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What changed in GeoVax Labs, Inc.'s 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of GeoVax Labs, Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+231 added−232 removedSource: 10-K (2024-02-29) vs 10-K (2023-03-23)

Top changes in GeoVax Labs, Inc.'s 2023 10-K

231 paragraphs added · 232 removed · 181 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

111 edited+24 added−25 removed124 unchanged
Biggest changeGV-MVA-VLP-Zika followed by GV-MVA-VLP-Ebola) can be given at 4 week intervals without any negative impact on their immunogenicity (lack of vector immunity). ● No need for adjuvants: MVA generally stimulates strong innate immune responses and does not require the use of adjuvants. ● Protection against MPOX and SPOX: MVA vectored vaccines have been previously shown to provide potential protection against MPOX/SPOX. ● Thermal stability: MVA is stable in both liquid and lyophilized formats (> 6 years of storage). ● Genetic stability and manufacturability: If appropriately engineered, MVA is genetically stable and can reliably be manufactured in either the established Chick Embryo Fibroblast cell substrate, or novel continuous cell lines that support scalability as well as greater process consistency and efficiency.
Biggest changeGV-MVA-VLP-Zika followed by GV-MVA-VLP-Ebola) can be given at ● No need for adjuvants : MVA generally stimulates strong innate immune responses and does not require the use of adjuvants. ● Protection against Mpox and Smallpox : MVA vectored vaccines have been previously shown to provide potential protection against Mpox and Smallpox. ● Thermal stability : MVA is stable in both liquid and lyophilized formats (> 6 years of storage). ● Genetic stability and manufacturability : If appropriately engineered, MVA is genetically stable and can reliably be manufactured in either the established Chick Embryo Fibroblast cell substrate, or novel continuous cell lines that support scalability as well as greater process consistency and efficiency. 8 Government Regulation Regulation by governmental authorities in the United States and other countries is a significant factor in our ongoing research and development activities and in the manufacture of our products.
The steps required before a human vaccine may be marketed in the United States include: ● Preclinical laboratory tests, in vivo preclinical studies and formulation studies; ● Manufacturing and testing of the product under strict compliance with current Good Manufacturing Practice (cGMP) regulations; ● Submission to the FDA of an Investigational New Drug application for human clinical testing which must become effective before human clinical trials can commence; ● Adequate and well-controlled human clinical trials to establish the safety and efficacy of the product; ● The submission of a Biologics License Application to the FDA, along with the required user fees; and ● FDA approval of the BLA prior to any commercial sale or shipment of the product 8 Before marketing any drug or biologic for human use in the United States, the product sponsor must obtain FDA approval.
The steps required before a human vaccine may be marketed in the United States include: ● Preclinical laboratory tests, in vivo preclinical studies and formulation studies; ● Manufacturing and testing of the product under strict compliance with current Good Manufacturing Practice (cGMP) regulations; ● Submission to the FDA of an Investigational New Drug application for human clinical testing which must become effective before human clinical trials can commence; ● Adequate and well-controlled human clinical trials to establish the safety and efficacy of the product; ● The submission of a Biologics License Application to the FDA, along with the required user fees; and ● FDA approval of the BLA prior to any commercial sale or shipment of the product Before marketing any drug or biologic for human use in the United States, the product sponsor must obtain FDA approval.
We provide our employees with competitive compensation, opportunity for equity ownership, and a robust employment package that promotes wellness across all aspects of their lives, including healthcare, retirement planning, and paid time off. Corporate Background Our primary business is conducted by our wholly owned subsidiary, GeoVax, Inc., which was incorporated under the laws of Georgia in June 2001.
We provide our employees with competitive compensation, opportunity for equity ownership, and a robust employment package that promotes wellness across all aspects of their lives, including healthcare, retirement planning, and paid time off. 16 Corporate Background Our primary business is conducted by our wholly owned subsidiary, GeoVax, Inc., which was incorporated under the laws of Georgia in June 2001.
We expect our vaccines may not only protect at-risk individuals against EBOV, SUDV, MARV and LASV, but also potentially reduce or modify the severity of other re-emerging pathogens such as Bundibugyo, Ivory Coast, and Reston viruses, based on antigenic cross reactivity and the elicitation of T cells to the more conserved matrix proteins (e.g.
We expect our vaccines may not only protect at-risk individuals against EBOV, SUDV and MARV, but also potentially reduce or modify the severity of other re-emerging pathogens such as Bundibugyo, Ivory Coast, and Reston viruses, based on antigenic cross reactivity and the elicitation of T cells to the more conserved matrix proteins (e.g.
We face general market competition from several subsectors of the vaccine development field, including large, multinational pharmaceutical companies including Sanofi, GSK, Merck, Janssen, Mitsubishi Tanabe, Takeda, and Pfizer, Inc.; mid-size pharmaceutical companies and emerging biotechnology companies including Dynavax, Novavax Inc., Moderna, BioNTech, Bavarian Nordic and Hookipa; and academic and not-for-profit vaccine researchers and developers including the NIH.
We face general market competition from several subsectors of the vaccine development field, including large, multinational pharmaceutical companies including Sanofi, GSK, Merck, Janssen, Mitsubishi Tanabe, Takeda, and Pfizer; mid-size pharmaceutical companies and emerging biotechnology companies including Dynavax, Novavax Inc., Moderna, BioNTech and Bavarian Nordic; and academic and not-for-profit vaccine researchers and developers including the NIH.
Additionally, we expect to benefit, where appropriate, from statutory frameworks in the United States, Europe, and other countries that provide a period of clinical data exclusivity to compensate for the time required for regulatory approval of our clinical product candidates. 11 We continually assess and refine our intellectual property strategies as we develop new technologies and product candidates.
Additionally, we expect to benefit, where appropriate, from statutory frameworks in the United States, Europe, and other countries that provide a period of clinical data exclusivity to compensate for the time required for regulatory approval of our clinical product candidates. We continually assess and refine our intellectual property strategies as we develop new technologies and product candidates.
Our Hemorrhagic Fever Virus Vaccines (Ebola Zaire, Ebola Sudan, Marburg and Lassa) Ebola (EBOV, formerly designated as Zaire ebolavirus), Sudan (SUDV), and Marburg viruses (MARV) are the most virulent species of the Filoviridae family, causing hemorrhagic fever illnesses with up to a 90% fatality rate in humans.
Our Hemorrhagic Fever Virus Vaccines (Ebola Zaire, Ebola Sudan, Marburg) Ebola (EBOV, formerly designated as Zaire ebolavirus), Sudan (SUDV), and Marburg viruses (MARV) are the most virulent species of the Filoviridae family, causing hemorrhagic fever illnesses with up to a 90% fatality rate in humans.
We believe that this capability puts us in the position to be the first supplier of MVA-based vaccines to implement such a transformative manufacturing process and becoming the first U.S.-based supplier of the MVA vaccine to prevent Mpox (monkeypox), Smallpox and other pox-related viruses.
We believe that this capability puts us in the position to be the first supplier of MVA-based vaccines to implement such a transformative manufacturing process and becoming the first U.S.-based supplier of the MVA vaccine to prevent Mpox, Smallpox and other pox-related viruses.
These suppliers operate under the FDA’s Good Manufacturing Practices and (in the case of European manufacturers) similar regulations of the European Medicines Agency. We anticipate that these suppliers will be able to provide sufficient vaccine supplies to complete our currently planned clinical trials.
These suppliers operate under the FDA’s Good Manufacturing Practices and (in the case of European manufacturers) similar regulations of the European Medicines Agency. We anticipate that these suppliers will be able to provide sufficient supplies to complete our currently planned clinical trials.
The modifications also resulted in the loss of immune evasion genes which assist the spread of wild type smallpox infections, even in the presence of human immune responses. 7 We collaborated with the laboratory of Dr.
The modifications also resulted in the loss of immune evasion genes which assist the spread of wild type smallpox infections, even in the presence of human immune responses. We collaborated with the laboratory of Dr.
We also make available our Code of Business Conduct on this website under the heading “Investors – Corporate Governance”. Information contained on our website is not incorporated into this Annual Report. 16
We also make available our Code of Business Conduct on this website under the heading “Investors – Corporate Governance”. Information contained on our website is not incorporated into this Annual Report.
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 conclude that GEO-CM04S1 and sMVA represent unique vaccine candidates to control the unforeseen global MPox outbreak.
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 represent unique vaccine candidates to control the unforeseen global Mpox outbreak.
Applications have been filed in the United States, Argentina, Australia, Brazil, Canada, China, Hong Kong, the European Patent Office, Israel, Japan, South Korea, Mexico, South Africa, and Taiwan. The patent applications in these families, if issued, valid, and enforceable, will expire in 2021, exclusive of any patent term adjustments or extensions. We have non-exclusively in-licensed from the U.S.
Applications have been filed in the United States, Argentina, Australia, Brazil, Canada, China, Hong Kong, the European Patent Office, Israel, Japan, South Korea, Mexico, South Africa, and Taiwan. The patent applications in these families, if issued, valid, and enforceable, will expire in 2041, exclusive of any patent term adjustments or extensions. We have non-exclusively in-licensed from the U.S.
Finn has shown that a combination of our MVA-VLP-MUC1 vaccine candidate with a MUC1 synthetic peptide was capable of breaking tolerance to human MUC1 in transgenic mice and inducing immune responses with efficacy against challenge in a lymphoma tumor model. ● In 2022, we initiated potentially IND enabling small animal studies with Dr.
Finn has shown that a combination of our MVA-VLP-MUC1 vaccine candidate with a MUC1 synthetic peptide was capable of breaking tolerance to human MUC1 in transgenic mice and inducing immune responses with efficacy against challenge in a lymphoma tumor model. ● In 2022, we initiated potential IND enabling small animal studies with Dr.
We believe that our current facilities are adequate to meet our immediate needs, but that if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms. Human Capital Resources We currently have fourteen full-time employees. None of our employees are covered by collective bargaining agreements and we believe that our employee relations are good.
We believe that our current facilities are adequate to meet our immediate needs, but that if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms. Human Capital Resources We currently have seventeen full-time employees. None of our employees are covered by collective bargaining agreements and we believe that our employee relations are good.
We design our vaccines such that, when VLPs for enveloped viruses like HIV, Ebola, Marburg or Lassa fever are produced in vivo (in the cells of the recipient), they include not only the protein antigens, but also an envelope consisting of membranes from the vaccinated individual’s cells.
We design our vaccines such that, when VLPs for enveloped viruses like HIV, Ebola or Marburg are produced in vivo (in the cells of the recipient), they include not only the protein antigens, but also an envelope consisting of membranes from the vaccinated individual’s cells.
The Company’s portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 115 granted or pending patent applications spread over 24 patent families, which are discussed in greater detail in the “Our Intellectual Property” section.
The Company’s portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 155 granted or pending patent applications spread over 24 patent families, which are discussed in greater detail in the “Our Intellectual Property” section.
HIV – Due to our corporate refocusing of development efforts prioritizing our SARS-CoV-2 and cancer immunotherapy programs, and to a lack of continuing government support for our HIV vaccine development efforts, in early 2022 we decided to discontinue active development of these programs.
HIV – Due to our corporate refocusing of development efforts prioritizing our SARS-CoV-2 and cancer immunotherapy programs, and to a lack of continuing government support for our HIV vaccine development efforts, in early 2022 we decided to suspend active development of these programs.
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.
Given the serious impact of other respiratory viruses in this vulnerable patient population, it is anticipated that hematology recipients of cell therapy may develop severe clinical disease, profoundly impacting morbidity and survival. Increasingly, there is evidence of the high risk of severe morbidity, hospitalization and death resulting from SARS-CoV-2 in hematology patients.
We wholly own one patent family, including one granted U.S. patent (US 11,098,086), directed to specific vaccine administration methods which, where issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments or extensions.
We wholly own one patent family, including two granted U.S. patents (US 11,098,086 and US 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.
The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted. Recent Government Initiatives US Regulators and Senior White House and Congressional Leaders have announced multiple objectives and initiatives in 2023 that may impact GeoVax.
The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted. 9 Recent Government Initiatives US Regulators and Senior White House and Congressional Leaders have recently announced multiple objectives and initiatives that may impact GeoVax.
Unlike conventional therapies (e.g. radiation, chemotherapy, antibody, etc.), therapeutic cancer vaccines have the potential to induce responses that not only result in the control and even clearance of tumors but also establish immunological memory that can suppress and prevent tumor recurrence.
Unlike conventional therapies (e.g. radiation, chemotherapy, antibody, etc.), therapeutic cancer vaccines have the potential to induce responses that not only contribute to the control of tumors but also establish immunological memory that can suppress and prevent tumor recurrence.
Now, after exploring various approaches to growing MVA in continuous cell lines in bioreactors more suitable for high-yield, commercial-scale manufacturing, we will accelerate activities towards fully implementing a proprietary, continuous cell line manufacturing system that will provide lower-cost, scalable versatility for broad MVA vaccine and immunotherapy applications.
After exploring various approaches to growing MVA, utilizing continuous avian cell lines in bioreactors more suitable for high-yield, commercial-scale manufacturing, we have accelerated activities towards fully implementing a proprietary, continuous avian cell line manufacturing system that will provide lower-cost, scalable versatility for broad MVA vaccine and immunotherapy applications.
In response to the global need to address the continued emerging threat from MPox and the unique opportunity offered by MVA-based vaccines, GeoVax recently secured rights from the NIH covering preclinical, clinical and commercial uses of the NIH-MVA against MPox or SPox viruses.
In response to the global need to address the continued emerging threat from Mpox and the unique opportunity offered by MVA-based vaccines, in November 2022, GeoVax secured rights from the NIH covering preclinical, clinical and commercial uses of the NIH-MVA against Mpox or smallpox viruses.
The in-licensed patent families are directed to synthetic MVA vectors, including synthetic MVA vaccines encoding one or more SARS-CoV-2 antigens, and their methods of production and use, and encompass COH04S1, a multi-antigenic SARS-CoV-2 vaccine currently undergoing Phase 2 human clinical trials.
The in-licensed patent families are directed to synthetic MVA vectors, including synthetic MVA vaccines encoding one or more SARS-CoV-2 antigens, and their methods of production and use including for the prevention of a coronavirus and monkeypox infection, and encompass COH04S1, a multi-antigenic pan-SARS vaccine currently undergoing Phase 2 human clinical trials.
Priority review means that the FDA aims to render a decision in 6 months. 9 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.
Priority review means that the FDA aims to render a decision in 6 months. The PRV may be sold. For example, a small company might win a voucher for developing a drug for a neglected disease and sell the voucher to a large company for use on a commercial disease. The price of the voucher depends on supply and demand.
The Company also issued a warrant to PNP, exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 100,000 shares of the Company’s common stock at an exercise price of $13.00 per share.
The Company also issued a warrant to PNP, exercisable at any time following March 28, 2022, and prior to September 28, 2026, for up to 6,667 shares of the Company’s common stock at an exercise price of $195.00 per share.
Additional research and development programs include preventive vaccines against Monkeypox (MPox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa) and Zika virus, as well as immunotherapies for multiple solid tumors.
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.
GEO-CM04S1 for Immunocompromised Patients – The CDC and other global public health agencies identify immunocompromised patients, including patients who have received therapeutic procedures for hematologic malignancy, as highest risk for SARS-CoV-2 disease.
GEO-CM04S1 for Immunocompromised/Cell Transplant Patients – The CDC and other global public health agencies identify immunocompromised patients, including patients who have received treatment for hematologic malignancy, as highest risk for SARS-CoV-2 disease.
This approach induces immune responses with greater breadth of specificity. Secondly, MVA is known to effectively induce T-cell responses in addition to antibodies and the responses are durable. Third, MVA replicates minimally in mammalian cells which contributes to it being an extremely safe vaccine platform for human vaccines.
This approach induces immune responses with greater breadth of specificity. ● MVA is known to effectively induce T-cell responses in addition to antibodies and the responses are durable. ● MVA does not replicate in human cells which contributes to it being an extremely safe vaccine platform for human vaccines.
Indication Current Status Coronavirus Vaccines COVID-19 (Booster to mRNA vaccines) Clinical – Phase 2 COVID-19 (Primary vaccine for immunocompromised patients) Clinical – Phase 2 Pan Coronavirus Preclinical/IND-Enabling Cancer Therapy Solid Tumors (Advanced Head and Neck Cancer)* Clinical – Phase 1/2 Solid Tumors (MUC1) Preclinical/IND-Enabling Other Infectious Disease Vaccines Monkeypox (MPox) & Smallpox (SPox) Preclinical/IND-Enabling Hemorrhagic Fever Viruses Preclinical/IND-Enabling Ebola Zaire** Ebola Sudan** Marburg** Lassa Fever** Zika** Preclinical/IND-Enabling Malaria** Exploratory * Orphan Drug status granted ** Indication within FDA Priority Review Voucher program 1 Our Coronavirus Vaccine Programs COVID-19, caused by the SARS-CoV-2 virus, a serious public health issue of international concern.
Indication Current Status Coronavirus/Covid-19 Vaccines Booster to mRNA vaccines Clinical – Phase 2 (enrollment completed) Primary vaccine for immunocompromised/cell transplant patients Clinical – Phase 2 (actively enrolling) Booster for immunocompromised/CLL patients Clinical – Phase 2 (actively enrolling) Cancer Therapy Solid Tumors (Advanced Head and Neck Cancer)* Clinical – Phase 1/2 (enrollment completed) Solid Tumors (MUC1) Preclinical/IND-Enabling Other Infectious Disease Vaccines Mpox & smallpox Preclinical/IND-Enabling Hemorrhagic Fever Viruses Ebola Zaire** Preclinical/IND-Enabling Ebola Sudan** Marburg** Zika** Preclinical/IND-Enabling Malaria** Exploratory * Orphan Drug status granted ** Indication within FDA Priority Review Voucher program 1 Our Coronavirus Vaccine Programs Severe respiratory illnesses caused by the SARS-CoV-2 virus, remain a serious public health issue of international concern.
National Institutes of Health (NIH) 3 patent families directed to certain aspects of our MVA-viral backbone used in our SARS-CoV2 vaccine, which will expire between 2023 and 2032, exclusive of any patent term adjustments or extensions. We have non-exclusively in-licensed from the NIH 2 patent families relating to coronavirus spike protein compositions relevant to our MVA SARS-CoV2 vaccine candidates.
National Institutes of Health (NIH) 2 patent families directed to certain aspects of our MVA-viral backbone used in our SARS-CoV2 vaccine, which will expire between 2027 and 2032. We have non-exclusively in-licensed from the NIH 2 patent families relating to coronavirus spike protein compositions relevant to our MVA SARS-CoV2 vaccine candidates.
Currently, MVA vaccines are manufactured in cells cultured from chicken embryonic fibroblasts (CEF), a suboptimal and time-consuming process useful primarily for niche markets and stockpile reserves.
Transition to high-yield, scalable MVA manufacturing process – Currently, MVA vaccines are manufactured in cells cultured from chicken embryonic fibroblasts (CEF), a suboptimal and time-consuming process useful primarily for niche markets and stockpile reserves.
We are developing our GV-MVA-VLP™ vaccine platform that is based on the aberrantly glycosylated forms of the cell surface-associated MUC1 protein that is expressed on a wide range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung, with the goal of raising therapeutic anti-tumor antibodies and T cell responses in cancer patients. ● We have produced a MVA-VLP-MUC1 vaccine candidate, demonstrated VLP production by electron microscopy using MUC1 immunogold staining, and showed that the VLPs express a hypo-glycosylated form of MUC1 in human cell lines. ● We collaborated with Dr.
Currently, there are only a few vectored cancer vaccines being tested in combination with ICIs, all of which are in early clinical stages. 4 We are developing our GV-MVA-VLP™ vaccine platform, which is based on the aberrantly glycosylated forms of the cell surface-associated MUC1 protein, and is expressed on a wide range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung, with the goal of raising therapeutic anti-tumor antibodies and T cell responses in cancer patients. ● We have produced a MVA-VLP-MUC1 vaccine candidate, demonstrated VLP production by electron microscopy using MUC1 immunogold staining, and showed that the VLPs express a hypo-glycosylated form of MUC1 in human cell lines. ● We collaborated with Dr.
The patent applications of these families, where issued, valid, and enforceable, will expire between 2037-2040, exclusive of any patent term adjustments or extensions. 12 We wholly own one pending patent family directed to various MVA-based vaccines for the treatment of SARS CoV-2.
Applications are pending in the United States, Australia, Canada, China, and 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. We wholly own one pending patent family directed to various MVA-based vaccines for the treatment of SARS CoV-2.
The patent applications in this patent family, if issued, valid, and enforceable, will expire in 2043, exclusive of any patent term adjustments or extensions. We co-own two patent families with Leidos, Inc. directed to viral constructs for use in enhancing T-cell priming during vaccination.
The patent applications for these families, where issued, valid, and enforceable, will expire between 2037 and 2041, exclusive of any patent term adjustments or extensions. We co-own with Leidos, Inc. one patent family directed to viral constructs for use in enhancing T-cell priming during vaccination.
The field of immuno-oncology has received new momentum with the discovery and commercial launch of immune checkpoint inhibitors (ICIs), a type of monoclonal antibodies (Mabs). ICIs block the naturally occurring and tumor-induced immune checkpoints, thus allowing functional T cells to more fully restore cellular proliferation, cytokine production and killing of tumor cells.
The field of immuno-oncology has received new momentum with the discovery and commercial launch of immune checkpoint inhibitors (ICIs), a type of monoclonal antibodies (Mabs). ICIs block the naturally occurring and tumor-induced immune checkpoints, thus allowing T cells to more fully function and respond against tumor cells.
The primary objectives were to evaluate the safety, tolerability and immunogenicity of the GEO-CM04S1 in healthy volunteers who were administered the vaccine at three different dose levels by intramuscular (IM) injection. Follow-up studies of the volunteers are continuing in order to better assess duration of immune responses.
The primary objectives were to evaluate the safety, tolerability and immunogenicity of the GEO-CM04S1 administered at three different dose levels by intramuscular (IM) injection. Follow-up studies of the volunteers are continuing to better characterize their immune responses.
The Phase 1 portion of the trial was designed as a dose-escalation safety study in healthy individuals between the ages of 18 to 55, who had not been previously infected with SARS-CoV-2.
The Phase 1 trial of GEO-CM04S1 (known at the time as COH-CM04S1) was designed as a dose-escalation safety study in healthy individuals between the ages of 18 to 55, who had not been previously infected or vaccinated with SARS-CoV-2.
We have in-licensed patents from Emory University and the U.S. National Institutes of Health (NIH) relevant to our HIV-vaccine program. These patents will expire between 2022 and 2028, exclusive of any patent term adjustments or extensions.
We have in-licensed one patent from Emory University and the U.S. National Institutes of Health (NIH) relevant to our HIV-vaccine program. This patent expires in 2028, exclusive of any patent term adjustments or extensions.
Incorporation of other sequence-conserved structural and nonstructural proteins will provide targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses. This strategy provides the basis for generating a universal vaccine with augmented potential to alleviate the burden of disease caused by circulating coronaviruses.
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.
These include: - Supporting the development of innovative vaccine platforms facilitating the production of a next generation broader performing COVID vaccine – GeoVax’s MVA-VLP platform is a logical candidate given the features and benefits noted throughout this report. - The reshoring and protection of the domestic biotech ecosystem – GeoVax represents the first domestic source for SPox and MPox production which is currently controlled by a single foreign entity. - Replenishing the US stockpile with additional vaccines addressing MPOX and Hemorrhagic Fevers – GeoVax has multiple products in advanced stages of development. - Assisting African countries in their quest to prevent an array of debilitating illnesses including those caused by hemorrhagic fever viruses Fevers – GeoVax has multiple products in advanced stages of development.
These include: - Project NextGen and the Rapid Response Partnership Vehicle (RRPV) -- Supporting the Biomedical Advanced Research and Development Authority (BARDA) in its objective to develop innovative vaccine platforms facilitating the production of a next generation broader performing Covid vaccines – GeoVax’s MVA-vectored Covid-19 vaccine candidates (e.g., GEO-CM04S1) is a logical candidate given the features and benefits noted throughout this report. - The reshoring and protection of the domestic biotech ecosystem – GeoVax represents the first domestic source for Smallpox and Mpox production which is currently controlled by a single foreign entity. - Replenishing the US stockpile with additional vaccines addressing Mpox and Hemorrhagic Fevers – GeoVax has multiple products in advanced stages of development. - Assisting African countries in their quest to prevent an array of debilitating illnesses including those caused by hemorrhagic fever viruses Fevers – GeoVax has multiple products in advanced stages of development.
The trial design involves repeat administration using Gedeptin followed by systemic fludarabine, as a way to gain additional information prior to expansion towards a larger patient trial. The initial stage of the study is being funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program.
The 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 MTA is royalty-free, non-exclusive, and worldwide. 13 We cannot be certain that any of the current pending patent applications we have or have licensed, or any new patent applications we may file or license, will ever be issued in the United States or any other country.
We cannot be certain that any of the current pending patent applications we have or have licensed, or any new patent applications we may file or license, will ever be issued in the United States or any other country.
We believe our technology therefore provides distinct advantages by producing VLPs that more closely resemble the authentic viruses. We believe this feature of our immunogens allows the body’s immune system to more readily recognize the virus. By producing VLPs in vivo , we believe we also avoid potential purification issues associated with in vitro production of VLPs.
We believe our technology therefore provides distinct advantages by producing VLPs that more closely resemble the authentic viruses. We believe this feature of our immunogens allows the body’s immune system to more readily recognize the virus.
As of December 31, 2022, our owned, co-owned, and in-licensed patent estate, on a worldwide basis, includes 20 granted or allowed U.S. patent applications, 13 pending U.S. patent applications; 53 granted foreign patents, 47 pending foreign patent applications, 1 Patent Cooperation Treaty (PCT) application, and 2 U.S. provisional applications spread over 23 patent families.
As of December 31, 2023, our owned, co-owned, and in-licensed patent estate, on a worldwide basis, includes 17 granted or allowed U.S. patent applications, 17 pending U.S. patent applications; 63 granted foreign patents, 62 pending foreign patent applications, 3 Patent Cooperation Treaty (PCT) application, and 2 U.S. provisional applications spread over 24 patent families.
This rVSV-ZEBOV showed safety concerns in Phase 1 trials and by virtue of being replication competent could pose threats to immunocompromised individuals, such as those infected with HIV living in West Africa where recent Ebola epidemics started.
In December 2019, FDA approved the first live recombinant Ebola vaccine for prevention of Ebola disease by Zaire virus. This rVSV-ZEBOV showed safety concerns in Phase 1 trials and by virtue of being replication competent could pose threats to immunocompromised individuals, such as those infected with HIV living in West Africa where recent Ebola epidemics started.
To date, there has been no clinical trial of an approved vaccine focused on immunocompromised patients. Thus, 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.
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.
As a result of the combination of these properties, MVA is an ideal vaccine vector platform for the design of the next generation Covid-19 vaccines, especially in targeting patient populations with compromised immune systems.
As a result of the combination of these properties, MVA is an ideal vaccine vector platform for the design of the next generation Covid-19 vaccines.
Competitors, however, may receive approval of either a different product for the same indication or the same product for a different indication; in the latter case, because health care professionals are free to prescribe products for off-label uses, the competitor’s product could be used for the orphan indication despite our orphan exclusivity.
Competitors, however, may receive approval of either a different product for the same indication or the same product for a different indication; in the latter case, because health care professionals are free to prescribe products for off-label uses, the competitor’s product could be used for the orphan indication despite our orphan exclusivity. 14 We are not a party to any litigation, opposition, interference, or other potentially adverse proceeding with regard to our patent positions.
Modified Vaccinia Ankara (MVA) is the vaccine vector platform utilized in a number of our vaccine candidates. There are several advantages to vaccines based on the MVA vectors. Firstly, MVA has a large genetic coding capacity which provides the foundation for vaccines based on multiple SARS-CoV-2 proteins, instead of the singular focus on the S protein.
There are several potential advantages to SARS-CoV-2 vaccines based on MVA vectors: ● MVA has a large genetic coding capacity which provides the foundation for vaccines based on multiple SARS-CoV-2 proteins, instead of the singular focus on the S protein.
We wholly own one allowed U.S. patent application directed to preventive vaccines against Ebola virus, and one pending U.S. patent application directed to Marburg virus and uses thereof. These applications, where issued, valid, and enforceable, will expire in 2036, exclusive of any patent term adjustments or extensions.
We wholly own one granted U.S. patent (US 11,701,418) directed to preventive vaccines against Ebola virus, and one granted U.S. patent (US 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.
These in-licensed NIH patents and patent applications, if and where issued, valid, and enforceable, will expire between 2023 and 2032, exclusive of any patent term adjustments or extensions.
These applications, where issued, valid, and enforceable, will expire in 2038, exclusive of any patent term adjustments or extensions.
These studies, which are ongoing, include assessment of the therapeutic benefit the vaccine in combination with a synthetic peptide, adjuvant and immune checkpoint inhibitor using a human MUC1 transgenic mouse model to optimally match existing and previously tested cancer treatment regimens. 4 MVA as Smallpox (SPox) and Monkeypox (MPox) Vaccine MVA was originally developed for use as a smallpox (SPox) vaccine more than 30 years ago.
These studies, which are ongoing, include assessment of the therapeutic benefit the vaccine in combination with a synthetic peptide, adjuvant and immune checkpoint inhibitor using a human MUC1 transgenic mouse model to optimally match existing and previously tested cancer treatment regimens.
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) 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.
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.
These results further validate the ability of the MVA-VLP platform to stimulate a robust T-cell response to various diseases. 6 Our GV-MVA-VLP ™ Platform GeoVax’s GV-MVA-VLP™ vaccine platform utilizes Modified Vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine.
Our GV-MVA-VLP ™ Platform GeoVax’s GV-MVA-VLP™ vaccine platform utilizes Modified Vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine.
Manufacturing To be successful, our products must be manufactured in commercial quantities in compliance with regulatory requirements and at an acceptable cost. To date, we have not commercialized any products, nor have we demonstrated that we can manufacture commercial quantities of our product candidates in accordance with regulatory requirements.
To date, we have not commercialized any products, nor have we demonstrated that we can manufacture commercial quantities of our product candidates in accordance with regulatory requirements.
These in-licensed NIH patents will expire in 2023, exclusive of any patent term extensions. The MVA backbone that we have been using in our vaccines was provided to us by the laboratory of Dr. Bernard Moss of the NIAID, Laboratory of Viral Diseases (LVD).
The MVA backbone that we have been using in our vaccines was provided to us by the laboratory of Dr. Bernard Moss of the NIAID, Laboratory of Viral Diseases (LVD).
The study is designed as a dose-escalation trial to specifically evaluate the safety profile and immunogenicity of COH04S1 as a booster. The immunological responses measured throughout the study will include the level of SARS-CoV-2 neutralizing antibodies against SARS-CoV-2 variants of concern (VOC), including the Omicron and Delta VOCs, as well as specific T-cell responses.
The study is designed as a comparison trial to evaluate the safety profile and immunogenicity of 2 dose levels of GEO-CM04S1 when administered as a heterologous booster. The immunological responses measured throughout the study will include SARS-CoV-2 neutralizing antibody and T-cell responses against SARS-CoV-2 variants of concern (VOC), including the Delta and contemporaneous Omicron variants.
GEO-CM04S1 is being studied in an ongoing Phase 2 clinical trial (NCT04977024) to evaluate its safety and immunogenicity, 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.
In November 2021, GeoVax entered into a license agreement with COH, granting GeoVax exclusive worldwide rights to further develop and commercialize the vaccine. 2 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.
The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.
The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. This trial will guide the design of larger studies involving patients at earlier stages in the disease process.
We have exclusively in-licensed three patent families from the City of Hope in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of COVID-19 pursuant to an Exclusive License Agreement entered into on November 9, 2021.
The MTA is royalty-free, non-exclusive, and worldwide. 13 We have exclusively in-licensed five patent families from the City of Hope in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of coronaviruses, including Covid-19, pursuant to an Exclusive License Agreement entered into on November 9, 2021, and as further amended on April 11, 2023.
NIH Licenses – On December 16, 2022, the Company entered into a Clinical Materials Transfer Agreement (MVA Vaccine Agreement) under which the Company has the right to develop and commercialize the unmodified (parental) MVA 1974/NTH Clone l strain as a vaccine against MPOX and SPOX.
NIH Licenses – On December 16, 2022, the Company entered into a Clinical Materials Transfer Agreement (MVA Vaccine Agreement) under which the Company has the right to develop and commercialize the unmodified (parental) MVA 1974/NTH Clone l strain as a vaccine against Mpox and smallpox. 15 On November 25, 2020, the Company entered into a Patent and Biological Materials License Agreement for Internal Research Use (the “Research License”) with the U.S.
Because GEO-CM04S1 is designed to stimulate potent humoral and cellular immune responses against both the S and N proteins of SARS-CoV-2, GeoVax believes its administration as a booster will provide additional antigenic targets to the immune system resulting in a broader immune response.
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 than that seen after mRNA vaccine boosting.
As such, an added potential benefit of our vaccines is that in those regions where MPox or SPox are of concern, vaccines built on an MVA vaccine platform will likely provide protection against MPox and SPox. MVA is the vaccine currently used and stockpiled in the US Strategic National Stockpile for immunization against the monkeypox (MPox) and smallpox (SPox) viruses.
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.
A number of companies are developing various types of therapeutic vaccines or other immunotherapy approaches to treat cancer including Advaxis, Immune Design, Oncothyreon, Bavarian Nordic, Roche Pharmaceuticals, Merck & Co, Bristol Myers Squibb, and AstraZeneca plc. There are currently no FDA licensed and commercialized Zika vaccines, or hemorrhagic fever virus vaccines (other than for Ebola) available in the world market.
A number of companies are developing various types of therapeutic vaccines or other immunotherapy approaches to treat cancer including Advaxis, Immune Design, Oncothyreon, Bavarian Nordic, Roche Pharmaceuticals, Merck & Co, Bristol Myers Squibb, and AstraZeneca plc.
Convenience, safety, and low toxicity of cancer vaccines could make them invaluable tools to be included in future immunotherapy approaches in combination with ICIs for treating tumors. Currently, there are only a few vectored cancer vaccines being tested in combination with ICIs, all of which are in early clinical stages.
Convenience, safety, and low toxicity of cancer vaccines could make them invaluable tools to be included in future immunotherapy approaches in combination with ICIs for treating tumors.
We wholly own one allowed U.S. patent application directed to preventive vaccines against Zika virus and uses thereof. This application, 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 11,638,750) directed to preventive vaccines against Zika virus and uses thereof. This patent where issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments. We wholly own two granted U.S. patents (U.S. 11,311,612 and US 11,857,611) directed to preventive vaccines against malaria and use thereof.
We cannot be sure that we can manufacture, either on our own or through contracts with third parties, such products at a cost or in quantities that are commercially viable. We do not currently have the facilities or internal expertise to manufacture any of the clinical or commercial supplies of any of our product.
We cannot be sure that we can manufacture, either on our own or through contracts with third parties, such products at a cost or in quantities that are commercially viable.
The COVID License provides GeoVax with nonexclusive rights to develop, manufacture and commercialize its COVID-19 vaccine and includes access to NIAID’s patent rights in the stabilized SPIKE protein, which is the protein that SARS-CoV-2 uses to gain entry into human tissue. 15 Research and Development Our expenditures for research and development activities were $9.1 million and $15.6 million during the years ended December 31, 2022 and 2021, respectively.
The Covid License provides GeoVax with nonexclusive rights to develop, manufacture and commercialize its Covid-19 vaccine and includes access to NIAID’s patent rights in the stabilized SPIKE protein, which is the protein that SARS-CoV-2 uses to gain entry into human tissue.
Rather, our strategy is to rely on third-party contract manufacturers to produce vaccines needed for research and clinical trials. We have arrangements with third party manufacturers for the supply of our DNA and MVA vaccines for use in our planned clinical trials.
Rather than establishing the necessary facilities to manufacture any of the clinical or commercial supplies of our products, our strategy is to rely on established, recognized third-party contract manufacturers to produce materials needed for research and clinical trials. We have arrangements with third party manufacturers for the supply of products for use in our planned clinical trials.
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.
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.
Our current patent portfolio includes 4 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.
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. 12 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.
A Phase 1/2 trial (NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options was initiated at the Stanford University Cancer Institute.
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.
This product currently is serving as the foundation for further internal experimental design and small animal model testing focusing on the use of highly conserved viral nonstructural proteins as additional T-cell immunogens to further increase the functional and specificity of induced immune responses. 3 Our Cancer Therapy Programs Gedeptin ® – Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT).
This program currently is serving as the foundation for further internal experimental design and small animal model testing focusing on the use of highly conserved viral nonstructural proteins as additional T-cell immunogens to further increase the functional and specificity of induced immune responses.
These in-licensed City of Hope patent families, if issued, valid, and enforceable, will expire between 2041 and 2042, exclusive of any patent term adjustments or extensions. We have exclusively in-licensed two patent families from the University of Alabama and the Southern Research Institute pursuant to an Assignment and License Agreement with PNP Therapeutics, Inc. entered into on September 28, 2021.
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 trial is also the first to compare an investigational multi-antigenic SARS-CoV-2vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccines from Pfizer/BioNTech and Moderna in people who are immunocompromised.
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.
To the extent that our commercial partners, collaborators, employees, and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. 14 License Agreements City of Hope License – On November 9, 2021, we entered into an Exclusive License Agreement (COH License) with City of Hope (COH), a California nonprofit public benefit corporation, under which the Company obtained exclusive worldwide rights to further develop and commercialize COH04S1, a multi-antigenic SARS-CoV-2 vaccine currently undergoing Phase 2 human clinical trials.
Primary License Agreements City of Hope License – On November 9, 2021, we entered into an Exclusive License Agreement (COH License) with City of Hope (COH), a California nonprofit public benefit corporation, under which the Company obtained exclusive worldwide rights to further develop and commercialize COH04S1, a multi-antigenic SARS-CoV-2 vaccine currently undergoing Phase 2 human clinical trials.
MVA has an outstanding safety record, which is particularly important given the need to include women of child-bearing age and newborns among those being vaccinated.
To address the unmet need for a ZIKV vaccine, we are developing novel vaccine candidates constructed using our GV-MVA-VLP platform. MVA has an outstanding safety record, which is particularly important given the need to include women of child-bearing age and newborns among those being vaccinated.
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. This has required the adjustment of vaccine composition and the administration of booster doses. Recently, the FDA indicated the likely need for continued vaccine adjustments and yearly boosters, similar to the approach used for influenza virus vaccines.
Unfortunately, the continued adaptation and mutation of SARS-CoV-2 has resulted in the emergence of variants that are not optimally neutralized by antibodies induced by currently available vaccines, reducing clinical efficacy. This has required the continued adjustment of vaccine composition and the repeated administration of booster doses.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe cannot assure investors that financing will be available in amounts or on terms acceptable to us, if at all. We are obligated to issue additional shares of our common stock in connection with our outstanding warrants if the warrant holders choose to exercise them.
Biggest changeThe sale of additional equity securities could result in significant additional dilution to our stockholders. The incurrence of indebtedness could result in debt service obligations and operating and financing covenants that would restrict our operations. We cannot assure investors that financing will be available in amounts or on terms acceptable to us, if at all.
Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for our intellectual property is uncertain.
Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for our intellectual property is uncertain.
Only limited protection may be available and may not adequately obtain, maintain, protect, and enforce our rights or permit us to gain or keep any competitive advantage.
Only limited protection may be available and may not adequately obtain, maintain, protect, and enforce our rights or permit us to gain or keep any competitive advantage.
Concerns about the safety and efficacy of our products could limit our future success. ● We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects. ● Failure to obtain timely regulatory approvals required to exploit the commercial potential of our products could increase our future development costs or impair our future sales. ● State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities. ● Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations. ● We may not be successful in establishing collaborations for product candidates we seek to commercialize, which could adversely affect our ability to discover, develop, and commercialize products. ● We do not have manufacturing, sales or marketing experience. ● Our products under development may not gain market acceptance. ● We may be required to defend lawsuits or pay damages for product liability claims. ● Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance.
Concerns about the safety and efficacy of our products could limit our future success. ● We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects. ● Failure to obtain timely regulatory approvals required to exploit the commercial potential of our products could increase our future development costs or impair our future sales. ● State pharmaceutical marketing compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities. ● Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations. 17 ● We may not be successful in establishing collaborations for product candidates we seek to commercialize, which could adversely affect our ability to discover, develop, and commercialize products. ● We do not have manufacturing, sales or marketing experience. ● Our products under development may not gain market acceptance. ● We may be required to defend lawsuits or pay damages for product liability claims. ● Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance.
Risks Related to Our Intellectual Property ● Our success depends on our ability to obtain, maintain, protect and enforce our intellectual property and our proprietary technologies. ● We could lose our license rights to our important intellectual property if we do not fulfill our contractual obligations to our licensors. ● Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products. 17 ● Any inability to protect our or our licensors’ intellectual property rights in the United States and foreign countries could limit our ability to prevent others from manufacturing or selling our products. ● Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates. ● The patent protection and patent prosecution for our product candidates is dependent in part on third parties.
Risks Related to Our Intellectual Property ● Our success depends on our ability to obtain, maintain, protect and enforce our intellectual property and our proprietary technologies. ● We could lose our license rights to our important intellectual property if we do not fulfill our contractual obligations to our licensors. ● Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products. ● Any inability to protect our or our licensors’ intellectual property rights in the United States and foreign countries could limit our ability to prevent others from manufacturing or selling our products. ● Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates. ● The patent protection and patent prosecution for our product candidates is dependent in part on third parties.
In particular, the patent landscape in the COVID-19 vaccine space is crowded, and a large number of patent applications have been filed by numerous entities since January 2020, including for the use of certain SARS-CoV-2 antigens and antigenic combinations, including from Moderna, Janssen Pharmaceuticals, Inc., Sementis LTD., VaxBio, Inc., Oxford University, BioNTech, Ichan School of Medicine at Mount Sinai, Diosynvax LTD., The University of Alberta, and Tonix Pharmaceuticals.
In particular, the patent landscape in the Covid-19 vaccine space is crowded, and a large number of patent applications have been filed by numerous entities since January 2020, including for the use of certain SARS-CoV-2 antigens and antigenic combinations, including from Moderna, Janssen Pharmaceuticals, Inc., Sementis LTD., VaxBio, Inc., Oxford University, BioNTech, Ichan School of Medicine at Mount Sinai, Diosynvax LTD., The University of Alberta, University of Texas, and Tonix Pharmaceuticals.
Any such inability to continue as a going concern may result in our stockholders losing their entire investment. There is no guarantee that we will become profitable or secure additional financing on acceptable terms. Our business will require continued funding. If we do not receive adequate funding, we may not be able to continue our operations.
Any such inability to continue as a going concern may result in our stockholders losing their entire investment. There is no guarantee that we will become profitable or secure additional financing on acceptable terms. 18 Our business will require continued funding. If we do not receive adequate funding, we may not be able to continue our operations.
Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product candidates and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.
Because patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product candidates and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.
Any litigation or interference proceedings, regardless of their outcome, would likely delay the regulatory approval process, be costly and require significant time and attention of our key management and technical personnel. 23 Any inability to protect our or our licensors ’ intellectual property rights in the United States and foreign countries could limit our ability to prevent others from manufacturing or selling our products.
Any litigation or interference proceedings, regardless of their outcome, may delay the regulatory approval process, be costly and require significant time and attention of our key management and technical personnel. 23 Any inability to protect our or our licensors ’ intellectual property rights in the United States and foreign countries could limit our ability to prevent others from manufacturing or selling our products.
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 million for the year ended December 31, 2022.
Since our inception, we have incurred operating losses each year due to costs incurred in connection with research and development activities and general and administrative expenses associated with our operations. We incurred a net loss of approximately $26 million for the year ended December 31, 2023.
Our Certificate of Incorporation, as amended, does not require the vote of a larger percentage of shares. As permitted under the Delaware General Corporation Law, our Bylaws give our board of directors the power to adopt, amend, or repeal our Bylaws.
Our Certificate of Incorporation, as amended, does not require the vote of a larger percentage of shares. As permitted under the Delaware General Corporation Law, our Bylaws give our board of directors the power to adopt, amend, or repeal our Bylaws. Our stockholders entitled to vote have concurrent power to adopt, amend, or repeal our Bylaws.
Risks Related to Our Common Stock ● The market price of our common stock is highly volatile. ● The sale or issuance of additional shares of our common stock or other equity securities could result in additional dilution to our stockholders. ● Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control. ● We have never paid dividends and have no plans to do so. ● Public company compliance may make it more difficult for us to attract and retain officers and directors. ● Our Certificate of Incorporation and Bylaws may be amended by the affirmative vote of a majority of our stockholders. ● Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules. ● We may be delisted from the Nasdaq Stock Market Risks Related to Our Business and Capital Requirements We have a history of operating losses, and we expect losses to continue for the foreseeable future.
Risks Related to Our Common Stock ● The market price of our common stock is highly volatile. ● The sale or issuance of additional shares of our common stock or other equity securities could result in additional dilution to our stockholders. ● Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control. ● We have never paid dividends and have no plans to do so. ● Public company compliance may make it more difficult for us to attract and retain officers and directors. ● Our Certificate of Incorporation and Bylaws may be amended by the affirmative vote of a majority of our stockholders. ● Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules.
Therefore, it will be necessary for us to look to other sources of funding to finance our development activities. 18 We expect that our current working capital will be sufficient to support our planned level of operations into the fourth quarter of 2023.
Therefore, it will be necessary for us to look to other sources of funding to finance our development activities. We expect that our current working capital will be sufficient to support our planned level of operations into the second quarter of 2024.
As with the FDA, we cannot predict if or when we may obtain these regulatory approvals. If we cannot demonstrate that our products can be used safely and successfully in a broad segment of the patient population on a long-term basis, our products would likely be denied approval by the FDA and the regulatory agencies of foreign governments.
If we cannot demonstrate that our products can be used safely and successfully in a broad segment of the patient population on a long-term basis, our products would likely be denied approval by the FDA and the regulatory agencies of foreign governments.
The shares of preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our Board of Directors without further action by the stockholders.
Our certificate of incorporation authorizes our Board of Directors to issue up to 10,000,000 shares of preferred stock. The shares of preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our Board of Directors without further action by the stockholders.
The manufacture, use and sale of biologic products have been subject to substantial patent litigation in the biopharmaceutical industry. Such lawsuits often relate to the validity or infringement of patents or other proprietary rights of third parties.
Our success will depend in part on our ability to operate without infringing the patents and proprietary rights of third parties. The manufacture, use and sale of biologic products have been subject to substantial patent litigation in the biopharmaceutical industry. Such lawsuits often relate to the validity or infringement of patents or other proprietary rights of third parties.
We cannot predict whether our products will be approved by the FDA. Even if they are approved, we cannot predict the time frame for approval. Foreign regulatory requirements differ from jurisdiction to jurisdiction and may, in some cases, be more stringent or difficult to meet than FDA requirements.
Even if they are approved, we cannot predict the time frame for approval. Foreign regulatory requirements differ from jurisdiction to jurisdiction and may, in some cases, be more stringent or difficult to meet than FDA requirements. As with the FDA, we cannot predict if or when we may obtain these regulatory approvals.
We have not had and do not have primary control over these activities for our patents or patent applications and other intellectual property rights. We cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights.
We cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights.
If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates. 19 Regulatory and legal uncertainties could result in significant costs or otherwise harm our business. To manufacture and sell our products, we must comply with extensive domestic and international regulation.
The ability to attract and retain personnel is adversely affected by our financial challenges. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates. 19 Regulatory and legal uncertainties could result in significant costs or otherwise harm our business.
A U.S. broker-dealer selling penny stock to anyone other than an established customer or “accredited investor” (generally, an individual with net worth in excess of $1,000,000 (exclusive of personal residence) or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to the transaction prior to sale, unless the broker-dealer or the transaction is otherwise exempt.
The additional sales practice and disclosure requirements imposed upon U.S. broker-dealers may discourage broker-dealers from effecting transactions in shares of our common stock, which could severely limit the market liquidity of such shares and impede their sale in the secondary market. 27 A U.S. broker-dealer selling penny stock to anyone other than an established customer or “accredited investor” (generally, an individual with net worth in excess of $1,000,000 (exclusive of personal residence) or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to the transaction prior to sale, unless the broker-dealer or the transaction is otherwise exempt.
In addition, the securities markets from time-to-time experience significant price and volume fluctuations that are unrelated to the operating performance of particular companies.
In addition, the securities markets from time-to-time experience significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.
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.
Risks Related to Our Business and Capital Requirements We have a history of operating losses, and we expect losses to continue for the foreseeable future. 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.
If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize products that we develop. 22 Risks Related to Our Intellectual Property Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies In general, our commercial success will depend in part on our and our licensors’ ability to obtain, maintain, protect, and enforce our intellectual property and proprietary technologies, including patent protection and trade secret protection for our product candidates, proprietary technologies and their uses as well as our ability to operate without infringing, misappropriating, or otherwise violating the intellectual property rights of others.
In general, our commercial success will depend in part on our and our licensors’ ability to obtain, maintain, protect, and enforce our intellectual property and proprietary technologies, including patent protection and trade secret protection for our product candidates, proprietary technologies and their uses as well as our ability to operate without infringing, misappropriating, or otherwise violating the intellectual property rights of others.
Litigation or interference proceedings could force us to: ● stop or delay selling, manufacturing or using products that incorporate, or are made using the challenged intellectual property; ● pay damages; or ● enter into licensing or royalty agreements that may not be available on acceptable terms, if at all.
If a third party were to assert an infringement claim against us in the future with respect to our current products or with respect to products that we may develop or license, such litigation or interference proceedings could force us to: ● stop or delay selling, manufacturing or using products that incorporate, or are made using the challenged intellectual property; ● pay damages; or ● enter into licensing or royalty agreements that may not be available on acceptable terms, if at all.
In order to meet our operating cash flow needs, we may plan additional offerings of our equity securities, debt, or convertible debt instruments. The sale of additional equity securities could result in significant additional dilution to our stockholders. The incurrence of indebtedness could result in debt service obligations and operating and financing covenants that would restrict our operations.
The sale or issuance of additional shares of our common stock or other equity securities could result in additional dilution to our stockholders. In order to meet our operating cash flow needs, we may plan additional offerings of our equity securities, debt, or convertible debt instruments.
The SEC has adopted a number of rules to regulate “penny stocks” that restrict transactions involving stock which is deemed to be penny stock. Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may have the effect of reducing the liquidity of penny stocks.
Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may have the effect of reducing the liquidity of penny stocks.
In order to sell our products in the United States, approval from the U.S. Food and Drug Administration (the “FDA”) is required. Satisfaction of regulatory requirements, including FDA requirements, typically takes many years, and if approval is obtained at all, it is dependent upon the type, complexity and novelty of the product, and requires the expenditure of substantial resources.
Satisfaction of regulatory requirements, including FDA requirements, typically takes many years, and if approval is obtained at all, it is dependent upon the type, complexity and novelty of the product, and requires the expenditure of substantial resources. We cannot predict whether our products will be approved by the FDA.
Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control. Our certificate of incorporation authorizes our Board of Directors to issue up to 10,000,000 shares of preferred stock.
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. 26 Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control.
Gilead Scis. Inc ., 941 F.3d 1149 (Fed. Cir. 2019), and Amgen Inc. v. Sanofi , 987 F.3d 1080 (Fed. Cir. 2021) have significantly heightened the standard for securing broad claims to pharmaceutical and biological products.
Gilead Scis. Inc ., 941 F.3d 1149 (Fed. Cir. 2019), and Amgen Inc. v. Sanofi , 598 U.S. 594 (2023) have significantly heightened the standard for securing broad claims to pharmaceutical and biological products. In addition, recent Federal Circuit rulings such as In re Cellect , 81 F.4th 1216 (Fed.
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.
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.
Should we become bankrupt or otherwise unable to fulfill our contractual obligations, our licensors could terminate our rights to critical technology that we rely upon.
Should we become bankrupt or otherwise unable to fulfill our contractual obligations, our licensors could terminate our rights to critical technology that we rely upon. Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products.
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.
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.
Risks Related to Development and Commercialization of Product Candidates and Dependence on Third Parties ● Our products are still being developed and are unproven. These products may not be successful. ● We depend upon key personnel who may terminate their employment with us at any time.
These products may not be successful. ● We depend upon key personnel who may terminate their employment with us at any time.
Our stockholders entitled to vote have concurrent power to adopt, amend, or repeal our Bylaws. 27 Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules.
Broker-dealers may be discouraged from effecting transactions in shares of our common stock if we are considered to be a penny stock and thus subject to the penny stock rules. The SEC has adopted a number of rules to regulate “penny stocks” that restrict transactions involving stock which is deemed to be penny stock.
If we do not receive adequate funding, we may not be able to continue our operations. ● Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business. ● Our business could be adversely affected by widespread public health epidemics or other catastrophic events beyond our control.
If we do not receive adequate funding, we may not be able to continue our operations. ● Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business. 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.
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.
Removed
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.
Added
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.
Removed
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.
Added
To manufacture and sell our products, we must comply with extensive domestic and international regulation. In order to sell our products in the United States, approval from the U.S. Food and Drug Administration (the “FDA”) is required.
Removed
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.
Added
If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize products that we develop. 22 Risks Related to Our Intellectual Property Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies.
Removed
Other parties may claim that we infringe their intellectual property or proprietary rights, which could cause us to incur significant expenses or prevent us from selling products Our success will depend in part on our ability to operate without infringing the patents and proprietary rights of third parties.
Added
Cir. 2023) have expanded the bases for invalidating a patent under the judicially created doctrine of obviousness-type double patenting.
Removed
We expect to be subject to infringement claims from time to time in the ordinary course of business, and third parties could assert infringement claims against us in the future with respect to our current products or with respect to products that we may develop or license.
Added
We have not had and do not have primary control over these activities for some of our in-licensed patents or patent applications and other intellectual property rights.
Removed
These market fluctuations may also materially and adversely affect the market price of our common stock. 26 The sale or issuance of additional shares of our common stock or other equity securities could result in additional dilution to our stockholders.
Added
We are obligated to issue additional shares of our common stock in connection with our outstanding warrants if the warrant holders choose to exercise them. There are warrants exercisable for approximately 2.0 million shares, 374,000 of which are prefunded ($-0- exercise price) with the remainder having a weighted-average exercise price of $14.58.
Removed
There are warrants exercisable for approximately13.4 million shares at exercise prices ranging from $1.65 to $13.00 per share. The exercise of these warrants will cause us to issue additional shares of our common stock and will dilute the percentage ownership of our shareholders.
Removed
The additional sales practice and disclosure requirements imposed upon U.S. broker-dealers may discourage broker-dealers from effecting transactions in shares of our common stock, which could severely limit the market liquidity of such shares and impede their sale in the secondary market.
Removed
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.
Removed
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.
Removed
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.
Removed
If we do not meet these continued listing requirements, our common stock could be delisted.
Removed
On December 9, 2022, we received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that, for the preceding 30 consecutive business days, the closing bid price for the Company’s common stock was below the minimum $1.00 per share requirement for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2).
Removed
In accordance with Nasdaq rules, the Company has been provided an initial period of 180 calendar days, or until June 7, 2023 (the “Compliance Date”), to regain compliance.
Removed
If the Company does not regain compliance with the Bid Price Requirement by the Compliance Date and is not eligible for an additional compliance period at that time, the Nasdaq staff will provide written notification to the Company that its common stock will be subject to delisting.
Removed
The Nasdaq Staff Deficiency Letter has no immediate effect on the listing or trading of our common stock.
Removed
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.
Removed
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.
Removed
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. 28

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe believe that our current facilities are adequate to meet our immediate needs and that if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.
Biggest changeWe believe that our current facilities are adequate to meet our immediate needs and that if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms. 28

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeFINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 35 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 35 ITEM 9A. CONTROLS AND PROCEDURES 35 ITEM 9B. OTHER INFORMATION 36
Biggest changeFINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 36 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 36
ITEM 4. MINE SAFETY DISCLOSURES 29 PART II 29 ITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 29 ITEM 6. RESERVED 29 ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 30 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 35 ITEM 8.
ITEM 4. MINE SAFETY DISCLOSURES 29 PART II 29 ITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 29 ITEM 6. RESERVED 29 ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 30 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 36 ITEM 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is currently traded on The Nasdaq Capital Market under the symbol “GOVX”. Holders On March 15, 2022, there were 15 holders of record of our common stock.
Biggest changeITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is currently traded on The Nasdaq Capital Market under the symbol “GOVX”. Holders On February 29, 2024, there were 14 holders of record of our common stock.
Recent Sales of Unregistered Securities There were no sales of unregistered securities during the period covered by this report that have not previously been reported on a Current Report on Form 8-K or a Quarterly Report Form 10-Q. Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the fourth quarter of 2022.
Recent Sales of Unregistered Securities There were no sales of unregistered securities during the period covered by this report that have not previously been reported on a Current Report on Form 8-K or a Quarterly Report Form 10-Q. Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the fourth quarter of 2023.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeOur programs are in various stages of development, the most significant of which are summarized below: ● GEO-CM04S1 is currently undergoing a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy as a preventive COVID-19 vaccine 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.
Biggest changeOur programs are in various stages of development, the most significant of which are summarized below along with recent developments: GEO-CM04S1 – Immunocompromised/Cell Transplant Trial ● GEO-CM04S1 is currently undergoing a Phase 2 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). ● 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.
Research and development costs are expensed as incurred and consist primarily of the following: ● personnel costs in our research, development and regulatory functions, which include salaries, benefits and stock-based compensation; 30 ● expenses incurred under agreements with contract research organizations (“CROs”), that conduct clinical trials on our behalf; ● expenses incurred under agreements with contract manufacturing organizations (“CMOs”), that manufacture product used in the clinical trials; ● expenses incurred in procuring materials and for analytical and release testing services required to produce vaccine candidates used in clinical trials; ● process development expenses incurred internally and externally to improve the efficiency and yield of the bulk vaccine; ● laboratory supplies, vendor expenses and other third-party contract expenses related to preclinical research activities; ● technology license fees; ● consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and ● facilities, depreciation and other general overhead expenses.
Research and development costs are expensed as incurred and consist primarily of the following: • personnel costs in our research, development and regulatory functions, which include salaries, benefits and stock-based compensation; • expenses incurred under agreements with contract research organizations (“CROs”), that conduct clinical trials on our behalf; • expenses incurred under agreements with contract manufacturing organizations (“CMOs”), that manufacture product used in the clinical trials; • expenses incurred in procuring materials and for analytical and release testing services required to produce vaccine candidates used in clinical trials; • process development expenses incurred internally and externally to improve the efficiency and yield of the bulk vaccine; • laboratory supplies, vendor expenses and other third-party contract expenses related to preclinical research activities; • technology license fees; • consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and • facilities, depreciation and other general overhead expenses.
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. 34
If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates.
We expect our research and development expenditures to increase during 2023 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 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.
Our significant accounting policies are summarized in Note 2 to our consolidated financial statements for the year ended December 31, 2022, which are included in this Form 10-K.
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 Form 10-K.
Overview GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and solid tumor cancers using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human clinical trials for a next-generation COVID-19vaccine and a gene-directed therapy against advanced head and neck cancer.
Overview and Recent Developments GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and solid tumor cancers using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human clinical trials for a next-generation Covid-19 vaccine and a gene-directed therapy against advanced head and neck cancer.
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.
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 ASC 606 and revenue is recognized accordingly.
Additional research and development programs include preventive vaccines against Monkeypox (MPox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa) and Zika virus, as well as immunotherapies for multiple solid tumors.
Additional research and development programs include preventive vaccines against Mpox and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), Zika virus and malaria, as well as immunotherapies for multiple solid tumors.
We have funded our operations to date primarily from sales of our equity securities and from government grants and clinical trial assistance. As of the date of this Annual Report, we expect our existing cash and cash equivalents will be sufficient to fund our operations into the fourth quarter of 2023.
We have funded our operations to date primarily from sales of our equity securities and from government grants and clinical trial assistance. As of the date of this Annual Report, we expect our existing cash and cash equivalents will be sufficient to fund our operations through the second quarter of 2024.
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.
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. 33 The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities.
We are subject to all of the risks incident to the development of new products, and may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating as a public company and anticipate that we will need substantial additional funding in connection with our continuing operations.
We are subject to all of the risks incident to the development of new products, and may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Funding Requirements and Sources of Capital To date, we have not generated any product revenue. We do not know when, or if, we will generate any product revenue and we do not expect to generate significant product revenue unless and until we obtain regulatory approval and commercialize one of our current or future product candidates.
We do not know when, or if, we will generate any product revenue and we do not expect to generate significant product revenue unless and until we obtain regulatory approval and commercialize one of our current or future product candidates.
We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements: 31 Revenue Recognition 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.
We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements: Revenue Recognition We recognize revenue in accordance with FASB Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606).
The increase during 2022 relates primarily to higher personnel costs (including the use of external consultants), patent costs, investor relations consulting costs, and travel expenses. General and administrative expense for 2022 and 2021 includes stock-based compensation expense of $677,043 and $273,173, respectively, associated with employee and consultant stock options and stock awards.
The increase during 2023 relates primarily to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses. General and administrative expense for 2023 and 2022 includes stock-based compensation expense of $783,863 and $677,043, respectively, associated with employee and consultant stock options and stock awards.
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.
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. 35 We have based our projections of operating capital requirements on assumptions that may prove to be incorrect, and we may use our available capital resources sooner than we expect.
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.
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. 32 General and administrative expenses Our general and administrative expenses consist primarily of personnel costs in our executive, finance and investor relations, business development and administrative functions, including stock-based compensation.
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.
Our grant revenues relate to grants and contracts from agencies of the U.S. government in support of our vaccine development activities. We record revenue associated with these grants as the related costs and expenses are incurred.
Research and development expense for 2022 and 2021 includes stock-based compensation expense of $225,031 and $96,814, respectively, associated with employee stock options. General and Administrative Expenses Our general and administrative expenses were $4,986,611 for the year ended December 31, 2022, as compared to $3,577,153 for 2021, representing an increase of $1,409,458 (39%).
Research and development expense for 2023 and 2022 includes stock-based compensation expense of $291,094 and $225,031, respectively, associated with employee stock options. General and Administrative Expenses Our general and administrative expenses were $6,022,173 for the year ended December 31, 2023, as compared to $4,983,611 for 2022, representing an increase of $1,035,562 (21%).
Net cash used in operating activities of $11,196,420 for 2021 was primarily due to our net loss of $18,570,317, offset by non-cash items such as depreciation expense, stock-based compensation expense and the gain recognized on debt extinguishment, and by changes in our working capital accounts.
Net cash used in operating activities of $19,030,208 for 2022 was primarily due to our net loss of $14,021,125, offset by non-cash items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts.
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.
The increase during 2023 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.
Liquidity and Capital Resources The following tables summarize our liquidity and capital resources as of December 31, 2022 and 2021, and our cash flows for the years then ended: As of December 31, Liquidity and Capital Resources 2022 2021 Cash and cash equivalents $ 27,612,732 $ 11,423,870 Working capital 24,190,836 6,193,756 Year Ended December 31, Cash Flow Data 2022 2021 Net cash provided by (used in): Operating activities $ (19,030,208 ) $ (11,196,420 ) Investing activities (134,258 ) (47,718 ) Financing activities 35,353,328 12,784,212 Net increase in cash and cash equivalents $ 16,188,862 $ 1,540,074 Operating Activities – Net cash used in operating activities of $19,030,208 for 2022 was primarily due to our net loss of $14,021,125, offset by non-cash items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts.
The variances between years are primarily attributable to the cash available for investment and to interest rate fluctuations. 34 Liquidity and Capital Resources The following tables summarize our liquidity and capital resources as of December 31, 2023 and 2022, and our cash flows for the years then ended: As of December 31, Liquidity and Capital Resources 2023 2022 Cash and cash equivalents $ 6,452,589 $ 27,612,732 Working capital 4,365,861 24,190,836 Year Ended December 31, Cash Flow Data 2023 2022 Net cash provided by (used in): Operating activities $ (25,173,639 ) $ (19,030,208 ) Investing activities (48,946 ) (134,258 ) Financing activities 4,062,442 35,353,328 Net increase (decrease) in cash and cash equivalents $ (21,160,143 ) $ 16,188,862 Operating Activities – Net cash used in operating activities of $25,173,639 for 2023 was primarily due to our net loss of $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.
As of December 31, 2022, all grant funds available for use directly by GeoVax have been expended. Research and Development Expenses 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%).
As of December 31, 2022, all grant funds available for use directly by GeoVax were expended. Research and Development Expenses Our research and development expenses were $20,720,766 for the year ended December 31, 2023, as compared to $9,123,479 for 2022, representing an increase of $11,597,287 (127%).
Investing Activities – Net cash used in investing activities was $134,258 and $47,718 for 2022 and 2021, respectively, and relates to purchases of property and equipment. 33 Financing Activities – Net cash provided by financing activities was $35,353,328 for 2022, consisting of (i) aggregate net proceeds of $27,727,194 from offerings of our common stock and (ii) $7,626,134 of net proceeds from the exercise of warrants.
Net cash provided by financing activities was $35,353,328 for 2022, consisting of (i) aggregate net proceeds of $27,727,194 from offerings of our common stock and (ii) $7,626,134 of net proceeds from the exercise of warrants. Funding Requirements and Sources of Capital To date, we have not generated any product revenue.
The trial is also the first to compare an investigational multi-antigenic COVID-19 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccine from Pfizer/BioNTech in people who are immunocompromised. ● GEO-CM04S1 is also undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. ● 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).
GEO-CM04S1 – Immunocompromised/CLL Trial ● In July 2023, an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 began, evaluating its use as a Covid-19 booster vaccine in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine. 30 Gedeptin ® – Advanced Head and Neck Cancer Trial ● Gedeptin® is currently undergoing a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC).
The trial is designed to inform the design of a larger patient trial that also may involve patients with other anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. ● We have additional research programs for vaccines and immunotherapies at various stages of preclinical development.
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 January 2024, we announced closure of patient enrollment for this trial. ● In July 2023, interim data were presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference, indicating that administration of Gedeptin® is safe and feasible, with observation of tumor growth impairment in a majority of the patients.
We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities. Financial Overview Revenues 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.
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.
Other Income (Expense) Interest income was $7,439 and $4,736 for the years ended December 31, 2022 and 2021, 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.
Other Income Interest income was $776,177 and $7,439 for the years ended December 31, 2023 and 2022, respectively.
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.
On the effective date, the Company’s 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. 31 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.
Results of Operations The following table summarizes our results of operations for the years ended December 31, 2022 and 2021: 2022 2021 Change Grant and collaboration revenue $ 81,526 $ 385,501 $ (303,975 ) Operating expenses: Research and development 9,123,479 15,554,171 (6,430,692 ) General and administrative 4,986,611 3,577,153 1,409,458 Total operating expenses 14,110,090 19,131,324 (5,021,234 ) Loss from operations (14,028,564 ) (18,745,823 ) 4,717,259 Total other income (expense) 7,439 175,506 (168,067 ) Net loss $ (14,021,125 ) $ (18,570,317 ) $ 4,549,192 32 Grant Revenues 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.
Results of Operations The following table summarizes our results of operations for the years ended December 31, 2023 and 2022: 2023 2022 Change Grant and collaboration revenue $ - $ 81,526 $ (81,526 ) Operating expenses: Research and development 20,720,766 9,123,479 11,597,287 General and administrative 6,022,173 4,986,611 1,035,562 Total operating expenses 26,742,939 14,110,090 12,632,849 Loss from operations (26,742,939 ) (14,028,564 ) (12,714,375 ) Total other income (expense) 776,177 7,439 768,738 Net loss $ (25,966,762 ) $ (14,021,125 ) $ (11,945,637 ) Grant Revenues There were no grant revenues during 2023.
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GEO-CM04S1 is the only COVID-19 vaccine that includes both SARS-CoV-2 spike and nucleocapsid proteins to advance to a Phase 2 trial in cancer patients.
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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.
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General and administrative expenses Our general and administrative expenses consist primarily of personnel costs in our executive, finance and investor relations, business development and administrative functions, including stock-based compensation.
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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).
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The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities.
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GEO-CM04S1 – Healthy Booster 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. ● In September 2023, we announced the completion of patient enrollment for this trial. ● In February 2024, we announced positive initial safety and immune responses findings at one-month following vaccine administration.
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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.
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Advanced Vaccine Manufacturing Process Development ● In September 2023, GeoVax and ProBioGen AG announced the signing of a commercial license agreement for ProBioGen’s AGE1.CR.pIX® suspension cell line. The agreement enhances our manufacturing capabilities for our entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio. This follows the May 2023 execution of a Master Services Agreement with Advanced Bioscience Laboratories, Inc.
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During 2021, we recorded a $172,056 gain on debt extinguishment associated with the forgiveness of the PPP loan principal and accrued interest.
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(ABL) to support current Good Manufacturing Practices (cGMP) production of our vaccine candidates through late-stage development toward eventual commercialization. These agreements move the Company toward fully implementing a continuous cell line manufacturing system that will provide lower-cost, scalable versatility for our entire MVA-based vaccine portfolio. Intellectual Property Development ● In July 2023, the U.S.
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Net cash provided by financing activities was $12,784,212 for 2021, consisting of (i) net proceeds of $9,408,920 from a public offering of our common stock, (ii) $3,404,156 of net proceeds from the exercise of warrants, (iii) $28,864 in principal repayments of a note payable and repurchase of preferred stock.
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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.
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We have based our projections of operating capital requirements on assumptions that may prove to be incorrect, and we may use our available capital resources sooner than we expect.
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The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus. ● In August 2023, the U.S. Patent and Trademark Office issued a Notice of Allowance to GeoVax for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria”.
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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.
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The patent (No. 11,857,611) was issued in January 2024. ● In October 2023, the U.S.
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Patent and Trademark Office issued a Notice of Allowance to GeoVax for Patent Application No. 17/584,231 titled “Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
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The patent (No. 11,896,657) was issued in February 2024. ● In October 2023, the U.S Patent and Trademark Office issued a Notice of Allowance to GeoVax for Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
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The patent (No. 11,897,919) was issued in February 2024. ● 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.
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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.
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General Corporate 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.
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The purpose of the reverse split was to regain compliance with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).
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On the effective date, every fifteen issued and outstanding shares of the Company's Common Stock was converted automatically into one share of the Company's Common Stock without any change in the par value per share. The total number of issued and outstanding shares of Common Stock was reduced proportionately from 29,757,823 shares to approximately 2,039,240 shares.
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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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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. Financial Overview Revenues We have not generated any revenues from product sales to date.
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Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization.
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Investing Activities – Net cash used in investing activities was $48,946 and $134,258 for 2023 and 2022, respectively, and relates to purchases of property and equipment. Financing Activities – Net cash provided by financing activities was $4,062,442 for 2023, consisting of net proceeds from the exercise of warrants.

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