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What changed in GeoVax Labs, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of GeoVax Labs, Inc.'s 2023 and 2024 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 2024 report.

+261 added−260 removedSource: 10-K (2025-03-27) vs 10-K (2024-02-29)

Top changes in GeoVax Labs, Inc.'s 2024 10-K

261 paragraphs added · 260 removed · 186 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

103 edited+25 added−37 removed119 unchanged
Biggest changeIndication 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.
Biggest changeClinical Development Programs Product Indication Clinical Trial Status BARDA Project NextGen 10,000 Patient Comparison Study Phase 2b Initiation 2H 2025 GEO-CM04S1 COVID-19 Primary Vaccine for Immunocompromised/Stem Cell Transplant Patients (NCT04977024) Phase 2 Currently enrolling Booster Vaccine for Immunocompromised/Chronic Lymphocytic Leukemia Patients (NCT05672355) Phase 2 Currently enrolling Booster Vaccine for Healthy Adults (NCT04639466) Phase 2 enrollment closed, data expected mid-2025 Gedeptin® Head & Neck Cancer* ICI Combination Therapy (NCT TBD) Phase 2 planned Preclinical Development Programs Product Indication Status GEO-MVA Mpox & Smallpox Vaccine Regulatory Discussions & Manufacturing Scale-up GEO-EM01-Z Ebola Zaire Vaccine** Non-Human Primate (completed) GEO-EM01-S Ebola Sudan Vaccine** Non-Human Primate (completed) GEO-MM01 Marburg Vaccine** Non-Human Primate (completed) GEO-ZM02 Zika Vaccine** Mouse Model (completed) * Orphan Drug status granted ** Indication within FDA Priority Review Voucher program Our Coronavirus Vaccine Programs Severe respiratory illnesses caused by the SARS-CoV-2 virus, remain a serious public health issue of international concern.
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.
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 (BLA) 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.
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.
Primary License Agreements City of Hope License – On November 9, 2021, we entered into an Exclusive License Agreement (COH License) with 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.
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 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.
SARS-CoV-2 is an enveloped, single-stranded, positive-sense RNA virus belonging to the family Coronavidae within the genus beta-coronavirus. The genome of SARS-CoV-2 encodes one large Spike (“S”) protein that plays a pivotal role during viral attachment to the host receptor and entry into host cells. The S protein is the basis for most approved vaccines used to protect against SARS-CoV-2.
SARS-CoV-2 is an enveloped, single-stranded, positive-sense RNA virus belonging to the family Coronavidae within the genus beta-coronavirus. The genome of SARS-CoV-2 encodes one large Spike (S) protein that plays a pivotal role during viral attachment to the host receptor and entry into host cells. The S protein is the basis for most approved vaccines used to protect against 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.
Applications are pending in the United States, 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.
Our address is 1900 Lake Park Drive, Smyrna, Georgia 30080, and our telephone number at that address is 678-384-7220. The predecessor of our parent company, GeoVax Labs, Inc. (the reporting entity) was originally incorporated in June 1988 under the laws of Illinois as Dauphin Technology, Inc. (“Dauphin”). In September 2006, Dauphin completed a merger with GeoVax, Inc.
Our address is 1900 Lake Park Drive, Smyrna, Georgia 30080, and our telephone number at that address is 678-384-7220. The predecessor of our parent company, GeoVax Labs, Inc. (the reporting entity) was originally incorporated in June 1988 under the laws of Illinois as Dauphin Technology, Inc. (Dauphin). In September 2006, Dauphin completed a merger with GeoVax, Inc.
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.
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 recently announced multiple objectives and initiatives that may impact GeoVax.
Of interest, recent results from a clinical study of a combinational HIV therapy that included GeoVax’s HIV booster vaccine candidate, MVA62B were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held February 19-22, 2023 in Seattle, Washington.
Of interest, results from a clinical study of a combinational HIV therapy that included GeoVax’s HIV booster vaccine candidate, MVA62B were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held February 19-22, 2023 in Seattle, Washington.
Neutralizing antibodies targeting the receptor binding domain (“RBD”) subunit of the S protein block the virus from binding to host cells. Over 90% of all neutralizing antibodies produced in response to infection are directed to the RBD subunit.
Neutralizing antibodies targeting the receptor binding domain (RBD) subunit of the S protein block the virus from binding to host cells. Over 90% of all neutralizing antibodies produced in response to infection are directed to the RBD subunit.
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.
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
Since the first voucher sale in 2014, the price of the vouchers has ranged from $68 million to $350 million. GeoVax believes that its vaccine programs in Ebola, Sudan, Marburg, Lassa Fever, Malaria and Zika may each be eligible for a PRV and we intend to apply for a PRV at the appropriate time.
Since the first voucher sale in 2014, the price of the vouchers has ranged from $68 million to $350 million. GeoVax believes that its vaccine programs in Ebola, Sudan, Marburg, Malaria and Zika may each be eligible for a PRV and we intend to apply for a PRV at the appropriate time.
Such patients have often shown a suboptimal immune response after receiving currently available Covid-19 vaccines. GEO-CM04S1 is also being studied as a booster vaccine in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355 ), in immunocompromised patients with chronic lymphocytic leukemia (CLL).
Such patients have often shown a suboptimal immune response after receiving currently available COVID-19 vaccines. 3 CLL Study . GEO-CM04S1 is also being studied in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355), as a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL).
The AGE1.CR.pIX cell line's versatility allows it to support a wide range of viruses and vaccine types, enhancing its suitability for various vaccines in development and as a replacement for traditional production systems. MVA grows particularly well on this cell line, making it even more advantageous for vaccine development.
The AGE1 cell line's versatility allows it to support a wide range of viruses and vaccine types, enhancing its suitability for various vaccines in development and as a replacement for traditional production systems. MVA grows particularly well on this cell line, making it even more advantageous for vaccine development.
This non-exclusive commercial license was further amended in December 2023 to expand the Field of Use to include the use of our SARS-CoV-2 vaccine against smallpox and/or monkeypox. We also have a non-exclusive research and development license to use the MVA backbone for our other vaccine candidates.
This non-exclusive commercial license was further amended in December 2023 to expand the Field of Use to include the use of our SARS-CoV-2 vaccine against smallpox and/or Mpox. We also have a non-exclusive research and development license to use the MVA backbone for our other vaccine candidates.
On October 22, 2020, the Company entered into a Patent and Biological Materials License Agreement (the “Covid License”) with HHS, as represented by NIAID, in support of the Company’s development of a vaccine against SARS-CoV-2, the virus that causes Covid-19.
On October 22, 2020, the Company entered into a Patent and Biological Materials License Agreement (COVID License) with HHS, as represented by NIAID, in support of the Company’s development of a vaccine against SARS-CoV-2, the virus that causes COVID-19.
The Covid License 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.
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 S protein, which is the protein that SARS-CoV-2 uses to gain entry into human tissue.
The in-licensed patent families are directed to synthetic MVA vectors, including synthetic MVA vaccines encoding one or more SARS-CoV-2 variant antigens, and their methods of production and use. Applications have been filed in the United States. These in-licensed City of Hope patent families, if issued, valid, and enforceable, will expire in 2042, exclusive of any patent term adjustments or extensions.
The in-licensed patent families are directed to synthetic MVA vectors, including synthetic MVA vaccines encoding one or more SARS-CoV-2 variant antigens, and their methods of production and use. Applications have been filed in the United States. These in-licensed COH patent families, if issued, valid, and enforceable, will expire in 2042, exclusive of any patent term adjustments or extensions.
The 12-year data exclusivity provision of the BPCIA does not prevent a competitor from seeking marketing approval of one of our products, or a product similar thereto, by submitting its own, original Biologics License Application (BLA). We intend to benefit, where applicable, from additional market exclusivity provisions in various jurisdictions that reward the treatments of rare diseases.
The 12-year data exclusivity provision of the BPCIA does not prevent a competitor from seeking marketing approval of one of our products, or a product similar thereto, by submitting its own, original BLA. We intend to benefit, where applicable, from additional market exclusivity provisions in various jurisdictions that reward the treatments of rare diseases.
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.
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 binding antibodies, as well as neutralizing antibody and T-cell responses against SARS-CoV-2 variants of concern (VOC), including the Delta and contemporaneous Omicron variants.
Other Infectious Disease Programs GEO-ZM02 for Zika – Zika disease is an emerging infectious disease caused by the Zika virus (ZIKV) and has been linked to an increase in microcephaly in infants and Guillain-Barre syndrome (a neurodegenerative disease) in adults.
GEO-ZM02 for Zika – Zika disease is an emerging infectious disease caused by the Zika virus (ZIKV) and has been linked to an increase in microcephaly in infants and Guillain-Barre syndrome (a neurodegenerative disease) in adults.
These results further validate the ability of the MVA-VLP platform to stimulate a robust T-cell response to various diseases. 6 Further development of our Zika, Malaria and HIV programs will be dependent upon additional funding support via federal grants, corporate collaborations, or other sources.
These results further validate the ability of the MVA-VLP platform to stimulate a robust T-cell response to various diseases. Further development of our Hemorrhagic Fever, Zika, Malaria and HIV programs will be dependent upon additional funding support via federal grants, corporate collaborations, or other sources.
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.
We have non-exclusively in-licensed from the 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.
We have a non-exclusive commercial license to the NIH MVA backbone for our SARS CoV-2 vaccine with the NIAID of the National Institutes of Health NIH on behalf of the United States, which includes the use of certain patents and patent applications arising from the Moss laboratory and the provided materials.
We have a non-exclusive commercial license to the NIH MVA backbone for our SARS CoV-2 vaccine with the NIAID of the NIH on behalf of the United States, which includes the use of certain patents and patent applications arising from the Moss laboratory and the provided materials.
In September 2021, GeoVax entered into an assignment and license agreement with PNP Therapeutics, Inc. (“PNP”), granting GeoVax exclusive worldwide rights to develop and commercialize Gedeptin. The Gedeptin technology was developed with funding support from the National Cancer Institute (NCI), part of the NIH.
In September 2021, GeoVax entered into an assignment and license agreement with PNP Therapeutics, Inc. (PNP), granting GeoVax exclusive worldwide rights to develop and commercialize Gedeptin. The Gedeptin technology was developed with funding support from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).
Despite a high vaccination rate, CLL patients may be at high risk for lethal Covid-19 infection due to their compromised ability to generate antibody responses against Covid infections or vaccinations. GEO-CM04S1 may be more effective at inducing protective immunity in CLL patients since MVA strongly induces T cell expansion even in the background of immunosuppression.
Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to their compromised ability to generate protective antibody responses against COVID infections or to currently available vaccines. GEO-CM04S1 may be more effective at inducing protective immunity in CLL patients since MVA strongly induces T cell expansion even in the background of immunosuppression.
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.
MVA-vector based vaccines tend to produce an immune response quickly – in less than 14 days – with only mild side effects. The trial is the first to compare an investigational multi-antigenic SARS-CoV-2 vaccine to the current FDA-approved mRNA vaccines from Pfizer/BioNTech and Moderna in people who are immunocompromised.
All these vaccines are based on the S protein of the SARS-CoV-2 virus but rely on different mechanisms for presentation or expression of the S antigen, including whole, inactivated virus, defective adenovirus vectors (three different types) or mRNA. The World Health Organization reports that there are 180 Covid products in clinical development.
All these vaccines are based on the S protein of the SARS-CoV-2 virus but rely on different mechanisms for presentation or expression of the S antigen, including whole, inactivated virus, defective adenovirus vectors (three different types) or mRNA. The WHO reports that there are 180 COVID products in clinical development.
To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against multiple SARS-CoV-2 variants (including contemporaneous Omicron variants) and specific T-cell responses.
To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include binding antibodies, as well as neutralizing antibodies against multiple SARS-CoV-2 variants (including contemporaneous Omicron variants) and specific T-cell responses.
Compliance with environmental protection laws and regulations has not had a material effect on our capital expenditures, earnings or competitive position to date. Scientific Advisors We seek advice from our Scientific Advisory Board, which consists of a number of leading scientists, on scientific and medical matters. The current members of our Scientific Advisory Board are: Name Position/Institutional Affiliation Harriet L.
Compliance with environmental protection laws and regulations has not had a material effect on our capital expenditures, earnings or competitive position to date. Scientific Advisors We seek advice from our Scientific Advisory Board, which consists of leading scientists, on scientific and medical matters. The current members of our Scientific Advisory Board are: Name Position/Institutional Affiliation Olivera J.
Only one patent applicable to an approved vaccine product is eligible for such an extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
Only one patent applicable to an approved vaccine product is eligible for such an extension and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office (USPTO), in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
The Research License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of preventive and/or therapeutic Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccines against Ebola-Zaire virus, Ebola-Sudan virus, Lassa virus, Marburg virus, Zika virus and malaria.
The Research License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of preventive and/or therapeutic MVA-VLP vaccines against Ebola-Zaire virus, Ebola-Sudan virus, Lassa virus, Marburg virus, Zika virus and malaria.
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.
This approach is intended to induce immune responses with greater breadth of specificity. ● MVA is known to effectively induce durable T-cell responses in addition to antibodies. ● MVA does not replicate in human cells, which contributes to it being an extremely safe vaccine platform for human vaccines.
The patent term restoration period is generally one half the time between the effective date of an IND and the submission date of a Biologics License Application (BLA), plus the time between the submission date of a BLA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.
The patent term restoration period is generally one half the time between the effective date of an Investigational New Drug (IND) application and the submission date of a BLA, plus the time between the submission date of a BLA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.
Our Intellectual Property Our commercial success depends in part on our ability, and our licensors’ ability, to obtain and maintain proprietary protection for our clinical product candidates, including our Modified Vaccinia Ankara-Virus-Like Particle (MVA-VLP) based vaccines, our in-licensed synthetic MVA Covid-19 vaccine candidate, and our in-licensed Gedeptin gene-directed enzyme prodrug therapy, and methods of treatment using the same.
Our Intellectual Property Our commercial success depends in part on our ability, and our licensors’ ability, to obtain and maintain proprietary protection for our clinical product candidates, including our MVA-VLP-based vaccines, our in-licensed synthetic MVA COVID-19 vaccine candidate, and our in-licensed Gedeptin gene-directed enzyme prodrug therapy, and methods of treatment using the same.
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.
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 2022 we suspended active development of these programs.
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.
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 and/or smallpox are of concern, vaccines built on an MVA vaccine platform offer the prospect of protection against Mpox and smallpox.
Targeting both the S and N protein antigens broaden the specificity of the immune responses and can protect against the loss of efficacy associated with the reduced antibody responses. The study is examining the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm.
Targeting both the S and N protein antigens broaden the specificity of the immune responses and may mitigate against the loss of efficacy associated with the inadequate antibody responses. The study is examining the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm.
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.
We have exclusively in-licensed two patent families from the University of Alabama at Birmingham (UAB) and the Southern Research Institute (SRI) pursuant to an Assignment and License Agreement with PNP entered into on September 28, 2021.
We make our SEC filings, such as proxy statements, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports available on this website under “Investors – SEC Reports,” free of charge, as soon as reasonably practicable after we electronically file or furnish such materials to the SEC.
Securities and Exchange Commission (SEC), such as proxy statements, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports available on this website under “Investors – SEC Reports,” free of charge, as soon as reasonably practicable after we electronically file or furnish such materials to the SEC.
The Covid License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of a preventive Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccine that primes and/or boosts the immune system against Covid-19.
The COVID License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of a preventive MVA-VLP vaccine that primes and/or boosts the immune system against COVID-19.
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.
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.
In December 2023, the Covid License was amended to expand GeoVax’s commercial license to include Mpox and smallpox as additional indications. Research and Development Our expenditures for research and development activities were $20.7 million and $9.1 million during the years ended December 31, 2023 and 2022, respectively.
In December 2023, the COVID License was amended to expand GeoVax’s commercial license to include Mpox and smallpox as additional indications. 15 Research and Development Our expenditures for research and development activities were $23.7 million and $20.7 million during the years ended December 31, 2024 and 2023, respectively.
The Company is now evaluating development and regulatory pathways towards expanding the public health options available to reduce and manage the risk of Mpox worldwide. The Company intends to successfully develop and commercialize GEO-MVA, becoming the first U.S.-based supplier of MVA as a vaccine against Mpox and smallpox.
GeoVax is now evaluating development and regulatory pathways towards expanding the public health options available to reduce and manage the risk of Mpox worldwide. The Company intends to successfully develop and commercialize GEO-MVA, becoming the first U.S.-based supplier of MVA as a vaccine against Mpox and smallpox. Clinical evaluation of the vaccine is expected to begin in 2025.
These vaccines are primarily designed to induce antibodies specific for the S protein of SARS-CoV-2 but rely on different mechanisms for presentation or expression of the S antigen, including recombinant proteins, whole inactivated virus, defective adenovirus vectors (three different types) or mRNA.
Vaccines currently authorized for use in the United States are primarily designed to induce antibodies specific for the S protein of SARS-CoV-2 but rely on different mechanisms for presentation or expression of the S antigen, including recombinant proteins, whole inactivated virus, defective adenovirus vectors (three different types) or mRNA.
To this end, in September 2023, we announced the signing of a commercial multi-product license agreement for ProBioGen's AGE1.CR.pIX ® suspension cell line, an innovative and proven platform that enables high-yield and scalable production, ensuring efficient industrial manufacturing processes.
To this end, in September 2023, we announced the signing of a commercial multi-product license agreement for ProBioGen's AGE suspension cell line, an innovative and proven platform that should enable high-yield and scalable production, ensuring efficient industrial manufacturing processes.
Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.
Consolidated data from all subjects tested one-month post-vaccination documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway. Patient enrollment for this study has been completed.
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 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., VP40 or Z) in addition to standard GP proteins used by us and other manufacturers.
We wholly own 3 patent families, which includes two granted U.S. patents (U.S. 11,278,607 and U.S. 11,413,341), and granted foreign applications in Australia, Europe (validated in Germany, Spain, France, Great Britian, Italy, Poland, Turkey, and Switzerland), China, Japan, India directed to our immuno-oncology vaccine compositions and methods of use thereof.
We wholly own two patent families, which include three granted U.S. patents (U.S. 11,278,607, U.S. 11,413,341 and U.S. 12,247,214), and granted foreign applications in Australia, Europe (validated in Germany, Spain, France, Great Britain, Italy, Poland, Turkey, and Switzerland), China, Japan, and India directed to our immuno-oncology vaccine compositions and methods of use thereof.
These in-licensed City of Hope patent families, if issued, valid, and enforceable, will expire between 2041 and 2043, exclusive of any patent term adjustments or extensions. We have also exclusively in-licensed two additional patent families from the City of Hope in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of Covid-19 variants.
These in-licensed COH patent families, if issued, valid, and enforceable, will expire between 2041 and 2043, exclusive of any patent term adjustments or extensions. 13 We have also exclusively in-licensed two additional patent families from COH in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of SARS-CoV-2 variants.
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.
These patents, where issued, valid, and enforceable, will expire in 2036, exclusive of any patent term 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.
GV-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.
In mouse experiments, we have shown that two of our vaccines (e.g., GV-MVA-VLP-Zika followed by GV-MVA-VLP-Ebola) can be given at 8 ● 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.
MVA as Smallpox and Mpox Vaccine - MVA was originally developed for use as a smallpox vaccine more than 30 years ago. Its preferred use is for individuals with compromised immune systems; individuals that would be put at risk if administered the normal smallpox vaccine (“vaccinia”) which can replicate in human cells.
GEO-MVA – Mpox and Smallpox Vaccine MVA was originally developed for use as a 3 rd generation smallpox vaccine nearly 50 years ago. Its preferred use is for individuals with compromised immune systems; individuals that would be put at risk if administered the normal smallpox vaccine (vaccinia) which can replicate in human cells.
In November 2022, we executed a Material Transfer Agreement (MTA) with the National Institutes of Health (NIH) for the clinical and commercial use of an unmodified (parental) MVA 1974/NIH Clone I as a vaccine against monkeypox virus.
In November 2022, we executed a Material Transfer Agreement (MTA) with the NIH for the clinical and commercial use of an unmodified (parental) MVA 1974/NIH Clone I as a vaccine against monkeypox virus. The MTA is royalty-free, non-exclusive, and worldwide.
The Company will also pay tiered percentage annual royalties in the low-to-mid teens on Net Sales (as defined in the Gedeptin License) of products covered under the Gedeptin License on a country-by-country and product-by-product basis, subject to specified reductions.
The terms of the Gedeptin License include milestone payments due upon the achievement of selected development and regulatory events. The Company will also pay tiered percentage annual royalties in the low-to-mid teens on Net Sales (as defined in the Gedeptin License) of products covered under the Gedeptin License on a country-by-country and product-by-product basis, subject to specified reductions.
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.
Transition to high-yield, scalable MVA manufacturing process – Currently, MVA vaccines are manufactured in primary cell cultures ofchicken embryonic fibroblasts (CEF) derived from SPF eggs, a suboptimal and time-consuming process useful primarily for niche markets and stockpile reserves.
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.
We have exclusively in-licensed five patent families from COH in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of coronaviruses, including SARS-CoV-2, pursuant to an Exclusive License Agreement entered into on November 9, 2021, and as further amended on April 11, 2023.
Gedeptin License – On September 28, 2021, we entered into an Assignment and License Agreement (the “Gedeptin License”) with PNP Therapeutics, Inc. (“PNP”) under which the Company obtained exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials, and trademarks.
Gedeptin License – On September 28, 2021, we entered into an Assignment and License Agreement (Gedeptin License) with PNP under which the Company obtained exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials, and trademarks. The Gedeptin patent portfolio was originally licensed from UAB and SRI by PNP.
The terms also include milestone payments due upon the achievement of selected development, regulatory and sales events. The Company will also pay COH an annual royalty on net sales of products covered by the patents licensed from COH on a country-by-country and licensed product-by-licensed product basis, subject to specified reductions.
The Company will also pay COH an annual royalty on net sales of products covered by the patents licensed from COH on a country-by-country and licensed product-by-licensed product basis, subject to specified reductions.
In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous if available at all.
In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous if available at all. 14 In addition to patents, we rely upon unpatented, proprietary trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position.
Our principal offices are in Smyrna, Georgia (metropolitan Atlanta). Available Information Our website address is www.geovax.com.
Our principal offices are in Smyrna, Georgia (metropolitan Atlanta). Available Information Our website address is www.geovax.com. We make our filings with the U.S.
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.
We recently completed a multi-site Phase 1b/2a trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with advanced head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options.
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.
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.
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 have recently produced a cGMPclinical batch of GEO-MVA to support our clinical programs. 5 Other Infectious Disease Programs (Preclinical) 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.
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.
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 blood cancer patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or CAR T cell therapy.
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.
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.
GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.
GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response. 6 We have collaborated with the Burnet Institute, a leading infectious diseases research institute in Australia, for the development of a vaccine to prevent malaria infection.
SARS-CoV-2 infection can be very serious in this vulnerable population of hematology patients, including autologous (auto) and allogeneic (allo) hematopoietic cell transplant (HCT), and recipients of chimeric antigen receptor (CAR)-T cell therapies.
SARS-CoV-2 infection can be very serious in these vulnerable patient groups, with hematologic cancer patients, including those receiving autologous (auto) and allogeneic (allo) hematopoietic cell transplant (HCT), and recipients of chimeric antigen receptor (CAR)-T cell therapies among the most vulnerable.
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.
Currently, our owned, co-owned, and in-licensed patent estate, on a worldwide basis, includes 18 granted or allowed U.S. patent applications, 18 pending U.S. patent applications; 31 granted foreign patents, 67 pending foreign patent applications, 1 Patent Cooperation Treaty (PCT) application, and 1 U.S. provisional application spread over 23 patent families.
A Phase 1 dose ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the therapy to be well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.
A cycle of Gedeptin therapy consists of intra-tumoral injections of Gedeptin followed by administration of a prodrug, fludarabine phosphate, over a pre-defined time period. A Phase 1 dose ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the therapy to be well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.
We believe the most successful of these purified antigens have been non-infectious virus-like particles (VLPs) as exemplified by vaccines for hepatitis B (Merck’s Recombivax® and GSK’s Engerix®) and Papilloma viruses (GSK’s Cervarix®, and Merck’s Gardasil®). Our approach uses recombinant DNA and/or recombinant MVA to produce VLPs in the person being vaccinated (in vivo) reducing complexity and costs of manufacturing.
We believe the most successful of these purified antigens have been non-infectious virus-like particles (VLPs) as exemplified by vaccines for hepatitis B (Merck’s Recombivax® and GSK’s Engerix®) and Papilloma viruses (GSK’s Cervarix®, and Merck’s Gardasil®).
The COH License grants GeoVax exclusive rights to key patents, know-how, regulatory filings and clinical materials for use against Covid-19.
The COH License grants GeoVax exclusive rights to key patents, know-how, regulatory filings and clinical materials for use against COVID-19. The terms of the COH License include milestone payments due upon the achievement of selected development, regulatory and sales events.
Moreover, these current vaccines tend to stimulate only modest T-cell responses, which have been shown to be critical to critical for induction of long-term immune memory and for protection against severe Covid-19 disease. Recently, the FDA indicated the likely need for continued vaccine adjustments and boosters at least annually, similar to the approach used for influenza virus vaccines.
Moreover, these current vaccines tend to stimulate only modest T-cell responses, which have been shown to be critical for induction of long-term immune memory and for protection against severe COVID-19 disease.
VP40 or Z) in addition to standard GP proteins used by us and other manufacturers. Thus, the GeoVax GV-MVA-VLP™ approach could offer a unique combination of advantages to achieve breadth and safety of a pan-filo vaccine.
Thus, the GeoVax GV-MVA-VLP™ approach could offer a unique combination of advantages to achieve breadth and safety of a pan-filo vaccine.
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.
GeoVax’s portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 135 granted or pending patent applications spread over 23 patent families, which are discussed in greater detail in the “Our Intellectual Property” section. 1 Our Product Development Pipeline The tables below summarize the status of our product development programs, which are discussed in greater detail in the following pages.
We also are subject to various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research.
The requirements governing the conduct of clinical trials and drug approvals vary widely from country to country, and the time required for approval may be longer or shorter than that required for FDA approval. 9 We also are subject to various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research.
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.
These include: - 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, Smallpox 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 vaccine design, construction, and characterization were performed at GeoVax with immunogenicity and challenge studies in animal models conducted at Burnet Institute using their unique functional assays.
The project included the design, construction, and characterization of multiple malaria vaccine candidates using GeoVax’s GV-MVA-VLP™ vaccine platform combined with malaria Plasmodium falciparum and Plasmodium vivax sequences identified by the Burnet Institute. The vaccine design, construction, and characterization were performed at GeoVax with immunogenicity and challenge studies in animal models conducted at Burnet Institute using their unique functional assays.
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.
This trial was funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.
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.
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 3 years post-vaccination.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs, once marketing approval is obtained. 21 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.
Biggest changeWe 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 expect to seek collaborations for the development and commercialization of product candidates in the future.
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.
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.
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.
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.
The exercise of these warrants will cause us to issue additional shares of our Common Stock and will dilute the percentage ownership of our shareholders. Certain provisions of our certificate of incorporation which authorize the issuance of shares of preferred stock may make it more difficult for a third party to effect a change in control.
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.
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. 22 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.
Therefore, any potential return investors may have in our common stock will be in the form of appreciation, if any, in the market value of their shares of common stock. Public company compliance may make it more difficult for us to attract and retain officers and directors.
Therefore, any potential return investors may have in our Common Stock will be in the form of appreciation, if any, in the market value of their shares of Common Stock. 26 Public company compliance may make it more difficult for us to attract and retain officers and directors.
The responses of potential physicians and others to information about complications could materially adversely affect the market acceptance of our products, which in turn would materially harm our business. We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects.
The responses of potential physicians and others to information about complications could materially adversely affect the market acceptance of our products, which in turn would materially harm our business. 19 We may experience delays in our clinical trials that could adversely affect our financial results and our commercial prospects.
The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates. 20 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.
The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates. 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.
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.
If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize products that we develop. Risks Related to Our Intellectual Property Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies.
In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations, and prospects. Risks Related to Our Common Stock The market price of our common stock is highly volatile.
In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations, and prospects. 25 Risks Related to Our Securities The market price of our Common Stock is highly volatile.
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.
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 $25 million for the year ended December 31, 2024.
We do not have experience in manufacturing, selling, or marketing. To obtain the expertise necessary to successfully manufacture, market, and sell our products, we must develop our own commercial infrastructure and/or collaborative commercial arrangements and partnerships. Our ability to execute our current operating plan is dependent on numerous factors, including, the performance of third-party collaborators with whom we may contract.
We do not have experience in manufacturing, selling, or marketing. To obtain the expertise necessary to successfully manufacture, market, and sell our products, we must develop our own commercial infrastructure and/or collaborative commercial arrangements and partnerships. Our ability to execute our current operating plan is dependent on numerous factors, including, the performance of third-party collaborators, vendors and contractors.
Patent and Trademark Office, or USPTO, courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that claims that may ultimately issue from our patent applications will not be found invalid or unenforceable if challenged.
We cannot be certain that the claims in our in-licensed pending patent applications will be considered patentable by the USPTO, courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that claims that may ultimately issue from our patent applications will not be found invalid or unenforceable if challenged.
For example, in September 2017, the California State Assembly approved SB17, which requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before any scheduled increases in the prices of their products if they exceed 16% over a two-year period, and further requiring pharmaceutical companies to explain the reasons for such increase and, effective in 2016, Vermont passed a law requiring certain manufacturers identified by the state to justify their price increases.
For example, in September 2017, the California State Assembly approved SB17, which requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before any scheduled increases in the prices of their products if they exceed 16% over a two-year period, and further requiring pharmaceutical companies to explain the reasons for such increase.
We may be required to defend lawsuits or pay damages for product liability claims. Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and for products that we sell after regulatory approval. We carry product liability insurance and we expect to continue such policies.
Product liability is a major risk in testing and marketing biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical trials and for products that we sell after regulatory approval. We carry product liability insurance and we expect to continue such policies.
In addition to heightened patentability requirements, recent Supreme Court and Federal Circuit cases relating to biosimilar product approval under the BPCIA, have held that the “patent dance” provisions of the statute, which are intended to resolve any patent infringement issues before the approval of a biosimilar, are discretionary, and a biosimilar applicant can opt out by refusing to provide a copy of its application and manufacturing information to the biologic sponsor (see Sandoz Inc. v.
Cir. 2023) have expanded the bases for invalidating a patent under the judicially created doctrine of obviousness-type double patenting. 24 In addition to heightened patentability requirements, recent Supreme Court and Federal Circuit cases relating to biosimilar product approval under the BPCIA, have held that the “patent dance” provisions of the statute, which are intended to resolve any patent infringement issues before the approval of a biosimilar, are discretionary, and a biosimilar applicant can opt out by refusing to provide a copy of its application and manufacturing information to the biologic sponsor (see Sandoz Inc. v.
We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations. In order to meet our operating cash flow needs we plan to seek sources of non-dilutive capital through government grant programs and clinical trial support. We may also plan additional offerings of our equity securities, debt, or convertible debt instruments.
In order to meet our operating cash flow needs we plan to seek sources of non-dilutive capital through government grant programs and clinical trial support. We may also plan additional offerings of our equity securities, debt, or convertible debt instruments.
We generally attempt to control and limit access to, and the distribution of, our product documentation and other proprietary information. Despite efforts to protect this proprietary information, unauthorized parties may obtain and use information that we may regard as proprietary. Other parties may independently develop similar know-how or may even obtain access to these technologies.
We generally attempt to control and limit access to, and the distribution of, our product documentation and other proprietary information. Despite efforts to protect this proprietary information, unauthorized parties may obtain and use information that we may regard as proprietary.
Significant factors in determining whether we will be able to compete successfully include: ● the efficacy and safety of our products; ● the time and scope of regulatory approval; ● reimbursement coverage from Medicare, Medicaid, insurance companies and others; ● the price and cost-effectiveness of our products, especially as compared to any competitive products; and ● the ability to maintain patent protection; and ● the market demand is not readily known.
Significant factors in determining whether we will be able to compete successfully include: ● the efficacy and safety of our products; ● the time and scope of regulatory approval; ● reimbursement coverage from Medicare, Medicaid, insurance companies and others; ● the price and cost-effectiveness of our products, especially as compared to any competitive products; and ● the ability to maintain patent protection. 21 We may be required to defend lawsuits or pay damages for product liability claims.
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.
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.
We and our licensors may not be able to develop patentable products with acceptable patent protection. Even if patent claims are allowed, the claims may not issue, or in the event of issuance, may not be sufficient to protect the technology owned by or licensed to us.
Even if patent claims are allowed, the claims may not issue, or in the event of issuance, may not be sufficient to protect the technology owned by or licensed to us.
We rely upon a combination of information technology systems and traditional recordkeeping to operate our business. In the ordinary course of business, we collect, store, and transmit confidential information (including, but not limited to, personal information and intellectual property).
In the ordinary course of business, we collect, store, and transmit confidential information (including, but not limited to, personal information and intellectual property).
The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries.
Other parties may independently develop similar know-how or may even obtain access to these technologies. 23 The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries.
These uncertainties and/or limitations in our ability to properly obtain, maintain, protect, and enforce the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations. We cannot be certain that the claims in our in-licensed pending patent applications will be considered patentable by the U.S.
These uncertainties and/or limitations in our ability to properly obtain, maintain, protect, and enforce the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.
We expect to seek collaborations for the development and commercialization of product candidates in the future. The timing and terms of any collaboration will depend on the evaluation by prospective collaborators of the clinical trial results and other aspects of a product’s safety and efficacy profile.
The timing and terms of any collaboration will depend on the evaluation by prospective collaborators of the clinical trial results and other aspects of a product’s safety and efficacy profile.
Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities.
Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities. 27 If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our Common Stock and related warrants could be delisted from the exchange.
We expect that these, and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in downward pressure on the price that we receive for any approved product.
Effective in 2016, Vermont passed a law requiring certain manufacturers identified by the state to justify their price increases. We expect that these, and other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in downward pressure on the price that we receive for any approved product.
We have not had and do not have primary control over these activities for some of our in-licensed patents or patent applications and other intellectual property rights.
We rely on third parties to file and prosecute patent applications and maintain patents and otherwise protect the licensed intellectual property under some of our license agreements. We have not had and do not have primary control over these activities for some of our in-licensed patents or patent applications and other intellectual property rights.
We 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.
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 pre-funded warrants currently exercisable for approximately 2.1 million shares and other warrants currently exercisable for approximately 10.1 million shares with a weighted average exercise price of $2.61 per share.
If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents.
If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.
These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents.
For example, the Leahy-Smith America Invents Act (the Leahy-Smith Act), signed into law on September 16, 2011, includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents.
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.
Competition for qualified personnel is intense among companies, academic institutions and other organizations. The ability to attract and retain personnel is adversely affected by our financial challenges. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.
We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents.
We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us.
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.
Regulatory and legal uncertainties could result in significant costs or otherwise harm our business. To manufacture and sell our products, we must comply with extensive domestic and international regulation. In order to sell our products in the United States, approval from the FDA is required.
In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products.
In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
The 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.
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.
Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects. Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business.
Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects. 17 A significant portion of the funding to further develop GEO-CM04S1, our next-generation COVID-19 vaccine candidate, is currently expected to come from the U.S. government.
We will rely on trade secrets, unpatented proprietary know-how, continuing technological innovation and, in some cases, patent protection to preserve our competitive position. Our patents and licensed patent rights may be challenged, invalidated, infringed or circumvented, and the rights granted in those patents may not provide proprietary protection or competitive advantages to us.
Our patents and licensed patent rights may be challenged, invalidated, infringed or circumvented, and the rights granted in those patents may not provide proprietary protection or competitive advantages to us. We and our licensors may not be able to develop patentable products with acceptable patent protection.
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.
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.
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.
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. 18 We depend upon key personnel who may terminate their employment with us at any time.
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.
Therefore, it will be necessary for us to look to other sources of funding to finance our development activities. We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations.
Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors.
Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs, once marketing approval is obtained.
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.
If alternative sources of funding are not available, we may be forced to suspend or terminate development activities for GEO-CM04S1, which could materially harm our business. Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business. We rely upon a combination of information technology systems and traditional recordkeeping to operate our business.
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Summary of Risk Factors Our business is subject to numerous risks and uncertainties, discussed in more detail in the following section.
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To the extent that we raise additional funds by issuance of equity securities, our stockholders would experience dilution, and debt financings, if available, may involve restrictive covenants and substantial fixed payments or may otherwise further constrain our financial flexibility.
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These risks include, among others, the following key risks: 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. ● We have received a going concern opinion from our auditors. ● Our business will require continued funding.
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If the government were to eliminate, reduce, or delay funding available to us under the ATI-RRPV Contract, this could have a significant negative impact on our revenues and cash flows, and we may be forced to suspend or terminate the continued development of the product candidate or obtain alternative sources of funding.
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These products may not be successful. ● We depend upon key personnel who may terminate their employment with us at any time.
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We anticipate that a significant portion of the funding for the continued development of GEO-CM04S1, our next generation self-COVID-19 vaccine candidate, will stem from the ATI-RRPV Contract.
Removed
If we were to lose the services of any of these individuals, our business and operations may be adversely affected. ● Regulatory and legal uncertainties could result in significant costs or otherwise harm our business. ● We face intense competition and rapid technological change that could result in products that are superior to, or earlier to the market than, the products we will be commercializing or developing. ● Our product candidates are based on new medical technology and, consequently, are inherently risky.
Added
As awarded, the ATI-RRPV Contract currently makes available an aggregate amount of up to $26.2 million (which may increase to as much as $45 million), for reimbursement of costs incurred for manufacturing of clinical materials and support for a 10,000 patient Phase 2b clinical trial, including regulatory activities.
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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.
Added
BARDA has made a separate award of $343 million to Allucent, a global CRO, to execute the clinical trial as part of BARDA’s Clinical Studies Network. As of December 31, 2024, we have recognized approximately $4.0 million in revenue pursuant to the ATI-RRPV Contract based on costs incurred.
Removed
If there is not sufficient reimbursement for our products, it is less likely that they will be widely used.
Added
As a standard government contract, BARDA is entitled to terminate the ATI-RRPV Contract for convenience at any time, in whole or in part, and is not required to provide continued funding beyond reimbursement of amounts currently incurred and obligated by us as a result of contract performance.
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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.
Added
Further, BARDA may suspend or terminate the ATI-RRPV Contract should we fail to achieve key milestones or fail to comply with the operating procedures and processes approved by BARDA and its audit agency.
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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.
Added
There can be no assurance that we will be able to achieve these milestones or continue to comply with these procedures and protocols, and there can also be no assurance that BARDA will not terminate or suspend the ATI-RRPV Contract.
Removed
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.
Added
If the ATI-RRPV Contract is terminated or suspended, or if there is any government decision not to continue funding or reduction or delay in funding under the ATI-RRPV Contract, our revenues and cash flows would be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not be available on non-dilutive terms, terms favorable to us, or at all.
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In August 2020, the Inflation Reduction Act included provisions to increase Medicare’s ability to negotiate prescription drug prices.
Added
Our products have not been proven in human clinical trials and have not been approved by any government agency for sale.
Removed
In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us. 24 For example, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed into law on September 16, 2011, includes a number of significant changes to U.S. patent law.
Added
In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles. For example, the current U.S. presidential administration has committed to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS and the FDA.
Removed
Cir. 2023) have expanded the bases for invalidating a patent under the judicially created doctrine of obviousness-type double patenting.
Added
Further, in an effort to contain the U.S. federal budget deficit, the pharmaceutical industry could be considered a potential source of savings and could be the target of legislative proposals aimed at reducing federal expenditures.
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Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business. 25 We rely on third parties to file and prosecute patent applications and maintain patents and otherwise protect the licensed intellectual property under some of our license agreements.
Added
Efforts by the current administration or Congress to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.
Added
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the Affordable Care Act), substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry.
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The Affordable Care Act includes a number of provisions that are intended to lower healthcare costs, including provisions relating to prescription drug prices and government spending on medical products.
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Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts by the former Trump administration to repeal or replace certain aspects of the statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our business.
Added
Changes in legislation, regulation or policy increase the likelihood that we will fail to appropriately adapt to changes in our compliance obligations, particularly when such changes happen abruptly, such as following a change in government.
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It is uncertain the extent to which any such changes may impact our business or financial condition. 20 There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products.
Added
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. We will rely on trade secrets, unpatented proprietary know-how, continuing technological innovation and, in some cases, patent protection to preserve our competitive position.
Added
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.
Added
Our Common Stock (GOVX) and related warrants (GOVXW) are currently listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance requirements.
Added
There can be no assurances that we will be able to continue to comply with the applicable listing standards.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeSuch processes include physical, procedural and technical safeguards, response plans, and routine review of our policies and procedures to identify risks and refine our practices. We engage independent third parties to assess and implement our cybersecurity procedures and enhance our oversight.
Biggest changeSuch processes include physical, procedural and technical safeguards, response plans, and routine review of our policies and procedures to identify risks and refine our practices. The Company’s information technology function (including cybersecurity) is centralized under the Chief Financial Officer, who has over three decades of business leadership experience including oversight of information technology functions.
Oversight of cybersecurity is integrated into the responsibilities of the Board. The Nominating and Governance Committee (the “NGC”) has been assigned oversight of cybersecurity matters, particularly as they relate to financial risk and controls, integrity of financial data and public disclosures, and security of overall digital data.
Oversight of cybersecurity is integrated into the responsibilities of the Board. The Nominating and Governance Committee (NGC) has been assigned oversight of cybersecurity matters, particularly as they relate to financial risk and controls, integrity of financial data and public disclosures, and security of overall digital data.
The NGC receives periodic updates from management regarding cybersecurity matters and is notified between such updates regarding any significant new cybersecurity threats or incidents. We do not believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect us or our business strategy, results of operations or financial condition.
We do not believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect us or our business strategy, results of operations or financial condition.
Added
We also engage independent third parties to assess and implement our cybersecurity procedures and enhance our oversight. The NGC receives periodic updates from management regarding cybersecurity matters and is notified between such updates regarding any significant new cybersecurity threats or incidents.

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. 28
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.

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 February 29, 2024, there were 14 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 March 25, 2025, there were 24 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 2023.
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 on Form 10-Q. Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the fourth quarter of 2024.

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 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.
Biggest changeTarget clinical sites are confirmed and manufacturing activities are underway for production of the vaccine product needed for study activation. o 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 high-risk immunocompromised patients (i.e. patients with blood cancers who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or CAR T cell therapy).
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.
Our goal is to advance products through 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.
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.
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. 32 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.
ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read together with “Selected Financial Data” and our consolidated financial statements and the related notes beginning on page F-1.
ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and the related notes beginning on page F-1.
Our future capital requirements will depend on many factors, which include but are not limited to: ● the timing and costs of our ongoing and planned clinical trials; ● the timing and costs of manufacturing material for use in clinical trials; ● the number and scope of our research programs and the speed at which they are advanced; ● the progress and success of our preclinical and clinical development activities; ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; ● the costs to attract and retain skilled personnel; ● the costs to maintain and expand our infrastructure to support our operations, our product development, and planned future commercialization efforts; ● the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; ● the costs associated with any products or technologies that we may in-license or acquire; and ● the costs and timing of regulatory approvals.
Our future capital requirements will depend on many factors, which include but are not limited to: ● the timing and costs of our ongoing and planned clinical trials; ● the timing and costs of manufacturing material for use in clinical trials; ● the timing and/or changes in funding we receive pursuant to the ATI-RRPV Contract; ● the number and scope of our research programs and the speed at which they are advanced; ● the progress and success of our preclinical and clinical development activities; ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; ● the costs to attract and retain skilled personnel; ● the costs to maintain and expand our infrastructure to support our operations, our product development, and planned future commercialization efforts; ● the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; ● the costs associated with any products or technologies that we may in-license or acquire; and ● the costs and timing of regulatory approvals.
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.
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. 31 General and administrative expenses Our general and administrative expenses consist primarily of personnel costs in our executive, finance, business development and other administrative functions, including stock-based compensation.
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.
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.
This projection takes into consideration contractual commitments we have made, and expect to make, in the normal course of operating our business, which include (i) obligations to our employees, (ii) our lease obligations, (iii) payments due under license agreements for various technologies and patent rights associated with our product development activities, (iv) arrangements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other third-party vendors for clinical trials services and production of materials for use in our clinical trials, and (v) other various firm purchase commitments and contractual obligations related to production and testing of our product candidates and the general operation of our business.
Our projection takes into consideration contractual commitments we have made, and expect to make, in the normal course of operating our business, which include (i) obligations to our employees, (ii) our lease obligations, (iii) payments due under license agreements for various technologies and patent rights associated with our product development activities, (iv) arrangements with CROs, CMOs, and other third-party vendors for clinical trials services and production of materials for use in our clinical trials, and (v) other various firm purchase commitments and contractual obligations related to production and testing of our product candidates and the general operation of our business.
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.
Research and development costs are expensed as incurred and consist primarily of the following: • personnel costs in our research and development functions, including salaries, benefits and stock-based compensation; • expenses incurred under agreements with CROs, for the conduct of clinical trials; • expenses incurred under agreements with contract manufacturing organizations (CMOs) that manufacture product used in 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 to improve the efficiency and yield of the bulk vaccine; • laboratory supplies, vendor expenses and other third-party contract expenses related to preclinical research activities; • technology license fees; • consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and • facilities, depreciation and other general overhead expenses.
We expect our research and development expenditures to increase during 2024 and beyond as we advance our existing and future product candidates into and through clinical trials and pursue regulatory approval, especially with regard to the Gedeptin and GEO-CM04S1 clinical programs.
We expect our research and development expenditures to increase as we advance our existing and future product candidates into and through clinical trials and pursue regulatory approval, especially with regard to the ongoing and planned GEO-CM04S1, Gedeptin and GEO-MVA clinical programs.
We expect our general and administrative expenses to continue to increase in the future as we support expanded research and development activities, prepare for potential commercialization of our current and future product candidates, maintain compliance with requirements of Nasdaq and the Securities and Exchange Commission, and other general corporate activities.
We expect our general and administrative expenses will increase in the future as we support expanded research and development activities, prepare for potential commercialization of our current and future product candidates, maintain compliance with requirements of Nasdaq and the SEC, and other general corporate activities.
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).
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 Update 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which created a new Topic, Accounting Standards Codification Topic 606.
See Note 6 to our financial statements for additional stock-based compensation information. Research and Development Expense Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates.
See Note 7 to our consolidated financial statements for the year ended December 31, 2024 for additional stock-based compensation information. Research and Development Expense Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates.
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.
Our significant accounting policies are summarized in Note 2 to our consolidated financial statements for the year ended December 31, 2024, which are included in this Annual Report.
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.
Overview and Recent Developments GeoVax is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers using novel proprietary platforms. GeoVax’s most advanced product candidates include a next-generation COVID-19 vaccine, a gene-directed therapy for solid tumor cancers, and a vaccine against Mpox and smallpox.
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.
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.
Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization.
We have not generated any revenue to date from the sale of the products we are developing. Our product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that we advance to clinical testing will require regulatory approval prior to commercial use and will require significant costs for commercialization.
Our 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.
Any of these actions could harm our business, results of operations and prospects. 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.
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.
Investing Activities – Net cash used in investing activities was $20,653 and $48,946 for 2024 and 2023, respectively, and relates to purchases of laboratory equipment. Financing Activities – Net cash provided by financing activities was $23,750,516 for 2024, consisting of primarily of net proceeds from offerings of our common stock and 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.
Net cash provided by financing activities was $4,062,442 for 2023, consisting of net proceeds from the exercise of warrants. Funding Requirements and Sources of Capital To date, we have not generated any product revenue.
The deferred amounts are expensed as the related goods are delivered or the services are performed. Off-Balance Sheet Arrangements We have no off-balance sheet arrangements that are likely or reasonably likely to have a material effect on our financial condition or results of operations, other than the operating lease for our office and laboratory space.
Off-Balance Sheet Arrangements We have no off-balance sheet arrangements that are likely or reasonably likely to have a material effect on our financial condition or results of operations.
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.
Interest expense was $21,375 and $-0-, for the years ended December 31, 2024 and 2023, respectively, associated with certain notes payable issued during May 2024 and repaid in August 2024. 33 Liquidity and Capital Resources The following tables summarize our liquidity and capital resources as of December 31, 2024 and 2023, and our cash flows for the years then ended: As of December 31, Liquidity and Capital Resources 2024 2023 Cash and cash equivalents $ 5,506,941 $ 6,452,589 Working capital 4,827,551 4,365,861 Year Ended December 31, Cash Flow Data 2024 2023 Net cash provided by (used in): Operating activities $ (24,675,511 ) $ (25,173,639 ) Investing activities (20,653 ) (48,946 ) Financing activities 23,750,516 4,062,442 Net decrease in cash and cash equivalents $ (945,648 ) $ (21,160,143 ) Operating Activities – Net cash used in operating activities of $24,675,511 for 2024 was primarily due to our net loss of $24,992,296, offset by non-cash items such as depreciation expense and stock-based compensation expense, and by changes in our working capital accounts.
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.
Data published from the safety lead-in portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing broad and durable neutralizing antibody and T cell responses. o GEO-CM04S1 is also undergoing the Phase 2 portion of a Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04639466), evaluating two vaccine dose levels as a heterologous COVID-19 booster vaccine to current FDA-approved mRNA vaccines from Pfizer/BioNTech and Moderna.
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).
Consolidated data (blinded to vaccine dose) from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5. o An investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 is evaluating its use as a COVID-19 vaccine booster in patients with CLL compared to the Pfizer/BioNTech mRNA-based vaccine. ● Gedeptin®: o Gedeptin recently completed a Phase 1/2 clinical trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933) for treatment of patients with advanced HNSCC.
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.
We have funded our operations to date primarily from sales of our equity securities and from government grants and clinical trial assistance. During 2024, we closed four registered direct offerings of our common stock and warrants, as well as established the ATM Program (see footnote 6 to the consolidated financial statements included in this Annual Report).
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.
If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market vaccine candidates that we would otherwise prefer to develop and market ourselves.
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%).
There were no revenues reported during the comparable 2023 period. Research and Development Expenses Our research and development expenses were $23,713,602 for the year ended December 31, 2024, as compared to $20,720,766 for 2023, representing an increase of $2,992,836 (14%).
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.
Additional research and development programs include preventive vaccines for hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), and Zika virus. 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.
This trial is being funded in part by the U.S. Food & Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program.
This trial is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. o In July 2024, we announced that a special clinical advisory board completed a comprehensive review of the PNP-002 trial results, together with the previously completed Phase 1 trial (PNP-001).
Other Income Interest income was $776,177 and $7,439 for the years ended December 31, 2023 and 2022, respectively.
General and administrative expense for 2024 and 2023 includes stock-based compensation expense of $306,442 and $783,863, respectively, associated with employee and consultant stock options and stock awards. Other Income Interest income was $173,359 and $776,177 for the years ended December 31, 2024 and 2023, respectively.
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%).
General and Administrative Expenses Our general and administrative expenses were $5,385,254 for the year ended December 31, 2024, as compared to $6,022,173 for 2023, representing a decrease of $636,919 (11%). The decrease during 2024 relates primarily to lower stock-based compensation expense, consulting costs, patent costs and franchise tax cost.
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.
Results of Operations The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: 2024 2023 Change Revenue from government contract $ 3,954,576 $ - $ 3,954,576 Operating expenses: Research and development 23,713,602 20,720,766 2,992,836 General and administrative 5,385,254 6,022,173 (636,919 ) Total operating expenses 29,098,856 26,742,939 2,355,917 Loss from operations (25,144,280 ) (26,742,939 ) 1,598,659 Interest income 173,359 776,177 (602,818 ) Interest expense (21,375 ) - (21,375 ) Net loss $ (24,992,296 ) $ (25,966,762 ) $ 974,466 Revenue from Government Contract During the year ended December 31, 2024, we reported $3,974,576 of revenues associated with the ATI-RRPV Contract.
Removed
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.
Added
Our programs are in various stages of development, the most significant of which are summarized below along with recent developments: ● GEO-CM04S1 – Next Generation COVID-19 Vaccine: o In June 2024, GeoVax announced the receipt of an award through the RRPV to advance development of GEO-CM04S1 in a Phase 2b clinical trial.
Removed
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.
Added
Under the ATI-RRPV Contract, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with an FDA-approved mRNA COVID-19 vaccine. The RRPV is a consortium funded by BARDA, part of the ASPR in the HHS.
Removed
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).
Added
The direct award to GeoVax, currently approximately $26.2 million and which may increase to as much as $45 million, is funding the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities.
Removed
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.
Added
BARDA has made a separate award of approximately $343 million through its Clinical Studies Network to Allucent, a global clinical research organization, to execute the clinical trial as part of BARDA’s Clinical Studies Network.
Removed
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.
Added
In February 2024, we announced positive interim safety and immune responses findings following vaccine administration.
Removed
(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.
Added
This review concluded that Gedeptin demonstrated an acceptable safety and efficacy profile to support continued development.
Removed
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.
Added
In addition, the therapy has demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin therapy in an expanded Phase 2 clinical trial. 30 o We have initiated activities in support of a Phase 2 trial in first-recurrence head and neck cancer.
Removed
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”.
Added
The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint.
Removed
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.
Added
We have initiated the necessary planning activities, including protocol development, manufacturing and CRO selection. ● GEO-MVA: o GEO-MVA is the Company vaccine candidate in development for protection against Mpox and smallpox. MVA is the vaccine recommended by both the WHO and the U.S.
Removed
The patent (No. 11,857,611) was issued in January 2024. ● In October 2023, the U.S.
Added
Centers for Disease Control and Prevention against both Mpox and smallpox, recognized for its safety and efficacy among all patient populations, including pregnant women, children and immunocompromised individuals.
Removed
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.
Added
MVA is the vaccine currently used and stockpiled in the United States Strategic National Stockpile for immunization against potential bioterrorism threats based on the smallpox virus. o A clinical batch of GEO-MVA has recently been produced under cGMP production.
Removed
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.
Added
We expect to begin clinical evaluation of the vaccine during 2025. ● Our additional research programs for vaccines and immunotherapies at various stages of preclinical development. Financial Overview Revenue Our revenues to date have been related to government grants and contracts and other collaborative arrangements in support of our product development activities.
Removed
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.
Added
The deferred amounts are expensed as the related goods are delivered or the services are performed.
Removed
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.
Added
The increase during 2024 relates to program-specific costs associated with the ATI-RRPV Contract, Gedeptin and GEO-MVA, partially offset by lower costs for the GEO-CM04S1 clinical trials not covered by the ATI-RRPV Contract.
Removed
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.
Added
The majority of the higher program costs relate to the ATI-RRPV Contract and include costs of manufacturing materials for use in our clinical trials, analytical expenses, third-party contracted research and consulting costs. Research and development expense for 2024 and 2023 includes stock-based compensation expense of $222,202 and $291,094, respectively, associated with employee stock options.
Removed
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).
Added
The variances between years are primarily attributable to the cash available for investment and to interest rate fluctuations.
Removed
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.
Added
Net proceeds to us from these offerings, after deducting commissions to the placement agent and sales agent, as applicable, and other related offering expenses, were approximately $21.4 million. We also received approximately $2.4 million upon the exercise of warrants.
Removed
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.
Added
During 2024, we entered into the ATI-RRPV Contract, which is intended to advance development of GEO-CM04S1 in a Phase 2b clinical trial.
Removed
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.
Added
Pursuant to the ATI-RRPV Contract, we expect to receive direct funding of $26.2 million (which may increase up to as much as $45 million) to fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities.
Removed
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.
Added
Through December 31, 2024, we have recognized approximately $4.0 million in revenue pursuant to the ATI-RRPV Contract based on costs incurred. BARDA has made a separate award of approximately $343 million through its Clinical Studies Network to Allucent, a global clinical research organization, to execute the clinical trial as part of BARDA’s Clinical Studies Network.
Removed
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.
Added
During the first quarter of 2025, we received approximately $3.8 million of net proceeds from sales of our common stock through the ATM Program. Additionally, on March 25, 2025, we closed a registered direct offering of our common stock and warrants for net proceeds of approximately $4.1 million.
Removed
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.
Added
As of the date of this Annual Report, we believe that our existing cash and cash equivalents are sufficient to fund our operations into the third quarter of 2025.
Removed
Financing strategies we may pursue include, but are not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding, collaborations, strategic alliances or licensing arrangements with third parties.
Added
We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources. 34 There can be no assurance that necessary funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern.
Removed
There can be no assurances additional capital will be available to secure additional financing, or if available, that it will be sufficient to meet our needs on favorable terms.
Added
Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed1 unchanged
Biggest changeThe primary objective of our investment activities is to preserve principal while at the same time maximizing the income received without significantly increasing risk. Due to the nature of our short-term investments, we believe that we are not subject to any material market risk exposure. We do not have any derivative financial instruments or foreign currency instruments.
Biggest changeThe primary objective of our investment activities is to preserve principal while at the same time maximizing the income received without significantly increasing risk. Due to the nature of our short-term investments, we believe that we are not subject to any material market risk exposure. We do not have any derivative financial instruments or foreign currency instruments. 35

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