GeoVax Labs(GOVX) - 2022 Q4 - Annual Report

Part I This section provides an overview of GeoVax Labs, Inc.'s business, product pipeline, strategic direction, intellectual property, and key risks Business GeoVax is a clinical-stage biotech company developing vaccines and immunotherapies for infectious diseases and cancers - GeoVax is a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases (COVID-19, MPox, Ebola, Zika) and solid tumor cancers (advanced head and neck cancer)[14] Product Development Pipeline Status | Indication | Current Status | | :--- | :--- | | Coronavirus Vaccines | | | COVID-19 (Booster to mRNA vaccines) | Clinical – Phase 2 | | COVID-19 (Primary for immunocompromised) | Clinical – Phase 2 | | Pan Coronavirus | Preclinical/IND-Enabling | | Cancer Therapy | | | Solid Tumors (Advanced Head and Neck Cancer)* | Clinical – Phase 1/2 | | Solid Tumors (MUC1) | Preclinical/IND-Enabling | | Other Infectious Disease Vaccines | | | Monkeypox (MPox) & Smallpox (SPox) | Preclinical/IND-Enabling | | Hemorrhagic Fever Viruses (Ebola, Sudan, Marburg, Lassa) | Preclinical/IND-Enabling | | Zika** | Preclinical/IND-Enabling | | Malaria** | Exploratory | Orphan Drug status granted Indication within FDA Priority Review Voucher program - The company's core technology is the GV-MVA-VLP™ platform, which uses a Modified Vaccinia Ankara (MVA) vector to produce Virus-Like Particles (VLPs) in the recipient, stimulating both humoral and cellular immune responses[52][53] - GeoVax relies on third-party contract manufacturers for clinical and commercial supplies and is developing a proprietary, continuous avian cell line manufacturing system to improve scalability and reduce costs[75][77] - As of December 31, 2022, the company's intellectual property portfolio includes over 115 granted or pending patent applications across 24 patent families, comprising owned, co-owned, and in-licensed assets[14][89] Risk Factors The company faces substantial financial, operational, and market risks, including ongoing losses, funding needs, and potential Nasdaq delisting - The company has a history of operating losses, expects them to continue, and has received a "going concern" opinion from its auditors, indicating substantial doubt about its ability to continue operations without raising additional capital[125][126] - Current working capital is projected to be sufficient to support operations only into the fourth quarter of 2023, requiring substantial additional financing to advance development programs[129] - The company's product candidates are based on new medical technology and are inherently risky, with no guarantee of safety, efficacy, or regulatory approval[133][137] - GeoVax received a deficiency letter from Nasdaq on December 9, 2022, for its stock price falling below the $1.00 minimum bid requirement, posing a risk of delisting if compliance is not regained by June 7, 2023[184][185] - The company's success is highly dependent on its ability to obtain, maintain, and enforce its intellectual property rights, and it faces risks of infringement claims from third parties, particularly in the crowded COVID-19 vaccine space[153][157] Unresolved Staff Comments The company reports that there are no unresolved staff comments from the SEC - There are no unresolved staff comments[187] Properties GeoVax leases 8,400 sq ft of office and lab space in Smyrna, Georgia, deeming current facilities adequate - The company's principal executive offices and laboratory are located in a leased 8,400 square foot facility in Smyrna, Georgia, with the lease scheduled to terminate on December 31, 2025[187] Legal Proceedings The company is not currently a party to any material legal proceedings - As of the report date, GeoVax is not involved in any material legal proceedings[188] Mine Safety Disclosures This section is not applicable to the company's operations - Not applicable[189] Part II This section covers the common stock market, stockholder matters, MD&A of financial condition, results of operations, liquidity, and market risk Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities GeoVax common stock trades on Nasdaq under GOVX; the company has never paid and does not anticipate paying cash dividends - The company's common stock is traded on The Nasdaq Capital Market under the symbol "GOVX"[191] - GeoVax has never paid cash dividends and does not plan to in the foreseeable future[193] Management's Discussion and Analysis of Financial Condition and Results of Operations GeoVax reported a net loss of $14.0 million in 2022, an improvement from 2021, with cash sufficient to fund operations into Q4 2023 Results of Operations (2022 vs. 2021) | | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Grant and collaboration revenue | $81,526 | $385,501 | $(303,975) | | Research and development | $9,123,479 | $15,554,171 | $(6,430,692) | | General and administrative | $4,986,611 | $3,577,153 | $1,409,458 | | Loss from operations | $(14,028,564) | $(18,745,823) | $4,717,259 | | Net loss | $(14,021,125) | $(18,570,317) | $4,549,192 | - Research and development expenses decreased by 41% to $9.1 million in 2022 from $15.6 million in 2021. The 2021 figure included $12.3 million in upfront license fees for GEO-CM04S1 and Gedeptin. Excluding these one-time costs, R&D expenses increased by 182% in 2022 due to higher clinical trial, manufacturing, and personnel costs[215] - General and administrative expenses increased by 39% to $5.0 million in 2022, driven by higher personnel, patent, investor relations, and travel costs[216] Liquidity and Capital Resources Summary | | As of Dec 31, 2022 | As of Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $27,612,732 | $11,423,870 | | Working capital | $24,190,836 | $6,193,756 | - Net cash provided by financing activities was $35.4 million in 2022, primarily from offerings of common stock ($27.7 million*) and the exercise of warrants ($7.6 million)[220] - The company expects its existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2023, but will require substantial additional funding to continue operations beyond that[222] Quantitative and Qualitative Disclosures About Market Risk The company's market risk is limited to interest rate sensitivity on cash and cash equivalents, with no derivative or foreign currency exposure - Market risk is primarily limited to interest rate sensitivity on cash and cash equivalents invested in short-term money market funds[225] - The company does not use derivative financial instruments or have no exposure to foreign currency risk[225] Financial Statements and Supplementary Data This section presents consolidated financial statements, including the auditor's report with a going concern emphasis due to recurring losses - The independent auditor's report expresses an opinion that the financial statements are presented fairly, but includes an "Emphasis of a Matter" paragraph regarding "Substantial Doubt about the Company's Ability to Continue as a Going Concern"[260] Consolidated Balance Sheet Data (as of Dec 31) | | 2022 | 2021 | | :--- | :--- | :--- | | Total Assets | $31,347,928 | $11,797,064 | | Total Current Liabilities | $4,747,894 | $5,435,360 | | Total Liabilities | $4,747,894 | $7,435,360 | | Total Stockholders' Equity | $26,600,034 | $4,361,704 | Consolidated Statements of Operations Data (Year Ended Dec 31) | | 2022 | 2021 | | :--- | :--- | :--- | | Grant revenue | $81,526 | $385,501 | | Total operating expenses | $14,110,090 | $19,131,324 | | Net loss | $(14,021,125) | $(18,570,317) | | Net loss per common share | $(0.83) | $(3.04) | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no disagreements with its accountants on accounting principles, financial disclosure, or auditing scope - There were no disagreements with accountants on accounting and financial disclosure[227] Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that as of December 31, 2022, the company's disclosure controls and procedures were effective[229] - Management concluded that as of December 31, 2022, the company's internal control over financial reporting was effective[230] Part III This section covers corporate governance, executive compensation, security ownership, and related party transactions, incorporated by reference from the 2023 proxy statement Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 proxy statement - Required information is incorporated by reference from the definitive proxy statement for the 2023 annual meeting of stockholders[236] Executive Compensation Information regarding executive compensation is incorporated by reference from the company's 2023 annual meeting proxy statement - Required information is incorporated by reference from the definitive proxy statement for the 2023 annual meeting of stockholders[239] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership information is incorporated by reference from the 2023 proxy statement, with a table on equity compensation plans - Required information is incorporated by reference from the definitive proxy statement for the 2023 annual meeting of stockholders[240] Securities Authorized for Issuance Under Equity Compensation Plans (as of Dec 31, 2022) | Plan Category | Securities to be issued upon exercise | Weighted-average exercise price | Securities available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by stockholders | 1,158,800 | $2.77 | 166,700 | | Equity compensation plans not approved by stockholders | | | | | Contingent options | 900,000 | $0.76 | -0- | | Management warrants | 272,997 | $5.00 | -0- | Certain Relationships and Related Party Transactions, and Director Independence Information on related party transactions and director independence is incorporated by reference from the 2023 proxy statement - Required information is incorporated by reference from the definitive proxy statement for the 2023 annual meeting of stockholders[244] Principal Accounting Fees and Services Information regarding principal accounting fees and services is incorporated by reference from the company's 2023 annual meeting proxy statement - Required information is incorporated by reference from the definitive proxy statement for the 2023 annual meeting of stockholders[245] Part IV This section lists financial statements, schedules, and exhibits filed with the Form 10-K, including required signatures Exhibits and Financial Statement Schedules This item lists all financial statements, schedules, and exhibits filed with the Form 10-K, including key corporate and contractual documents - This section lists all documents filed as part of the report, including financial statements, schedules, and exhibits such as material contracts and corporate governance documents[247][248] Form 10-K Summary The company has not provided a summary under this item - None[250]