Document And Entity Information
Document And Entity Information | 9 Months Ended |
Sep. 30, 2023 | |
Document Information [Line Items] | |
Document Type | S-1 |
Entity Registrant Name | GEOVAX LABS, INC. |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 87-0455038 |
Entity Address, Address Line One | 1900 Lake Park Drive, Suite 380 |
Entity Address, City or Town | Smyrna |
Entity Address, State or Province | GA |
Entity Address, Postal Zip Code | 30080 |
City Area Code | 678 |
Local Phone Number | 384-7220 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Central Index Key | 0000832489 |
Document Fiscal Year Focus | 2023 |
Document Fiscal Period Focus | Q3 |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Assets [Abstract] | ||||||
Cash and cash equivalents | $ 12,687,041 | $ 27,612,732 | $ 11,423,870 | |||
Prepaid expenses | 2,113,249 | 1,325,998 | 156,240 | |||
Total current assets | 14,800,290 | 28,938,730 | 11,629,116 | |||
Property and equipment, net | 212,953 | 234,912 | 156,938 | |||
Other assets | 1,187,788 | 2,174,286 | 11,010 | |||
Total assets | 16,201,031 | 31,347,928 | 11,797,064 | |||
Current liabilities: | ||||||
Accounts payable | 4,213,295 | 1,747,682 | 2,057,534 | |||
Accrued expenses | 2,868,390 | 3,000,212 | 3,377,826 | |||
Total current liabilities | 7,081,685 | 4,747,894 | 5,435,360 | |||
Equity [Abstract] | ||||||
Common stock, $.001 par value: Authorized shares – 600,000,000 Issued and outstanding shares – 26,695,287 and 26,334,953 at September 30, 2023 and December 31, 2022, respectively | 26,695 | 26,335 | 6,382 | |||
Additional paid-in capital | 105,864,028 | 104,970,722 | 68,731,220 | |||
Accumulated deficit | (96,771,377) | (78,397,023) | (64,375,898) | |||
Total stockholders’ equity | 9,119,346 | $ 17,163,550 | $ 22,865,157 | 26,600,034 | 4,361,704 | $ 9,568,852 |
Total liabilities and stockholders’ equity | $ 16,201,031 | $ 31,347,928 | $ 11,797,064 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized (in shares) | 600,000,000 | 600,000,000 | 600,000,000 |
Common Stock, Shares, Issued (in shares) | 26,695,287 | 26,334,953 | 6,381,541 |
Common Stock, Shares, Outstanding (in shares) | 26,695,287 | 26,334,953 | 6,381,541 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Grant revenue | $ 0 | $ 0 | $ 0 | $ 81,526 | $ 81,526 | $ 385,501 | ||
Operating expenses: | ||||||||
Research and development | 6,947,979 | 2,721,196 | 14,486,896 | 5,358,917 | 9,123,479 | 15,554,171 | ||
General and administrative | 1,651,775 | 1,249,337 | 4,562,293 | 3,363,672 | 4,986,611 | 3,577,153 | ||
Total operating expenses | 8,599,754 | 3,970,533 | 19,049,189 | 8,722,589 | 14,110,090 | 19,131,324 | ||
Loss from operations | (8,599,754) | (3,970,533) | (19,049,189) | (8,641,063) | (14,028,564) | (18,745,823) | ||
Other income: | ||||||||
Interest income | 190,936 | 2,431 | 674,835 | 3,747 | 7,439 | 4,736 | ||
Net loss | $ (8,408,818) | $ (5,927,620) | $ (4,037,916) | $ (3,968,102) | $ (18,374,354) | $ (8,637,316) | $ (14,021,125) | $ (18,570,317) |
Basic and diluted: | ||||||||
Net loss per common share (in dollars per share) | $ (0.32) | $ (0.17) | $ (0.69) | $ (0.63) | $ (0.83) | $ (3.04) | ||
Weighted average shares outstanding (in shares) | 26,544,058 | 23,461,665 | 26,442,847 | 13,818,315 | 16,973,194 | 6,099,933 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2020 | 3,834,095 | |||
Balance at Dec. 31, 2020 | $ 3,834 | $ 55,294,504 | $ (45,805,581) | $ 9,568,852 |
Issuance of common stock for services (in shares) | 13,707 | 13,707 | ||
Issuance of common stock for services | $ 14 | 71,827 | 0 | $ 71,841 |
Stock option expense | 0 | 269,427 | 0 | 269,427 |
Net loss | $ 0 | 0 | (18,570,317) | (18,570,317) |
Balance (in shares) at Dec. 31, 2021 | 6,381,541 | |||
Balance at Dec. 31, 2021 | $ 6,382 | 68,731,220 | (64,375,898) | $ 4,361,704 |
Issuance of common stock for services (in shares) | 143,500 | 143,500 | ||
Issuance of common stock for services | $ 144 | 132,606 | 0 | $ 132,750 |
Stock option expense | 0 | 773,377 | 0 | 773,377 |
Net loss | $ 0 | 0 | (14,021,125) | (14,021,125) |
Balance (in shares) at Dec. 31, 2022 | 26,334,953 | |||
Balance at Dec. 31, 2022 | $ 26,335 | 104,970,722 | (78,397,023) | 26,600,034 |
Issuance of common stock for services (in shares) | 108,696 | |||
Issuance of common stock for services | $ 109 | 74,891 | 0 | 75,000 |
Stock option expense | 0 | 228,039 | 0 | 228,039 |
Net loss | $ 0 | 0 | (4,037,916) | (4,037,916) |
Balance (in shares) at Dec. 31, 2022 | 26,334,953 | |||
Balance at Dec. 31, 2022 | $ 26,335 | 104,970,722 | (78,397,023) | 26,600,034 |
Net loss | (18,374,354) | |||
Balance (in shares) at Mar. 31, 2023 | 26,443,649 | |||
Balance at Mar. 31, 2023 | $ 26,444 | 105,273,652 | (82,434,939) | 22,865,157 |
Stock option expense | 0 | 226,013 | 0 | 226,013 |
Net loss | $ 0 | 0 | (5,927,620) | (5,927,620) |
Balance (in shares) at Jun. 30, 2023 | 26,443,649 | |||
Balance at Jun. 30, 2023 | $ 26,444 | 105,499,665 | (88,362,559) | 17,163,550 |
Issuance of common stock for services (in shares) | 251,638 | |||
Issuance of common stock for services | $ 251 | 137,249 | 0 | 137,500 |
Stock option expense | 0 | 227,114 | 0 | 227,114 |
Net loss | $ 0 | $ 0 | $ (8,408,818) | $ (8,408,818) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (18,374,354) | $ (14,021,125) | $ (18,570,317) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 51,956 | 56,284 | 38,521 |
Stock-based compensation expense | 813,499 | 902,074 | 369,987 |
Changes in assets and liabilities: | |||
Grant funds receivable | 0 | (49,006) | (133,657) |
Prepaid expenses and other current assets | 707,084 | 1,165,705 | 16,270 |
Other assets | (986,498) | 2,163,276 | 0 |
Accounts payable and accrued expenses | 2,333,791 | (2,687,466) | 6,810,233 |
Total adjustments | 3,478,660 | (5,009,083) | 7,373,897 |
Net cash used in operating activities | (14,895,694) | (19,030,208) | (11,196,420) |
Cash flows from investing activities: | |||
Purchase of equipment | 29,997 | 134,258 | 47,718 |
Net cash used in investing activities | (29,997) | (134,258) | (47,718) |
Cash flows from financing activities: | |||
Net proceeds from sale of common stock and warrants | 0 | 27,727,194 | 9,408,920 |
Net proceeds from warrant exercise | 0 | 7,626,134 | 3,404,156 |
Net cash provided by financing activities | 0 | 35,353,328 | 12,784,212 |
Net increase (decrease) in cash and cash equivalents | (14,925,691) | 16,188,862 | 1,540,074 |
Cash and cash equivalents at beginning of period | 27,612,732 | 11,423,870 | 9,883,796 |
Cash and cash equivalents at end of period | $ 12,687,041 | $ 27,612,732 | $ 11,423,870 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Assets [Abstract] | ||
Cash and cash equivalents | $ 27,612,732 | $ 11,423,870 |
Grant funds receivable | 0 | 49,006 |
Prepaid expenses | 1,325,998 | 156,240 |
Total current assets | 28,938,730 | 11,629,116 |
Property and equipment, net | 234,912 | 156,938 |
Other assets | 2,174,286 | 11,010 |
Total assets | 31,347,928 | 11,797,064 |
Current liabilities: | ||
Accounts payable | 1,747,682 | 2,057,534 |
Accrued expenses | 3,000,212 | 3,377,826 |
Total current liabilities | 4,747,894 | 5,435,360 |
Other liabilities | 0 | 2,000,000 |
Total liabilities | 4,747,894 | 7,435,360 |
Stockholders’ equity: | ||
Common stock, $.001 par value: Authorized shares – 600,000,000 Issued and outstanding shares – 26,695,287 and 26,334,953 at September 30, 2023 and December 31, 2022, respectively | 26,335 | 6,382 |
Additional paid-in capital | 104,970,722 | 68,731,220 |
Accumulated deficit | (78,397,023) | (64,375,898) |
Total stockholders’ equity | 26,600,034 | 4,361,704 |
Total liabilities and stockholders’ equity | $ 31,347,928 | $ 11,797,064 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized (in shares) | 600,000,000 | 600,000,000 | 600,000,000 |
Common Stock, Shares, Issued (in shares) | 26,695,287 | 26,334,953 | 6,381,541 |
Common Stock, Shares, Outstanding (in shares) | 26,695,287 | 26,334,953 | 6,381,541 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Grant revenue | $ 81,526 | $ 385,501 |
Operating expenses: | ||
Research and development | 9,123,479 | 15,554,171 |
General and administrative | 4,986,611 | 3,577,153 |
Total operating expenses | 14,110,090 | 19,131,324 |
Loss from operations | (14,028,564) | (18,745,823) |
Other income: | ||
Interest income | 7,439 | 4,736 |
Interest expense | 0 | (1,286) |
Gain on debt extinguishment | 0 | 172,056 |
Total other income (expense) | 7,439 | 175,506 |
Net loss | $ (14,021,125) | $ (18,570,317) |
Basic and diluted: | ||
Net loss per common share (in dollars per share) | $ (0.83) | $ (3.04) |
Weighted average shares outstanding (in shares) | 16,973,194 | 6,099,933 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2020 | 100 | 3,834,095 | |||
Balance at Dec. 31, 2020 | $ 76,095 | $ 3,834 | $ 55,294,504 | $ (45,805,581) | $ 9,568,852 |
Sale of common stock for cash (in shares) | 0 | 1,644,000 | |||
Sale of common stock for cash | $ 0 | $ 1,644 | 9,407,276 | 0 | 9,408,920 |
Issuance of common stock upon warrant exercise (in shares) | 0 | 889,739 | |||
Issuance of common stock upon warrant exercise | $ 0 | $ 890 | 3,403,266 | 0 | $ 3,404,156 |
Issuance of common stock for services (in shares) | 0 | 13,707 | 13,707 | ||
Issuance of common stock for services | $ 0 | $ 14 | 71,827 | 0 | $ 71,841 |
Issuance of warrant for technology license | $ 0 | $ 0 | 209,825 | 0 | 209,825 |
Repurchase of preferred stock (in shares) | (100) | 0 | |||
Repurchase of preferred stock | $ (76,095) | $ 0 | 75,095 | 0 | (1,000) |
Stock option expense | 0 | 0 | 269,427 | 0 | 269,427 |
Net loss | $ 0 | $ 0 | 0 | (18,570,317) | (18,570,317) |
Balance (in shares) at Dec. 31, 2021 | 0 | 6,381,541 | |||
Balance at Dec. 31, 2021 | $ 0 | $ 6,382 | 68,731,220 | (64,375,898) | 4,361,704 |
Sale of common stock for cash (in shares) | 0 | 1,757,484 | |||
Sale of common stock for cash | $ 0 | $ 1,757 | 27,725,437 | 0 | $ 27,727,194 |
Issuance of common stock upon warrant exercise (in shares) | 0 | 7,608,082 | |||
Issuance of common stock upon warrant exercise | $ 18,052 | $ 0 | 7,626,134 | ||
Issuance of common stock for services (in shares) | 0 | 143,500 | 143,500 | ||
Issuance of common stock for services | $ 0 | $ 144 | 132,606 | 0 | $ 132,750 |
Stock option expense | 0 | 0 | 773,377 | 0 | 773,377 |
Net loss | $ 0 | $ 0 | 0 | (14,021,125) | (14,021,125) |
Balance (in shares) at Dec. 31, 2022 | 0 | 26,334,953 | |||
Balance at Dec. 31, 2022 | $ 0 | $ 26,335 | 104,970,722 | (78,397,023) | 26,600,034 |
Issuance of common stock for services (in shares) | 108,696 | ||||
Issuance of common stock for services | $ 109 | 74,891 | 0 | 75,000 | |
Stock option expense | 0 | 228,039 | 0 | 228,039 | |
Net loss | $ 0 | 0 | (4,037,916) | (4,037,916) | |
Balance (in shares) at Mar. 31, 2023 | 26,443,649 | ||||
Balance at Mar. 31, 2023 | $ 26,444 | 105,273,652 | (82,434,939) | 22,865,157 | |
Balance (in shares) at Dec. 31, 2022 | 0 | 26,334,953 | |||
Balance at Dec. 31, 2022 | $ 0 | $ 26,335 | 104,970,722 | (78,397,023) | 26,600,034 |
Net loss | (18,374,354) | ||||
Balance (in shares) at Sep. 30, 2023 | 26,695,287 | ||||
Balance at Sep. 30, 2023 | $ 26,695 | 105,864,028 | (96,771,377) | 9,119,346 | |
Balance (in shares) at Mar. 31, 2023 | 26,443,649 | ||||
Balance at Mar. 31, 2023 | $ 26,444 | 105,273,652 | (82,434,939) | 22,865,157 | |
Stock option expense | 0 | 226,013 | 0 | 226,013 | |
Net loss | $ 0 | 0 | (5,927,620) | (5,927,620) | |
Balance (in shares) at Jun. 30, 2023 | 26,443,649 | ||||
Balance at Jun. 30, 2023 | $ 26,444 | 105,499,665 | (88,362,559) | 17,163,550 | |
Issuance of common stock for services (in shares) | 251,638 | ||||
Issuance of common stock for services | $ 251 | 137,249 | 0 | 137,500 | |
Stock option expense | 0 | 227,114 | 0 | 227,114 | |
Net loss | $ 0 | 0 | (8,408,818) | (8,408,818) | |
Balance (in shares) at Sep. 30, 2023 | 26,695,287 | ||||
Balance at Sep. 30, 2023 | $ 26,695 | $ 105,864,028 | $ (96,771,377) | $ 9,119,346 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (14,021,125) | $ (18,570,317) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 56,284 | 38,521 |
Stock-based compensation expense | 902,074 | 369,987 |
Warrant issued for technology license | 0 | 209,825 |
Gain on debt extinguishment | 0 | (172,056) |
Changes in assets and liabilities: | ||
Grant funds receivables | 49,006 | 133,657 |
Prepaid expenses and other current assets | (1,165,705) | (16,270) |
Other assets | (2,163,276) | 0 |
Accounts payable, accrued expenses and other liabilities | (2,687,466) | 6,810,233 |
Total adjustments | (5,009,083) | 7,373,897 |
Net cash used in operating activities | (19,030,208) | (11,196,420) |
Cash flows from investing activities: | ||
Purchase of equipment | (134,258) | (47,718) |
Net cash used in investing activities | (134,258) | (47,718) |
Cash flows from financing activities: | ||
Net proceeds from sale of common stock and warrants | 27,727,194 | 9,408,920 |
Net proceeds from warrant exercise | 7,626,134 | 3,404,156 |
Repurchase of preferred stock | 0 | (1,000) |
Principal repayment of note payable | 0 | (27,864) |
Net cash provided by financing activities | 35,353,328 | 12,784,212 |
Net increase (decrease) in cash and cash equivalents | 16,188,862 | 1,540,074 |
Cash and cash equivalents at beginning of period | 11,423,870 | 9,883,796 |
Cash and cash equivalents at end of period | $ 27,612,732 | $ 11,423,870 |
Note 1 - Nature of Business
Note 1 - Nature of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Nature of Operations [Text Block] | 1. Nature of Business GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as “GeoVax” or the “Company”. The Company is focused on developing immunotherapies and vaccines against cancers and infectious diseases 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 for advanced head and neck cancer. Additional preclinical research and development programs include preventive vaccines against Mpox (monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever) Zika virus, and malaria, as well as immunotherapies for solid tumors. | 1. Description of Business and Recent Developments GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as “GeoVax” or the “Company”. The Company is focused on developing immunotherapies and vaccines against infectious diseases and cancers using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human clinical trials for vaccines against COVID-19 and a therapy for advanced head and neck cancer. Additional research and development programs include preventive vaccines against hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever) Zika virus, and malaria, as well as immunotherapies for solid tumors. |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | 2. Summary of Significant Accounting Policies We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 those accounting policies that we consider significant in determining our results of operations and financial position. During the nine months ended September 30, 2023, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K. Basis of Presentation The accompanying financial statements include the accounts of GeoVax Labs, Inc. and GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. The financial statements are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of interim periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods. We believe that our existing cash resources will be sufficient to continue our planned operations into the first quarter of 2024. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. 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. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements are issued. 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. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. Recent Accounting Pronouncements During the nine months ended September 30, 2023, there have been no new accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements. | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of GeoVax Labs, Inc. together with GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. Basis of Presentation The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the issue date of these consolidated financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates. We expect to incur future net losses and require substantial funds as we continue our research and development activities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our product candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to need to raise additional funding. Since inception, the Company’s activities have consisted primarily of performing research and development to advance its technologies. We expect to continue to generate operating losses in the foreseeable future and will require additional funding to continue our research and development activities. We believe that our existing cash resources will be sufficient to continue our planned operations into the fourth quarter of 2023. Due to our history of operating losses and our continuing need for capital to conduct our research and development activities, there is substantial doubt concerning our ability to operate as a going concern beyond that date. We are currently exploring sources of capital and intend to fund our future operations through additional private and/or public offerings of debt or equity securities. We also intend to seek additional capital through government grants, arrangements with strategic partners or from other sources. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern. There can be no assurance that additional funding will be available on favorable terms or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back, or eliminate some or all of our research and development programs as well as reduce our general and administrative expenses. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles (GAAP) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Our cash and cash equivalents consist primarily of bank deposits and money market accounts. The recorded values approximate fair market values due to the short maturities. Fair Value of Financial Instruments and Concentration of Credit Risk Financial instruments that subject us to concentration of credit risk consist primarily of cash and cash equivalents, which are maintained by high credit quality financial institutions. The carrying values reported in the balance sheets for cash and cash equivalents approximate fair values. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Expenditures for maintenance and repairs are charged to operations as incurred, while additions and improvements are capitalized. We calculate depreciation using the straight-line method over the estimated useful lives of the assets (generally 5 We recognize leases in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No. 2016-02, Leases Impairment of Long-Lived Assets We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future net cash flows expected to be generated by such assets. If we consider such assets to be impaired, the impairment to be Accrued Expenses As part of the process of preparing our financial statements, we estimate expenses that we believe we have incurred, but have not yet been billed by our third-party vendors. This process involves identifying services and activities that have been performed by such vendors on our behalf and estimating the level to which they have been performed and the associated cost incurred for such service as of each balance sheet date. Net Loss Per Share Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company’s additional potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 15,442,915 and 3,778,931 shares at December 31, 2022 and 2021, respectively. Revenue Recognition We recognize revenue in accordance with FASB Accounting Standards Update 2014-09, Revenue from Contracts with Customers We receive payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds. From time to time, we may enter into collaborative research and development agreements for specific vaccine development approaches and/or disease indications whereby we receive third-party funding for preclinical research under certain of these arrangements. Each agreement is evaluated in accordance with the process defined by ASU 2014-09 and revenue is recognized accordingly. Research and Development Expense Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates. These expenses consist primarily of (i) salaries, benefits, and stock-based compensation for personnel, (ii) laboratory supplies and facility-related expenses to conduct development, (iii) fees paid to third-party service providers to perform, monitor and accumulate data related to our preclinical studies and clinical trials, (iv) costs related to sponsored research agreements, (v) costs to procure and manufacture materials used in clinical trials, and (vi) license fees and other expenses associated with technology license agreements. We accrue for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies or trials, including clinical trial participant enrollment, completion of events, invoices received and other events. Advance payments for research and development activities are deferred and included in prepaid expenses and other assets. The deferred amounts are expensed as the related goods are delivered or the services are performed. Patent Costs Our expenditures relating to obtaining and protecting patents are charged to expense when incurred and are included in general and administrative expense. Period-to-Period Comparisons Our operating results are expected to fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results for future periods. Income Taxes We account for income taxes using the liability method. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance unless, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Stock-Based Compensation We account for stock-based transactions in which the Company receives services from employees, directors or others in exchange for equity instruments based on the fair value of the award at the grant date. Stock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Stock-based compensation cost for stock options or warrants is estimated at the grant date based on each instrument’s fair value as calculated by the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award. See Note 6 for additional stock-based compensation information. Other Recent Accounting Pronouncements There have been no recent accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements, nor do we believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on our financial statements. |
Note 3 - Balance Sheet Componen
Note 3 - Balance Sheet Components | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Supplemental Balance Sheet Disclosures [Text Block] | 3. Balance Sheet Components Prepaid Expenses September 30, 2023 December 31, 2022 Prepaid clinical trial costs (current portion) $ 1,986,037 $ 1,171,077 Prepaid insurance premiums - 107,876 Prepaid rent 13,045 13,045 Other prepaid expenses 114,167 34,000 Total prepaid expenses $ 2,113,249 $ 1,325,998 Property and Equipment September 30, 2023 December 31, 2022 Equipment and furnishings $ 755,809 $ 725,812 Leasehold improvements 115,605 115,605 Total property and equipment 871,414 841,417 Accumulated depreciation and amortization (658,461 ) (606,505 ) Total property and equipment, net $ 212,953 $ 234,912 Other Assets September 30, 2023 December 31, 2022 Prepaid clinical trial costs (noncurrent portion) $ 1,106,778 $ 2,083,276 Prepaid technology license fees 70,000 80,000 Deposits 11,010 11,010 Total other assets $ 1,187,788 $ 2,174,286 Accrued Expenses September 30, 2023 December 31, 2022 Accrued technology license fees $ 2,000,000 $ 2,000,000 Payroll-related liabilities 133,665 550,810 Other accrued expenses 734,725 449,402 Total accrued expenses $ 2,868,390 $ 3,000,212 | 3. Balance Sheet Components Prepaid Expenses 2022 2021 Prepaid clinical trial costs (current portion) $ 1,171,077 $ - Prepaid insurance premiums 107,876 123,248 Prepaid rent 13,045 13,045 Other prepaid expenses 34,000 19,947 Total prepaid expenses $ 1,325,998 $ 156,240 Property and Equipment 2022 2021 Equipment and furnishings $ 725,812 $ 591,554 Leasehold improvements 115,605 115,605 Total property and equipment 841,417 707,159 Accumulated depreciation and amortization (606,505 ) (550,221 ) Property and equipment, net $ 234,912 $ 156,938 Depreciation expense was $56,284 and $38,521 during the years ended December 31, 2022 and 2021, respectively. Other Assets 2022 2021 Prepaid clinical trial costs (noncurrent portion) $ 2,083,276 $ - Prepaid technology license fees 80,000 - Deposits 11,010 11,010 Total other assets $ 2,174,286 $ 11,010 Accrued Expenses Accrued license fees (current portion) $ 2,000,000 $ 3,000,000 Payroll-related liabilities 550,810 269,000 Other accrued expenses 449,402 108,826 Total accrued expenses $ 3,000,212 $ 3,377,826 Other Liabilities |
Note 4 - Commitments
Note 4 - Commitments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Commitments Disclosure [Text Block] | 4. Commitments Operating Lease We lease approximately 8,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2025. Rent expense for the three-month and nine-month periods ended September 30, 2023 was $45,414 and $136,242, respectively, as compared to $44,089 and $132,267, respectively, for the same periods of 2022. Future minimum lease payments total $45,414 in 2023, $187,056 in 2024, and $192,708 in 2025 although the lease may be terminated at any time by either party with one hundred eighty days written notice. License Agreements We have entered into license agreements for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Due to the uncertainty of the achievement and timing of the contingent events requiring payment under these agreements, the amounts to be paid by us in the future are not determinable. Other Commitments In the normal course of business, we enter into various contracts and purchase commitments including those with contract research organizations (“CROs”) for clinical trial services, contract manufacturing organizations (“CMOs”) for production of materials for use in our clinical trials, and other independent contractors or academic institutions for preclinical research activities and other services and products. Most contracts are generally cancellable, with notice, at the Company’s option. Payments due upon cancellation may consist of payments for services provided or expenses incurred to date, or cancellation penalties depending on the time of cancellation. | 4. Commitments Operating Lease. License Agreements Other Commitments |
Note 5 - Stockholders' Equity
Note 5 - Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | 5. Stockholders Equity Common Stock Transactions During March, August and September 2023 we issued 108,696, 178,253 and 73,385 shares of our common stock, respectively, pursuant to professional services and consulting agreements. Stock Options We have stock-based incentive plans (the “Plans”) pursuant to which our Board of Directors may grant stock options and other stock-based awards to our employees, directors and consultants. During the nine months ended September 30, 2023, 40,000 stock options were cancelled and there were no new grants of stock options or other transactions related to the Plans. As of September 30, 2023, there are 2,018,800 stock options outstanding, with a weighted-average exercise price of $1.89 per share and a weighted-average remaining contractual term of 7.5 years. Including the outstanding stock options, a total of 5,018,800 shares of our common stock are reserved for future issuance pursuant to the Plans. Stock Purchase Warrants We have issued stock purchase warrants in connection with past financing and licensing transactions. On December 2, 2023, we entered into a common stock warrant exercise inducement offer letter (the “Inducement Letter”) with the holder (the “Holder”) of existing warrants to purchase shares of the Company’s common stock at an exercise price of $3.26 per share, issued on January 19, 2022 and warrants to purchase shares of the Company’s common stock at an exercise price of $1.65 per share issued on May 27, 2022 (together, the “Existing Warrants”), pursuant to which the Holder agreed to exercise for cash its Existing Warrants to purchase an aggregate of 10,567,484 shares of the Company’s common stock, at a reduced exercised price of $0.414 per share, in consideration for the Company’s agreement to issue new warrants (the “2023 Common Warrant”) to purchase up to 21,134,968 shares of the Company’s common stock (the “2023 Warrant Shares”) with an exercise price of $0.414 per share, exercisable at any on or after six months from the date of issuance and will expire five |
Note 6 - Stock-Based Compensati
Note 6 - Stock-Based Compensation Expense | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Share-Based Payment Arrangement [Text Block] | 6. Stock-Based Compensation Expense Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual to whom the award is granted. Stock-based compensation expense related to stock option grants was $227,114 and $681,166 during the three-month and nine-month periods ended September 30, 2023, respectively, as compared to $190,191 and $570,573, respectively, during the same periods of 2022. As of September 30, 2023, there is $738,281 of unrecognized compensation expense that we expect to recognize over a weighted-average period of 1.6 years. We have also issued shares of our restricted common stock to consultants and recognize the related expense over the terms of the related agreements. During the three-month and nine-month periods ended September 30, 2023 we recorded stock-based compensation expense of $70,833 and $132,333, respectively, associated with common stock issued for consulting services, as compared to $48,375 and $80,322, respectively, for the same periods of 2022. As of September 30, 2023, there is $104,167 recorded as a prepaid expense for these arrangements, which will be recognized as expense over the term of the related agreements. | 6. Stock-Based Compensation Expense Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual to whom the award is granted. We use the Black-Scholes model for determining the grant date fair value of our stock option grants. This model utilizes certain information, such as the interest rate on a risk-free security with a term generally equivalent to the expected life of the option being valued and requires certain other assumptions, such as the expected amount of time an option will be outstanding until it is exercised or expired, to calculate the fair value of stock options granted. The significant assumptions we used in our fair value calculations were as follows: 2022 2021 Weighted average risk-free interest rates 3.54 % 1.43 % Expected dividend yield 0.0 % 0.0 % Expected life of option (in yrs) 7.0 7.0 Expected volatility 160.0 % 84.8 % The weighted-average grant date fair values of stock options granted during 2022 and 2021 were $0.73 and $2.87, respectively. As of December 31, 2022, there is $1,449,405 of unrecognized compensation expense that will be recognized over a weighted-average period of 2.0 years. We also have issued shares of restricted common stock to consultants and recognize the related expense over the terms of the related agreements. As of December 31, 2022, there is $24,000 recorded as a prepaid expense for these arrangements, which will be recognized as expense over the terms of the related agreements. The following table summarizes our total stock-based compensation expense for employees, directors and consultants for the years ended December 31, 2022 and 2021: 2022 2021 Stock options: Research and development $ 225,031 $ 96,814 General and administrative 548,346 172,613 Total stock option expense 773,377 269,427 Stock awards (consultants): General and administrative 128,697 100,560 Total stock-based compensation expense $ 902,074 $ 369,987 During September 2021, we recorded $209,825 of expense associated with the issuance of a stock purchase warrant in connection with our entering into a technology licensing agreement; such amount was recorded as research and development expense. |
Note 7 - Net Loss Per Share
Note 7 - Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 7. Net Loss Per Share Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company’s potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 15,402,915 and 14,346,415 shares at September 30, 2023 and 2022, respectively. |
Note 8 - Income Taxes
Note 8 - Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Income Tax Disclosure [Text Block] | 8. Income Taxes No provision for income taxes was recorded in either of the nine-month periods ended September 30, 2023 and 2022. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of September 30, 2023. | 8. Income Taxes At December 31, 2022, we have a consolidated federal net operating loss (“NOL”) carryforward of approximately $76 million available to offset against future taxable income of which approximately $38.5 million expires in varying amounts in 2023 through 2037. Additionally, we have approximately $2.2 million in research and development (“R&D”) tax credits that expire in 2023 through 2042 unless utilized earlier. No Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. We have established a full valuation allowance equal to the amount of our net deferred tax assets due to uncertainties with respect to our ability to generate sufficient taxable income to realize these assets in the future. The table below presents significant components of our deferred tax assets and liabilities at December 31, 2022 and 2021. 2022 2021 Deferred tax assets: Net operating loss carryforward $ 19,764,569 $ 18,449,694 Research and development tax credit carryforward 2,202,603 1,566,293 Stock-based compensation expense 330,553 129,475 Accrued expenses 663,211 69,940 Total deferred tax assets 22,960,936 20,215,402 Deferred tax liabilities Depreciation 51,466 30,945 Net deferred tax assets 22,909,470 20,184,457 Valuation allowance (22,909,470 ) (20,184,457 ) Net deferred tax asset after reduction for valuation allowance $ -0- $ -0- A reconciliation of the U.S. federal income tax rate to the Company’s effective tax rate is as follows: 2022 2021 U.S. federal statutory rate applied to pretax loss 21.0 % 21.0 % State income tax (benefit) 3.9 4.0 Permanent differences (0.0 ) 0.2 NOL carryforward expiration (15.6 ) (5.3 ) R&D tax credits, net of expiration 4.6 2.0 Change in valuation allowance and other adjustments (13.9 ) (21.9 ) Effective tax rate 0.0 % 0.0 % |
Note 1 - Description of Busines
Note 1 - Description of Business and Recent Developments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Nature of Operations [Text Block] | 1. Nature of Business GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as “GeoVax” or the “Company”. The Company is focused on developing immunotherapies and vaccines against cancers and infectious diseases 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 for advanced head and neck cancer. Additional preclinical research and development programs include preventive vaccines against Mpox (monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever) Zika virus, and malaria, as well as immunotherapies for solid tumors. | 1. Description of Business and Recent Developments GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as “GeoVax” or the “Company”. The Company is focused on developing immunotherapies and vaccines against infectious diseases and cancers using novel vector vaccine platforms. GeoVax’s product pipeline includes ongoing human clinical trials for vaccines against COVID-19 and a therapy for advanced head and neck cancer. Additional research and development programs include preventive vaccines against hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa Fever) Zika virus, and malaria, as well as immunotherapies for solid tumors. |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | 2. Summary of Significant Accounting Policies We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 those accounting policies that we consider significant in determining our results of operations and financial position. During the nine months ended September 30, 2023, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K. Basis of Presentation The accompanying financial statements include the accounts of GeoVax Labs, Inc. and GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. The financial statements are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of interim periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods. We believe that our existing cash resources will be sufficient to continue our planned operations into the first quarter of 2024. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. 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. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements are issued. 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. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. Recent Accounting Pronouncements During the nine months ended September 30, 2023, there have been no new accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements. | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of GeoVax Labs, Inc. together with GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. Basis of Presentation The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the issue date of these consolidated financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates. We expect to incur future net losses and require substantial funds as we continue our research and development activities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our product candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to need to raise additional funding. Since inception, the Company’s activities have consisted primarily of performing research and development to advance its technologies. We expect to continue to generate operating losses in the foreseeable future and will require additional funding to continue our research and development activities. We believe that our existing cash resources will be sufficient to continue our planned operations into the fourth quarter of 2023. Due to our history of operating losses and our continuing need for capital to conduct our research and development activities, there is substantial doubt concerning our ability to operate as a going concern beyond that date. We are currently exploring sources of capital and intend to fund our future operations through additional private and/or public offerings of debt or equity securities. We also intend to seek additional capital through government grants, arrangements with strategic partners or from other sources. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern. There can be no assurance that additional funding will be available on favorable terms or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back, or eliminate some or all of our research and development programs as well as reduce our general and administrative expenses. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles (GAAP) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Our cash and cash equivalents consist primarily of bank deposits and money market accounts. The recorded values approximate fair market values due to the short maturities. Fair Value of Financial Instruments and Concentration of Credit Risk Financial instruments that subject us to concentration of credit risk consist primarily of cash and cash equivalents, which are maintained by high credit quality financial institutions. The carrying values reported in the balance sheets for cash and cash equivalents approximate fair values. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Expenditures for maintenance and repairs are charged to operations as incurred, while additions and improvements are capitalized. We calculate depreciation using the straight-line method over the estimated useful lives of the assets (generally 5 We recognize leases in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No. 2016-02, Leases Impairment of Long-Lived Assets We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future net cash flows expected to be generated by such assets. If we consider such assets to be impaired, the impairment to be Accrued Expenses As part of the process of preparing our financial statements, we estimate expenses that we believe we have incurred, but have not yet been billed by our third-party vendors. This process involves identifying services and activities that have been performed by such vendors on our behalf and estimating the level to which they have been performed and the associated cost incurred for such service as of each balance sheet date. Net Loss Per Share Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company’s additional potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 15,442,915 and 3,778,931 shares at December 31, 2022 and 2021, respectively. Revenue Recognition We recognize revenue in accordance with FASB Accounting Standards Update 2014-09, Revenue from Contracts with Customers We receive payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds. From time to time, we may enter into collaborative research and development agreements for specific vaccine development approaches and/or disease indications whereby we receive third-party funding for preclinical research under certain of these arrangements. Each agreement is evaluated in accordance with the process defined by ASU 2014-09 and revenue is recognized accordingly. Research and Development Expense Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates. These expenses consist primarily of (i) salaries, benefits, and stock-based compensation for personnel, (ii) laboratory supplies and facility-related expenses to conduct development, (iii) fees paid to third-party service providers to perform, monitor and accumulate data related to our preclinical studies and clinical trials, (iv) costs related to sponsored research agreements, (v) costs to procure and manufacture materials used in clinical trials, and (vi) license fees and other expenses associated with technology license agreements. We accrue for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies or trials, including clinical trial participant enrollment, completion of events, invoices received and other events. Advance payments for research and development activities are deferred and included in prepaid expenses and other assets. The deferred amounts are expensed as the related goods are delivered or the services are performed. Patent Costs Our expenditures relating to obtaining and protecting patents are charged to expense when incurred and are included in general and administrative expense. Period-to-Period Comparisons Our operating results are expected to fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results for future periods. Income Taxes We account for income taxes using the liability method. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance unless, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Stock-Based Compensation We account for stock-based transactions in which the Company receives services from employees, directors or others in exchange for equity instruments based on the fair value of the award at the grant date. Stock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Stock-based compensation cost for stock options or warrants is estimated at the grant date based on each instrument’s fair value as calculated by the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award. See Note 6 for additional stock-based compensation information. Other Recent Accounting Pronouncements There have been no recent accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements, nor do we believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on our financial statements. |
Note 3 - Balance Sheet Compon_2
Note 3 - Balance Sheet Components (10K) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Supplemental Balance Sheet Disclosures [Text Block] | 3. Balance Sheet Components Prepaid Expenses September 30, 2023 December 31, 2022 Prepaid clinical trial costs (current portion) $ 1,986,037 $ 1,171,077 Prepaid insurance premiums - 107,876 Prepaid rent 13,045 13,045 Other prepaid expenses 114,167 34,000 Total prepaid expenses $ 2,113,249 $ 1,325,998 Property and Equipment September 30, 2023 December 31, 2022 Equipment and furnishings $ 755,809 $ 725,812 Leasehold improvements 115,605 115,605 Total property and equipment 871,414 841,417 Accumulated depreciation and amortization (658,461 ) (606,505 ) Total property and equipment, net $ 212,953 $ 234,912 Other Assets September 30, 2023 December 31, 2022 Prepaid clinical trial costs (noncurrent portion) $ 1,106,778 $ 2,083,276 Prepaid technology license fees 70,000 80,000 Deposits 11,010 11,010 Total other assets $ 1,187,788 $ 2,174,286 Accrued Expenses September 30, 2023 December 31, 2022 Accrued technology license fees $ 2,000,000 $ 2,000,000 Payroll-related liabilities 133,665 550,810 Other accrued expenses 734,725 449,402 Total accrued expenses $ 2,868,390 $ 3,000,212 | 3. Balance Sheet Components Prepaid Expenses 2022 2021 Prepaid clinical trial costs (current portion) $ 1,171,077 $ - Prepaid insurance premiums 107,876 123,248 Prepaid rent 13,045 13,045 Other prepaid expenses 34,000 19,947 Total prepaid expenses $ 1,325,998 $ 156,240 Property and Equipment 2022 2021 Equipment and furnishings $ 725,812 $ 591,554 Leasehold improvements 115,605 115,605 Total property and equipment 841,417 707,159 Accumulated depreciation and amortization (606,505 ) (550,221 ) Property and equipment, net $ 234,912 $ 156,938 Depreciation expense was $56,284 and $38,521 during the years ended December 31, 2022 and 2021, respectively. Other Assets 2022 2021 Prepaid clinical trial costs (noncurrent portion) $ 2,083,276 $ - Prepaid technology license fees 80,000 - Deposits 11,010 11,010 Total other assets $ 2,174,286 $ 11,010 Accrued Expenses Accrued license fees (current portion) $ 2,000,000 $ 3,000,000 Payroll-related liabilities 550,810 269,000 Other accrued expenses 449,402 108,826 Total accrued expenses $ 3,000,212 $ 3,377,826 Other Liabilities |
Note 4 - Commitments_2
Note 4 - Commitments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Commitments Disclosure [Text Block] | 4. Commitments Operating Lease We lease approximately 8,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2025. Rent expense for the three-month and nine-month periods ended September 30, 2023 was $45,414 and $136,242, respectively, as compared to $44,089 and $132,267, respectively, for the same periods of 2022. Future minimum lease payments total $45,414 in 2023, $187,056 in 2024, and $192,708 in 2025 although the lease may be terminated at any time by either party with one hundred eighty days written notice. License Agreements We have entered into license agreements for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Due to the uncertainty of the achievement and timing of the contingent events requiring payment under these agreements, the amounts to be paid by us in the future are not determinable. Other Commitments In the normal course of business, we enter into various contracts and purchase commitments including those with contract research organizations (“CROs”) for clinical trial services, contract manufacturing organizations (“CMOs”) for production of materials for use in our clinical trials, and other independent contractors or academic institutions for preclinical research activities and other services and products. Most contracts are generally cancellable, with notice, at the Company’s option. Payments due upon cancellation may consist of payments for services provided or expenses incurred to date, or cancellation penalties depending on the time of cancellation. | 4. Commitments Operating Lease. License Agreements Other Commitments |
Note 5 - Stockholders' Equity_2
Note 5 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Preferred Stock [Text Block] | 5. Stockholders Equity Preferred Stock In June 2021, we repurchased the remaining 100 shares of our Series B convertible preferred stock for a total price of $1,000. There are no Common Stock 2021 Public Offering 2021 Warrant Exercises January 2022 Private Placement “January 2022 Warrant”). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $9.2 million. During March 2022, the pre-funded warrant was exercised in full. May 2022 Private Placement Other Common Stock Transactions Common Stock Reserved for Future Issuance Shares Stock warrants outstanding 13,384,115 Stock options outstanding 2,058,800 Stock options authorized for future grants 16,700 Total 15,459,615 Stock Options We have two stock-based incentive plans, the 2020 Plan and the 2023 Plan, pursuant to which our Board of Directors may grant stock options to our employees, directors and consultants. A total of 2,250,000 shares of our common stock are currently reserved for issuance pursuant to the 2020 Plan. The exercise price for any option granted may not be less than fair value (110% of fair value for ISO’s granted to certain employees). Options have a maximum ten A summary of the Company’s stock option activity during 2022 is presented below. Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (yrs) Aggregate Intrinsic Value Outstanding at December 31, 2021 962,300 $ 3.18 9.3 $ 499,660 Granted 1,096,500 0.76 Exercised - - Forfeited or expired - - Outstanding at December 31, 2022 2,058,800 $ 1.89 9.2 $ - Exercisable at December 31, 2022 588,089 $ 3.12 8.3 $ - Stock Warrants The table below summarizes information concerning warrants outstanding as of December 31, 2022, all of which are currently exercisable. Issue Date Number of Shares Exercise Price Expiration June 2020 120,000 $ 1.65 June 2025 September 2020 2,396,631 5.00 September 2025 September 2020 128,000 5.50 March 2024 February 2021 72,000 6.88 August 2024 September 2021 100,000 13.00 September 2026 January 2022 3,067,484 3.26 February 2027 May 2022 7,500,000 1.65 May 2028 Outstanding at December 31, 2022 13,384,115 As a result of anti-dilution price adjustments related to our equity transactions in January and May 2022, the exercise price of the June 2020 Warrants was reduced from $5.00 to $1.65 during 2022. |
Note 6 - Stock-based Compensa_2
Note 6 - Stock-based Compensation Expense | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Share-Based Payment Arrangement [Text Block] | 6. Stock-Based Compensation Expense Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual to whom the award is granted. Stock-based compensation expense related to stock option grants was $227,114 and $681,166 during the three-month and nine-month periods ended September 30, 2023, respectively, as compared to $190,191 and $570,573, respectively, during the same periods of 2022. As of September 30, 2023, there is $738,281 of unrecognized compensation expense that we expect to recognize over a weighted-average period of 1.6 years. We have also issued shares of our restricted common stock to consultants and recognize the related expense over the terms of the related agreements. During the three-month and nine-month periods ended September 30, 2023 we recorded stock-based compensation expense of $70,833 and $132,333, respectively, associated with common stock issued for consulting services, as compared to $48,375 and $80,322, respectively, for the same periods of 2022. As of September 30, 2023, there is $104,167 recorded as a prepaid expense for these arrangements, which will be recognized as expense over the term of the related agreements. | 6. Stock-Based Compensation Expense Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual to whom the award is granted. We use the Black-Scholes model for determining the grant date fair value of our stock option grants. This model utilizes certain information, such as the interest rate on a risk-free security with a term generally equivalent to the expected life of the option being valued and requires certain other assumptions, such as the expected amount of time an option will be outstanding until it is exercised or expired, to calculate the fair value of stock options granted. The significant assumptions we used in our fair value calculations were as follows: 2022 2021 Weighted average risk-free interest rates 3.54 % 1.43 % Expected dividend yield 0.0 % 0.0 % Expected life of option (in yrs) 7.0 7.0 Expected volatility 160.0 % 84.8 % The weighted-average grant date fair values of stock options granted during 2022 and 2021 were $0.73 and $2.87, respectively. As of December 31, 2022, there is $1,449,405 of unrecognized compensation expense that will be recognized over a weighted-average period of 2.0 years. We also have issued shares of restricted common stock to consultants and recognize the related expense over the terms of the related agreements. As of December 31, 2022, there is $24,000 recorded as a prepaid expense for these arrangements, which will be recognized as expense over the terms of the related agreements. The following table summarizes our total stock-based compensation expense for employees, directors and consultants for the years ended December 31, 2022 and 2021: 2022 2021 Stock options: Research and development $ 225,031 $ 96,814 General and administrative 548,346 172,613 Total stock option expense 773,377 269,427 Stock awards (consultants): General and administrative 128,697 100,560 Total stock-based compensation expense $ 902,074 $ 369,987 During September 2021, we recorded $209,825 of expense associated with the issuance of a stock purchase warrant in connection with our entering into a technology licensing agreement; such amount was recorded as research and development expense. |
Note 7 - Retirement Plan
Note 7 - Retirement Plan | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Retirement Benefits [Text Block] | 7. Retirement Plan We participate in a multi-employer defined contribution retirement plan (the “401k Plan”) administered by a third-party service provider, and the Company contributes to the 401k Plan on behalf of its employees based upon a matching formula. During the years ended December 31, 2022 and 2021 our contributions to the 401k Plan were $53,643 and $36,980, respectively. |
Note 8 - Income Taxes_2
Note 8 - Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes to Financial Statements | ||
Income Tax Disclosure [Text Block] | 8. Income Taxes No provision for income taxes was recorded in either of the nine-month periods ended September 30, 2023 and 2022. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of September 30, 2023. | 8. Income Taxes At December 31, 2022, we have a consolidated federal net operating loss (“NOL”) carryforward of approximately $76 million available to offset against future taxable income of which approximately $38.5 million expires in varying amounts in 2023 through 2037. Additionally, we have approximately $2.2 million in research and development (“R&D”) tax credits that expire in 2023 through 2042 unless utilized earlier. No Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. We have established a full valuation allowance equal to the amount of our net deferred tax assets due to uncertainties with respect to our ability to generate sufficient taxable income to realize these assets in the future. The table below presents significant components of our deferred tax assets and liabilities at December 31, 2022 and 2021. 2022 2021 Deferred tax assets: Net operating loss carryforward $ 19,764,569 $ 18,449,694 Research and development tax credit carryforward 2,202,603 1,566,293 Stock-based compensation expense 330,553 129,475 Accrued expenses 663,211 69,940 Total deferred tax assets 22,960,936 20,215,402 Deferred tax liabilities Depreciation 51,466 30,945 Net deferred tax assets 22,909,470 20,184,457 Valuation allowance (22,909,470 ) (20,184,457 ) Net deferred tax asset after reduction for valuation allowance $ -0- $ -0- A reconciliation of the U.S. federal income tax rate to the Company’s effective tax rate is as follows: 2022 2021 U.S. federal statutory rate applied to pretax loss 21.0 % 21.0 % State income tax (benefit) 3.9 4.0 Permanent differences (0.0 ) 0.2 NOL carryforward expiration (15.6 ) (5.3 ) R&D tax credits, net of expiration 4.6 2.0 Change in valuation allowance and other adjustments (13.9 ) (21.9 ) Effective tax rate 0.0 % 0.0 % |
Note 9 - Grant Revenue
Note 9 - Grant Revenue | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Government Grants and Contracts [Text Block] | 9. Grant Revenue During 2022 and 2021 we received payments from government entities under our grants from the National Institute of Allergy and Infectious Diseases (NIAID) and from the U.S. Department of Defense in support of our vaccine research and development efforts. We record revenue associated with government grants as the reimbursable costs are incurred. Total revenues recorded for these grants during 2022 and 2021, were $81,526 and $385,501, respectively. As of December 31, 2022, all funds available under these grants for our direct use have been utilized. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
SEC Schedule, 12-09, Schedule of Valuation and Qualifying Accounts Disclosure [Text Block] | GEOVAX LABS, INC. SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS For the Years Ended December 31, 2022 and 2021 Additions (Reductions) Description Balance at Beginning Of Period Charged to Costs and Expenses Charged to Other Accounts Deductions Balance at End Of Period Reserve Deducted in the Balance Sheet From the Asset to Which it Applies: Allowance for Deferred Tax Assets Year ended December 31, 2022 $ 20,184,457 $ 2,725,013 $ -0- $ -0- $ 22,909,470 Year ended December 31, 2021 $ 15,975,667 $ 4,208,790 $ -0- $ -0- $ 20,184,457 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The accompanying financial statements include the accounts of GeoVax Labs, Inc. and GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. The financial statements are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of interim periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods. We believe that our existing cash resources will be sufficient to continue our planned operations into the first quarter of 2024. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. 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. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements are issued. 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. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. | Basis of Presentation The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the issue date of these consolidated financial statements. We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates. We expect to incur future net losses and require substantial funds as we continue our research and development activities. Our transition to profitability will be dependent upon, among other things, the successful development and commercialization of our product candidates. We may never achieve profitability or positive cash flows, and unless and until we do, we will continue to need to raise additional funding. Since inception, the Company’s activities have consisted primarily of performing research and development to advance its technologies. We expect to continue to generate operating losses in the foreseeable future and will require additional funding to continue our research and development activities. We believe that our existing cash resources will be sufficient to continue our planned operations into the fourth quarter of 2023. Due to our history of operating losses and our continuing need for capital to conduct our research and development activities, there is substantial doubt concerning our ability to operate as a going concern beyond that date. We are currently exploring sources of capital and intend to fund our future operations through additional private and/or public offerings of debt or equity securities. We also intend to seek additional capital through government grants, arrangements with strategic partners or from other sources. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern. There can be no assurance that additional funding will be available on favorable terms or at all. If we fail to obtain additional capital when needed, we will be required to delay, scale back, or eliminate some or all of our research and development programs as well as reduce our general and administrative expenses. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements During the nine months ended September 30, 2023, there have been no new accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements. | Other Recent Accounting Pronouncements There have been no recent accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements, nor do we believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on our financial statements. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The accompanying consolidated financial statements include the accounts of GeoVax Labs, Inc. together with GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. | |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles (GAAP) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. | |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Our cash and cash equivalents consist primarily of bank deposits and money market accounts. The recorded values approximate fair market values due to the short maturities. | |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments and Concentration of Credit Risk Financial instruments that subject us to concentration of credit risk consist primarily of cash and cash equivalents, which are maintained by high credit quality financial institutions. The carrying values reported in the balance sheets for cash and cash equivalents approximate fair values. | |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Expenditures for maintenance and repairs are charged to operations as incurred, while additions and improvements are capitalized. We calculate depreciation using the straight-line method over the estimated useful lives of the assets (generally 5 We recognize leases in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No. 2016-02, Leases | |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future net cash flows expected to be generated by such assets. If we consider such assets to be impaired, the impairment to be | |
Accrued Liabilities [Policy Text Block] | Accrued Expenses As part of the process of preparing our financial statements, we estimate expenses that we believe we have incurred, but have not yet been billed by our third-party vendors. This process involves identifying services and activities that have been performed by such vendors on our behalf and estimating the level to which they have been performed and the associated cost incurred for such service as of each balance sheet date. | |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Share Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company’s additional potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 15,442,915 and 3,778,931 shares at December 31, 2022 and 2021, respectively. | |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition We recognize revenue in accordance with FASB Accounting Standards Update 2014-09, Revenue from Contracts with Customers We receive payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds. From time to time, we may enter into collaborative research and development agreements for specific vaccine development approaches and/or disease indications whereby we receive third-party funding for preclinical research under certain of these arrangements. Each agreement is evaluated in accordance with the process defined by ASU 2014-09 and revenue is recognized accordingly. | |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expense Research and development costs are charged to expense as incurred and consist of costs incurred in the discovery, development, testing and manufacturing of our product candidates. These expenses consist primarily of (i) salaries, benefits, and stock-based compensation for personnel, (ii) laboratory supplies and facility-related expenses to conduct development, (iii) fees paid to third-party service providers to perform, monitor and accumulate data related to our preclinical studies and clinical trials, (iv) costs related to sponsored research agreements, (v) costs to procure and manufacture materials used in clinical trials, and (vi) license fees and other expenses associated with technology license agreements. We accrue for estimated costs of research and development activities conducted by third-party service providers, which may include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies or trials, including clinical trial participant enrollment, completion of events, invoices received and other events. Advance payments for research and development activities are deferred and included in prepaid expenses and other assets. The deferred amounts are expensed as the related goods are delivered or the services are performed. | |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Patent Costs Our expenditures relating to obtaining and protecting patents are charged to expense when incurred and are included in general and administrative expense. | |
Reclassification, Comparability Adjustment [Policy Text Block] | Period-to-Period Comparisons Our operating results are expected to fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results for future periods. | |
Income Tax, Policy [Policy Text Block] | Income Taxes We account for income taxes using the liability method. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance unless, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. | |
Share-Based Payment Arrangement [Policy Text Block] | Stock-Based Compensation We account for stock-based transactions in which the Company receives services from employees, directors or others in exchange for equity instruments based on the fair value of the award at the grant date. Stock-based compensation cost for awards of common stock is estimated based on the price of the underlying common stock on the date of issuance. Stock-based compensation cost for stock options or warrants is estimated at the grant date based on each instrument’s fair value as calculated by the Black-Scholes option pricing model. We recognize stock-based compensation cost as expense ratably on a straight-line basis over the requisite service period for the award. See Note 6 for additional stock-based compensation information. |
Note 3 - Balance Sheet Compon_3
Note 3 - Balance Sheet Components (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes Tables | ||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | September 30, 2023 December 31, 2022 Prepaid clinical trial costs (current portion) $ 1,986,037 $ 1,171,077 Prepaid insurance premiums - 107,876 Prepaid rent 13,045 13,045 Other prepaid expenses 114,167 34,000 Total prepaid expenses $ 2,113,249 $ 1,325,998 | 2022 2021 Prepaid clinical trial costs (current portion) $ 1,171,077 $ - Prepaid insurance premiums 107,876 123,248 Prepaid rent 13,045 13,045 Other prepaid expenses 34,000 19,947 Total prepaid expenses $ 1,325,998 $ 156,240 |
Property, Plant and Equipment [Table Text Block] | September 30, 2023 December 31, 2022 Equipment and furnishings $ 755,809 $ 725,812 Leasehold improvements 115,605 115,605 Total property and equipment 871,414 841,417 Accumulated depreciation and amortization (658,461 ) (606,505 ) Total property and equipment, net $ 212,953 $ 234,912 | 2022 2021 Equipment and furnishings $ 725,812 $ 591,554 Leasehold improvements 115,605 115,605 Total property and equipment 841,417 707,159 Accumulated depreciation and amortization (606,505 ) (550,221 ) Property and equipment, net $ 234,912 $ 156,938 |
Schedule of Other Assets [Table Text Block] | September 30, 2023 December 31, 2022 Prepaid clinical trial costs (noncurrent portion) $ 1,106,778 $ 2,083,276 Prepaid technology license fees 70,000 80,000 Deposits 11,010 11,010 Total other assets $ 1,187,788 $ 2,174,286 | 2022 2021 Prepaid clinical trial costs (noncurrent portion) $ 2,083,276 $ - Prepaid technology license fees 80,000 - Deposits 11,010 11,010 Total other assets $ 2,174,286 $ 11,010 |
Schedule of Accrued Liabilities [Table Text Block] | September 30, 2023 December 31, 2022 Accrued technology license fees $ 2,000,000 $ 2,000,000 Payroll-related liabilities 133,665 550,810 Other accrued expenses 734,725 449,402 Total accrued expenses $ 2,868,390 $ 3,000,212 | Accrued license fees (current portion) $ 2,000,000 $ 3,000,000 Payroll-related liabilities 550,810 269,000 Other accrued expenses 449,402 108,826 Total accrued expenses $ 3,000,212 $ 3,377,826 |
Note 3 - Balance Sheet Compon_4
Note 3 - Balance Sheet Components (10K) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Notes Tables | ||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | September 30, 2023 December 31, 2022 Prepaid clinical trial costs (current portion) $ 1,986,037 $ 1,171,077 Prepaid insurance premiums - 107,876 Prepaid rent 13,045 13,045 Other prepaid expenses 114,167 34,000 Total prepaid expenses $ 2,113,249 $ 1,325,998 | 2022 2021 Prepaid clinical trial costs (current portion) $ 1,171,077 $ - Prepaid insurance premiums 107,876 123,248 Prepaid rent 13,045 13,045 Other prepaid expenses 34,000 19,947 Total prepaid expenses $ 1,325,998 $ 156,240 |
Property, Plant and Equipment [Table Text Block] | September 30, 2023 December 31, 2022 Equipment and furnishings $ 755,809 $ 725,812 Leasehold improvements 115,605 115,605 Total property and equipment 871,414 841,417 Accumulated depreciation and amortization (658,461 ) (606,505 ) Total property and equipment, net $ 212,953 $ 234,912 | 2022 2021 Equipment and furnishings $ 725,812 $ 591,554 Leasehold improvements 115,605 115,605 Total property and equipment 841,417 707,159 Accumulated depreciation and amortization (606,505 ) (550,221 ) Property and equipment, net $ 234,912 $ 156,938 |
Schedule of Other Assets [Table Text Block] | September 30, 2023 December 31, 2022 Prepaid clinical trial costs (noncurrent portion) $ 1,106,778 $ 2,083,276 Prepaid technology license fees 70,000 80,000 Deposits 11,010 11,010 Total other assets $ 1,187,788 $ 2,174,286 | 2022 2021 Prepaid clinical trial costs (noncurrent portion) $ 2,083,276 $ - Prepaid technology license fees 80,000 - Deposits 11,010 11,010 Total other assets $ 2,174,286 $ 11,010 |
Schedule of Accrued Liabilities [Table Text Block] | September 30, 2023 December 31, 2022 Accrued technology license fees $ 2,000,000 $ 2,000,000 Payroll-related liabilities 133,665 550,810 Other accrued expenses 734,725 449,402 Total accrued expenses $ 2,868,390 $ 3,000,212 | Accrued license fees (current portion) $ 2,000,000 $ 3,000,000 Payroll-related liabilities 550,810 269,000 Other accrued expenses 449,402 108,826 Total accrued expenses $ 3,000,212 $ 3,377,826 |
Note 5 - Stockholders' Equity (
Note 5 - Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Common Stock Reserved for Future Issuance [Table Text Block] | Shares Stock warrants outstanding 13,384,115 Stock options outstanding 2,058,800 Stock options authorized for future grants 16,700 Total 15,459,615 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number of Shares Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (yrs) Aggregate Intrinsic Value Outstanding at December 31, 2021 962,300 $ 3.18 9.3 $ 499,660 Granted 1,096,500 0.76 Exercised - - Forfeited or expired - - Outstanding at December 31, 2022 2,058,800 $ 1.89 9.2 $ - Exercisable at December 31, 2022 588,089 $ 3.12 8.3 $ - |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Issue Date Number of Shares Exercise Price Expiration June 2020 120,000 $ 1.65 June 2025 September 2020 2,396,631 5.00 September 2025 September 2020 128,000 5.50 March 2024 February 2021 72,000 6.88 August 2024 September 2021 100,000 13.00 September 2026 January 2022 3,067,484 3.26 February 2027 May 2022 7,500,000 1.65 May 2028 Outstanding at December 31, 2022 13,384,115 |
Note 6 - Stock-based Compensa_3
Note 6 - Stock-based Compensation Expense (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2022 2021 Weighted average risk-free interest rates 3.54 % 1.43 % Expected dividend yield 0.0 % 0.0 % Expected life of option (in yrs) 7.0 7.0 Expected volatility 160.0 % 84.8 % |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | 2022 2021 Stock options: Research and development $ 225,031 $ 96,814 General and administrative 548,346 172,613 Total stock option expense 773,377 269,427 Stock awards (consultants): General and administrative 128,697 100,560 Total stock-based compensation expense $ 902,074 $ 369,987 |
Note 8 - Income Taxes (Tables)
Note 8 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | 2022 2021 Deferred tax assets: Net operating loss carryforward $ 19,764,569 $ 18,449,694 Research and development tax credit carryforward 2,202,603 1,566,293 Stock-based compensation expense 330,553 129,475 Accrued expenses 663,211 69,940 Total deferred tax assets 22,960,936 20,215,402 Deferred tax liabilities Depreciation 51,466 30,945 Net deferred tax assets 22,909,470 20,184,457 Valuation allowance (22,909,470 ) (20,184,457 ) Net deferred tax asset after reduction for valuation allowance $ -0- $ -0- |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 2022 2021 U.S. federal statutory rate applied to pretax loss 21.0 % 21.0 % State income tax (benefit) 3.9 4.0 Permanent differences (0.0 ) 0.2 NOL carryforward expiration (15.6 ) (5.3 ) R&D tax credits, net of expiration 4.6 2.0 Change in valuation allowance and other adjustments (13.9 ) (21.9 ) Effective tax rate 0.0 % 0.0 % |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Summary of Valuation Allowance [Table Text Block] | Additions (Reductions) Description Balance at Beginning Of Period Charged to Costs and Expenses Charged to Other Accounts Deductions Balance at End Of Period Reserve Deducted in the Balance Sheet From the Asset to Which it Applies: Allowance for Deferred Tax Assets Year ended December 31, 2022 $ 20,184,457 $ 2,725,013 $ -0- $ -0- $ 22,909,470 Year ended December 31, 2021 $ 15,975,667 $ 4,208,790 $ -0- $ -0- $ 20,184,457 |
Note 3 - Balance Sheet Compon_5
Note 3 - Balance Sheet Components - Prepaid Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid clinical trial costs (current portion) | $ 1,986,037 | $ 1,171,077 | $ 0 |
Prepaid insurance premiums | 0 | 107,876 | 123,248 |
Prepaid rent | 13,045 | 13,045 | 13,045 |
Other prepaid expenses | 114,167 | 34,000 | 19,947 |
Total prepaid expenses | $ 2,113,249 | $ 1,325,998 | $ 156,240 |
Note 3 - Balance Sheet Compon_6
Note 3 - Balance Sheet Components - Schedule of Property and Equipment (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Total property and equipment | $ 871,414 | $ 841,417 | $ 707,159 |
Accumulated depreciation and amortization | (658,461) | (606,505) | (550,221) |
Total property and equipment, net | 212,953 | 234,912 | 156,938 |
Equipment and Furnishings [Member] | |||
Total property and equipment | 755,809 | 725,812 | 591,554 |
Leasehold Improvements [Member] | |||
Total property and equipment | $ 115,605 | $ 115,605 | $ 115,605 |
Note 3 - Balance SHeet Compon_7
Note 3 - Balance SHeet Components - Schedule of Other Assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid clinical trial costs (noncurrent portion) | $ 1,106,778 | $ 2,083,276 | $ 0 |
Prepaid technology license fees | 70,000 | 80,000 | 0 |
Deposits | 11,010 | 11,010 | 11,010 |
Total other assets | $ 1,187,788 | $ 2,174,286 | $ 11,010 |
Note 3 - Balance Sheet Compon_8
Note 3 - Balance Sheet Components - Schedule of Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued technology license fees | $ 2,000,000 | $ 2,000,000 | $ 3,000,000 |
Payroll-related liabilities | 133,665 | 550,810 | 269,000 |
Other accrued expenses | 734,725 | 449,402 | 108,826 |
Total accrued expenses | $ 2,868,390 | $ 3,000,212 | $ 3,377,826 |
Note 4 - Commitments (Details T
Note 4 - Commitments (Details Textual) - Office and Laboratory Lease Agreement [Member] | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Area of Real Estate Property | ft² | 8,400 | 8,400 | 8,400 | |||
Operating Lease, Expense | $ 45,414 | $ 44,089 | $ 136,242 | $ 132,267 | $ 176,797 | $ 166,242 |
Lessee, Operating Lease, Liability, to be Paid, Remainder of Fiscal Year | 45,414 | 45,414 | ||||
Lessee, Operating Lease, Liability, to be Paid, Year One | 187,056 | 187,056 | 182,000 | |||
Lessee, Operating Lease, Liability, to be Paid, Year Two | $ 192,708 | $ 192,708 | $ 187,000 |
Note 5 - Stockholders' Equity_3
Note 5 - Stockholders' Equity (Details Textual) - $ / shares | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Aug. 31, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 02, 2023 | Nov. 09, 2022 | May 27, 2022 | Jan. 19, 2022 | |
Stock Issued During Period, Shares, Issued for Services | 73,385 | 178,253 | 108,696 | 143,500 | 13,707 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 2,058,800 | 962,300 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 1.89 | $ 3.18 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 9 years 2 months 12 days | 9 years 3 months 18 days | ||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 15,459,615 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.414 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 10,567,484 | |||||||||
Common Warrant [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.26 | $ 3.26 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,067,484 | |||||||||
Preferred Investment Options [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.65 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 12,121,214 | |||||||||
The 2023 Common Warrant [Member] | Subsequent Event [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.414 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 21,134,968 | |||||||||
Warrants and Rights Outstanding, Term | 5 years 6 months | |||||||||
Stock Incentive Plan 2020 [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Forfeitures in Period | 40,000 | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number | 2,018,800 | 2,018,800 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 1.89 | $ 1.89 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 6 months | |||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 5,018,800 | 5,018,800 | 2,250,000 |
Note 6 - Stock-Based Compensa_4
Note 6 - Stock-Based Compensation Expense (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Expense | $ 902,074 | $ 369,987 | ||||
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 738,281 | $ 738,281 | $ 1,449,405 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 7 months 6 days | 2 years | ||||
Prepaid Expense, Value of Stock Issued for Services During Period | 104,167 | $ 104,167 | $ 24,000 | |||
Expense Related To Consulting And Investment Banking Agreements [Member] | ||||||
Share-Based Payment Arrangement, Expense | 70,833 | $ 48,375 | 132,333 | $ 80,322 | ||
Share-Based Payment Arrangement, Option [Member] | ||||||
Share-Based Payment Arrangement, Expense | $ 227,114 | $ 190,191 | $ 681,166 | $ 570,573 | $ 773,377 | $ 269,427 |
Note 7 - Net Loss Per Share (De
Note 7 - Net Loss Per Share (Details Textual) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 15,402,915 | 14,346,415 | 15,442,915 | 3,778,931 |
Note 2 - Summary of Significa_3
Note 2 - Summary of Significant Accounting Policies (Details Textual) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 15,402,915 | 14,346,415 | 15,442,915 | 3,778,931 |
Maximum [Member] | ||||
Property, Plant and Equipment, Useful Life (Year) | 5 years |
Note 3 - Balance Sheet Compon_9
Note 3 - Balance Sheet Components (10K) (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Depreciation, Depletion and Amortization, Nonproduction | $ 56,284 | $ 38,521 |
Other Liabilities | $ 2,000,000 |
Note 3 - Balance Sheet Compo_10
Note 3 - Balance Sheet Components - Prepaid Expenses (10K) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid clinical trial costs (current portion) | $ 1,986,037 | $ 1,171,077 | $ 0 |
Prepaid insurance premiums | 0 | 107,876 | 123,248 |
Prepaid rent | 13,045 | 13,045 | 13,045 |
Other prepaid expenses | 114,167 | 34,000 | 19,947 |
Total prepaid expenses | $ 2,113,249 | $ 1,325,998 | $ 156,240 |
Note 3 - Balance Sheet Compo_11
Note 3 - Balance Sheet Components - Schedule of Property and Equipment (10K) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Total property and equipment | $ 871,414 | $ 841,417 | $ 707,159 |
Accumulated depreciation and amortization | (658,461) | (606,505) | (550,221) |
Total property and equipment, net | 212,953 | 234,912 | 156,938 |
Equipment and Furnishings [Member] | |||
Total property and equipment | 755,809 | 725,812 | 591,554 |
Leasehold Improvements [Member] | |||
Total property and equipment | $ 115,605 | $ 115,605 | $ 115,605 |
Note 3 - Balance Sheet Compo_12
Note 3 - Balance Sheet Components - Schedule of Other Assets (10K) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid clinical trial costs (noncurrent portion) | $ 1,106,778 | $ 2,083,276 | $ 0 |
Prepaid technology license fees | 70,000 | 80,000 | 0 |
Deposits | 11,010 | 11,010 | 11,010 |
Total other assets | $ 1,187,788 | $ 2,174,286 | $ 11,010 |
Note 3 - Balance Sheet Compo_13
Note 3 - Balance Sheet Components - Schedule of Accrued Expenses (10K) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued technology license fees | $ 2,000,000 | $ 2,000,000 | $ 3,000,000 |
Payroll-related liabilities | 133,665 | 550,810 | 269,000 |
Other accrued expenses | 734,725 | 449,402 | 108,826 |
Total accrued expenses | $ 2,868,390 | $ 3,000,212 | $ 3,377,826 |
Note 4 - Commitments (Details_2
Note 4 - Commitments (Details Textual) - Office and Laboratory Lease Agreement [Member] | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Area of Real Estate Property | ft² | 8,400 | 8,400 | 8,400 | |||
Operating Lease, Expense | $ 45,414 | $ 44,089 | $ 136,242 | $ 132,267 | $ 176,797 | $ 166,242 |
Lessee, Operating Lease, Liability, to be Paid, Year One | 187,056 | 187,056 | 182,000 | |||
Lessee, Operating Lease, Liability, to be Paid, Year Two | $ 192,708 | $ 192,708 | 187,000 | |||
Lessee, Operating Lease, Liability, to be Paid, Year Three | $ 193,000 |
Note 5 - Stockholders' Equity_4
Note 5 - Stockholders' Equity (Details Textual) - USD ($) | 1 Months Ended | 2 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
May 27, 2022 | Jan. 19, 2022 | Feb. 11, 2021 | Sep. 30, 2023 | Aug. 31, 2023 | Mar. 31, 2023 | Aug. 31, 2022 | Jul. 31, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 09, 2022 | Jun. 01, 2021 | Sep. 29, 2020 | |
Stock Issued During Period, Shares, New Issues | 1,644,000 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 9,400,000 | |||||||||||||
Proceeds from Warrant Exercises | $ 0 | $ 7,626,134 | $ 3,404,156 | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 10,567,484 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.414 | |||||||||||||
Stock Issued During Period, Shares, Issued for Services | 73,385 | 178,253 | 108,696 | 143,500 | 13,707 | |||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 15,459,615 | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Purchase Price of Common Stock, Percent | 110% | |||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | |||||||||||||
Stock Incentive Plan 2020 [Member] | ||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 5,018,800 | 5,018,800 | 2,250,000 | |||||||||||
Private Placement [Member] | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 1,050,000 | 707,484 | ||||||||||||
Proceeds from Issuance or Sale of Equity | $ 18,500,000 | $ 9,200,000 | ||||||||||||
Unit Warrant [Member] | ||||||||||||||
Class of Warrant or Right, Exercised During Period | 740,034 | |||||||||||||
Proceeds from Warrant Exercises, Gross | $ 3,400,000 | |||||||||||||
Proceeds from Warrant Exercises | $ 3,400,000 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.65 | $ 5 | ||||||||||||
Stock Purchase Warrants [Member] | ||||||||||||||
Class of Warrant or Right, Exercised During Period | 149,705 | |||||||||||||
Stock Issued During Period, Shares, Warrants Exercised | 215,672 | |||||||||||||
Pre-Funded Warrants [Member] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 11,071,214 | 2,360,000 | ||||||||||||
Class of Warrant or Right, Exercised | 9,090,910 | |||||||||||||
Common Warrant [Member] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,067,484 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.26 | $ 3.26 | ||||||||||||
Preferred Investment Options [Member] | ||||||||||||||
Proceeds from Warrant Exercises | $ 7,626,000 | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 12,121,214 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.65 | |||||||||||||
Class of Warrant or Right, Exercised | 4,621,214 | |||||||||||||
Series B Convertible Preferred Stock [Member] | ||||||||||||||
Preferred Stock, Shares Outstanding | 0 | 100 | ||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 |
Note 5 - Stockholders' Equity -
Note 5 - Stockholders' Equity - Common Stock Reserved for Future Issuance (Details) | Dec. 31, 2022 shares |
Common stock reserved for future issuance (in shares) | 15,459,615 |
Share-Based Payment Arrangement, Option [Member] | |
Common stock reserved for future issuance (in shares) | 2,058,800 |
Stock options authorized for future grants (in shares) | 16,700 |
Warrants [Member] | |
Common stock reserved for future issuance (in shares) | 13,384,115 |
Note 5 - Stockholders' Equity-
Note 5 - Stockholders' Equity- Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Outstanding, number of shares (in shares) | 962,300 | |
Outstanding, weighted average exercise price (in dollars per share) | $ 3.18 | |
Outstanding, weighted average remaining contractual term (Year) | 9 years 2 months 12 days | 9 years 3 months 18 days |
Outstanding, aggregate intrinsic value | $ 0 | $ 499,660 |
Granted, number of shares (in shares) | 1,096,500 | |
Granted, weighted average exercise price (in dollars per share) | $ 0.76 | |
Exercised, number of shares (in shares) | 0 | |
Exercised, weighted average exercise price (in dollars per share) | $ 0 | |
Forfeited or expired, number of shares (in shares) | 0 | |
Outstanding, number of shares (in shares) | 2,058,800 | 962,300 |
Outstanding, weighted average exercise price (in dollars per share) | $ 1.89 | $ 3.18 |
Exercisable, number of shares (in shares) | 588,089 | |
Exercisable, weighted average exercise price (in dollars per share) | $ 3.12 | |
Exercisable, weighted average remaining contractual term (Year) | 8 years 3 months 18 days | |
Exercisable, aggregate intrinsic value | $ 0 |
Note 5 - Stockholders' Equity_5
Note 5 - Stockholders' Equity - Schedule of Warrants (Details) | Dec. 31, 2022 $ / shares shares |
Number of shares (in shares) | shares | 13,384,115 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.414 |
Warrants 2020 [Member] | |
Number of shares (in shares) | shares | 120,000 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 1.65 |
Unit Warrants 2020 [Member] | |
Number of shares (in shares) | shares | 2,396,631 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 5 |
Representative Warrants 2020 [Member] | |
Number of shares (in shares) | shares | 128,000 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 5.5 |
Representative Warrants 2021 [Member] | |
Number of shares (in shares) | shares | 72,000 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 6.88 |
Warrants 2021 [Member] | |
Number of shares (in shares) | shares | 100,000 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 13 |
January 2022 Common Warrants [Member] | |
Number of shares (in shares) | shares | 3,067,484 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.26 |
May 2022 Preferred Investment Options 1 [Member] | |
Number of shares (in shares) | shares | 7,500,000 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 1.65 |
Note 6 - Stock-based Compensa_5
Note 6 - Stock-based Compensation Expense (Details Textual) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0.73 | $ 2.87 | ||
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 738,281 | $ 1,449,405 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 7 months 6 days | 2 years | ||
Prepaid Expense, Value of Stock Issued for Services During Period | $ 104,167 | $ 24,000 | ||
Research and Development Expense [Member] | ||||
Warrant Issuance Expense | $ 209,825 |
Note 6 - Stock-based Compensa_6
Note 6 - Stock-based Compensation Expense (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted average risk-free interest rates | 3.54% | 1.43% |
Expected dividend yield | 0% | 0% |
Expected life of option (in yrs) (Year) | 7 years | 7 years |
Expected volatility | 160% | 84.80% |
Note 6 - Stock-Based Compensa_7
Note 6 - Stock-Based Compensation Expense - Schedule of Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Total stock-based compensation expense | $ 902,074 | $ 369,987 | ||||
Share-Based Payment Arrangement, Option [Member] | ||||||
Total stock-based compensation expense | $ 227,114 | $ 190,191 | $ 681,166 | $ 570,573 | 773,377 | 269,427 |
Share-Based Payment Arrangement, Option [Member] | Research and Development Expense [Member] | ||||||
Total stock-based compensation expense | 225,031 | 96,814 | ||||
Share-Based Payment Arrangement, Option [Member] | General and Administrative Expense [Member] | ||||||
Total stock-based compensation expense | 548,346 | 172,613 | ||||
Restricted Stock [Member] | General and Administrative Expense [Member] | ||||||
Total stock-based compensation expense | $ 128,697 | $ 100,560 |
Note 7 - Retirement Plan (Detai
Note 7 - Retirement Plan (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 53,643 | $ 36,980 |
Note 8 - Income Taxes (Details
Note 8 - Income Taxes (Details Textual) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Income Taxes Paid | $ 0 |
Research Tax Credit Carryforward [Member] | |
Tax Credit Carryforward, Amount | 2,200 |
Domestic Tax Authority [Member] | |
Operating Loss Carryforwards, Total | 76,000 |
Operating Loss Carryforwards, Subject to Expiration | $ 38,500 |
Note 8 - Income Taxes - Deferre
Note 8 - Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Net operating loss carryforward | $ 19,764,569 | $ 18,449,694 |
Research and development tax credit carryforward | 2,202,603 | 1,566,293 |
Stock-based compensation expense | 330,553 | 129,475 |
Accrued expenses | 663,211 | 69,940 |
Total deferred tax assets | 22,960,936 | 20,215,402 |
Depreciation | 51,466 | 30,945 |
Net deferred tax assets | 22,909,470 | 20,184,457 |
Valuation allowance | (22,909,470) | (20,184,457) |
Net deferred tax asset after reduction for valuation allowance | $ 0 | $ 0 |
Note 8 - Income Taxes - Reconci
Note 8 - Income Taxes - Reconciliation of Income Tax Benefit (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
U.S. federal statutory rate applied to pretax loss | 21% | 21% |
State income tax (benefit) | 3.90% | 4% |
Permanent differences | (0.00%) | 0.20% |
NOL carryforward expiration | (15.60%) | (5.30%) |
R&D tax credits, net of expiration | 4.60% | 2% |
Change in valuation allowance and other adjustments | (13.90%) | (21.90%) |
Effective tax rate | 0% | 0% |
Note 9 - Grant Revenue (Details
Note 9 - Grant Revenue (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 0 | $ 0 | $ 0 | $ 81,526 | $ 81,526 | $ 385,501 |
NIH Grants [Member] | ||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 81,526 | $ 385,501 |
Schedule II 0 Valuation and Qua
Schedule II 0 Valuation and Qualifying Accounts - Summary of Valuation Allowances (Details) - SEC Schedule, 12-09, Valuation Allowance, Deferred Tax Asset [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Balance at Beginning Of Period | $ 20,184,457 | $ 15,975,667 |
Charged to Costs and Expenses | 2,725,013 | 4,208,790 |
Charged to Other Accounts | 0 | 0 |
Deductions | 0 | 0 |
Balance at End Of Period | $ 22,909,470 | $ 20,184,457 |