GeoVax Labs(GOVX) - 2019 Q4 - Annual Report

PART I ITEM 1. BUSINESS GeoVax Labs, Inc. develops immunotherapies and vaccines for cancers and infectious diseases using its GV-MVA-VLP™ platform, leveraging collaborations and grants for product advancement Overview GeoVax is a clinical-stage biotech company developing immunotherapies and vaccines using its GV-MVA-VLP™ platform, with its most advanced HIV vaccine entering trials in late 2020 - GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on developing immunotherapies and vaccines for cancers and infectious diseases using its GV-MVA-VLP™ platform[12] - Current development programs include preventive and therapeutic vaccines for HIV, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), Zika virus, malaria, chronic hepatitis B virus infections, and immunotherapies for solid tumor cancers[12] - A collaboration with BravoVax has been initiated to develop a vaccine for COVID-19[12] - The most advanced vaccine program is GOVX-B11 for preventive HIV (clade B), which will be included in an upcoming clinical trial (HVTN 132) in late 2020[15] Our Differentiated Vaccine and Immunotherapy Platform GeoVax's GV-MVA-VLP™ platform utilizes recombinant MVA vectors to produce highly immunogenic Virus-Like Particles (VLPs) in vivo, offering safety, durability, and cost-effective manufacturing - GeoVax's GV-MVA-VLP™ platform uses recombinant MVA vectors to express target proteins on highly immunogenic Virus-Like Particles (VLPs) in vivo, aiming for durable immune responses with a safe, replication-deficient MVA vector and cost-effective manufacturing[13][20] - The in vivo production of VLPs for enveloped viruses (like HIV, Ebola) includes membranes from the vaccinated individual's cells, making them highly similar to authentic viruses and potentially enhancing immune recognition compared to in vitro produced VLPs[21] - The MVA vector was selected for its established safety record, ability to carry sufficient viral sequences for VLP production, and limited pre-existing immunity in the population[26][28] - Key advantages of the GV-MVA-VLP™ platform include demonstrated safety in human clinical trials, durability of vaccine responses, limited pre-existing immunity to the vector, potential for repeated use, no need for adjuvants, and thermal stability[28] Our Product Development Pipeline GeoVax maintains a diverse product development pipeline across cancer and infectious diseases, strategically prioritizing programs based on opportunities and resource availability Product Development Pipeline Status | Product Area / Indication | Stage of Development | Collaborators / Sponsors | | :------------------------ | :------------------- | :----------------------- | | Cancer | | | | HPV-related cancers | Preclinical | Emory, Virometix | | MUC1-expressing tumors | Preclinical completed| Univ of Pittsburgh, ViaMune | | Cyclin B1-expressing tumors | Preclinical | | | Checkpoint inhibitors | Preclinical | Leidos | | Infectious Diseases | | | | HIV (preventive) | Phase 2a completed | NIH, HVTN, Emory | | HIV (immunotherapy) | Phase 1 | AGT, UCSF | | Zika | Preclinical completed| NIH, CDC | | Malaria | Preclinical | Leidos, Burnet Institute | | Ebola, Marburg, Sudan | Preclinical completed| NIH, USAMRIID, UTMB | | Lassa Fever | Preclinical | NIH, DoD, Scripps, IHV, UTMB, USNRL, Geneva Foundation | | Hepatitis B (immunotherapy)| Preclinical | GSURF | | Coronavirus (COVID-19) | Preclinical | BravoVax | | Novel vaccine delivery | Preclinical | Enesi | - The company prioritizes development based on opportunities, resources, and circumstances, shifting focus as needed, such as dedicating resources to immuno-oncology in 2019 and COVID-19 in early 2020[30] Our Cancer Immunotherapy Programs GeoVax is developing therapeutic cancer vaccines using its GV-MVA-VLP™ platform, focusing on inducing immune responses against various tumor types through strategic collaborations - GeoVax is developing therapeutic cancer vaccines using its GV-MVA-VLP™ platform, aiming to induce immune responses that control tumors and establish immunological memory to prevent recurrence[32] - Collaborations include: University of Pittsburgh and ViaMune for MUC1-expressing tumors, Emory Vaccine Center and Virometix for HPV-related cancers (specifically head and neck cancer), and Leidos for combining GV-MVA-VLP™ with novel peptide PD-1 checkpoint inhibitors[33][34][35][36][37] - In September 2019, GeoVax incorporated Immutak Oncology, Inc. as a wholly-owned subsidiary to focus on immuno-oncology programs and seek additional complementary technologies and clinical-stage products[39] Our Infectious Disease Vaccine Programs GeoVax actively develops vaccines for a range of infectious diseases, including a recent collaboration for a COVID-19 vaccine, and ongoing programs for HIV/AIDS, Filoviruses, Lassa Fever, Zika, Malaria, and Hepatitis B - GeoVax is actively developing vaccines for a range of infectious diseases, including a recent collaboration for a COVID-19 vaccine, and ongoing programs for HIV/AIDS, Filoviruses (Ebola, Sudan, Marburg), Lassa Fever, Zika, Malaria, and Hepatitis B[40][47][55][62][67][72][76] - The company's most clinically advanced program is GOVX-B11 for preventive HIV (clade B), which has completed Phase 1 and 2a trials and will enter HVTN 132 in late 2020[47][48][50] - Preclinical studies for Ebola, Sudan, Marburg, Lassa, and Zika vaccine candidates have shown 100% single-dose protection against lethal challenges in animal models[59][60][63][69] - Immunotherapy programs for HIV (with AGT and UCSF) and Hepatitis B (with GSURF) aim for functional cures or significantly increased cure rates by inducing strong immune responses[53][54][79][80] Novel Vaccine Delivery Evaluation GeoVax is collaborating with Enesi Pharma to develop thermostable, needle-free vaccine formulations to simplify administration and reduce storage costs, particularly for developing countries - GeoVax is collaborating with Enesi Pharma to develop thermostable solid-dose needle-free vaccine formulations using its GV-MVA-VLP™ platform and Enesi's ImplaVax® device and formulation technology[83] - This initiative aims to simplify vaccine administration, reduce storage and distribution costs, and potentially improve vaccine responses, especially for infectious diseases prevalent in developing countries[82][83] Support from the United States Government GeoVax receives significant federal support through grants, contracts, and in-kind contributions from agencies like DoD, NIAID, and CDC for its vaccine development programs - GeoVax has received multiple federal grants and contracts, including a $2.44 million DoD cooperative agreement for Lassa Fever vaccine development and SBIR grants for Lassa Fever, Zika, and HIV programs[84][85][86][88] - NIAID has funded all human clinical trials for GeoVax's preventive HIV vaccines through the HVTN, providing significant indirect support not reflected in GeoVax's financial statements[89] - Additional in-kind federal support has been received from CDC, NIAID's Rocky Mountain Laboratory, and USAMRIID for preclinical animal studies[90] Government Regulation GeoVax's products are subject to stringent federal and international regulations, requiring extensive testing, manufacturing compliance, and a multi-stage approval process for market entry - The company's products are subject to rigorous federal and state regulations in the U.S. (FDA) and other countries, governing testing, manufacturing, safety, efficacy, labeling, and approval[92][93] - The approval process involves preclinical tests, cGMP manufacturing, Investigational New Drug (IND) application, human clinical trials, and Biologics License Application (BLA) submission and approval[96] - Compliance with FDA's cGMP regulations is crucial for outsourced manufacturing operations, with potential enforcement actions ranging from minor deficiency corrections to product withdrawal or criminal charges for serious violations[95][96] Manufacturing GeoVax relies entirely on third-party contract manufacturers for its product supplies, facing challenges in ensuring regulatory compliance and achieving cost-effective commercial-scale production - GeoVax relies entirely on third-party contract manufacturers for clinical and commercial supplies of its products, as it lacks in-house facilities or expertise[100][101] - Ensuring compliance with regulatory requirements (e.g., FDA's Good Manufacturing Practices) and achieving cost-effective commercial-scale manufacturing are critical challenges[100][101] - The company is exploring approaches to grow the MVA component of its vaccine in continuous cell lines suitable for commercial-scale manufacturing, as current production uses embryonated eggs[102] Competition The biotechnology and pharmaceutical industries are highly competitive, with GeoVax facing numerous larger, more resourced companies developing similar vaccine and immunotherapy candidates - The biotechnology and pharmaceutical industries are highly competitive, with numerous established companies (e.g., Janssen, Sanofi-Aventis, GlaxoSmithKline, Merck, Pfizer) and development-stage firms (e.g., Aduro Biotech, Moderna, Novavax) engaged in vaccine/immunotherapy R&D[103] - Many competitors possess substantially greater financial, technical, and human resources, and more experience in product development, regulatory approvals, and commercialization[104] - While there are no FDA-licensed HIV, Zika, or most hemorrhagic fever virus vaccines (except Merck's Ervebo for Ebola), numerous companies are actively researching and developing candidates in these areas, as well as for chronic HBV and cancer immunotherapies[105][106][107][108][109] Our Intellectual Property GeoVax protects its proprietary technology through patents and trade secrets, holding exclusive and non-exclusive licenses for its HIV, hemorrhagic fever, and immuno-oncology vaccine platforms - GeoVax protects its proprietary rights through patents and trade secrets, actively pursuing patent protection for its DNA and MVA-based HIV vaccines, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), Zika, malaria, immuno-oncology, and therapeutic HBV vaccines[110] - The company is the exclusive, worldwide licensee of several patents and applications from Emory University for HIV or smallpox vaccines, and a non-exclusive licensee of NIH patents related to its MVA vector vaccine[111] - Litigation or interference proceedings related to intellectual property could result in significant costs, delays in regulatory approval, damages, or injunctions preventing product development or sales[113][115] Research and Development GeoVax's R&D expenditures are expected to increase as vaccine candidates advance through regulatory approval, reflecting ongoing investment in its development pipeline Research and Development Expenditures | Year Ended December 31, | Expenditures | | :---------------------- | :------------- | | 2019 | $1,910,715 | | 2018 | $1,878,652 | - Research and development costs are expected to increase as vaccine candidates progress through regulatory approval[116] Scientific Advisors GeoVax maintains a Scientific Advisory Board comprising leading scientists to provide expert scientific and medical guidance for its development programs - GeoVax maintains a Scientific Advisory Board composed of leading scientists, including Thomas P. Monath, Stanley A. Plotkin, Barney S. Graham, Scott C. Weaver, and Olivera J. Finn, to provide scientific and medical guidance[117] Properties and Employees GeoVax leases office and laboratory space in Smyrna, Georgia, and operates with a small team of full-time and part-time employees - GeoVax leases approximately 8,400 square feet of office and laboratory space in Smyrna, Georgia, under a lease expiring December 31, 2022[118] - The company currently has six full-time and one part-time employees, with good employee relations and no collective bargaining agreements[118] Corporate Background GeoVax Labs, Inc. was reincorporated in Delaware in 2008, operating through its wholly-owned subsidiaries, including Immutak Oncology, Inc. established in 2019 - GeoVax Labs, Inc. was reincorporated in Delaware in June 2008, with its primary business conducted by its wholly-owned subsidiary, GeoVax, Inc. (incorporated in 2001)[119] - In September 2019, the company incorporated Immutak Oncology, Inc. as another wholly-owned subsidiary[119] Reverse Stock Split and Outstanding Rights to Acquire our Common Stock A 1-for-2000 reverse stock split was effected in January 2020, and outstanding preferred stock and warrants pose significant potential for future common stock dilution - A 1-for-2000 reverse stock split was effected on January 21, 2020, reducing outstanding common stock to 299,835 shares as of that date[122] - Holders of convertible preferred stock (Series B and Series J) have rights to acquire significant amounts of common stock, with conversion prices based on a variable formula (lower of $2.00/share or 80% of 10-day VWAP)[123][124] Outstanding Capital Stock (Post-Split) | Class | January 21, 2020 Outstanding Shares | March 23, 2020 Outstanding Shares | | :-------------------------- | :---------------------------------- | :-------------------------------- | | Common Stock ($0.01 par) | 299,835 | 13,791,601 | | Series B Convertible Preferred Stock ($0.01 par) | 100 ($100,000 stated value) | 100 ($100,000 stated value) | | Series H Convertible Preferred Stock ($0.01 par) | 1,686 ($1,686,029 stated value) | -0- ($-0- stated value) | | Series I Convertible Preferred Stock ($0.01 par) | 700 ($700,000 stated value) | -0- ($-0- stated value) | | Series J Convertible Preferred Stock ($0.01 par) | -0- ($-0- stated value) | 300 ($300,000 stated value) | - Between January 21, 2020, and March 18, 2020, preferred stock holders converted approximately 2,386 shares of convertible preferred stock into 13,481,079 shares of common stock[125] ITEM 1A. RISK FACTORS GeoVax faces significant risks from dilution, funding, unproven products, competition, regulatory, and intellectual property challenges - The conversion of outstanding preferred stock and exercise of options/warrants may cause significant dilution to common stockholders and depress the stock price, impacting future fundraising ability[128] - GeoVax has a history of operating losses, an accumulated deficit of $42.8 million as of December 31, 2019, and has received a 'going concern' opinion from its auditors, indicating substantial doubt about its ability to continue operations without additional funding[131][132][213] - The company's product candidates are still in development, unproven in human clinical trials, and face intense competition from larger pharmaceutical and biotechnology companies with greater resources[141][144] - Significant regulatory and legal uncertainties exist, including the lengthy and costly FDA approval process, potential delays in clinical trials, and the risk of not obtaining timely approvals or market acceptance[143][147][149] - Reliance on third parties for clinical trials, manufacturing, and intellectual property licensing exposes the company to risks if these parties fail to meet obligations or if license rights are terminated[148][100][162] Risk of Substantial Dilution to Stock Ownership Percentage The conversion of preferred stock and exercise of warrants could significantly dilute common stockholders and depress the market price of GeoVax's stock - The conversion of outstanding preferred stock (Series B and Series J) and exercise of warrants can lead to significant dilution for common stockholders[128] - The variable conversion price of Series J Preferred Stock (80% of the lowest 10-day VWAP or $2.00/share) allows for conversion at lower prices, exacerbating dilution[128] - Sales of common stock by preferred share holders have historically depressed and are likely to continue to depress the market price of GeoVax's common stock, impairing its ability to raise capital[128] Risks Related to Our Business GeoVax faces ongoing operating losses, a 'going concern' opinion, and the critical need for continuous funding, alongside vulnerability to public health crises - GeoVax has a history of operating losses since 2001, with an accumulated deficit of approximately $42.8 million as of December 31, 2019, and expects losses to continue[131] - The company has received a 'going concern' opinion from its auditors, reflecting substantial doubt about its ability to continue operations without securing additional capital[132] - Continued funding is essential for operations, clinical trials, and regulatory approvals; failure to secure adequate financing could lead to delays, curtailment of operations, or relinquishing product rights[133][136] - The business is vulnerable to disruptions from widespread public health epidemics (like COVID-19) or other catastrophic events, potentially impacting clinical trials, employee productivity, and manufacturing capabilities[139][140] Risks Related to Development and Commercialization of Product Candidates and Dependence on Third Parties GeoVax's unproven product candidates face risks of ineffectiveness, regulatory delays, and market acceptance issues, compounded by reliance on third-party collaborators - GeoVax's product candidates are unproven and based on new medical technology, carrying inherent risks of ineffectiveness, unsafety, or manufacturing difficulties, which could prevent profitability[141][145] - The company relies heavily on third parties (HVTN, clinical investigators, manufacturers) for clinical trials and manufacturing, but does not control all aspects of their activities, posing risks of delays or non-compliance[148] - Failure to obtain timely regulatory approvals (FDA, foreign authorities) could increase development costs, impair future sales, and severely harm the business[149] - Market acceptance of products is uncertain and depends on efficacy, safety, regulatory approval, reimbursement coverage, pricing, and competition, which could be adversely affected by healthcare law changes and pricing scrutiny[159][151][154] Risks Related to Our Intellectual Property GeoVax risks losing license rights, facing infringement claims, and encountering challenges in securing broad patent protection for its proprietary technologies - GeoVax could lose its license rights to critical intellectual property if it fails to fulfill contractual obligations to licensors, such as milestone payments, royalties, or patent expenses[162] - The company faces risks of third-party infringement claims, which could lead to costly litigation, delays in regulatory approval, damages, or the need for unfavorable licensing agreements[163][164] - There is no assurance that current or future patent applications will be issued, or that issued patents will be broad enough to prevent competitors, or that proprietary information will be adequately protected in all jurisdictions[115][165][167] Risks Related To Our Common Stock GeoVax's common stock is highly volatile, has a limited public market, is subject to 'penny stock' rules, and future equity offerings could cause significant dilution - The market price of GeoVax's common stock is highly volatile, influenced by company developments, regulatory matters, financial position, and potential dilutive effects of future equity sales or conversions[170] - The common stock has a limited active public market, making it difficult for investors to sell shares, and is subject to SEC 'penny stock' rules, which further reduce trading activity[171][172] - Future equity offerings or debt instruments to raise additional capital could result in significant dilution to existing stockholders and impose restrictive covenants[173] - Provisions in the certificate of incorporation authorizing preferred stock issuance could make a change in control more difficult or costly, potentially reducing the value of common stock[174] - GeoVax has never paid dividends and has no plans to do so, meaning investor returns depend solely on stock price appreciation[175] ITEM 1B. UNRESOLVED STAFF COMMENTS There are no unresolved staff comments to report - No unresolved staff comments were reported[177] ITEM 2. PROPERTIES GeoVax leases approximately 8,400 square feet of office and laboratory space in Smyrna, Georgia, under an agreement that expires on December 31, 2022, which is deemed adequate for current needs - GeoVax leases 8,400 square feet of office and laboratory space at 1900 Lake Park Drive, Suite 380, Smyrna, Georgia[177] - The lease agreement for this space expires on December 31, 2022[177] - The company believes the current space is adequate for its needs[177] ITEM 3. LEGAL PROCEEDINGS GeoVax is not currently involved in any material legal proceedings, though it may encounter various legal actions in the ordinary course of business - GeoVax is not currently a party to any material legal proceedings[178] - The company may become involved in various legal proceedings arising in the ordinary course of business from time to time[178] ITEM 4. MINE SAFETY DISCLOSURES This item is not applicable to GeoVax Labs, Inc - Mine Safety Disclosures are not applicable to the registrant[179] PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES GeoVax's common stock trades on OTC Markets 'Pink', has few record holders, no dividends, and limited equity compensation plan securities - GeoVax's common stock is traded on the OTC Markets 'Pink' market under the symbol 'GOVX'[181] - As of March 23, 2020, there were three holders of record for common stock, with most shares held by brokers[182] - The company has not paid any dividends since its inception and does not contemplate paying dividends in the foreseeable future, intending to retain earnings for business operations[175][183] - No sales of unregistered securities occurred during the reporting period, and no equity securities were repurchased in the fourth quarter of 2019[184][185] Securities Authorized for Issuance Under Equity Compensation Plans (as of Dec 31, 2019) | Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) | Weighted-average exercise price of outstanding options, warrants and rights (b) | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) | | :---------------------------------------------- | :-------------------------------------------------------------------------------- | :------------------------------------------------------------------------------ | :------------------------------------------------------------------------------------------------------------------------------------------------ | | Equity compensation plans approved by stockholders | -0- | -0- | -0- | | Equity compensation plans not approved by stockholders | 11 | $33,909 | 5 | ITEM 6. SELECTED FINANCIAL DATA GeoVax's selected financial data shows consistent net losses, increasing revenues, decreasing assets, and a growing stockholders' deficiency over five years Selected Statement of Operations Data (Years Ended December 31) | Indicator | 2019 | 2018 | 2017 | 2016 | 2015 | | :------------------------------ | :------------ | :------------ | :------------ | :------------ | :------------ | | Total revenues | $1,175,896 | $963,203 | $1,075,270 | $828,918 | $428,081 | | Net loss | $(2,370,629) | $(2,560,094) | $(2,170,162) | $(3,271,701) | $(2,689,287) | | Basic and diluted net loss per common share | $(39.25) | $(15,610.33) | $(31,451.62) | $(78,804.81) | $(84,169.60) | Selected Balance Sheet Data (As of December 31) | Indicator | 2019 | 2018 | 2017 | 2016 | 2015 | | :------------------------------ | :------------ | :------------ | :------------ | :------------ | :------------ | | Total assets | $468,880 | $642,064 | $490,235 | $610,217 | $1,331,593 | | Total stockholders' equity (deficiency) | $(1,574,556) | $(1,022,347) | $(321,057) | $240,370 | $1,204,603 | ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS GeoVax, a clinical-stage biotech, reports continued losses, an accumulated deficit, and a 'going concern' opinion, relying on grants for revenue amidst fluctuating expenses - GeoVax is a clinical-stage biotechnology company developing immunotherapies and vaccines, with no product revenue to date and expectations of continued operating losses for the foreseeable future[191][196] - The company's accumulated deficit was $42.8 million as of December 31, 2019, and it has received a 'going concern' opinion, highlighting the need for substantial additional financing to continue operations[131][132][213] Grant and Collaboration Revenues (Years Ended December 31) | Revenue Type | 2019 | 2018 | | :------------------------ | :------------ | :------------ | | Grant and collaboration revenue | $1,175,896 | $963,203 | | Grant Revenues (as % of total) | 84% | 97% | | Collaboration Revenues (as % of total) | 16% | 3% | Operating Expenses (Years Ended December 31) | Expense Category | 2019 | 2018 | | :------------------------ | :------------ | :------------ | | Research and development | $1,910,715 | $1,878,652 | | General and administrative| $1,637,674 | $1,647,268 | | Total operating expenses | $3,548,389 | $3,525,920 | | Net loss | $(2,370,629) | $(2,560,094) | - Management and director salaries are being deferred to conserve cash, with accumulated deferrals totaling $1,732,702 as of December 31, 2019[206] Overview GeoVax is a clinical-stage biotechnology company with no product revenue, anticipating continued losses due to R&D, and expects its most advanced HIV vaccine to enter trials in late 2020 - GeoVax Labs, Inc. is a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases using its GV-MVA-VLP™ platform[191] - The company's most advanced vaccine program, GOVX-B11 for preventive HIV (clade B), is expected to enter clinical trial HVTN 132 in late 2020[194] - GeoVax has not generated product revenues and anticipates significant additional R&D efforts and costs for regulatory approval and commercialization, with no expectation of profitability for several years[196] Critical Accounting Policies and Estimates GeoVax's critical accounting policies cover revenue recognition for grants and collaborations, and stock-based compensation, with recent ASU adoptions having no material impact - Revenue recognition for grants and collaborations follows ASU 2014-09 (Topic 606), recognizing revenue when reimbursable costs are incurred and conditions are met[198][199][200] - Stock-based compensation is accounted for based on the fair value of awards at the grant date, estimated using the Black-Scholes model for options/warrants, and expensed ratably over the service period[201] - Adoption of ASU 2014-09 (Revenue from Contracts with Customers), ASU 2017-09 (Scope of Modification Accounting), and ASU 2018-07 (Improvements to Nonemployee Share-Based Payment Accounting) had no material impact on financial statements[198][202][203] Liquidity and Capital Resources GeoVax faces a working capital deficit and requires substantial additional financing beyond Q2 2020, despite available grant funds and committed equity capital Liquidity and Capital Resources (as of December 31) | Metric | 2019 | 2018 | | :------------------------ | :------------ | :------------ | | Cash and cash equivalents | $283,341 | $259,701 | | Total assets | $468,880 | $642,064 | | Working capital deficit | $(1,568,929) | $(1,005,127) | | Accrued management salaries and director fees (deferred) | $1,732,702 | $1,220,179 | Cash Flows (Years Ended December 31) | Activity | 2019 | 2018 | | :------------------------ | :------------ | :------------ | | Net cash used in operating activities | $(1,398,497) | $(1,543,026) | | Net cash used in investing activities | $(7,606) | $-0- | | Net cash provided by financing activities | $1,429,743 | $1,490,000 | - As of December 31, 2019, $1,605,505 in approved grant funds are available for use in 2020, with $1,053,776 expected to reimburse third-party services[205] - The company expects existing cash, grants, and committed equity capital to fund operations into Q2 2020, but requires additional funds beyond that, planning further equity offerings or debt instruments[213] Net Operating Loss Carryforwards GeoVax holds significant federal net operating loss and R&D tax credit carryforwards, but their utilization may be limited by ownership changes under Section 382 - As of December 31, 2019, GeoVax had consolidated federal net operating loss (NOL) carryforwards of approximately $65.7 million, with $62.6 million expiring between 2020 and 2037[214] - The company also has approximately $1.1 million in research and development (R&D) tax credits expiring between 2022 and 2039[214] - Utilization of these NOL and R&D tax credit carryforwards may be limited by Section 382 of the Internal Revenue Code due to past or future changes in ownership interests[214] Off-Balance Sheet Arrangements GeoVax has no material off-balance sheet arrangements other than its operating leases - GeoVax has no off-balance sheet arrangements that are likely to have a material effect on its financial condition or results of operations, other than operating leases[215] Results of Operations GeoVax's operating results, characterized by net losses, fluctuate primarily due to the timing and costs of research and development and general and administrative expenses Net Losses (Years Ended December 31) | Year | Net Loss | | :--- | :------------ | | 2019 | $(2,370,629) | | 2018 | $(2,560,094) | - Operating results fluctuate based on the timing and costs of research and development activities and general and administrative expenses[216] Grant and Collaboration Revenues Grant and collaboration revenues, primarily from government agencies, increased in 2019, with a significant portion of grant funds remaining available for 2020 Grant and Collaboration Revenues (Years Ended December 31) | Revenue Type | 2019 | 2018 | | :------------------------ | :------------ | :------------ | | Total Grant and Collaboration Revenue | $1,175,896 | $963,203 | | Grant Revenues | $983,682 | $934,575 | | Collaboration Revenues | $192,214 | $28,628 | - Grant revenues, primarily from U.S. government agencies, constituted 84% and 97% of total revenues in 2019 and 2018, respectively, fluctuating with the timing of expenditures[218] - As of December 31, 2019, $1,605,505 in grant funds remained available for use in 2020[219] Research and Development Expenses R&D expenses increased slightly in 2019, driven by grant expenditures, and are expected to be volatile as vaccine candidates progress, excluding NIAID-funded HIV trials Research and Development Expenses (Years Ended December 31) | Year | R&D Expenses | | :--- | :----------- | | 2019 | $1,910,715 | | 2018 | $1,878,652 | - R&D expenses increased by $32,063 (1.7%) from 2018 to 2019, primarily due to the timing of government grant expenditures[221] - These expenses do not include costs incurred by the HVTN for preventive HIV vaccine clinical trials, which are directly funded by NIAID[221] - Forward-looking estimates for R&D costs and completion times are not provided due to uncertainties in vaccine development, with future expenditures expected to be highly volatile[223] General and Administrative Expenses General and administrative expenses, excluding stock-based compensation, increased in 2019 due to special stockholder meetings and the reverse stock split, with further increases anticipated General and Administrative Expenses (Years Ended December 31) | Year | G&A Expenses | | :--- | :----------- | | 2019 | $1,637,674 | | 2018 | $1,647,268 | - Excluding stock-based compensation, G&A expenses increased by $134,434 (11%) from 2018 to 2019, mainly due to costs associated with special stockholder meetings and the reverse stock split[224] - G&A costs are expected to increase in the future to support expanded R&D and other corporate activities[224] Stock-Based Compensation Expense Total stock-based compensation expense decreased in 2019, allocated between general and administrative and research and development expenses Stock-Based Compensation Expense (Years Ended December 31) | Component | 2019 | 2018 | | :---------------------------- | :------------ | :------------ | | Stock option expense | $104,420 | $155,304 | | Stock issued for non-employee services | $223,080 | $314,419 | | Total stock-based compensation expense | $327,500 | $469,723 | Allocation of Stock-Based Compensation Expense (Years Ended December 31) | Allocation | 2019 | 2018 | | :---------------------------- | :------------ | :------------ | | General and administrative expense | $283,699 | $427,725 | | Research and development expense | $43,801 | $41,998 | | Total | $327,500 | $469,723 | Other Income (Expense) Other income and expense primarily consist of interest income from cash investments and interest expense related to the GRA Note and insurance premium financing Other Income (Expense) (Years Ended December 31) | Item | 2019 | 2018 | | :-------------- | :---------- | :---------- | | Interest income | $6,359 | $5,213 | | Interest expense| $(4,495) | $(2,590) | - Interest income variations are due to cash available for investment and interest rate fluctuations, while interest expense relates to the GRA Note and insurance premium financing costs[226] Impact of Inflation Inflation and changing prices did not materially impact GeoVax's operations or financial results for the two-year period ended December 31, 2019 - Inflation and changing prices did not have a material impact on GeoVax's operations or financial results for the two-year period ended December 31, 2019[227] ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK GeoVax's market risk exposure is primarily limited to interest income sensitivity due to changes in U.S. interest rates, as its investments are mainly in institutional money market funds. The company does not use derivative financial instruments or foreign currency instruments - Market risk exposure is primarily limited to interest income sensitivity, affected by changes in U.S. interest rates[228] - Investments are predominantly in institutional money market funds, with the primary objective of preserving principal while maximizing income[228] - GeoVax does not hold any derivative financial instruments or foreign currency instruments[228] ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA This section refers to the consolidated financial statements, supplemental schedules, and notes for the years ended December 31, 2019 and 2018, which are included in pages F-1 to F-18 of the Annual Report on Form 10-K - Consolidated financial statements, supplemental schedules, and notes for December 31, 2019 and 2018 are presented on pages F-1 to F-18 of the Annual Report[229] ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE There were no disagreements with GeoVax's accountants on accounting or financial disclosure matters, nor any other reportable events requiring disclosure under this item - No disagreements with accountants on accounting or financial disclosure were reported[230] - No other reportable events requiring disclosure under Item 9 occurred[230] ITEM 9A. CONTROLS AND PROCEDURES GeoVax's management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of December 31, 2019, providing reasonable assurance for financial reporting reliability. There were no material changes in internal control over financial reporting during the most recent fiscal quarter. However, management acknowledges that no control system can prevent or detect all errors and fraud - As of December 31, 2019, GeoVax's Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures were effective[232] - Management assessed and concluded that internal control over financial reporting was effective as of December 31, 2019, providing reasonable assurance regarding financial reporting reliability[233] - No material changes in internal control over financial reporting occurred during the most recent fiscal quarter[234] - Management acknowledges that control systems provide only reasonable, not absolute, assurance and may not prevent or detect all errors and fraud[235] ITEM 9B. OTHER INFORMATION There is no other information to report under this item - No other information is reported under this item[236] PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE Information regarding directors, executive officers, and corporate governance, including the Code of Business Conduct and Ethics, is incorporated by reference from GeoVax's definitive proxy statement for its 2020 annual meeting of stockholders. The Code of Ethics outlines requirements for ethical conduct, compliance, and reporting, with any amendments or waivers for executive officers disclosed publicly - Information on directors, executive officers, and corporate governance is incorporated by reference from the 2020 annual meeting proxy statement[239] - The Board of Directors adopted a Code of Business Conduct and Ethics, requiring officers, directors, and employees to adhere to ethical conduct, comply with laws, and report violations[240] - Any amendments or waivers to the Code of Ethics for the CEO or CFO will be disclosed on the company's website or via a Form 8-K[241] ITEM 11. EXECUTIVE COMPENSATION Information concerning executive compensation is incorporated by reference from GeoVax's definitive proxy statement for its 2020 annual meeting of stockholders - Executive compensation information is incorporated by reference from the definitive proxy statement for the 2020 annual meeting of stockholders[242] ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS Details regarding security ownership of beneficial owners and management, along with related stockholder matters, are incorporated by reference from GeoVax's definitive proxy statement for its 2020 annual meeting of stockholders - Information on security ownership of certain beneficial owners and management, and related stockholder matters, is incorporated by reference from the definitive proxy statement for the 2020 annual meeting of stockholders[243] ITEM 13. CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE Information on certain relationships, related party transactions, and director independence is incorporated by reference from GeoVax's definitive proxy statement for its 2020 annual meeting of stockholders - Information on certain relationships and related party transactions, and director independence, is incorporated by reference from the definitive proxy statement for the 2020 annual meeting of stockholders[244] ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES Information regarding principal accounting fees and services is incorporated by reference from GeoVax's definitive proxy statement for its 2020 annual meeting of stockholders - Information on principal accounting fees and services is incorporated by reference from the definitive proxy statement for the 2020 annual meeting of stockholders[246] PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES This section lists the financial statements, supplemental schedules, and exhibits filed as part of the Annual Report on Form 10-K. It includes reports of independent registered public accounting firms, consolidated financial statements (Balance Sheets, Statements of Operations, Stockholders' Equity, Cash Flows, and Notes), and Schedule II – Valuation and Qualifying Accounts. Additionally, it provides a comprehensive list of exhibits, including corporate governance documents, employment agreements, license agreements, and certifications - The report includes consolidated financial statements: Reports of Independent Registered Public Accounting Firms, Consolidated Balance Sheets, Consolidated Statements of Operations, Consolidated Statements of Stockholders' Equity, Consolidated Statements of Cash Flows, and Notes to Consolidated Financial Statements[248] - Financial statement schedule II – Valuation and Qualifying Accounts for 2019 and 2018 is also included[249] - A comprehensive list of exhibits is provided, covering corporate documents (Certificate of Incorporation, Bylaws), stock certificates, preferred stock designations, employment agreements, license agreements, and various certifications (e.g., Sarbanes-Oxley Act)[250][251][252][254] ITEM 16. FORM 10-K SUMMARY This section indicates that no Form 10-K Summary is provided - No Form 10-K Summary is provided[253]