares issuable upon exercise thereof, the "Pre-Funded Warrant Shares"). In a concurrent private placement, the Company offered 2024 Common Warrants to the purchaser, with each warrant exercisable to purchase one share of Common Stock, with two 2024 Common Warrants to accompany each share of Common Stock or Pre-Funded Warrant sold in the Offering, and to purchase in the aggregate up to 1,605,688 shares of Common Stock (the "Common Warrant Shares"). The public offering price for each Share was $1.68 and the public offering price for each Pre-Funded Warrant was $1.67999. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire five years from the date of issuance. The 2024 Common Warrants have an exercise price of $1.68 per share, are immediately exercisable and will expire five years from the date of issuance. The net proceeds of the offering, after deducting Roth's fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the 2024 Common Warrants, is approximately $1,180,000. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The offering closed on May 21, 2024.
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Our business could be adversely affected by widespread public health epidemics or other catastrophic events beyond our control.
29 unchanged paragraphs
A portion of the 2023 Common Stock Purchase Warrant is not exercisable until stockholder approval and may have limited value.
We may be delisted from the Nasdaq Stock Capital Market LLC due to noncompliance with Nasdaq Listing Rules.
2 unchanged paragraphs
29,657,287 shares of Common Stock.
Summary of the Offering
21,134,968 1,605,688 shares of Common Stock by the Selling Stockholder, consisting entirely of shares of Common Stock issuable upon the exercise of the 2023 2024 Common Warrant.
Shares of common stock outstanding prior to this offering
We will not receive any proceeds from the sale of the shares of common stock by the Selling Stockholder. All net proceeds from the sale of the shares of common stock covered by this prospectus will go to the Selling Stockholder. However, we will receive the proceeds from any cash exercise of the 2023 2024 Common Warrant. See "Use of Proceeds."
Our common stock issued to investors is and warrants are listed on the Nasdaq Capital Market under the symbols "GOVX" and "GOVXW", respectively.
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Unless otherwise indicated, the number of shares of our common stock outstanding prior to this offering is based on 29,657,287 2,528,309 shares of Common Stock outstanding as of December 31, 2023. June 5, 2024, and excludes as of such date:
1,605,688 shares of common stock issuable upon the exercise of the 2024 Common Warrant with an exercise price of $1.68 per share;
2,409,091 shares of common stock issuable upon the exercise of other outstanding warrants with a weighted average exercise price of $6.71 per share ● 333,648 shares of common stock which are reserved for issuance under our 2020 and 2023 Stock Incentive Plans, of which 133,648 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $28.39 per share.
Risk factors 19 changes
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As a research and development-focused company, we have had no product revenue to date and revenues from our government grants and other collaborations have not generated sufficient cash flows to cover operating expenses. Since our inception, we have incurred operating losses each year due to costs incurred in connection with research and development activities and general and administrative expenses associated with our operations. We incurred a net loss of approximately $14 $26 million for the year ended December 31, 2022 2023 and of approximately $18.4 $5.9 million for the nine three months ended September 30, 2023. March 31, 2024. We expect to incur additional operating losses and expect cumulative losses to increase as our research and development, preclinical, clinical, and manufacturing efforts expand. Our ability to generate revenue and achieve profitability depends on our ability to successfully complete the development of our product candidates, conduct preclinical tests and clinical trials, obtain the necessary regulatory approvals, and manufacture and market or otherwise commercialize our products. Unless we are able to successfully meet these challenges, we will not be profitable and may not remain in business.
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We expect that our current working capital will be sufficient to support our planned level of operations through the first quarter of 2024. We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations. In order to meet our operating cash flow needs we plan to seek sources of non-dilutive capital through government grant programs and clinical trial support. We may also plan additional offerings of our equity securities, debt, or convertible debt instruments. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects.
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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.
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The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "Affordable Care Act"), substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The Affordable Care Act includes a number of provisions that are intended to lower healthcare costs, including provisions relating to prescription drug prices and government spending on medical products.
Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts by the former Trump administration to repeal or replace certain aspects of the statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our business. It is uncertain the extent to which any such changes may impact our business or financial condition.
There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products. There have been several Congressional inquiries and proposed bills, as well as state efforts, designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. In June 2017, the FDA issued a Drug Competition Action plan intended to lower prescription drug prices by encouraging competition from generic versions of existing products. In July 2018, the FDA issued a Biosimilar Action Plan, intended to similarly promote competition to prescription biologics from biosimilars. In August 2020, the Inflation Reduction Act included provisions to increase Medicare's ability to negotiate prescription drug prices.
Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. For example, in September 2017, the California State Assembly approved SB17, which requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before any scheduled increases in the prices of their products if they exceed 16% over a two-year period, and further requiring pharmaceutical companies to explain the reasons for such increase. and, Effective in 2016, Vermont passed a law requiring certain manufacturers identified by the state to justify their price increases.
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the price and cost-effectiveness of our products, especially as compared to any competitive products; and the ability to maintain patent protection. and the market demand is not readily known.
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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. Excluding the shares of our common stock issuable upon exercise of In addition to the 2023 2024 Common Warrant, there are warrants exercisable for approximately 31.6 2.4 million shares at exercise prices ranging from $0.414 $-0- to $13.00 $195 per share. The exercise of these warrants will cause us to issue additional shares of our common stock and will dilute the percentage ownership of our shareholders.
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We currently do not meet certain of Nasdaq Capital Market ' s continued listing requirements and other Nasdaq rules. If we are unable to regain compliance, we are likely to be delisted. Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.
We are required to meet the continued listing requirements of the Nasdaq Capital Market and other Nasdaq rules, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price and certain other corporate governance requirements. For example, we are required to maintain a minimum bid price for our listed common stock of $1.00 per share. If we do not meet these continued listing requirements, our common stock could be delisted.
On December 6, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market, LLC ("Nasdaq") stating that Nasdaq has determined to delist the Company's securities from the Nasdaq Capital Market for failure to maintain a minimum bid price of $1.00 per share in accordance with Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Requirement").
The Company has appealed the Nasdaq determination and has requested a hearing (the "Hearing") before a Nasdaq Hearings Panel (the "Panel") to seek continued listing pending its return to compliance with the Bid Price Requirement. The Hearing request will stay the delisting of the Company's securities pending the Panel's decision. At the Hearing, which is scheduled for March 5, 2024, the Company intends to discuss the events that it believes will enable it to regain compliance, including a commitment to effect a reverse stock split, as soon as reasonably practicable, subject to applicable law and Nasdaq rules. In this regard, the Company plans to hold a Special Stockholders meeting on January 16, 2024 for the purpose of seeking stockholder approval for such reverse stock split.
Delisting from the Nasdaq Capital Market would cause us to pursue eligibility for trading of these securities on other markets or exchanges, or on the "pink sheets." In such case, our stockholders' ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices of these securities. There can be no assurance that our securities, if delisted from the Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the over-the-counter markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would also result in negative publicity, make it more difficult for us to raise additional capital, adversely affect the market liquidity of our securities, decrease securities analysts' coverage of us or diminish investor, supplier and employee confidence.
A portion of the 2023 Common Stock Purchase Warrant is not exercisable until stockholder approval and may have limited value.
Under Nasdaq Stock Market Rule 5635(d), the 2023 Common Warrant will only be exercisable up to 19.9% of the outstanding shares of our common stock until we obtain stockholder approval for the issuance of shares issuable upon exercise of the 2023 Common Warrant in excess of 19.9%. While we intend to promptly seek stockholder approval at a special meeting, there is no guarantee that such approval will be obtained. In the event that the price of a share of our common stock does not exceed the exercise price of the common stock purchase warrants during the period when the common stock purchase warrants are exercisable, the common stock purchase warrants may not have any value. Until such time as we obtain the stockholder approval, the 2023 Common Warrant may have limited value.
If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our Common Stock and related warrants could be delisted from the exchange.
Our common stock (GOVX) and related warrants (GOVXW) are currently listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price, and certain corporate governance requirements. There can be no assurances that we will be able to continue to comply with the applicable listing standards. For example, on May 23, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq notifying the Company that it no longer complied with the $2,500,000 minimum stockholders' equity required for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1) (the "Stockholders' Equity Requirement"), because the Company's stockholders' equity as reported in its Form 10-Q for the period ended March 31, 2024 did not meet the required minimum, and as of the date of the Notice, the Company did not meet the alternatives of market value of listed securities or net income from continuing operations (together with the Stockholders' Equity Requirement, the "Listing Rule"). We are currently reviewing potential transactions that, if implemented, could remedy the shortfall in our stockholders' equity. We do not know at this time, however, whether we will be able to remedy the non-compliance. If we are unable to maintain compliance with these Nasdaq requirements, our Common Stock and warrants will be delisted from Nasdaq. In that event, and if our Common Stock is not then eligible for quotation on another market or exchange, trading of our Common Stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the OTC Pink. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our Common Stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on an exchange.
Use of proceeds 2 changes
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We will receive proceeds from any cash exercise of the 2023 2024 Common Warrant and related issuance of shares of common stock. If the 2023 2024 Common Warrant is exercised for cash in full, the gross proceeds would be approximately $8.7 $2.7 million. We intend to use the net proceeds from the exercise of the 2023 2024 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 2023 2024 Common Warrant will be exercised, or if exercised, that it will be exercised for cash, the quantity which will be exercised or in the period in which it will be exercised.
Capitalization 6 changes
The following table sets forth our capitalization as of September 30, 2023: March 31, 2024:
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on an as adjusted basis to give effect to (i) the issuance and sale by us of 10,567,484 802,844 shares of common stock in the Private Placement Registered Direct Offering (inclusive of 7,605,484 582,844 shares of common stock issuable upon the exercise of pre-funded warrants), (ii) receipt of the gross proceeds from the registered direct offering after deducting commissions and offering expenses payable by us, and (iii) the issuance of 21,134,968 1,605,688 shares of common stock issuable upon the exercise of the 2023 2024 Common Warrant at a price of $0.414 $1.68 per share. and (iii) receipt of the gross proceeds from the Private Placement after deducting commissions and offering expenses payable by us.
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As of September 30, 2023
As of March 31, 2024
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The table and discussion above are based on 26,695,287 2,308,309 shares of common stock outstanding as of September 30, 2023, March 31, 2024, and 58,397,739 4,716,841 shares as adjusted, and do not include, as of that date:
2,816,631 2,409,091 shares of common stock issuable upon the exercise of other outstanding warrants with a weighted average exercise price of $5.16 $6.71 per share and ● 5,018,800 333,648 shares of common stock which are reserved for issuance under our 2020 and 2023 Stock Incentive Plans, of which 2,018,800 133,648 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $1.89 $28.39 per share.
Business 43 changes
GeoVax Labs, Inc. ("GeoVax" or "the Company") is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers using novel proprietary platforms. GeoVax's product pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and a gene-directed therapy against advanced head and neck cancers. Additional research and development programs include preventive vaccines against Mpox (formerly known as monkeypox) and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), Zika virus and malaria, as well as immunotherapies for multiple solid tumors. The Company's portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 115 155 granted or pending patent applications spread over 24 patent families, which are discussed in greater detail in the "Our Intellectual Property" section.
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Coronavirus Vaccines
COVID-19 (Booster for Chronic Lymphocytic Leukemia patients)
Clinical – Phase 2 (Investigator Initiated Trial)
Coronavirus/COVID-19 Vaccines
COVID-19 Booster to mRNA vaccines
Clinical – Phase 2 (enrollment completed)
COVID-19 Primary vaccine for immunocompromised immunocompromised/cell transplant patients
Clinical – Phase 2 (actively enrolling)
Booster for immunocompromised/CLL patients
Clinical – Phase 2 (actively enrolling)
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Clinical – Phase 1/2 (enrollment completed)
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Based on our research, there are currently forty vaccines authorized for use in one or more countries around the world, including four in the United States. These vaccines are primarily designed to induce antibodies specific for the S protein of SARS-CoV-2 but rely on different mechanisms for presentation or expression of the S antigen, including recombinant proteins, whole inactivated virus, defective adenovirus vectors (three different types) or mRNA. Unfortunately, the continued adaptation and mutation of SARS-CoV-2 has resulted in the emergence of variants that are not optimally neutralized by vaccine-induced antibodies induced by currently available vaccines, reducing vaccine clinical efficacy. This has required the continued adjustment of vaccine composition and the repeated administration of booster doses. Moreover, these current vaccines tend to stimulate only modest T-cell responses, which have been shown to be critical to critical for induction of long-term immune memory and for protection against severe COVID-19 disease. Recently, the FDA indicated the likely need for continued vaccine adjustments and yearly boosters at least annually, similar to the approach used for influenza virus vaccines.
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GEO-CM04S1 for Immunocompromised Immunocompromised/Cell Transplant Patients – The CDC and other global public health agencies identify immunocompromised patients, including patients who have received therapeutic procedures treatment for hematologic malignancy, as highest risk for SARS-CoV-2 disease. SARS-CoV-2 infection can be very serious in this vulnerable population of hematology patients, including autologous (auto) and allogeneic (allo) hematopoietic cell transplant (HCT), and recipients of chimeric antigen receptor (CAR)-T cell therapies.
Given the serious impact of other respiratory viruses in this vulnerable patient population, it is anticipated that hematology recipients of cell therapy may develop severe clinical disease, profoundly impacting the therapy outcomes, such as morbidity and survival. Increasingly, there is evidence of the high risk of severe morbidity, hospitalization and death resulting from SARS-CoV-2 in hematology patients. The efficacy and safety of a SARS-CoV-2 vaccine remains to be established in the different immunocompromised patient populations and it is likely that candidate SARS-CoV-2 vaccines may differ in their efficacy and safety for these patients.
Our vaccine candidate, GEO-CM04S1, 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) Medical Center for immunocompromised patients. In a placebo-controlled Phase 1 clinical trial of healthy adults conducted by COH, GEO-CM04S1 was shown to be safe and immunogenic. In November 2021, GeoVax entered into a license agreement with COH, granting GeoVax exclusive worldwide rights to further develop and commercialize the vaccine.
GEO-CM04S1 is being studied in an ongoing Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) to evaluate its safety and immunogenicity as a primary vaccine, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. MVA-vector based vaccines tend to produce an immune response quickly – in less than 14 days – with only mild side effects. The trial is also the first to compare an investigational multi-antigenic SARS-CoV-2 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccines from Pfizer/BioNTech and Moderna in people who are immunocompromised. Such patients have often shown a weak antibody suboptimal immune response after receiving currently available COVID-19 vaccines.
GEO-CM04S1 is also being studied as a booster vaccine in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355 ), in immunocompromised patients with chronic lymphocytic leukemia (CLL). Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to inadequate their compromised ability to generate antibody responses being generated against COVID infections or vaccinations. GEO-CM04S1 may be more effective at inducing protective immunity in CLL patients since MVA strongly induces T cell expansion even in the background of immunosuppression. Targeting both the S and N protein antigens broaden the specificity of the immune responses and can protect against the loss of efficacy associated with the reduced antibody responses. The study is examining the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm.
GEO-CM04S1 as a Booster Vaccine – GEO-CM04S1 is also being studied in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal heterologous booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna.
Because GEO-CM04S1 is designed to stimulate potent humoral and cellular immune responses against both the S and N proteins of SARS-CoV-2, GeoVax believes its administration as a booster will induce a broader and more sustained immune response The GEO-CM04S1 vaccine's MVA backbone may also be more effective at inducing immunity since MVA is known to strongly induce T cell responses. than that seen after mRNA vaccine boosting. In addition, GEO-CM04S1 may offer greater better protection against the significant sequence variation observed with the S antigen because the N antigen is tends not variable to change significantly amongst evolving variants.
The Phase 1 portion trial of GEO-CM04S1 (known at the trial time as COH-CM04S1) was designed as a dose-escalation safety study in healthy individuals between the ages of 18 to 55, who had not been previously infected or vaccinated with SARS-CoV-2. The primary objectives were to evaluate the safety, tolerability and immunogenicity of the GEO-CM04S1 administered at three different dose levels by intramuscular (IM) injection. Follow-up studies of the volunteers are continuing to better assess duration of characterize their immune responses.
The Phase 2 booster study, for which patient enrollment was completed in October September 2023, includes 63 healthy adults who were previously vaccinated with one of the FDA-approved SARS-CoV-2 mRNA vaccines, manufactured by either Pfizer/BioNTech or Moderna. The study is designed as a comparison trial to specifically evaluate the safety profile and immunogenicity of COH04S1 2 dose levels of GEO-CM04S1 when administered as a heterologous booster. The immunological responses measured throughout the study will include the level of SARS-CoV-2 neutralizing antibodies antibody and T-cell responses against SARS-CoV-2 variants of concern (VOC), including the Omicron and Delta VOCs, as well as specific T-cell responses. and contemporaneous Omicron variants.
In February 2024, we announced positive initial safety and immune response findings at one month following vaccine administration. While the study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against multiple SARS-CoV-2 variants (including contemporaneous Omicron variants) and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.
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GeoVax has developed a design strategy for vaccines to induce broader immunity through inclusion of multiple, genetically conserved structural and nonstructural proteins from SARS-CoV-2 and other beta-coronaviruses with the potential to infect humans. This is possible, through the use of our MVA platform to incorporate other sequence-conserved structural and nonstructural proteins as targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses. This strategy provides the basis for generating a universal vaccine with augmented potential to alleviate the burden of disease caused by circulating coronaviruses. Unique when compared to other vaccines approved or under development, the GeoVax pan-coronavirus vaccine candidates are 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. other similar coronaviruses which could pose a risk of human infection.
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In GDEPT, an a replication-deficient adenovirus vector is used to selectively infect and transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a inactive prodrug into an active antitumor compound, in situ . A cycle of Gedeptin therapy consists of three intra-tumoral injections of Gedeptin over a two-day period followed by infusion administration of a prodrug, fludarabine phosphate, once over a day for three days. pre-defined time period. A Phase 1 dose ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the therapy to be well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.
A multi-site Phase 1/2a trial (ClinicalTrials.gov Identifier: NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options is ongoing, with patient enrollment closed in December 2023.
A multi-site Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT03754933), evaluating The safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options is ongoing. The trial design involves repeat administration using Gedeptin followed by systemic fludarabine phosphate, in order to gain preliminary information on the utility of multiple cycles of Gedeptin therapy, prior to expansion towards a larger patient trial. The initial stage of the study is being funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. This trial will guide the design of a larger study that also may involve studies involving patients with other anatomically accessible oral and pharyngeal cancers and, at earlier stages in the disease process. These studies may lead to labeling discussions with the FDA and initiation of further Gedeptin investigations including in combination with immune checkpoint inhibitors for additional cancerous and non-cancerous tumor indications.
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MVA as Smallpox and Mpox Vaccine - MVA was originally developed for use as a smallpox vaccine more than 30 years ago. Its preferred use is for individuals with compromised immune systems; individuals that would be put at risk if administered the normal smallpox vaccine ("vaccinia") which can replicate in human cells. It is also approved as the vaccine for other orthopox vaccines, including Mpox. As such, an added potential benefit of our vaccines is that in those regions where Mpox or smallpox are of concern, vaccines built on an MVA vaccine platform will likely also provide protection against Mpox and smallpox.
MVA is the vaccine currently used and stockpiled in the US Strategic National Stockpile for immunization against the MPox and smallpox viruses. GeoVax previously demonstrated that an experimental HIV vaccine, utilizing NIH-MVA as the vaccine vector, protected non-human primates challenged with a lethal dose of the Mpox virus. Further, in August 2022, the City of Hope team, which originally developed GEO-CM04S1, published results demonstrating that both their proprietary sMVA (synthetic MVA) and GEO-CM04S1 (referred to as "COH04S1" in the publication) elicited robust orthopoxvirus-specific binding and neutralizing antibody responses. The authors concluded that GEO-CM04S1 and sMVA prepresent represent unique vaccine candidates to control the unforeseen global Mpox outbreak.
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Our initial preclinical studies in rodents and nonhuman primates for our MVA-VLP-EBOV vaccine candidate have shown significant levels of protection against lethal doses of EBOV. Recent studies in lethal challenge guinea pig models demonstrated that GeoVax vaccines MVA-VLP-SUDV 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. The nonhuman primate studies conducted in collaboration with NIAID and the U.S. Department of Defense (DoD) have been completed and potential clinical development programs are being defined with these same partners with a focus on potentially developing products for the US Strategic National Stockpile. considered.
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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 combined 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 GEO-MM02 will be dependent upon additional funding support via federal grants or other sources.
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Further development of our Zika, Malaria and HIV programs will be dependent upon additional funding support via federal grants, corporate collaborations, or other sources.
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The PRV may be sold. For example, a small company might win a voucher for developing a drug for a neglected disease and sell the voucher to a large company for use on a commercial disease. The price of the voucher depends on supply and demand. The voucher's value derives from three factors: shifting sales earlier, longer effective patent life due to earlier entry, and competitive benefits from earlier entry relative to competitors. Top-selling treatments can yield billions in sales each year, so being approved months earlier can be worth hundreds of millions of dollars to the voucher. Since the first voucher sale in 2014, the price of the vouchers has ranged from $68 million to $350 million. GeoVax believes that its vaccine programs in Ebola, Sudan, Marburg, Lassa Fever, Malaria and Zika may each be eligible for a PRV and we intend to apply for a PRV at the appropriate time. There can be no assurance, however, that we will qualify or be approved for a PRV.
GeoVax believes that its vaccine programs in Ebola, Sudan, Marburg, Lassa Fever, Malaria and Zika may each be eligible for a PRV and we intend to apply for a PRV at the appropriate time. There can be no assurance, however, that we will qualify or be approved for a PRV.
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As of December 31, 2023, our owned, co-owned, and in-licensed patent estate, on a worldwide basis, includes 18 17 granted or allowed U.S. patent applications, 15 17 pending U.S. patent applications; 63 granted foreign patents, 67 62 pending foreign patent applications, 4 3 Patent Cooperation Treaty (PCT) application, and 2 U.S. provisional applications spread over 24 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 a patent term extension under the 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 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 restoration. 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 a court of final jurisdiction in the United States or a foreign country.
Our current patent portfolio includes 2 patent families directed to various aspects of our DNA and MVA-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. We have in-licensed one patent from Emory University and the U.S. National Institutes of Health (NIH) relevant to our HIV-vaccine program. This patents patent expires in 2028, exclusive of any patent term adjustments or extensions. We wholly own one patent family, including one two granted U.S. patent patents (US 11,098,086 and one allowed US application (US App. No. 17/409,574), 11,897,919), 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 granted U.S. patent (US 11,701,418) directed to preventive vaccines against Ebola virus, and one allowed granted U.S. patent application (US 17/584,231) 11,896,657) directed to Marburg virus and uses thereof. These patents, where issued, valid, and enforceable, will expire in 2036, exclusive of any patent term extensions. The '418 patent has 134 days of patent term adjustment.
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We wholly own one two granted U.S. patent patents (U.S. 11,311,612 and one allowed US patent application (US 17/726,254) 11,857,611) directed to preventive vaccines against malaria and use thereof. These applications, where issued, valid, and enforceable, will expire in 2038, exclusive of any patent term adjustments or extensions.
We wholly own 3 patent families, which includes two granted U.S. patents (U.S. 11,278,607 and U.S. 11,413,341), and granted foreign applications in Australia, Europe (validated in Germany, Spain, France, Great Britian, Italy, Poland, Turkey, and Switzerland), China, Japan, India directed to our immuno-oncology vaccine compositions and methods of use thereof. Applications are pending in the United States, Australia, Canada, China, Honk Kong, and Japan. Hong Kong,. The patent applications of these families, where issued, valid, and enforceable, will expire between 2037-2040, exclusive of any patent term adjustments or extensions.
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We are the exclusive, worldwide licensee a patent family, 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 agreement originally entered into on August 23, 2002 and restated on June 23, 2004 (the "Emory License"). The in-licensed Emory University patent will expire in 2028, exclusive of any patent term extensions.
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We have exclusively in-licensed two patent families from the University of Alabama at Birmingham ("UAB") and the Southern Research Institute pursuant to an Assignment and License Agreement with PNP Therapeutics, Inc. entered into on September 28, 2021. The two patent families are directed to the use of tail-mutant purine nucleoside phosphorylase enzymes and fludarabine for the treatment of cancer, and cover aspects of the use of our Gedeptin clinical product candidate. These in-licensed patent families, where issued, valid, and enforceable, will expire between 2029 and 2032, exclusive of any patent term adjustments or extensions.
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The terms of the Gedeptin License, include (i) an upfront payment at closing, (ii) milestone payments due upon the achievement of selected development and regulatory events, and (iii) quarterly support payments for the lesser period of three years or the Company's filing for FDA approval of its Biologics License Application on the use of Gedeptin for the treatment of head and neck cancer in humans. The Company will also pay tiered percentage annual royalties in the low-to-mid teens on Net Sales (as defined in the Gedeptin License) of products covered under the Gedeptin License on a country-by-country and product-by-product basis, subject to specified reductions. The Company also issued a warrant to PNP, exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 100,000 6,667 shares of the Company's common stock at an exercise price of $13.00 $195.00 per share. The Gedeptin License will remain in effect during the original term, which concludes upon FDA approval of a generic or biosimilar product, and then will automatically renew for 5-year additional terms, subject to customary termination rights.
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Our expenditures for research and development activities were $9.1 $20.7 million and $15.6 $9.1 million during the years ended December 31, 2022 2023 and 2021, 2022, respectively. and $14.5 million for the nine-months ended September 30, 2023. As our vaccines continue to go through the process to obtain regulatory approval, we expect our research and development costs to 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.
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MD&A 77 changes
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Our corporate strategy is to advance, protect and exploit our differentiated vaccine/immunotherapy technologies leading to the successful development of preventive and therapeutic vaccines and immunotherapies against infectious diseases and various cancers. Our goal is to advance products through to human clinical testing, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.
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GEO-CM04S1 – Immunocompromised Trial
In September 2023, the journal, Vaccines, published data from the open-label safety portion of the trial indicating that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
In September 2023, preclinical vaccine efficacy data for GEO-CM02 were presented during the Keystone Symposia on Molecular and Cellular Biology, Vaccinology During and After COVID-19, demonstrating that our multi-antigen SARS-CoV-2 vaccine, GEO-CM02, induced efficacious immune responses against the original Wuhan strain and BA.1 Omicron variant with a single dose. The data generated in the GEO-CM02 studies validate our hypothesis that vaccines such as GEO-CM04S1, which are designed to induce both antibodies and T-cells to multiple viral structural proteins, can address the issue of viral variation and escape from the immune system.
In October 2023, we announced commencement of the planned site expansion for this trial to accelerate patient enrollment. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial is now open to eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and the Fred Hutchinson Cancer Center (Seattle, Washington).
In September 2023, we announced the completion of patient enrollment for this trial.
GEO-CM04S1 – CLL Trial
In September 2023, GeoVax and ProBioGen AG announced the signing of a commercial license agreement for ProBioGen's AGE1.CR.pIX® suspension cell line. The agreement enhances our manufacturing capabilities for our entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio. This follows the May 2023 execution of a Master Services Agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of our vaccine candidates through late-stage development toward eventual commercialization. These agreements move the Company toward fully implementing a continuous cell line manufacturing system that will provide lower-cost, scalable versatility for our entire MVA-based vaccine portfolio.
GEO-CM04S1 – Immunocompromised/Cell Transplant Phase 2 Trial
GEO-CM04S1 is currently undergoing a Phase 2 multi-site clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in high-risk immunocompromised patients (e.g. patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy). Data published from the open-label safety portion of the trial indicating that GEO-CM04S1 is highly immunogenic, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
GEO-CM04S1 – Healthy Booster Phase 2 Trial
GEO-CM04S1 is undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal COVID-19 booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. Patient enrollment was completed in September 2023.
In February 2024, we announced positive interim safety and immune responses findings following vaccine administration. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5.
GEO-CM04S1 – Immunocompromised/CLL Trial Phase 2 Trial
In July 2023, GEO-CM04S1 is undergoing an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355), of GEO-CM04S1 began, evaluating its use as a COVID-19 booster vaccine in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine.
Gedeptin ® – Advanced Head and Neck Cancer Phase 1/2 Trial
Gedeptin® is currently undergoing a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC). This trial is being funded in part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The trial is designed to inform the design of a larger patient trial that also may involve patients with other anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.
In July 2023, Interim data were presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference indicating in July 2023, indicated that administration of Gedeptin® is safe and feasible, with observation of tumor growth impairment in a majority of the patients.
In January 2024, we announced closure of patient enrollment for this trial. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of 2024. Our intent is to discuss a follow-on protocol with the FDA for a Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal, in conjunction with a complete review of the results of the current trial. We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.
Advanced MVA-Based Vaccine Manufacturing Process Development
In March 2024, we announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for our MVA-based vaccines, with the release of the first lot of GEO-CM04S1 produced with a commercial manufacturing platform. This marked the successful completion of the transfer and scale-up of manufacturing to Oxford Biomedica, the Company's cGMP (current Good Manufacturing Procedures) manufacturing partner.
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In July 2023, the U.S. Patent and Trademark Office issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company's patent application No. 15/543,139 titled "Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40), covering GeoVax's vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus.
On December 2, 2023, we entered into a common stock warrant exercise inducement offer letter (the "Inducement Letter") with the holder (the "Holder") of existing warrants to purchase shares of the Company's common stock at an exercise price of $3.26 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $1.65 per share issued on May 27, 2022 (together, the "Existing Warrants"), pursuant to which the Holder agreed to exercise for cash its Existing Warrants to purchase an aggregate of 10,567,484 shares of the Company's common stock, at a reduced exercised price of $0.414 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 21,134,968 Common Shares with an exercise price of $0.414 per share, exercisable at any on or after six months from the date of issuance and will expire five and one-half (5 ½) years following the date of issuance.
On December 6, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market, LLC ("Nasdaq") stating that Nasdaq has determined to delist the Company's securities from the Nasdaq Capital Market for failure to maintain a minimum bid price of $1.00 per share in accordance with Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Requirement").
The Company has appealed the Nasdaq determination and has requested a hearing (the "Hearing") before a Nasdaq Hearings Panel (the "Panel") to seek continued listing pending its return to compliance with the Bid Price Requirement. The Hearing request will stay the delisting of the Company's securities pending the Panel's decision.
At the Hearing, which is scheduled for March 5, 2024, the Company intends to discuss the events that it believes will enable it to regain compliance, including a commitment to effect a reverse stock split, as soon as reasonably practicable, subject to applicable law and Nasdaq rules. In this regard, the Company plans to hold a Special Stockholders meeting on January 16, 2024 for the purpose of seeking stockholder approval for such reverse stock split.
Our corporate strategy is to advance, protect and exploit our differentiated vaccine/immunotherapy technologies leading to the successful development of preventive and therapeutic vaccines and immunotherapies against infectious diseases and various cancers. Our goal is to advance products through to human clinical testing, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.
We have not generated any revenues from product sales to date. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization. Our grant revenues relate to grants and contracts from agencies of the U.S. government in support of our vaccine development activities. We record revenue associated with these grants as the related costs and expenses are incurred.
In August 2023, January 2024, the U.S. Patent and Trademark Office issued a Notice of Allowance Patent No. 11,857,611 to GeoVax, for pursuant to patent application No. 17/726,254 titled "Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria". The allowed claims cover compositions comprising GeoVax's modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the allowed claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.
In October 2023, February 2024, the U.S. Patent and Trademark Office issued a Notice of Allowance Patent No. 11,896,657 to GeoVax, for pursuant to patent application No. 17/584,231 titled "Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40)." The allowed claims generally cover GeoVax's vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
In October 2023, February 2024, the U.S Patent and Trademark Office issued a Notice of Allowance Patent No. 11,897,919 to GeoVax, for pursuant to patent application No. 17/409,574 titled "Multivalent HIV Vaccine Boost Compositions and Methods of Use." The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax's vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
In February 2024, the Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company's Patent Application No. 2022-153352 titled " Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen ." The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax's MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims. This represents an extension of the GeoVax MVA-VLP platform that was originally developed for vaccines targeting infectious diseases.
Effective January 31, 2024, following approval by our stockholders at a special meeting held on January 16, 2024, we effected a reverse stock split of our common stock at a ratio of 1-for-15. The purpose of the reverse split was to regain compliance with the $1.00 minimum bid price required for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). On the effective date, every fifteen issued and outstanding shares of our common stock was converted automatically into one share of the Company's Common Stock without any change in the par value per share, and our publicly-traded warrants were adjusted to require fifteen warrants to be exercised to receive one share of common stock at a price of $75 per share.
We have not generated any revenues to date from the sale of the products we are developing. and we do not expect to generate any such revenues for at least the next several years. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.
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We expect our research and development expenditures to increase during 2024 and beyond as we advance our existing and future product candidates into and through clinical trials and pursue regulatory approval, especially with regard to the Gedeptin and GEO-CM04S1 clinical programs. We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with biotechnology research and development. Due to these uncertainties, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. As we obtain data from preclinical studies and clinical trials, we may elect to discontinue or delay certain development programs to focus our resources on more promising product candidates. Completion of preclinical studies and human clinical trials may take several years or more, but the length of time can vary substantially depending upon several factors. The duration and the cost of future clinical trials may vary significantly over the life of the project because of differences arising during development of the human clinical trial protocols, including the length of time required to enroll suitable patient subjects, the number of patients that ultimately participate in the clinical trial, the duration of patient follow-up, and the number of clinical sites included in the clinical trials.
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Our significant accounting policies are summarized in Note 2 to our consolidated financial statements for the year ended December 31, 2022, 2023, which are included in this prospectus. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements:
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We account for stock-based transactions in which the Company receives services from employees, directors or others in exchange for equity instruments based on the fair value of the award at the grant date. Stock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Stock-based compensation cost for stock options or warrants is estimated at the grant date based on each instrument's fair value as calculated by using the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award. See Note 6 to our consolidated financial statements for the year ended December 31, 2023 for additional stock-based compensation information.
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The following table summarizes our results of operations for the years ended December 31, 2022 2023 and 2021 2022 and for the three-month and nine-month periods ended September 30, 2023 March 31, 2024 and 2022: 2023:
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Total other income (expense)
Research and development
General and administrative
Total operating expenses
Loss from operations
Nine Months Ended September 30,
Three Months Ended September 30, March 31,
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Grant revenues decreased by $303,975 (79%) for the year ended December 30, 2022 compared to 2021, attributable to the differing mix of active grants as well as the timing of grant-related expenditures.
There were no grant revenues during either of the three-month periods ended September 30, 2023 and 2022. Grant revenue decreased by $81,526 (100%) for the nine-month period ended September 30, 2023 compared to the nine-month period ended September 30, 2022, reflective of the wind-down of the Company's grant from the U.S. Department of Defense for our Lassa Fever vaccine program. As of September 30, 2023, all approved grant funds have been utilized.
There were no grant revenues during 2023 or during the three-month period ended March 31, 2024. As of December 31, 2022, all grant funds available for use directly by GeoVax were expended.
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Our research and development expenses were $9,123,479 for the year ended December 31, 2022, as compared to $15,554,171 for 2021, representing a decrease of $6,430,692 (41%). Research and development expense for 2021 includes $12,324,125 of upfront license fees and other costs related to our licenses of GEO-CM04S1 and Gedeptin; excluding these costs, research and development expense increased by $5,893,433 (182%) from 2021 to 2022. The increase during 2022 relates primarily to higher personnel costs (including the use of external consultants), costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, and a generally higher level of activity. Research and development expense for 2022 and 2021 includes stock-based compensation expense of $225,031 and $96,814, respectively, associated with employee stock options.
For the three-month and nine-month periods ending September 30, 2023, Our research and development expenses increased by $4,226,783 (155%) and $9,127,979 (170%), respectively, versus were $20,720,766 for the comparable year ended December 31, 2023, as compared to $9,123,479 for 2022, periods. representing an increase of $11,597,287 (127%). The overall increase during the 2023 periods relates primarily to costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs. Research and development expense for the three-month and nine-month periods of 2023 included and 2022 includes stock-based compensation expense of $77,873 and $232,516, respectively; as compared to $54,293 $291,094 and $162,878 $225,031, respectively, for the comparable 2022 periods. associated with employee stock options.
Our research and development expenses were $4,425,728 for the three-month period ended March 31, 2024, as compared to $2,819,189 for the comparable 2023 period, representing an increase of $1,606,539 (57%). The increase during 2024 relates primarily to costs of manufacturing materials for use in our clinical trials and other related costs, personnel costs, and costs of preclinical research activities. Research and development expense for 2024 and 2023 includes stock-based compensation expense of $53,099 and $77,873, respectively, associated with employee stock options.
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For the three-month and nine-month periods ending September 30, 2023, general and administrative expenses increased by $402,438 (32%) and $1,198,621 (36%), respectively, versus the comparable 2022 periods. The overall increase during the 2023 periods relates primarily to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses. General and administrative expense for the three-month and nine-month periods of 2023 included stock-based compensation expense of $220,075 and $580,983, respectively; as compared to $184,273 and $488,017, respectively, for the comparable periods of 2022.
Interest income for the three-month and nine-month periods ended September 30, 2023 was $190,936 and $674,835, respectively, as compared to $2,431 and $3,747, respectively, for comparable periods of 2022. The variances between periods are primarily attributable to cash available for investment and higher interest rates.
Our general and administrative expenses were $4,986,611 $6,022,173 for the year ended December 31, 2022, 2023, as compared to $3,577,153 $4,983,611 for 2021, 2022, representing an increase of $1,409,458 (39%). $1,035,562 (21%). The increase during 2022 2023 relates primarily to higher personnel costs, (including the use of external consultants), patent costs, investor relations consulting costs, legal fees, patent costs and travel expenses. General and administrative expense for 2022 2023 and 2021 2022 includes stock-based compensation expense of $677,043 $783,863 and $273,173, $677,043, respectively, associated with employee and consultant stock options and stock awards.
Our general and administrative expenses were $1,457,353 for the three-month period ended March 31, 2024, as compared to $1,451,425 for the comparable 2023 period, representing an increase of $5,928 (0.4%). General and administrative expense for 2024 and 2023 includes stock-based compensation expense of $104,637 and $168,166, respectively, associated with employee and consultant stock options and stock awards.
Interest income was $7,439 $776,177 and $4,736 $7,439 for the years ended December 31, 2022 2023 and 2021, 2022, respectively. The variances between years are primarily attributable to the cash available for investment and to interest rate fluctuations. Interest expense was $-0- and $1,286 for the years ended December 31, 2022 and 2021, respectively. During 2021, we recorded a $172,056 gain on debt extinguishment associated with the forgiveness of the PPP loan principal and accrued interest.
Interest income for the three-month periods ended March 31, 2024 and 2023 was $32,949 and $232,698, respectively. The decrease during 2024 is attributable to lower cash balances.
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The following table summarizes our liquidity and capital resources as of September 30, 2023 March 31, 2024 and December 31, 2022 2023 and 2021: 2022:
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Working capital (deficit)
The following tables summarize our cash flows for the years ended December 31, 2022 2023 and 2021, 2022, and the nine-month three-month periods ended September 30, 2023 March 31, 2024 and 2022: 2023:
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Nine Months Ended September 30,
Net increase (decrease) in cash and cash equivalents
Three Months Ended March 31,
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Net increase decrease in cash and cash equivalents
Operating Activities – Net cash used in operating activities of $19,030,208 $25,173,639 for 2022 2023 was primarily due to our net loss of $14,021,125, $25,966,762, 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 $11,196,420 $19,030,208 for 2021 2022 was primarily due to our net loss of $18,570,317, $14,021,125, offset by non-cash items such as depreciation expense and stock-based compensation expense, and the gain recognized on debt extinguishment, and by changes in our working capital accounts.
Net cash used in operating activities of $14,895,694 $5,683,730 for the nine three months ended September 30, 2023, March 31, 2024 was primarily due to our net loss of $18,374,354, $5,850,132, offset by non-cash items charges such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts. Net cash used in operating activities of $11,965,972 $3,762,872 for the nine three months ended September 30, 2022, March 31, 2023 was primarily due to our net loss of $8,637,316, also $4,037,916, 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 $134,258 and $47,718 for the the years ended December 31, 2022 and 2021, respectively, and $29,997 $48,946 and $134,258 for the nine-month periods ended September 30, 2023 and 2022, respectively, and relates to purchases of property and laboratory equipment. There were no cash flows from investing activities for the three-month periods ended March 31, 2024 and 2023.
Financing Activities – Net cash provided by financing activities was $35,353,328 $4,062,442 for 2022, 2023, consisting of (i) aggregate net proceeds of $27,727,194 from offerings of our common stock and (ii) $7,626,134 of net proceeds from the exercise of warrants. Net cash provided by financing activities was $12,784,212 $35,353,328 for 2021, 2022, consisting of (i) aggregate net proceeds of $9,408,920 $27,727,194 from a public offering offerings of our common stock and (ii) $3,404,156 $7,626,134 of net proceeds from the exercise of warrants. (iii) $28,864 in principal repayments of a note payable and repurchase of preferred stock Net There were no cash provided by flows from financing activities was $-0- and $35,353,328 for the nine-month three-month periods ended September 30, 2023 and 2022, respectively. Net cash provided by financing activities for the 2022 period relates primarily to net proceeds from offerings of our common stock March 31, 2024 and warrants. 2023.
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Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties and is based on assumptions that may prove to be wrong; actual results could vary materially.
On May 10, 2024, we conducted a bridge financing through the issuance and sale of 10% Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $150,000 to members of our Board of Directors and senior management. The Notes are unsecured, bear interest at a rate of 15% per annum, and mature upon the earlier of (i) six months from the issue date or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $5 million.
On May 16, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which we agreed to sell, in the Registered Direct Offering, an aggregate of (i) 220,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 582,844 shares of common stock. In a concurrent private placement, we issued warrants to the investor to purchase up to 1,605,688 shares of common. The transaction closed on May 21, 2024 and net proceeds to us, after deducting placement agent fees and expenses and other offering expenses, was approximately $1,180,000.
As of the date of this prospectus, our existing cash and cash equivalents were insufficient to fund our operations significantly beyond the second quarter of 2024 without additional funding, which we are actively pursuing. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources. We also continue to be in advanced discussions with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), for a potential award as part of Project NextGen, an initiative to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19. We are highly encouraged by the negotiations with BARDA thus far, but there is no assurance that such an award may be made.
There can be no assurance that necessary funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company's ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company's planned operations, but that our plans do not fully alleviate the substantial doubt about the Company's ability to operate as a going concern.
We will need to continue to raise additional capital to support our future operating activities, including progression of our development programs, preparation for commercialization, and other operating costs. We may fund a significant portion of our ongoing operations through partnering and collaboration agreements which, while reducing our risks and extending our cash runway, will also reduce our share of eventual revenues, if any, from our vaccine candidates. We may be able to fund certain activities with assistance from government programs.
The sale of additional equity would result in additional dilution to our stockholders. We may also fund our operations through debt financing, which would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market vaccine candidates that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and prospects.
As Our forecast of the date period of this prospectus, we expect time through which our existing cash and cash equivalents financial resources will be sufficient adequate to fund support our operations through the first quarter of 2024. This is a forward-looking statement that involves risks and uncertainties and is based on assumptions that may prove to be wrong; actual results could vary materially. Our projection takes into consideration contractual commitments we have made, and expect to make, in the normal course of operating our business, which include (i) obligations to our employees, (ii) our lease obligations, (iii) payments due under license agreements for various technologies and patent rights associated with our product development activities, (iv) arrangements with contract research organizations ("CROs"), contract manufacturing organizations ("CMOs"), and other third-party vendors for clinical trials services and production of materials for use in our clinical trials, and (v) other various firm purchase commitments and contractual obligations related to production and testing of our product candidates and the general operation of our business.
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We will need to continue to raise additional capital to support our future operating activities, including progression of our 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.
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Management 2 changes
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Nicole Lemerond. Ms. Lemerond joined the Board of Directors in August 2022. Ms. Lemerond is a public company board director and financial executive with over 25 years of experience in investment management, private equity, investment banking, mergers/acquisitions, and leveraged finance. She also serves as a director for MediciNova, Inc. and InMed Pharmaceuticals, Inc., where she chairs the Compensation Committees and serves on the Audit Committees. Most recently, serving Ms. Lemerond served as Managing Partner of NV Capital from February 2010 to August 2022. Prior to that she worked for The Carlyle Group and Lehman Brothers. She has significant corporate governance experience executing complex transactions, investing in healthcare and during her tenure as a board member, she has advised companies raising and management teams on multiple equity financings and capital raises, various business development opportunities and structuring balance sheets. Her breadth the hiring / onboarding of industry expertise includes providers, payors, medical device manufacturers, HCIT providers, pharmaceutical new c-suite executives and life sciences companies. auditors. Ms. Lemerond also serves as a director for InMed Pharmaceuticals, Inc. has had significant experience in many different facets of finance throughout her career, working with both public and private company management teams and boards to increase stakeholder value. She has led diligence on and executed M&A, Reg D and leveraged finance transactions, totaling over $3 billion while at Lehman Brothers and The Carlyle Group. In addition, she established and led healthcare groups at leading investment firms and has also worked at several large financial institutions, including Lehman Brothers and in the Carlyle Group. process, raising over $1 billion of capital from institutional investors for these investment funds. Ms. Lemerond holds a Bachelor of Science degree from Cornell University and is a CFA charter holder. Charterholder. The Board of Directors has concluded that Ms. Lemerond should serve on the Board of Directors due to her extensive experience in investment management and her experience working with management teams to increase stakeholder value.
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Jayne Morgan, M.D. Dr. Morgan joined the Board of Directors in December 2022. She is a Cardiologist and the Executive Director of Health and Community Education at the Piedmont Healthcare Corporation in Atlanta, GA, the largest healthcare system in Georgia. Within this role she serves to address health literacy and information both internally to the 35,000 employee system, as well as to external stakeholders. Previously she served as the system COVID vaccine expert as the Executive Director of the COVID Task Force, analyzing the science and data from Piedmont and nationally, publishing 5 scientific articles, and driving efforts at addressing vaccine hesitancy and increasing vaccine uptake. In doing so, she created a social media series called The Stairwell Chronicles , providing up to date medical and scientific information in an easy to understand format. Dr. Morgan is the recipient of several awards acknowledging her work in providing accurate science and medicine to all communities including the NAACP Award, the National Women's Empowerment Award, the Atlanta Business Chronicle Award, and the Medical Association of GA Humanitarian Award. Further she serves as a CNN medical expert, holds an appointment as an Adjunct Assistant Professor of Medicine at The Morehouse School of Medicine, was selected to support the Department of Health in its series of "Ask The Experts", and has been a diligent and long-time advocate for health equity for all communities via access to clinical trials. Dr. Morgan further serves on the Board of Georgia Bio, the Medical Association of Atlanta, and the National Board of the American Heart Association Diversity and Inclusion. Dr. Morgan is published in the areas of Congenital Heart Disease, Interventional Cardiology, and COVID-19; serves as the Health Equity Advisor for Moderna, and is on Steering Committees of both Pfizer, and Novartis, where she also serves as the National Lead of the Horizon trial (Novartis). Previously she served as the Chief Medical Officer of the American Chemistry Council, Cardiology advisor to the MitraClip Team at Abbott Labs, the Global Director of the Cardiorenal Division of Solvay Pharmaceuticals, the Assistant Professor of Medicine at the Cleveland Clinic, and the first African American President of the Southeast Life Sciences Association (single largest biotech association in the Southeast). Dr. Morgan completed her B.S. degree at Spelman College, Medical Degree at Michigan State University, Internal Medicine Residency at George Washington University and her Cardiology and Pacemaker Fellowships at Mount Sinai Medical Center. The Board of Directors has concluded that Dr. Morgan should serve on the Board of Directors due to her medical background and experience.
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Executive compensation 12 changes
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Represents the grant date fair value of the stock options for financial statement reporting purposes. See footnotes 2 and 6 to our consolidated financial statements for the year ended December 31, 2022 2023 for a discussion of the assumptions made and methods used for determining stock compensation values.
2 unchanged paragraphs
Represents the grant date fair value for stock options granted on December 7, 2022 for 250,000 16,667 shares with an exercise price of $0.755 $11.325 per share, vesting over a three-year period.
Represents the grant date fair value for stock options granted on December 7, 2022 for 15,000 1,000 shares with an exercise price of $0.755 $11.325 per share, vesting over a three-year period (6) Represents the grant date fair value for stock options granted on December 7, 2022 for 100,000 6,667 shares with an exercise price of $0.755 $11.325 per share, vesting over a three-year period.
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Mark J. Newman, PhD . Dr. Newman serves as our Chief Scientific Officer under an employment agreement dated August 25, 2020, which was amended and restated effective March 1, 2022. The employment agreement has no specified term. The employment agreement, as amended, provides for an annual base salary to Dr. Newman (currently $291,500), subject to periodic increases as determined by the Compensation Committee. The Board of Directors may also approve the payment of a discretionary bonus annually. Dr. Newman is eligible for annual grants of awards from our equity incentive plans as determined by the Board. Dr. Newman is eligible for health insurance and 401(k) benefits at the same level and subject to the same conditions as provided to all other employees.
Our employment agreement with Dr. Newman provides that, if we terminate his employment without cause, we will pay a severance payment in the form of monthly payments of base salary for a period equal to one week for each full year of service. Additionally, if we terminate Dr. Newman's employment at any time during the three month period which immediately precedes a change in control (as defined in the amended employment agreement) or during the one year period following a change in control, then we would pay an amount in cash equal to (a) two times his then base salary and target annual bonus, (b) two times the cost to provide 401(k) or other deferred compensation or health and welfare benefits to him, (c) full, complete vesting of all stock options, restricted stock grants or other equity or equity-type grants, and (d) a tax gross-up payment (if an excise tax is imposed by §4999 of the Internal Revenue Code or any related interest or penalties are incurred by him). The change of control provision also provides for full and complete vesting of all stock option grants held by him.
2 unchanged paragraphs
Mark J. Newman, PhD . Dr. Newman serves as our Chief Scientific Officer under an employment agreement dated August 25, 2020, which was amended and restated effective March 1, 2022. The employment agreement has no specified term. The employment agreement, as amended, provides for an annual base salary to Dr. Newman (currently $291,500), subject to periodic increases as determined by the Compensation Committee. The Board of Directors may also approve the payment of a discretionary bonus annually. Dr. Newman is eligible for annual grants of awards from our equity incentive plans as determined by the Board. Dr. Newman is eligible for health insurance and 401(k) benefits at the same level and subject to the same conditions as provided to all other employees.
Our employment agreement with Dr. Newman provides that, if we terminate his employment without cause, we will pay a severance payment in the form of monthly payments of base salary for a period equal to one week for each full year of service. Additionally, if we terminate Dr. Newman's employment at any time during the three month period which immediately precedes a change in control (as defined in the amended employment agreement) or during the one year period following a change in control, then we would pay an amount in cash equal to (a) two times his then base salary and target annual bonus, (b) two times the cost to provide 401(k) or other deferred compensation or health and welfare benefits to him, (c) full, complete vesting of all stock options, restricted stock grants or other equity or equity-type grants, and (d) a tax gross-up payment (if an excise tax is imposed by §4999 of the Internal Revenue Code or any related interest or penalties are incurred by him). The change of control provision also provides for full and complete vesting of all stock option grants held by him.
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The unexercisable portion of these stock options will vest and become exercisable in equal installments on December 7, 2024 and 2025.
The unexercisable portion of these stock options will vest and become exercisable on December 7, 2024.
Represents stock purchase warrants granted as partial payment of deferred compensation occurring on September 29, 2020.
Each of the 2020 Plan and 2023 Plan contains provisions that could lead to an accelerated vesting of options or other awards. In the event of certain change-in-control transactions described in such plans, (i) outstanding options or other awards may be assumed, converted or replaced; (ii) the successor corporation may substitute equivalent options or other awards or provide substantially similar consideration to the 2020 Plan or 2023 Plan, as applicable, participants as were provided to stockholders (after taking into account the existing provisions of the options or other awards); or (iii) the successor corporation may replace options or awards with substantially similar shares or other property. In the event the successor corporation (if any) refuses to assume or substitute options or other awards as described (i) the vesting of any or all options or awards granted pursuant to the 2020 Plan or 2023 Plan, as applicable, will accelerate upon the change-in-control transaction, and (ii) any or all options granted pursuant to the Plans will become exercisable in full prior to the consummation of the change-in-control transaction at such time and on such conditions as the Compensation Committee determines. If the options are not exercised prior to the consummation of the change-in-control transaction, they shall terminate at such time as determined by the Compensation Committee. Subject to any greater rights granted to 2020 Plan participants under the 2020 Plan or 2023 Plan participants under the 2023 Plan, as applicable, in the event of the occurrence of a change-in-control transaction any outstanding options or other awards will be treated as provided in the applicable agreement or plan of merger, consolidation, dissolution, liquidation, or sale of assets. If the Company had experienced a change-in-control event as described in each of the 2020 Plan and 2023 Plan on December 31, 2022, 2023, the value of accelerated options the Named Executive Officers, based on the difference between the closing price of our common stock on the Nasdaq Stock Market on December 31, 2022, 2023, and, if lower, the exercise price per share of each option for which vesting would be accelerated for each Named Executive Officer, would be an aggregate of $-0-.
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Stock Option Grants – We currently do not have a formula for determining stock option grants to directors (upon their election to the Board of Directors, or otherwise). Such option grants are currently determined by the Board of Directors, upon recommendation by the Compensation Committee based on the Compensation Committee's annual deliberations and review of the director compensation structure of similar companies. At its meeting in December 2022, upon a recommendation of the Compensation Committee, the Board of Directors approved an annual stock option grant of 50,000 3,334 shares to each of its non-employee members for ongoing service as members of the Board of Directors. At its meeting in December 2023, the Board of Directors determined to adjust the calendar cycle of all stock option grants to employees as well as the Board of Director, such that no stock options were granted during 2023 and that annual grants would be considered in early 2024.
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Certain relationships and related person transactions 5 changes
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On December 2, 2023, we entered into a common stock warrant exercise inducement offer letter (the "Inducement Letter") with the holder (the "Holder") of existing warrants to purchase shares of the Company's common stock at an exercise price of $3.26 $48.90 per share, issued on January 19, 2022 and warrants to purchase shares of the Company's common stock at an exercise price of $1.65 $24.75 per share issued on May 27, 2022 (together, the "Existing Warrants"), pursuant to which the Holder agreed to exercise for cash its Existing Warrants to purchase an aggregate of 10,567,484 704,499 shares of the Company's common stock, at a reduced exercised price of $0.414 $6.21 per share, in consideration for the Company's agreement to issue the 2023 Common Warrant to purchase up to 21,134,968 1,408,998 shares of Common Stock with an exercise price of $0.414 $6.21 per share, exercisable at any on or after six months from the date of issuance and will expire five and one-half (5 ½) years following the date of issuance.
May 2024 Bridge Loan
On May 10, 2024, we conducted a bridge financing through the issuance and sale of 10% Original Issue Discount Promissory Notes (the "Notes") with an aggregate principal amount of $150,000 to members of our Board of Directors and senior management. The Notes are unsecured, bear interest at a rate of 15% per annum, and mature upon the earlier of (i) six months from the issue date or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $5 million.
May 2024 Registered Direct Offering
On May 16, 2024, the "Company entered into a placement agency agreement (the "Placement Agency Agreement") with Roth Capital Partners, LLC (the "Roth") and the "Purchase Agreement with a purchaser pursuant to which the Company agreed to sell, in the Registered Direct Offering, an aggregate of (i) 220,000 shares of the Company's Common Stock, and (ii) Pre-Funded Warrants to purchase up to an aggregate of 582,844 shares of Common Stock ("Pre-Funded Warrant Shares"). In a concurrent private placement, the Company offered 2024 Common Warrants to the purchaser, with each warrant exercisable to purchase one share of Common Stock, with two 2024 Common Warrants to accompany each share of Common Stock or Pre-Funded Warrant sold in the offering, and to purchase in the aggregate up to 1,605,688 Common Warrant Shares. The public offering price for each Share was $1.68 and the public offering price for each Pre-Funded Warrant was $1.67999. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire five years from the date of issuance. The 2024 Common Warrants have an exercise price of $1.68 per share, are immediately exercisable and will expire five years from the date of issuance. The net proceeds of the offering, after deducting the Roth's fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the 2024 Common Warrants, is approximately $1,180,000. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The offering closed on May 21, 2024.
Security ownership of principal stockholders, directors and officers 13 changes
Based solely upon information made available to us, the following table sets forth information with respect to the beneficial ownership of our common stock as of December 31, 2023 June 5, 2024 by (i) each principal stockholder, (ii) each director; (iii) each of the executive officers named in the summary compensation table; and (iv) all executive officers and directors as a group. Other than Armistice we do not know of any person who beneficially owns more than 5% of our common stock as of December 31, 2023. June 5, 2024. Except as otherwise indicated in footnotes to this table or, where applicable, to the extent authority is shared by spouses under community property laws, to our knowledge, the holders listed below have sole voting and investment power with respect to all shares of common stock beneficially owned by them.
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This table is based upon information supplied by officers and directors, and with respect to principal stockholders, any Schedules 13D and 13G filed with the SEC. Beneficial ownership is determined in accordance with the rules of the SEC. Applicable percentage ownership is based on 29,657,287 2,528,309 shares of Common Stock outstanding as of December 31, 2023. June 5, 2024. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of Common Stock subject to options or warrants currently exercisable, or exercisable within 60 days after December 31, 2023 June 5, 2024 (subject to specified limits), at any time at the option of the holder, are deemed outstanding.
These shares are directly held by Armistice and may be deemed to be indirectly beneficially owned by: (i) Armistice Capital, LLC ("Armistice Capital"), as the investment manager of Armistice; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice Capital and Steven Boyd disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein. The number of shares beneficially owned includes (i) 7,605,484 220,000 shares of common stock, (ii) 238,000 shares of common stock issuable upon the exercise of pre-funded warrants and (ii) 21,134,968 issued in December 2023, (iii) 1,408,998 shares of common stock issuable upon the exercise of common warrants issued in December 2023, (iv) 582,844 shares of common stock issuable upon the exercise of pre-funded warrants issued in May 2024, and (v) 1,605,688 shares of common stock issuable upon the exercise of the 2024 Common Warrant, each of which are subject to beneficial ownership limitations that prohibit Armistice from exercising any portion of a warrant that would result in Armistice owning a percentage of our outstanding common stock exceeding the ownership limitations contained within each instrument (9.99% and 4.99%, respectively) after giving effect to the issuance of common stock in connection with Armistice's exercise. The percentage of shares owned assumes the exercise of all warrants held by Armistice, up to the beneficial ownership limitations described above. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.
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Includes 36,613 2,441 shares of Common Stock and stock options/warrants to purchase 116,613 7,776 shares of common stock. exercisable within 60 days.
Includes 11,987 18,661 shares of Common Stock and stock options/warrants to purchase 111,987 33,791 shares of common stock. exercisable within 60 days.
Includes 53,925 800 shares of Common Stock and stock options/warrants to purchase 153,925 7,468 shares of common stock. exercisable within 60 days.
Includes stock options to purchase 50,000 3,334 shares of common stock. exercisable within 60 days.
Includes 28,838 2,386 shares of Common Stock and stock options to purchase 5,000 333 shares of common stock. exercisable within 60 days.
Includes 21,024 3,595 shares of Common Stock and stock options/warrants to purchase 121,024 10,263 shares of common stock. exercisable within 60 days.
Includes stock options to purchase 50,000 3,334 shares of common stock. exercisable within 60 days.
Includes stock options to purchase 85,466 5,698 shares of common stock exercisable within 60 days.
Includes 148,957 1,402 shares of Common Stock and stock options/warrants to purchase 506,869 8,070 shares of common stock. exercisable within 60 days.
Includes 382,388 27,959 shares of Common Stock and stock options/warrants to purchase 1,494,533 99,644 shares of common stock. exercisable within 60 days.
Selling stockholder 9 changes
Maximum Number of Shares of
Common Stock to be Sold
The common stock being offered by the Selling Stockholder are those issuable to such Selling Stockholder, upon exercise of the 2023 2024 Common Warrant, consisting of 21,134,968 1,605,688 shares of common stock. For additional information regarding the issuances of those Warrants, see "Prospectus Summary–Recent Developments–Private Placement" Developments–Registered Direct Offering" above. We are registering the shares of common stock issuable upon exercise of the 2023 2024 Common Warrant in order to permit the Selling Stockholder to offer the shares for resale from time to time. Except for as noted in this prospectus, the Selling Stockholder has had any material relationship with us within the past three years.
The table below lists the Selling Stockholder and other information regarding the beneficial ownership of the shares of common stock by such Selling Stockholder. The second column lists the number of shares of common stock beneficially owned by the Selling Stockholder as of December 18, 2023. June 5, 2024. The third column lists the shares of common stock being offered by this prospectus by the Selling Stockholder.
In accordance with the terms of the 2023 2024 Common Warrant, this prospectus generally covers the resale of the maximum number of shares of common stock issuable upon exercise of the 2023 2024 Common Warrant, determined as if the outstanding Warrant was 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 2024 Common Warrant, the Selling Stockholder may not exercise the 2023 2024 Common Warrant 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 warrant 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."
Shares of Common Stock
to be Sold Pursuant to this Prospectus
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The number of shares beneficially owned includes 21,134,968 1,605,688 shares of common stock issuable upon exercise of the 2023 2024 Common Warrant. The warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the Selling Stockholder from exercising that portion of the warrants that would result in the Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares owned before and after this offering assumes the exercise of all warrants held by the Selling Stockholder, notwithstanding the existence of the beneficial ownership limitations described above.
Description of the securities 4 changes
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As of the date of this prospectus, our authorized capital stock currently consists of 610,000,000 160,000,000 shares, which are divided into two classes consisting of 600,000,000 150,000,000 shares of common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.01 per share.
As of December 31, 2023, June 5, 2024, there were 26,695,287 2,528,309 shares of common stock outstanding and no shares of preferred stock outstanding. 7,605,484 shares As of common stock June 5, 2024, there are issuable upon the exercise of pre-funded warrants pursuant to the Private Placement, together with the 2023 Common Warrant to purchase up to 21,134,968 shares of common stock with an exercise price of $0.414 per share, and other outstanding warrants to purchase up to 2,816,631 4,014,779 shares of common stock with a weighted average exercise price of $5.16 $4.70 per share. An additional 5,018,800 333,648 shares of common stock are reserved for issuance under our 2020 and 2023 Stock Incentive Plans, of which 2,018,800 133,648 shares of common stock are issuable upon exercise of outstanding options at an average exercise price of $1.89 $28.39 per share.
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 therefor. In the event of liquidation, dissolution or winding up of the Company, holders of common stock are to share in all assets remaining after the payment of liabilities. Holders of common stock have no pre-emptive or conversion rights and are not subject to further calls or assessments. There are no redemption or sinking fund provisions applicable to the common stock. The rights of the holders of the common stock are subject to any rights that may be fixed in the future for holders of preferred stock. All of the outstanding shares of common stock are fully paid and non-assessable.
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Our common stock is listed on The Nasdaq Capital Market under the symbol "GOVX."
Plan of distribution 2 changes
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We agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by a Selling Stockholder without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for us to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with. Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, each Selling Stockholder will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by such Selling Stockholder or any other person. We will make copies of this prospectus available to a Selling Stockholder and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, each Selling Stockholder will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by such Selling Stockholder or any other person. We will make copies of this prospectus available to a Selling Stockholder and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
Experts 1 change
Our consolidated financial statements as of and for the years ended December 31, 2022 2023 and 2021 2022 included in this prospectus and elsewhere in the registration statement have been audited by Wipfli LLP, an independent registered public accounting firm, as indicated in their report with respect thereto, and are included herein in reliance upon the authority of said firm as experts in auditing and accounting in giving said report.
Where you can find more information 2 changes
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Information contained on our website is not a prospectus and does not constitute a part of this prospectus.
Information contained on our website is not a prospectus and does not constitute a part of this prospectus. You should rely only on the information contained in or incorporated by reference or provided in this prospectus. We have not authorized anyone else to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted. You should not assume the information in this prospectus is accurate as of any date other than the date on the front of this prospectus.
Financial statements 38 changes
Condensed Consolidated Balance Sheets as of September 30, 2023 (unaudited) and December 31, 2022 Condensed Consolidated Statements of Operations for the three-month periods ended September 30, 2023 (unaudited) and 2022 Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficiency) for the three-month periods ended September 30, 2023 (unaudited) and December 31, 2022 Condensed Consolidated Statements of Cash Flows for the three-month periods ended September 30, 2023 (unaudited) and December 31, 2022
CONDENSED CONSOLIDATED BALANCE SHEETS
Cash and cash equivalents
Total current assets
Property and equipment, net
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Total current liabilities
Commitments (Note 4)
Stockholders' equity:
Common stock, $ .001 par value:
Authorized shares – 150,000,000 and 600,000,000 at March 31, 2024 and December 31, 2023, respectively Issued and outstanding shares – 2,308,309 and 1,977,152 at March 31, 2024 and December 31, 2023, respectively 2,308 1,977 Additional paid-in capital 110,265,884 110,125,146 Accumulated deficit ( 110,213,917 ) ( 104,363,785 ) Total stockholders' equity 54,275 5,763,338 Total liabilities and stockholders' equity $ 3,358,182 $ 9,283,219 See accompanying notes to condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended March 31,
Research and development
General and administrative
Total operating expenses
Loss from operations
Net loss per common share
Weighted average shares outstanding
See accompanying notes to condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ' EQUITY (Unaudited) Three Months Ended March 31, 2024 Total Common Stock Additional Accumulated Stockholders' Shares Amount Paid-in Capital Deficit Equity Balance at December 31, 2023 1,977,152 $ 1,977 $ 110,125,146 $ ( 104,363,785 ) $ 5,763,338 Issuance of common stock for services 6,703 37,493 - 37,500 Issuance of common stock upon warrant exercise 269,032 ( 269 ) - - Fractional share roundup following reverse split 55,422 ( 55 ) - - Stock option expense - - 103,569 - 103,569 Net loss for the three months ended March 31, 2024 - - - ( 5,850,132 ) ( 5,850,132 ) Balance at March 31, 2024 2,308,309 $ 2,308 $ 110,265,884 $ ( 110,213,917 ) $ 54,275 Three Months Ended March 31, 2023 Total Common Stock Additional Accumulated Stockholders' Shares Amount Paid-in Capital Deficit Equity Balance at December 31, 2022 1,755,664 $ 1,756 $ 104,995,301 $ ( 78,397,023 ) $ 26,600,034 Issuance of common stock for services 7,246 74,993 - 75,000 Stock option expense - - 228,039 - 228,039 Net loss for the three months ended March 31, 2023 - - - ( 4,037,916 ) ( 4,037,916 ) Balance at March 31, 2023 1,762,910 $ 1,763 $ 105,298,333 $ ( 82,434,939 ) $ 22,865,157 See accompanying notes to condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended March 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
Stock-based compensation expense
Changes in assets and liabilities:
Prepaid expenses and other current assets
Accounts payable, accrued expenses and other liabilities
Net cash used in operating activities
Cash flows from investing activities:
Cash flows from financing activities:
Net decrease in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
See accompanying notes to condensed consolidated financial statements.
Notes to the financial statements 181 changes
Years Ended December 31, 2022 and 2021
Description of Business and Recent Developments
1 unchanged paragraph
The Company is focused on developing immunotherapies and vaccines against cancers and infectious diseases and cancers using novel vector vaccine platforms. GeoVax's product pipeline includes ongoing human clinical trials for vaccines against a next-generation Covid-19 vaccine and a gene-directed therapy for advanced head and neck cancer. Additional preclinical research and development programs include preventive vaccines against Mpox (monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever), Zika virus, and malaria, as well as immunotherapies for solid tumors.
1 unchanged paragraph
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of GeoVax Labs, Inc. together with GeoVax, Inc. All intercompany transactions have been eliminated in consolidation.
We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 those accounting policies that we consider significant in determining our results of operations and financial position. During the three months ended March 31, 2024, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.
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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 twelve-month period following the issue date of these consolidated financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates. We expect to incur future net losses and require substantial funds as we continue our research and development activities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our product candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to need to raise additional funding.
The preparation of financial statements in conformity with generally accepted accounting principles (GAAP) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates.
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 high credit quality financial institutions. 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 (generally 5 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 be recognized is measured by the amount by which the carrying amount of the assets exceeds the expected future net cash flows from the assets.
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-party vendors. This process involves identifying services and activities that have been performed by such vendors on our behalf and estimating the level to which they have been performed and the associated cost incurred for such service as of each balance sheet date.
Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company's additional potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 15,442,915 and 3,778,931 shares at December 31, 2022 and 2021, respectively.
We recognize revenue in accordance with FASB Accounting Standards Update 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which created a new Topic, Accounting Standards Codification Topic 606. The standard is principle-based and provides a five-step model to determine when and how revenue is recognized. The core principle is that an entity should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
We receive payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds. From time to time, we may enter into collaborative research and development agreements for specific vaccine development approaches and/or disease indications whereby we receive third-party funding for preclinical research under certain of these arrangements. Each agreement is evaluated in accordance with the process defined by ASU 2014-09 and revenue is recognized accordingly.
Research and Development Expense
Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates. These expenses consist primarily of (i) salaries, benefits, and stock-based compensation for personnel, (ii) laboratory supplies and facility-related expenses to conduct development, (iii) fees paid to third-party service providers to perform, monitor and accumulate data related to our preclinical studies and clinical trials, (iv) costs related to sponsored research agreements, (v) costs to procure and manufacture materials used in clinical trials, and (vi) license fees and other expenses associated with technology license agreements.
We accrue for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies or trials, including clinical trial participant enrollment, completion of events, invoices received and other events. Advance payments for research and development activities are deferred and included in prepaid expenses and other assets. The deferred amounts are expensed as the related goods are delivered or the services are performed.
Our expenditures relating to obtaining and protecting patents are charged to expense when incurred and are included in general and administrative expense.
Period-to-Period Comparisons
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.
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. Stock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Stock-based compensation cost for stock options or warrants is estimated at the grant date based on each instrument's fair value as calculated by the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award. See Note 6 for additional stock-based compensation information.
The accompanying financial statements include the accounts of GeoVax Labs, Inc. and GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. The financial statements are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of interim periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
Since inception, the Company's activities have consisted primarily We are devoting substantially all of performing our present efforts to research and development to advance its technologies. We expect to continue to generate operating losses in the foreseeable future of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. We believe that Our existing cash resources will be sufficient are insufficient to continue our planned operations into beyond the fourth second quarter of 2023. Due to our history of operating losses and our continuing need for capital to conduct our research and development activities, there is substantial doubt concerning our ability to operate as a going concern beyond that date. 2024 without additional funding, which we are currently exploring sources of capital and intend actively pursuing. We plan to fund our future operations through pursue additional private and/or cash resources through public offerings of debt or private equity securities. We also intend to seek additional capital through or debt financings, government grants, grants/contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company's ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company's planned operations, but that our plans do not fully alleviate the substantial doubt about the Company's ability to operate as a going concern. There can be no assurance that additional funding will be available on favorable terms or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back, or eliminate some or all of our research and development programs as well as reduce our general and administrative expenses.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
The accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock split described in Note 5.
Other Recent Accounting Pronouncements
During the three months ended March 31, 2024, there have been no recent new 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.
1 unchanged paragraph
Prepaid Expenses – Prepaid expenses consist of the following: as of December 31, 2022 and 2021:
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Property and Equipment – Property and equipment consist of the following: as of December 31, 2022 and 2021:
4 unchanged paragraphs
Depreciation expense was $ 56,284 and $ 38,521 during the years ended December 31, 2022 and 2021, respectively.
Total property and equipment, net
Other Assets – Other assets consist of the following: as of December 31, 2022 and 2021:
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Accrued license fees (current portion)
Accrued Expenses – Accrued expenses consist of the following: as of December 31, 2022 and 2021:
3 unchanged paragraphs
Other Liabilities – Other liabilities were $ 2,000,000 at December 31, 2021 and consist of the noncurrent portion of accrued technology license fees.
Operating Lease. We lease approximately 8,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2025. Rent expense for the years three-month periods ended December March 31, 2022 2024 and 2021 2023 was $ 176,797 46,764 and $ 166,242 45,414 , respectively. Future minimum lease payments total approximately $ 182,000 in 2023, $ 187,000 140,292 in 2024, and $ 193,000 192,708 in 2025 although the lease may be terminated at any time by either party with one hundred eighty days written notice.
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In June 2021, we repurchased the remaining 100 shares of our Series B convertible preferred stock for a total price of $ 1,000 . There are no shares of our preferred stock outstanding.
2021 Public Offering – On February 11, 2021, we closed an underwritten public offering of 1,644,000 shares of our common stock. Net proceeds after deducting underwriting discounts and commissions and other offering expenses were approximately $ 9.4 million.
2021 Warrant Exercises – During 2021, we issued 740,034 shares of our common stock upon the exercise of warrants, resulting in net proceeds to us of approximately $ 3.4 million, and we issued 149,705 shares of our common stock upon the exercise of 215,672 warrants using the cashless exercise feature of the warrants.
January 2022 Private Placement – On January 19, 2022, we closed a private placement of 707,484 shares of common stock, a pre-funded warrant to purchase 2,360,000 shares of common stock for a nominal exercise price per share and a warrant to purchase 3,067,484 shares of common stock at an exercise price of $ 3.26 per share (the "January 2022 Warrant"). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $ 9.2 million. During March 2022, the pre-funded warrant was exercised in full.
May 2022 Private Placement – On May 27, 2022, we closed a private placement of 1,050,000 shares of common stock, a pre-funded warrant to purchase 11,071,214 shares of common stock for a nominal exercise price per share, and a warrant to purchase 12,121,214 shares of common stock at an exercise price of $ 1.65 per share (the "May 2022 Warrant"). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $ 18.5 million. The pre-funded warrant was exercised as to 1,980,304 shares concurrent with the closing and as to the remaining 9,090,910 shares during June and July. During August, the May 2022 Warrant was exercised as to 4,621,214 shares, resulting in net proceeds to us of approximately $ 7,626,000 .
Other Common Stock Transactions – During 2022 and 2021 we issued 143,500 and 13,707 shares, respectively, of our common stock pursuant to consulting agreements.
Common Stock Reserved for Future Issuance – Common stock reserved for future issuance consists of the following at December 31, 2022:
Stock warrants outstanding
Stock options outstanding
Stock options authorized for future grants
We have two stock-based incentive plans, the 2020 Plan and the 2023 Plan, pursuant to which our Board of Directors may grant stock options to our employees, directors and consultants. A total of 2,250,000 shares of our common stock are currently reserved for issuance pursuant to the 2020 Plan. The exercise price for any option granted may not be less than fair value ( 110 % of fair value for ISO's granted to certain employees). Options have a maximum ten -year term.
A summary of the Company's stock option activity during 2022 is presented below.
Outstanding at December 31, 2021
Forfeited or expired
Outstanding at December 31, 2022
Exercisable at December 31, 2022
The table below summarizes information concerning warrants outstanding as of December 31, 2022, all of which are currently exercisable.
Outstanding at December 31, 2022
As a result of anti-dilution price adjustments related to our equity transactions in January and May 2022, the exercise price of the June 2020 Warrants was reduced from $ 5.00 to $ 1.65 during 2022.
Reverse Stock Split and Reduction of Authorized Shares of Common Stock At a special meeting of our stockholders held on January 16, 2024, our stockholders approved an amendment to our certificate of incorporation to (i) reduce our authorized shares of common stock from 600,000,000 to 150,000,000 and (ii) effect a one-for-fifteen reverse split of our common stock. The amendment to our certificate of incorporation was filed with the Delaware Secretary of State on January 30, 2024 and our common stock began trading on the split-adjusted basis on January 31, 2024. The accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock split.
Common Stock Transactions
During January 2024, we issued 6,703 shares of our common stock pursuant to a professional relations and consulting agreement and we issued 55,422 shares of our common stock for the roundup of fractional shares associated with the reverse stock split. In February and March 2024, we issued 133,032 and 136,000 shares of our common stock, respectively, pursuant to the exercise of prefunded warrants.
We have stock-based incentive plans (the "Plans") pursuant to which our Board of Directors may grant stock options and other stock-based awards to our employees, directors and consultants. During the three months ended March 31, 2024, 961 stock options were cancelled and there were no new grants of stock options or other transactions related to the Plans. As of March 31, 2024, there are 133,648 stock options outstanding, with a weighted-average exercise price of $ 28.39 per share and a weighted-average remaining contractual term of 7.9 years. Including the outstanding stock options, a total of 333,648 shares of our common stock are reserved for future issuance pursuant to the Plans.
Stock Purchase Warrants
We have issued stock purchase warrants in connection with past financing and licensing transactions. As described under "Common Stock Transactions" above, during the three months ended March 31, 2024, we issued 269,032 shares of our common stock pursuant to the exercise of prefunded warrants; there were no other transactions related to our stock purchase warrants. The table below summarizes information concerning warrants outstanding as of March 31, 2024.
Outstanding at March 31, 2024
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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:
Weighted average risk-free interest rates
Expected dividend yield
Expected life of option (in yrs)
The weighted-average grant date fair values of stock options granted during 2022 and 2021 were $ 0.73 and $ 2.87 , respectively. As of December 31, 2022, there is $ 1,449,405 of unrecognized compensation expense that will be recognized over a weighted-average period of 2.0 years.
We also have issued shares of restricted common stock to consultants and recognize the related expense over the terms of the related agreements. As of December 31, 2022, there is $ 24,000 recorded as a prepaid expense for these arrangements, which will be recognized as expense over the terms of the related agreements.
The following table summarizes our total stock-based compensation expense for employees, directors and consultants for the years ended December 31, 2022 and 2021:
Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual individuals to whom the award is awards are granted. Stock-based compensation expense related to stock option grants was $ 103,569 and $ 228,039 during the three-month periods ended March 31, 2024 and 2023, respectively, and as of March 31, 2024, there is $ 451,023 of unrecognized compensation expense that we expect to recognize over a weighted-average period of 1.3 years.
We have also issued shares of our restricted common stock to consultants and recognize the related expense over the terms of the related agreements. During the three-month periods ended March 31, 2024 and 2023 we recorded stock-based compensation expense of $ 54,167 and $ 18,000 , respectively, associated with common stock issued for consulting services.
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and 101 more changes in the filing
Recent Sales of Unregistered Securities 8 changes
On September 28, 2023, we 2021, in connection with entering into an assignment and license agreement, the Company issued 73,385 warrants to PNP Therapeutics, Inc. ("PNP"), exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 6,667 shares of our restricted the Company's common stock to Acorn Management Partners, LLC pursuant to a professional relations and consulting agreement. at an exercise price of $195.00 per share. The Company relied on an exemption from the registration requirements of the Securities Act afforded by Section 4(a) (2) 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 47,166 shares of common stock, 157,333 shares of common stock issuable upon the exercise of a pre-funded warrant (the "January Pre-Funded Warrant") and 204,499 shares of common stock issuable upon the exercise of a warrant (the "2022 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 2022 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.
Effective as of May 1, 2022, 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. In connection with the agreement, we issued 4,567 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 approximately $72,000. 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.
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 606,061 shares of our common stock issuable upon exercise of a pre-funded warrant and a preferred investment option to purchase up to 606,061 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 70,000 shares of our common stock, a pre-funded warrant to purchase up to 132,020 shares of our common stock and a preferred investment option to purchase up to 202,020 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.
On August 10, 2023, Effective as of June 30, 2022, we entered into a Consulting Agreement and Subscription Agreement with Sully Entertainment Group LLC. In July 2022, pursuant to the agreement we issued 178,253 5,000 shares of our restricted common stock to Outside the Box Capital, Inc. pursuant to with Sully Entertainment Group LLC as a professional services agreement. restricted stock award under our 2020 Stock Incentive Plan with a value at that date of approximately $60,750. 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 August 10, 2023, we issued 11,883 shares of our restricted common stock to Outside the Box Capital, Inc. pursuant to a professional services 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 September 28, 2023, we issued 4,892 shares of our restricted common stock to Acorn Management Partners, LLC pursuant to a professional relations and consulting 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 January 2, 2024, we issued 6,703 shares of our restricted common stock to Acorn Management Partners, LLC pursuant to a professional relations and consulting 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.
1 unchanged paragraph
Exhibits 26 changes
Certificate of Incorporation (3)
Summary of the GeoVax Labs, Inc. Director Compensation Plan (31)
Assignment and License Agreement by and between GeoVax, Inc. and PNP Therapeutics, Inc. dated September 28, 2021 (28) 10.13 Exclusive License Agreement by and between GeoVax, Inc. and City of Hope, dated November 9, 2021 (29) 10.13.1 Amendment to Exclusive License Agreement, dated April 11, 2023, between GeoVax, Inc. and City of Hope ( 36 ) 10.14 At The Market Offering Agreement, by and between GeoVax Labs, Inc. and H.C. Wainwright & Co., LLC, dated July 18, 2023 ( 37 ) 10.15 Inducement Letter, dated December 2, 2023 ( 38 ) 23.1 * Consent of Wipfli LLP 23.2 * Consent of Womble Bond Dickenson (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 (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) Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) 107 * Filing fee table * Filed herewith.
Restated Certificate of Incorporation filed April 12, 2024 (25)
Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 13, 2010 (5) 3.1.2 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 27, 2010 (6) 3.1.3 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed August 2, 2013 (7) 3.1.4 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed May 13, 2015 (8) 3.1.5 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed June 14, 2016 (10) 3.1.6 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed August 4, 2017 (11) 3.1.7 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed April 30, 2019 (14) 3.1.8 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed January 21, 2020 (16) 3.1.9 Certificate of Amendment to the Certificate of Incorporation of GeoVax Labs, Inc. filed September 24, 2020 (23) 3.2 Bylaws (3) 4.1 Form of Stock Certificate representing the Company's Company ' s Common Stock, par value $0.001 per share (20) 4.1.1 (24) 4.2 Form of Common Stock Purchase Warrant, dated September 29, 2020 (22) 4.1.2 Form of Representative's Warrant Agreement, dated September 29, 2020 (21) 4.1.3 (11) 4.3 Form of Warrant Agent Agreement (21) 4.1.4 (10) 4.4 Form of Warrant issued to certain Management Creditors, dated September 29, 2020 (21) 4.1.5 (10) 4.5 Form of Common Stock Purchase Warrant, dated June 26, 2020 (19) 4.1.6 (9) 4.6 Form of Underwriters Warrant Agreement dated February 11, 2021 (26) 4.1.7 (14) 4.7 Form of Common Stock Purchase Warrant, dated September 28, 2021 (28) 4.1.8 Form of (16) 4.8 Common Stock Purchase Warrant, dated January 19, 2022 (30) 4.1.9 December 2, 2023 (23) 4.9 Form of Preferred Investment Option, Pre-Funded Warrant, dated May 27, 2022 (32) 4.2 21, 2024 (26) 4.10 Form of Common Stock Purchase Warrant, dated December 2, 2023 ( 38 ) May 21, 2024 (26) 5.1* * Opinion of Womble Bond Dickenson Dickinson (US) LLP 10.1** ** Employment Agreement between GeoVax Labs, Inc. and David A. Dodd (12) (5) 10.2** ** Employment Agreement between GeoVax, Inc. and Mark W. Reynolds (4) (3) 10.2.1** ** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Mark W. Reynolds (8) (4) 10.3** ** Employment Agreement between GeoVax, Inc. and Mark J. Newman, PhD, as Amended and Restated March 9, 2022 (31) (18) 10.3.1** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Mark J. Newman, PhD (33) (19) 10.4** ** Consulting Agreement by and between GeoVax, Inc. and Kelly T. McKee, MD, dated December 22, 2021 (31) II-3 10.4.1 ** Employment Agreement between GeoVax, Inc. and Kelly T. McKee, MD (35) 10.4.2 ** (21) 10.4.1** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and Kelly T. McKee, MD (35) (21) 10.5** ** Employment Agreement between GeoVax, Inc. and John W. Sharkey, PhD (33) (19) 10.5.1** ** Amendment No. 1 to Employment Agreement between GeoVax Labs, Inc. and John W. Sharkey, PhD (33) (19) 10.6** ** GeoVax Labs, Inc. 2020 Stock Incentive Plan, as amended and restated August 11, 2021 (18) (8) 10.6.1** ** Form of Non-Qualified Stock Option Agreement (2020 Stock Incentive Plan) (27) (15) 10.6.2** GeoVax Labs, Inc. 2023 Stock Incentive Plan (34) (20) 10.7 License Agreement (as amended and restated) between GeoVax, Inc. and Emory University (2) 10.8 Patent and Biological Materials License Agreement with the National Institute of Allergy and Infectious Diseases, dated October 22, 2020 (24) (12) 10.9 Patent and Biological Materials License Agreement for Internal Research Use with the National Institute of Allergy and Infectious Diseases, dated November 25, 2020 (25) (13) 10.10 Office and Laboratory Lease between UCB, Inc. and GeoVax, Inc. (17) (7) 10.10.1 Amendment to Office Lease Agreement between UCB, Inc. and GeoVax, Inc. (35). (21) 10.11 Summary of the GeoVax Labs, Inc. Director Compensation Plan (18) 10.12 Assignment and License Agreement by and between GeoVax, Inc. and PNP Therapeutics, Inc. dated September 28, 2021 (16) 10.13 Exclusive License Agreement by and between GeoVax, Inc. and City of Hope, dated November 9, 2021 (17) 10.13.1 Amendment to Exclusive License Agreement, dated April 11, 2023, between GeoVax, Inc. and City of Hope (22) 10.14 Inducement Letter, dated December 2, 2023 (23) 10.15 Securities Purchase Agreement, dated May 16, 2024 (26) 21.1 Subsidiaries of the Registrant (6) 23.1* Consent of Wipfli LLP (U.S. PCAOB Auditor Firm ID 344) 23.2* Consent of Womble Bond Dickinson (US) LLP (included in Exhibit 5.1) 107* Filing Fee Table 101.INS Inline XBRL Instance Document (1) 101.SCH Inline XBRL Taxonomy Extension Schema Document (1) 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document (1) 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document (1) 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document (1) 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document (1) II-4 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) * Filed herewith.
Indicates a management contract or compensatory plan or arrangement.
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.
Incorporated by reference from the registrant's Current Report on Form 8-K filed October 4, 2006.
1 unchanged paragraph
Incorporated by reference from the registrant's Current Report on Form 8-K filed April 14, 2010.
Incorporated by reference from the registrant's Current Report on Form 8-K filed April 28, 2010.
Incorporated by reference from the registrant's Current Report on Form 8-K filed August 2, 2013.
1 unchanged paragraph
Incorporated by reference from the registrant's Current Report on Form 8-K filed August 4, 2017.
Incorporated by reference from the registraint's Current Report on Form 8-K filed September 7, 2018 (13) [reserved] (14) Incorporated by reference from the registraint's Current Report on Form 8-K filed April 30, 2019 (15) [reserved] (16) Incorporated by reference from the registrant's Current Report on Form 8-K filed January 21, 2020.
Incorporated by reference from the registrant's Current Report on Form 8-K filed May 14, 2015. September 7, 2018.
Incorporated by reference from the registrant's Current Quarterly Report on Form 8-K 10-Q filed June 16, 2016. November 7, 2019.
3 unchanged paragraphs
Incorporated by reference from the registrant's Current Report on Form 8-K filed September 25, 2020.
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 (22) 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.
Incorporated by reference from the Amendment No. 2 4 to registrant's Registration Statement on Form S-1 (File No. 333-239958) filed August 26, September 23, 2020.
5 unchanged paragraphs
Incorporated by reference from the registrant's Current Report on Form 8-K filed January 20, 2022.
Incorporated by reference from the registrant's Current Report on Form 8-K filed November 10, 2021. Pursuant to Item 399 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted as (i) the Company has determined the omitted information is not material and (ii) the Company customarily and actually treats the omitted information as private or confidential.
1 unchanged paragraph
Incorporated by reference from the registrant's Current Report on Form 8-K filed May 27, 2022.
4 unchanged paragraphs
Incorporated by reference from the registrant's Current Report on Form 8-K filed July 18, 2023.
1 unchanged paragraph
Incorporated by reference from the registrant's Current Report on Form 8-K filed January 31, 2024.
and 3 more changes in the filing
Undertakings 4 changes
13 unchanged paragraphs
12 unchanged paragraphs
and 4 more changes in the filing
Unchanged: About this prospectus, Forward-looking statements, Determination of offering price, Dividend policy, Legal matters, Other Expenses of Issuance and Distribution, Indemnification of Directors and Officers
Only in this filing: Note 5: Stockholders ' Equity
Compared by code from the two drafts’ text: offering terms first, then sections and risk factors added or removed, numbers that moved, and rewording. No model wrote this list. Not investment advice.
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