Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-32188 | |
Entity Registrant Name | ORAGENICS, INC. | |
Entity Central Index Key | 0001174940 | |
Entity Tax Identification Number | 59-3410522 | |
Entity Incorporation, State or Country Code | FL | |
Entity Address, Address Line One | 4902 Eisenhower Blvd. | |
Entity Address, Address Line Two | Suite 125 | |
Entity Address, City or Town | Tampa | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33634 | |
City Area Code | 813 | |
Local Phone Number | 286-7900 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | OGEN | |
Security Exchange Name | NYSE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 2,539,385 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 6,473,822 | $ 11,426,785 |
Other receivables | 13,163 | |
Prepaid expenses and other current assets | 1,611,849 | 2,844,798 |
Total current assets | 8,098,834 | 14,271,583 |
Property and equipment, net | 98,456 | 121,062 |
Operating lease right-of-use assets | 249,256 | 347,440 |
Deposits | 17,940 | 17,940 |
Total assets | 8,464,486 | 14,758,025 |
Current liabilities: | ||
Accounts payable and accrued expenses | 951,019 | 1,124,197 |
Short-term notes payable | 267,640 | |
Operating lease liabilities - Current | 190,242 | 204,447 |
Total current liabilities | 1,141,261 | 1,596,284 |
Long-term liabilities: | ||
Operating lease liabilities - Long Term | 65,752 | 152,439 |
Total long-term liabilities | 65,752 | 152,439 |
Shareholders’ equity: | ||
Preferred stock, no par value; 50,000,000 shares authorized; 5,417,000 and 5,417,000 Series A shares, 4,050,000 and 4,050,000 Series B shares, -0- and -0- Series C shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 1,592,723 | 1,592,723 |
Common stock, $0.001 par value; 4,166,666 shares authorized 2,024,657 and 2,024,657 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 2,025 | 2,025 |
Additional paid-in capital | 197,120,665 | 196,977,071 |
Accumulated deficit | (191,457,940) | (185,562,517) |
Total shareholders’ equity | 7,257,473 | 13,009,302 |
Total liabilities and shareholders’ equity | $ 8,464,486 | $ 14,758,025 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Preferred stock, no par value | $ 0 | $ 0 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 4,166,666 | 4,166,666 |
Common stock, shares issued | 2,024,657 | 2,024,657 |
Common stock, shares outstanding | 2,024,657 | 2,024,657 |
Series A Preferred Stock [Member] | ||
Preferred stock, shares issued | 5,417,000 | 5,417,000 |
Preferred stock, shares outstanding | 5,417,000 | 5,417,000 |
Series B Preferred Stock [Member] | ||
Preferred stock, shares issued | 4,050,000 | 4,050,000 |
Preferred stock, shares outstanding | 4,050,000 | 4,050,000 |
Series C Preferred Stock [Member] | ||
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Grant revenue | $ 13,163 | $ 30,391 | $ 30,187 | $ 45,474 |
Operating expenses: | ||||
Research and development | 2,006,696 | 2,590,032 | 3,679,272 | 5,883,693 |
General and administrative | 1,115,785 | 1,044,334 | 2,365,048 | 2,375,883 |
Local business tax | 490 | 980 | ||
Total operating expenses | 3,122,481 | 3,634,856 | 6,044,320 | 8,260,556 |
Loss from operations | (3,109,318) | (3,604,465) | (6,014,133) | (8,215,082) |
Other income (expense): | ||||
Interest income | 58,954 | 15,369 | 121,155 | 27,275 |
Interest expense | (843) | (816) | (4,190) | (4,062) |
Miscellaneous income | 621 | 369 | 1,745 | 11,333 |
Total other income, net | 58,732 | 14,922 | 118,710 | 34,546 |
Loss before income taxes | (3,050,586) | (3,589,543) | (5,895,423) | (8,180,536) |
Income tax benefit | ||||
Net loss | $ (3,050,586) | $ (3,589,543) | $ (5,895,423) | $ (8,180,536) |
Basic net loss per share | $ (1.51) | $ (1.85) | $ (2.91) | $ (4.22) |
Diluted net loss per share | $ (1.51) | $ (1.85) | $ (2.91) | $ (4.22) |
Shares used to compute basic net loss per share | 2,024,766 | 1,939,913 | 2,024,766 | 1,939,913 |
Shares used to compute diluted net loss per share | 2,024,766 | 1,939,913 | 2,024,766 | 1,939,913 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2021 | $ 2,003 | $ 2,656,713 | $ 195,101,611 | $ (171,274,128) | $ 26,486,199 |
Balance, shares at Dec. 31, 2021 | 2,002,946 | 16,017,000 | |||
Compensation expense relating to option issuances | 90,247 | 90,247 | |||
Net loss | (4,590,993) | (4,590,993) | |||
Balance at Mar. 31, 2022 | $ 2,003 | $ 2,656,713 | 195,191,858 | (175,865,121) | 21,985,453 |
Balance, shares at Mar. 31, 2022 | 2,002,946 | 16,017,000 | |||
Balance at Dec. 31, 2021 | $ 2,003 | $ 2,656,713 | 195,101,611 | (171,274,128) | 26,486,199 |
Balance, shares at Dec. 31, 2021 | 2,002,946 | 16,017,000 | |||
Net loss | (8,180,536) | ||||
Balance at Jun. 30, 2022 | $ 2,003 | $ 2,656,713 | 195,470,846 | (179,454,664) | 18,674,898 |
Balance, shares at Jun. 30, 2022 | 2,002,946 | 16,017,000 | |||
Balance at Mar. 31, 2022 | $ 2,003 | $ 2,656,713 | 195,191,858 | (175,865,121) | 21,985,453 |
Balance, shares at Mar. 31, 2022 | 2,002,946 | 16,017,000 | |||
Compensation expense relating to option issuances | 278,988 | 278,988 | |||
Net loss | (3,589,543) | (3,589,543) | |||
Balance at Jun. 30, 2022 | $ 2,003 | $ 2,656,713 | 195,470,846 | (179,454,664) | 18,674,898 |
Balance, shares at Jun. 30, 2022 | 2,002,946 | 16,017,000 | |||
Balance at Dec. 31, 2022 | $ 2,025 | $ 1,592,723 | 196,977,071 | (185,562,517) | 13,009,302 |
Balance, shares at Dec. 31, 2022 | 2,024,657 | 9,467,000 | |||
Compensation expense relating to option issuances | 79,966 | 79,966 | |||
Net loss | (2,844,837) | (2,844,837) | |||
Balance at Mar. 31, 2023 | $ 2,025 | $ 1,592,723 | 197,057,037 | (188,407,354) | 10,244,431 |
Balance, shares at Mar. 31, 2023 | 2,024,657 | 9,467,000 | |||
Balance at Dec. 31, 2022 | $ 2,025 | $ 1,592,723 | 196,977,071 | (185,562,517) | 13,009,302 |
Balance, shares at Dec. 31, 2022 | 2,024,657 | 9,467,000 | |||
Net loss | (5,895,423) | ||||
Balance at Jun. 30, 2023 | $ 2,025 | $ 1,592,723 | 197,120,665 | (191,457,940) | 7,257,473 |
Balance, shares at Jun. 30, 2023 | 2,024,657 | 9,467,000 | |||
Balance at Mar. 31, 2023 | $ 2,025 | $ 1,592,723 | 197,057,037 | (188,407,354) | 10,244,431 |
Balance, shares at Mar. 31, 2023 | 2,024,657 | 9,467,000 | |||
Compensation expense relating to option issuances | 63,628 | 63,628 | |||
Net loss | (3,050,586) | (3,050,586) | |||
Balance at Jun. 30, 2023 | $ 2,025 | $ 1,592,723 | $ 197,120,665 | $ (191,457,940) | $ 7,257,473 |
Balance, shares at Jun. 30, 2023 | 2,024,657 | 9,467,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||||
Net loss | $ (3,050,586) | $ (3,589,543) | $ (5,895,423) | $ (8,180,536) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 11,303 | 10,379 | 22,606 | 18,847 |
Gain on sale of property and equipment | (10,964) | |||
Stock-based compensation expense | 63,628 | 278,988 | 143,594 | 369,235 |
Changes in operating assets and liabilities: | ||||
Other receivables | (13,163) | 6,987 | ||
Operating Lease Right of Use Assets | 98,184 | |||
Prepaid expenses and other current assets | 1,232,949 | (1,555,350) | ||
Deposits | ||||
Accounts payable and accrued expenses | (274,070) | 332,024 | ||
Net cash used in operating activities | (4,685,323) | (9,019,757) | ||
Cash flows from investing activities: | ||||
Proceeds from sale of property and equipment | 12,000 | |||
Purchase of property and equipment | (87,047) | |||
Net cash used in investing activities | (75,047) | |||
Cash flows from financing activities: | ||||
Payments on short-term notes payable | (267,640) | (303,416) | ||
Net cash used in financing activities | (267,640) | (303,416) | ||
Net decrease in cash and cash equivalents | (4,952,963) | (9,398,220) | ||
Cash and cash equivalents at beginning of period | 11,426,785 | 27,265,703 | ||
Cash and cash equivalents at end of period | $ 6,473,822 | $ 17,867,483 | 6,473,822 | 17,867,483 |
Supplemental disclosure of cash flow information: | ||||
Interest paid | $ 3,347 | $ 4,062 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Oragenics, Inc. (the “Company” or “we”, or “our”) is focused on the development of the NT-CoV2-1 intranasal vaccine candidate to combat the novel Severe Acute Respiratory Syndrome coronavirus (“SARS-CoV-2”) and further development of effective treatments for novel antibiotics against infectious disease. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The accompanying unaudited interim consolidated financial statements as of June 30, 2023, the December 31, 2022, and the three and six-months ended June 30, 2023 and 2022, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) for interim consolidated financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete consolidated financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the financial condition, results of operations and cash flows for the periods presented. The results of operations for the interim period ended June 30, 2023, are not necessarily indicative of the results of operations that may be expected for the year ended December 31, 2023, or any future period. Prior Period Restatements On April 4, 2023 the Company’s management and Audit Committee of the Company’s Board of Directors concluded that the unaudited consolidated financial statements for the three and six-month periods ended June 30, 2022 should be restated and should no longer be relied upon. Management reviewed the terms and conditions of the Company’s contracts and the payments and concluded that during the three and six-month periods ending June 30, 2022 amounts were paid as part of a prepayment arrangement. Management reviewed Accounting Standards Codification Topic 730 Research and Development guidance related to recording initial upfront payments to vendors; and determined that the unaudited consolidated financial statements originally reported for the three and six-month periods ended June 30, 2022 classified as research and development expense on the unaudited consolidated statement of operations that should be classified as prepaid expense on the Company’s unaudited consolidated balance sheet. On April 14, 2023 the Company filed Amendment 1 on Form 10-Q/A with the SEC. Amendment 1 was filed for the sole purpose of restating certain financial statements included in the Original Form 10-Q. When referencing prior period comparisons for the three and six-month periods ended June 30, 2022 in this Form 10-Q the financial information reflects the restated financials as reported in Amendment 1. Going Concern Consideration These consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2022, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 17, 2023. The Company has incurred recurring losses and negative cash flows from operations since inception. To date, the Company has not generated significant revenues from operations. The Company incurred a net loss of $ 5,895,423 4,685,323 191,457,940 The Company expects to incur substantial expenditures to further develop its technologies. The Company believes the working capital at June 30, 2023 will be sufficient to meet the business objectives as presently structured only through the fourth quarter of 2023. As such, there is substantial doubt that we can continue as a going concern beyond that date. As a result, the Company has implemented certain cost-saving initiatives, including reducing our efforts and staff focused on our lantibiotics program, which are expected to negatively impact the development of our lantibiotics program. See, “Risk Factors.” The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations. The Company intends to seek additional funding through sublicensing arrangements, joint venturing or partnering, sales of rights to technology, government grants and public or private financings. The Company’s future success depends on its ability to raise capital and ultimately generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company may be required to curtail its current development programs, cut operating costs and forego future development and other opportunities. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 3. Significant Accounting Policies Basis of Consolidation The consolidated financial statements include the accounts of Oragenics, Inc. and our wholly-owned subsidiary Noachis Terra, Inc.(“NTI”). All intercompany balances and transactions have been eliminated. New Accounting Standards There are no additional accounting pronouncements issued or effective during the three months ended June 30, 2023, that have had, or are expected to have, a material impact on our consolidated financial statements. Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management 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 consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. The principal area of estimation reflected in the consolidated financial statements are estimates for research and development expenses and related prepaid and accrued expenses, which are based on the percentage of completion of the Company’s contracts with Contract Research Organizations. Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. Adjustments to the Consolidated Balance Sheet and Consolidated Statement of Cash Flows for the six-month period ended June 30, 2022 were as follows: ● Deposits of $ 17,940 ● Changes in Operating Lease Right of Use Assets of $ 45,921 ● Changes in Operating Lease Liabilities of ($47,327) Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, and warrants are measured at their fair value on the awards’ grant date using a Black-Scholes Option Pricing Model. Stock-based compensation awards issued to all employees and non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us. To the extent the stock option grants, or warrants do not vest at the grant date they are subject to forfeiture. Stock-Based Compensation US GAAP requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the consolidated financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. In connection with adopting ASU 2016-09, the Company made an accounting policy election to account for forfeitures in compensation expense as they occur. Warrants The Company used the Black-Scholes Option Pricing Model in calculating the fair value of any warrants that have been issued. Net Loss Per Share During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive because the Company reported a net loss for all periods presented. All references to common stock for the comparative three and six-month periods ended June 30, 2022, have been adjusted to reflect the effect of the reverse split. Net loss per share is computed using the weighted average number of shares of common stock outstanding. Concentrations Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes there is a minimal credit risk on cash and cash equivalents. Cash and cash equivalents could be adversely impacted, including the loss of uninsured deposits and other uninsured financial assets, if one or more of the financial institutions in which the Company holds its cash or cash equivalents fails or is subject to other adverse conditions in the financial or credit markets. Grant Revenue Grant revenues are derived from a small business innovation research grant in the amount of $ 250,000 |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 4. Property and Equipment, net Property and equipment, net consists of the following as of June 30, 2023 and December 31, 2022: Summary of Property and Equipment, Net June 30, 2023 December 31, 2022 Furniture and fixtures $ 20,742 $ 20,742 Laboratory equipment 676,744 676,744 Leasehold improvements 487,871 487,871 Office and computer equipment 298,944 298,944 Property and equipment, gross 1,484,301 1,484,301 Accumulated depreciation and amortization (1,385,845 ) (1,363,239 ) Property and equipment, net $ 98,456 $ 121,062 Depreciation and amortization expense for the three months ended June 30, 2023 and 2022 was $ 11,303 10,379 22,606 18,847 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 5. Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following as of June 30, 2023, and December 31, 2022: Summary of Accounts Payable and Accrued Expenses June 30, 2023 December 31, 2022 Accounts payable trade $ 590,576 $ 246,690 Accrued Expense 334,441 812,861 Professional fees - 31,101 Vacation 26,002 33,545 Total accounts payable and accrued expenses $ 951,019 $ 1,124,197 |
Short-Term Notes Payable
Short-Term Notes Payable | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Short-Term Notes Payable | 6. Short-Term Notes Payable The Company had the following short-term notes payable as of June 30, 2023 and December 31, 2022: Summary of Short-Term Notes Payable June 30, 2023 December 31, 2022 Directors’ and officers’ liability insurance financing of $ 528,429 600,169 54,366 61,496 6.24 5.34 May 24, 2024 May 24, 2023 $ - $ 267,640 Directors’ and officers’ liability - 267,640 The Company’s policy renewals will be completed in subsequent periods and the Company will evaluate if premium financing is necessary at that time. The Company also maintains a product liability insurance policy which has been renewed in subsequent periods without premium financing. |
Prepaid Expense and Other Curre
Prepaid Expense and Other Current Assets | 6 Months Ended |
Jun. 30, 2023 | |
Prepaid Expense And Other Current Assets | |
Prepaid Expense and Other Current Assets | 7. Prepaid Expense and Other Current Assets Schedule of Prepaid Expense and Other Current Assets at June 30, 2023 and December 31, 2022: Schedule of Prepaid Expense and Other Current Assets June 30, 2023 December 31, 2022 Prepaid research and expense $ 1,455,456 $ 2,471,809 Prepaid insurance 56,393 372,989 Prepaid financing costs 75,000 - Other prepaid costs 25,000 - Total accounts payable and accrued expenses $ 1,611,849 $ 2,844,798 As of June 30, 2023 and December 31, 2022, the Company had approximately $ 1.6 2.8 1.5 |
Shareholders_ Equity
Shareholders’ Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Shareholders’ Equity | 8. Shareholders’ Equity Common Stock Reverse Stock Split On December 22, 2022, the Board of Directors approved an amendment to our Amended and Restated Articles of Incorporation to effect a reverse stock split of our common stock by a ratio of one for sixty . The Company’s common stock began trading on a split-adjusted basis on January 23, 2023. All references to common stock for the comparative three and six-month periods ended June 30, 2022, have been adjuste d to reflect the effect of the reverse split. The stock split was also reflected in the December 31, 2022 stock amounts. As a result of the reverse stock split, the Company’s common stock began trading on a split-adjusted basis on January 23, 2023. Shares issued under At-The-Market (“ATM”) program For the three and six-month periods ended June 30, 2022 and 2023 the Company did not issue any shares of common stock under its ATM program. During the three-month period ended December 31, 2022, the Company issued 6,544 72,000 On December 19, 2022, the Company sent written notice of termination to A.G.P./Alliance Global Partners (“AGP”), pursuant to the terms of the Company’s Sales Agreement with AGP in connection with the Company’s ATM Program. The termination took effect on December 29, 2022. As a result of the termination, the Company will not, and during the six months ended June 30, 2023 did not, consummate any further sale of its common stock through the AGP Sales Agreement. On February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its common stock. The Company intends to use the proceeds from the ATM to continue funding its pre-clinical development of its SARS-CoV-2 vaccine candidates, Terra CoV-2 and NT-CoV2-1 and its lantibiotics program and for the general corporate purposes, including capital expenditures, working capital, and research and development activities. Other Share Issuances During the three and six-month periods ended June 30, 2022 and 2023 the Company issued no During the three-month period ended September 30, 2022 and prior to the reverse stock split, the holders of 4,000,000 2,550,000 15,000 During the twelve-months ended December 31, 2022, the Company issued 13,019 363,139 Preferred Stock Issuance of Series A Convertible Preferred Stock Financing In May of 2017 we entered into a securities purchase agreement to sell up to $ 3 3 9,029 150.00 17,742 seven years 186.00 The Series A Preferred Stock also includes certain demand registration rights, piggyback registration rights and liquidation preference rights. On May 10, 2017, we filed a Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Florida. Except as otherwise required by law, as long as any shares of Series A Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (c) increase the number of authorized shares of Series A Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing. Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary that is not a Fundamental Transaction (as defined in the Certificate of Designation), the holders of Series A Preferred Stock shall be entitled to receive out of the assets, the greater of (i) the product of the number of shares of Series A Preferred Stock then held by such holder, multiplied by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation in respect of Common Stock issuable upon conversion of such shares of Series A Preferred Stock if all outstanding shares of Series A Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The Series A Preferred Stock is classified as permanent equity. The Series B Non-Voting, Convertible Preferred Stock Financing On November 8, 2017, we completed a private placement of $ 3.3 The full $ 3.3 13,500 150.00 17,742 seven years 186.00 In connection with the Series B Preferred Financing, we filed a Certificate of Designation and Rights of Series B Convertible Preferred Stock with the Secretary of State of the State of Florida, to be effective November 8, 2017. Except as otherwise required by law, the Series B Preferred Stock shall have no voting rights. However, as long as any shares of Series B Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock, (c) increase the number of authorized shares of Series B Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing. The Series B Preferred Stock ranks (i) on par with the Common Stock and Series A Preferred Stock as to dividend rights and (ii) on par with Series A Preferred Stock and senior to the Common Stock as to distribution of assets upon liquidation, dissolution or winding-up by us, whether voluntary or involuntary. Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary, the holders of Series B Preferred Stock shall be entitled to receive out of the assets, on par with the holders of Series A Preferred Stock and in preference to the holders of the Common Stock, an amount of cash equal to the greater of (i) the product of the number of shares of Series B Preferred Stock then held by such holder, multiplied by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation in respect of Common Stock issuable upon conversion of such shares of Series B Preferred Stock if all outstanding shares of Series B Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The Series B Preferred Stock is classified as permanent equity. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2023 | |
Warrants | |
Warrants | 9. Warrants The Company’s outstanding and exercisable warrants as of June 30, 2023 are presented below: Schedule of Warrants Outstanding and Exercisable Exercise Price Total Warrants Outstanding Exercisable Warrants Outstanding Expiration Date $ 54.00 32,033 32,033 3/25/2024 $ 186.00 5,135 5,135 5/10/2024 $ 186.00 6,694 6,694 7/25/2024 $ 186.00 10,888 10,888 11/8/2024 $ 75.00 153,334 153,334 5/1/2025 $ 60.00 52,911 52,911 7/17/2025 $ 260,995 260,995 All outstanding warrants are classified as equity on the Company’s Consolidated Balance Sheets. |
Stock Compensation Plan
Stock Compensation Plan | 6 Months Ended |
Jun. 30, 2023 | |
Retirement Benefits [Abstract] | |
Stock Compensation Plan | 10. Stock Compensation Plan On February 25, 2022, the Company held its 2020 Annual Meeting. At the 2020 Annual Meeting, the shareholders of the Company approved and ratified the Company’s 2021 Equity Incentive Plan (the “2021 Incentive Plan”), which is a successor to the 2012 Incentive Plan. The 2021 Incentive Plan provides the aggregate number of shares of Common Stock that may be issued under the 2021 Plan will not exceed the sum of (i) 166,667 139,091 148,455 Options are granted at the fair market value of the Company’s stock on the date of grant which determines the exercise price after the completion of the vesting period. Options can vest either immediately or over a period of up to three years 10 Total compensation cost related to stock options was approximately $ 63,628 278,988 143,594 369,235 118,874 During the six-months ended June 30, 2023, the Company granted 7,000 4.00 3.92 Summary of Assumptions Used to Estimate the Fair Value of Stock Options Granted Six-months ended June 30, 2023 Risk free interest rate 4.0 % Expected volatility of common stock 143.0 % Dividend yield 0.0 % Expected life of options 10 |
License Agreements
License Agreements | 6 Months Ended |
Jun. 30, 2023 | |
License Agreements | |
License Agreements | 11. License Agreements Inspirevax License On February 23, 2023, the Company entered into a Commercial License Agreement (the “License Agreement”) with Inspirevax Inc. (“Inspirevax”) pursuant to which Inspirevax granted the Company an exclusive worldwide license to use Inspirevax’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical information created by or on behalf of Inspirevax (the “Inspirevax Technologies”) relating to its novel lipid-protein based intranasal adjuvants, to make, research, and develop an intra-nasal vaccine in combination with an antigen (“Combination Product”) to be used in an intranasal vaccine for use against diseases caused by coronaviruses and any genetic variants thereof to be sold by us. The Company agreed to pay in consideration for the License Agreement an upfront signing fee and to certain milestone payment obligations. NIH License Through NTI, the Company is a party to a Patent License and Biological Materials License Agreement (the “License Agreement” or “NIH License”), dated March 23, 2020, with the United States Department of Health and Human Services (the “HHS”), as represented by the National Institute of Allergy and Infectious Diseases (“NIAID”), an Institute within the National Institutes of Health (“NIH”). Under the terms of the License Agreement, the Company holds a nonexclusive, worldwide license to certain specified patent rights (including patent applications, provisional patent applications and Patent Cooperation Treaty (“PCT”) patent applications) and biological materials relating to the use of pre-fusion coronavirus spike proteins to exploit products (“Licensed Products”) and practice processes (“Licensed Processes”) that are covered by the licensed patent rights and biological materials for the purpose of developing and commercializing a vaccine product candidate for SARS-CoV-2. NRC License On July 26, 2021, the Company entered into a non-exclusive Technology License Agreement (the “License Agreement”) with the National Research Council of Canada (“NRC”) pursuant to which the NRC grants to the Company a license to use NRC’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical information created by or on behalf of the NRC (the “NRC Technologies”) relating to the derivatives of CHO 2353 TM ”) |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Additional Consideration−Noachis Terra Inc.(“NTI”) Acquisition. In connection with the Company’s acquisition of NTI, the Company is obligated to pay the former sole shareholder of NTI contingent consideration based upon the exercise of certain of the Company’s outstanding warrants as follows: (i) twenty percent ( 20 45.00 54.00 45 60.00 The Company’s previously issued warrants carrying an exercise price of $45.00 have expired by their terms. As a result, no additional consideration will be due to the former sole shareholder of NTI relating to these warrants At December 31, 2021, 41,210 6,000 60.00 35,210 54.00 As of the six-month period ended June 30, 2023, there are 32,033 54.00 March 25, 2024 52,911 60.00 July 17, 2025 Inspirevax As consideration for the License Agreement with Inspirevax the Company will be subject to certain milestone payments related to various events including but not limited to: (a) the Company’s decision for an appropriate nasal spray device, (b) phase 2a and 2b/3 clinical trials and patient participation, (c) certain license applications submitted to the FDA; (d) certain filing events for marketing authorizations out of the United States; and (e) certain metrics for sales within the United States, Europe and other countries or regions. Additionally, the Company is required to pay to Inspirevax certain royalties based upon net sales and subject to revenue limitations at which time the royalty amount will decrease. The amount of the milestone obligations could range from $ 0.1 7.25 On May 25, 2023 the Company and Inspirevax agreed to amend certain payment terms of the License Agreement related to the purchase of biological materials. The amended payment terms provide the Company with longer periods to make payment and are based on the earlier of certain vaccine development milestones or June 30, 2024. Unless terminated earlier, the License Agreement will terminate the later of (i) twenty ( 20 NIH License Under the terms of the NIH License Agreement, the NIAID is entitled to receive lump sum nonrefundable minimum annual royalties, which increase in the year after the first commercial sale of any Licensed Products or the practice of any Licensed Processes, as well as lump sum benchmark royalties following our completion of certain commercial development and sales-related benchmarks. The NIH is entitled to receive earned royalties on the annual net sales of Licensed Products and the practice of any Licensed Processes (subject to certain reductions), at certain low- to mid-single digit royalty rates, which rates vary based on the total amount of annual net sales and the geographic market in which those sales occur. We must provide regular written reports to the NIAID on the development status of and royalty payments relating to the Licensed Products and the Licensed Processes. The License Agreement will expire upon (a) twenty ( 20 NRC License As consideration for the grant of the NRC license, the Company will pay to the NRC an annual (low five digits) license fee, with the initial portion of the fee covering the first three years of the license (already paid). Additionally, we will pay certain milestone payments (a) upon transfer of each Stable Cell listed in the Agreement and (b) with regard to each of the first three Products, (i) upon submission of the Investigational New Drug application (IND) related thereto, (ii) upon dosing the first patient in a Phase 1 or Phase 2 clinical trial, (iii) upon dosing the first patient in a Phase 3 clinical trial and (iv) upon first regulatory approval. Milestone payments range from the low five digits to high six digits. In addition, Oragenics will pay a low single-digit royalty to the NRC for the sale of Products, based on sales revenue, commencing after the first commercial sale. Pursuant to the License Agreement, the NRC is required to bear the responsibility and pay the costs to obtain and maintain patents related to the NRC Technologies in certain countries, additional countries may be requested by us at our expense. In addition, the Company is required to provide certain indemnifications to the NRC and its employees. Unless terminated earlier, the License Agreement will terminate twenty ( 20 Three-Way Collaborative Agreement In May of 2023 the Company entered into a Collaborative Research Agreement (the “Collaboration”) with Inspirevax, and the NRC (the “Collaborators”). The Collaboration received non-dilutive funding from Consortium Québécois Sur La Découverte Du Médicament (the “CQDM”) a not-for-profit corporation governed by Canada created to promote, stimulate, and support drug research, development and discovery. The CQDM also provides funding for drug research and discovery projects. The project is budgeted to cost approximately $ 1.7 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases | |
Leases | 13. Leases Lab Facility-Alachua five years five years 12,870 13,338 85,230 Corporate Office-Tampa. In November of 2016, the Company entered into an amendment for the leased office space for corporate personnel located in Tampa, FL. The amended lease is for approximately 2,207 thirty-six February 29, 2024 4,944 16,878 33,578 Schedule of Other Information Related to Leases For the Six For the Twelve Weighted Average Remaining Lease Term In Years Operating leases 1.21 1.72 Weighted Average Discount Rate Operating leases 5.77 % 5.78 % Maturities of operating lease liabilities are as follows: Schedule of Maturities of Operating Lease Liabilities Year ended December 31: 2023 109,690 2024 156,605 2025 - Total $ 266,295 Less: effect of discounting (10,301 ) Present value of lease liabilities $ 255,994 The cost component of operating leases is as follows: Schedule of Cost Component of Operating Leases For the Six Months Ended June 30, 2023 For the Six Months Ended June 30, 2022 Operating lease cost $ 116,098 $ 114,259 Short-term lease cost - 1,965 Total lease cost $ 116,098 $ 116,224 Supplemental cash flow information related to operating leases is as follows: Schedule of Supplemental Cash Flow Information Related to Operating Leases For the Six Months Ended June 30, 2023 For the Six Months Ended June 30, 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 118,807 $ 117,350 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events Securities Purchase Agreement On August 4, 2023 the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two healthcare-focused investors, pursuant to which the Company agreed to issue in a private placement (the “Offering”), an aggregate of (i) 404,728 0.001 404,728 The gross proceeds from the offering are approximately $ 850,000 The Common Stock and Series E Preferred Stock sold in the Offering were issued in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, have not been registered under the Act, or applicable state securities laws. Accordingly, the Common Stock and Series E Preferred Stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties and termination provisions. Series E Preferred Stock In connection with the Securities Purchase Agreement referenced above, the Company filed a Certificate of Designation with the Secretary of State for the State of Florida (the “Series E Certificate of Designation”) designating 404,728 shares out of the authorized but unissued shares of its preferred stock as Series E Preferred Stock. The descriptions of the Certificate of Designation and Purchase Agreement are qualified by reference to the full text of such documents, which were attached to the Form 8-K as Exhibits 3.1 and 10.1 respectively, filed with the Securities and Exchange Commission on August 7, 2023. Restricted Stock Award On August 8 2023, the Compensation Committee and Board of Directors approved restricted stock awards to certain of our executive officers under the Company’s 2021 Equity Incentive Plan, consisting of 25,000 shares to our Chief Executive Officer, Ms. Kimberly Murphy, with 20,000 shares to vest immediately and 5,000 shares to vest within six (6) months from date of the award and 15,000 shares to our Chief Financial Officer, Ms. Janet Huffman, with 10,000 shares to vest immediately and 5,000 shares to vest within six (6) months from date of the award. The restricted stock awards are subject to the terms and conditions of the Company’s form of restricted stock award agreement which includes, earlier vesting upon a change in control of the Company. An additional 100,000 shares of common stock were awarded to directors of the Company with 80,000 shares to vest immediately and 20,000 shares to vest within six (6) months from date of the award. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of Oragenics, Inc. and our wholly-owned subsidiary Noachis Terra, Inc.(“NTI”). All intercompany balances and transactions have been eliminated. |
New Accounting Standards | New Accounting Standards There are no additional accounting pronouncements issued or effective during the three months ended June 30, 2023, that have had, or are expected to have, a material impact on our consolidated financial statements. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management 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 consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. The principal area of estimation reflected in the consolidated financial statements are estimates for research and development expenses and related prepaid and accrued expenses, which are based on the percentage of completion of the Company’s contracts with Contract Research Organizations. |
Reclassification | Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. Adjustments to the Consolidated Balance Sheet and Consolidated Statement of Cash Flows for the six-month period ended June 30, 2022 were as follows: ● Deposits of $ 17,940 ● Changes in Operating Lease Right of Use Assets of $ 45,921 ● Changes in Operating Lease Liabilities of ($47,327) |
Stock-Based Payment Arrangements | Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, and warrants are measured at their fair value on the awards’ grant date using a Black-Scholes Option Pricing Model. Stock-based compensation awards issued to all employees and non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us. To the extent the stock option grants, or warrants do not vest at the grant date they are subject to forfeiture. |
Stock-Based Compensation | Stock-Based Compensation US GAAP requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the consolidated financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. In connection with adopting ASU 2016-09, the Company made an accounting policy election to account for forfeitures in compensation expense as they occur. |
Warrants | Warrants The Company used the Black-Scholes Option Pricing Model in calculating the fair value of any warrants that have been issued. |
Net Loss Per Share | Net Loss Per Share During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive because the Company reported a net loss for all periods presented. All references to common stock for the comparative three and six-month periods ended June 30, 2022, have been adjusted to reflect the effect of the reverse split. Net loss per share is computed using the weighted average number of shares of common stock outstanding. |
Concentrations | Concentrations Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes there is a minimal credit risk on cash and cash equivalents. Cash and cash equivalents could be adversely impacted, including the loss of uninsured deposits and other uninsured financial assets, if one or more of the financial institutions in which the Company holds its cash or cash equivalents fails or is subject to other adverse conditions in the financial or credit markets. |
Grant Revenue | Grant Revenue Grant revenues are derived from a small business innovation research grant in the amount of $ 250,000 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment, Net | Property and equipment, net consists of the following as of June 30, 2023 and December 31, 2022: Summary of Property and Equipment, Net June 30, 2023 December 31, 2022 Furniture and fixtures $ 20,742 $ 20,742 Laboratory equipment 676,744 676,744 Leasehold improvements 487,871 487,871 Office and computer equipment 298,944 298,944 Property and equipment, gross 1,484,301 1,484,301 Accumulated depreciation and amortization (1,385,845 ) (1,363,239 ) Property and equipment, net $ 98,456 $ 121,062 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Summary of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following as of June 30, 2023, and December 31, 2022: Summary of Accounts Payable and Accrued Expenses June 30, 2023 December 31, 2022 Accounts payable trade $ 590,576 $ 246,690 Accrued Expense 334,441 812,861 Professional fees - 31,101 Vacation 26,002 33,545 Total accounts payable and accrued expenses $ 951,019 $ 1,124,197 |
Short-Term Notes Payable (Table
Short-Term Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Short-Term Notes Payable | The Company had the following short-term notes payable as of June 30, 2023 and December 31, 2022: Summary of Short-Term Notes Payable June 30, 2023 December 31, 2022 Directors’ and officers’ liability insurance financing of $ 528,429 600,169 54,366 61,496 6.24 5.34 May 24, 2024 May 24, 2023 $ - $ 267,640 Directors’ and officers’ liability - 267,640 |
Prepaid Expense and Other Cur_2
Prepaid Expense and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Prepaid Expense And Other Current Assets | |
Schedule of Prepaid Expense and Other Current Assets | Schedule of Prepaid Expense and Other Current Assets at June 30, 2023 and December 31, 2022: Schedule of Prepaid Expense and Other Current Assets June 30, 2023 December 31, 2022 Prepaid research and expense $ 1,455,456 $ 2,471,809 Prepaid insurance 56,393 372,989 Prepaid financing costs 75,000 - Other prepaid costs 25,000 - Total accounts payable and accrued expenses $ 1,611,849 $ 2,844,798 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Warrants | |
Schedule of Warrants Outstanding and Exercisable | The Company’s outstanding and exercisable warrants as of June 30, 2023 are presented below: Schedule of Warrants Outstanding and Exercisable Exercise Price Total Warrants Outstanding Exercisable Warrants Outstanding Expiration Date $ 54.00 32,033 32,033 3/25/2024 $ 186.00 5,135 5,135 5/10/2024 $ 186.00 6,694 6,694 7/25/2024 $ 186.00 10,888 10,888 11/8/2024 $ 75.00 153,334 153,334 5/1/2025 $ 60.00 52,911 52,911 7/17/2025 $ 260,995 260,995 |
Stock Compensation Plan (Tables
Stock Compensation Plan (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Retirement Benefits [Abstract] | |
Summary of Assumptions Used to Estimate the Fair Value of Stock Options Granted | Summary of Assumptions Used to Estimate the Fair Value of Stock Options Granted Six-months ended June 30, 2023 Risk free interest rate 4.0 % Expected volatility of common stock 143.0 % Dividend yield 0.0 % Expected life of options 10 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases | |
Schedule of Other Information Related to Leases | Schedule of Other Information Related to Leases For the Six For the Twelve Weighted Average Remaining Lease Term In Years Operating leases 1.21 1.72 Weighted Average Discount Rate Operating leases 5.77 % 5.78 % |
Schedule of Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities are as follows: Schedule of Maturities of Operating Lease Liabilities Year ended December 31: 2023 109,690 2024 156,605 2025 - Total $ 266,295 Less: effect of discounting (10,301 ) Present value of lease liabilities $ 255,994 |
Schedule of Cost Component of Operating Leases | The cost component of operating leases is as follows: Schedule of Cost Component of Operating Leases For the Six Months Ended June 30, 2023 For the Six Months Ended June 30, 2022 Operating lease cost $ 116,098 $ 114,259 Short-term lease cost - 1,965 Total lease cost $ 116,098 $ 116,224 |
Schedule of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows: Schedule of Supplemental Cash Flow Information Related to Operating Leases For the Six Months Ended June 30, 2023 For the Six Months Ended June 30, 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 118,807 $ 117,350 |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||||||
Net loss | $ 3,050,586 | $ 2,844,837 | $ 3,589,543 | $ 4,590,993 | $ 5,895,423 | $ 8,180,536 | |
Cash used in operating activities | 4,685,323 | $ 9,019,757 | |||||
Accumulated deficit | $ 191,457,940 | $ 191,457,940 | $ 185,562,517 |
Significant Accounting Polici_3
Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Product Information [Line Items] | |||||
Deposits | $ 17,940 | $ 17,940 | $ 17,940 | ||
Changes in operating lease right of use assets | (98,184) | ||||
Revenue | $ 13,163 | $ 30,391 | 30,187 | 45,474 | |
Grant [Member] | |||||
Product Information [Line Items] | |||||
Revenue | $ 250,000 | ||||
Revision of Prior Period, Reclassification, Adjustment [Member] | |||||
Product Information [Line Items] | |||||
Deposits | $ 17,940 | 17,940 | |||
Changes in operating lease right of use assets | 45,921 | ||||
Changes in operating lease liabilities | $ (47,327) |
Summary of Property and Equipme
Summary of Property and Equipment, Net (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,484,301 | $ 1,484,301 |
Accumulated depreciation and amortization | (1,385,845) | (1,363,239) |
Property and equipment, net | 98,456 | 121,062 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 20,742 | 20,742 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 676,744 | 676,744 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 487,871 | 487,871 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 298,944 | $ 298,944 |
Property and Equipment, net (De
Property and Equipment, net (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization expense | $ 11,303 | $ 10,379 | $ 22,606 | $ 18,847 |
Summary of Accounts Payable and
Summary of Accounts Payable and Accrued Expenses (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable trade | $ 590,576 | $ 246,690 |
Accrued Expense | 334,441 | 812,861 |
Professional fees | 31,101 | |
Vacation | 26,002 | 33,545 |
Total accounts payable and accrued expenses | $ 951,019 | $ 1,124,197 |
Summary of Short-Term Notes Pay
Summary of Short-Term Notes Payable (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Directors’ and officers’ liability | $ 267,640 |
Summary of Short-Term Notes p_2
Summary of Short-Term Notes payable (Details) (Parenthetical) - Directors and Officers Liability [Member] | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Director [Member] | |
Short-term notes payable, face amount | $ 528,429 |
Short-term notes payable, monthly payments | $ 54,366 |
Short-term notes payable, interest rate | 6.24% |
Short-term notes payable, maturity date | May 24, 2024 |
Officers [Member] | |
Short-term notes payable, face amount | $ 600,169 |
Short-term notes payable, monthly payments | $ 61,496 |
Short-term notes payable, interest rate | 5.34% |
Short-term notes payable, maturity date | May 24, 2023 |
Schedule of Prepaid Expense and
Schedule of Prepaid Expense and Other Current Assets (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense And Other Current Assets | ||
Prepaid research and expense | $ 1,455,456 | $ 2,471,809 |
Prepaid insurance | 56,393 | 372,989 |
Prepaid financing costs | 75,000 | |
Other prepaid costs | 25,000 | |
Total accounts payable and accrued expenses | $ 1,611,849 | $ 2,844,798 |
Prepaid Expense and Other Cur_3
Prepaid Expense and Other Current Assets (Details Narrative) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Defined Benefit Plan Disclosure [Line Items] | ||
Prepaid expenses | $ 1,600,000 | $ 2,800,000 |
Prepaid research and development expense | 1,455,456 | $ 2,471,809 |
Third Party Vendor [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Prepaid research and development expense | $ 1,500,000 |
Shareholders_ Equity (Details N
Shareholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Dec. 22, 2022 | Nov. 08, 2017 | May 31, 2017 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stockholders' Equity, Reverse Stock Split | reverse stock split of our common stock by a ratio of one for sixty | |||||||
Number of common stock issued | 0 | 0 | ||||||
Sale of shares authorized | $ 1,592,723 | $ 1,592,723 | $ 1,592,723 | $ 1,592,723 | ||||
Private Placement [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Number of shares issued during conversion | 13,500 | |||||||
Conversion price | $ 150 | |||||||
Series A Preferred Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Number of shares converted | 4,000,000 | |||||||
Series B Preferred Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Number of shares converted | 2,550,000 | |||||||
Series B Convertible Preferred Stock [Member] | Private Placement [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Shares converted value | $ 3,300,000 | |||||||
Proceeds from issuance of private placement | $ 3,300,000 | |||||||
Securities Purchase Agreement [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Conversion price | $ 150 | |||||||
Securities Purchase Agreement [Member] | Series A Convertible Preferred Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Shares converted value | $ 3,000,000 | |||||||
Securities Purchase Agreement [Member] | Series A Convertible Preferred Stock [Member] | Maximum [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Sale of shares authorized | $ 3,000,000 | |||||||
Common Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Number of shares issued during conversion | 15,000 | |||||||
Stock issued during exercise of stock options | 13,019 | |||||||
Proceeds from exercise of stock options | $ 363,139 | |||||||
Common Stock [Member] | ATM Program [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Number of common stock issued | 6,544 | |||||||
Proceeds from issuance of common stock | $ 72,000 | |||||||
Common Stock [Member] | Securities Purchase Agreement [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Number of shares issued during conversion | 9,029 | |||||||
Warrant [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Warrants exercise price | $ 54 | $ 54 | ||||||
Warrant [Member] | Private Placement [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Warrants to purchase common stock | 17,742 | |||||||
Warrants term | 7 years | |||||||
Warrants exercise price | $ 186 | |||||||
Warrant [Member] | Securities Purchase Agreement [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Warrants to purchase common stock | 17,742 | |||||||
Warrants term | 7 years | |||||||
Warrants exercise price | $ 186 |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding and Exercisable (Details) | Jun. 30, 2023 $ / shares shares |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding | 260,995 |
Exercisable Warrants Outstanding | 260,995 |
Range One [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price | $ / shares | $ 54 |
Warrants Outstanding | 32,033 |
Exercisable Warrants Outstanding | 32,033 |
Expiration Date | Mar. 25, 2024 |
Range Two [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price | $ / shares | $ 186 |
Warrants Outstanding | 5,135 |
Exercisable Warrants Outstanding | 5,135 |
Expiration Date | May 10, 2024 |
Range Three [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price | $ / shares | $ 186 |
Warrants Outstanding | 6,694 |
Exercisable Warrants Outstanding | 6,694 |
Expiration Date | Jul. 25, 2024 |
Range Four [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price | $ / shares | $ 186 |
Warrants Outstanding | 10,888 |
Exercisable Warrants Outstanding | 10,888 |
Expiration Date | Nov. 08, 2024 |
Range Five [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price | $ / shares | $ 75 |
Warrants Outstanding | 153,334 |
Exercisable Warrants Outstanding | 153,334 |
Expiration Date | May 01, 2025 |
Range Six [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price | $ / shares | $ 60 |
Warrants Outstanding | 52,911 |
Exercisable Warrants Outstanding | 52,911 |
Expiration Date | Jul. 17, 2025 |
Summary of Assumptions Used to
Summary of Assumptions Used to Estimate the Fair Value of Stock Options Granted (Details) | 6 Months Ended |
Jun. 30, 2023 | |
Retirement Benefits [Abstract] | |
Risk free interest rate | 4% |
Expected volatility of common stock | 143% |
Dividend yield | 0% |
Expective life of options | 10 years |
Stock Compensation Plan (Detail
Stock Compensation Plan (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Feb. 25, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||||||
Compensation cost | $ 63,628 | $ 278,988 | $ 143,594 | $ 369,235 | ||
Unrecognized compensation costs | $ 118,874 | $ 118,874 | ||||
Chief Financial Officer [Member] | ||||||
Defined Benefit Plan Disclosure [Line Items] | ||||||
Stock options granted | 7,000 | |||||
Fair value of stock option, stock price | $ 4 | $ 4 | ||||
Fair value of stock options | $ 3.92 | $ 3.92 | ||||
2021 Equity Incentive Plan [Member] | ||||||
Defined Benefit Plan Disclosure [Line Items] | ||||||
Aggregate shares of common stock outstanding option awards | 139,091 | |||||
common stock are available for future awards | 148,455 | |||||
Options expiration period | 10 years | |||||
2021 Equity Incentive Plan [Member] | Maximum [Member] | ||||||
Defined Benefit Plan Disclosure [Line Items] | ||||||
Shares authorized for issuance | 166,667 | |||||
Vesting period | 3 years |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||
May 31, 2020 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | May 31, 2023 | |
Inspirevax License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Agreement expiration term | 20 years | ||||
NIH License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Agreement expiration term | 20 years | ||||
NRC License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Agreement expiration term | 20 years | ||||
Collaborative Research Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Project cost | $ 1,700,000 | ||||
Range One [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 54 | ||||
Warrant expiration date | Mar. 25, 2024 | ||||
Range Two [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 186 | ||||
Warrant expiration date | May 10, 2024 | ||||
Minimum [Member] | Inspirevax License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Milestone obligations amount | $ 100,000 | ||||
Maximum [Member] | Inspirevax License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Milestone obligations amount | $ 7,250,000 | ||||
Warrant [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 54 | ||||
Warrant exercised | 41,210 | ||||
Warrants outstanding | $ 32,033 | ||||
Warrant expiration date | Mar. 25, 2024 | ||||
Warrant [Member] | Range One [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 60 | ||||
Warrant exercised | 6,000 | ||||
Warrant [Member] | Range Two [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 54 | ||||
Warrant exercised | 35,210 | ||||
Warrant One [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 60 | ||||
Warrants outstanding | $ 52,911 | ||||
Warrant expiration date | Jul. 17, 2025 | ||||
Noachis Terra Inc. [Member] | Warrant [Member] | |||||
Loss Contingencies [Line Items] | |||||
Percentage of warrant exercise | 20% | ||||
Warrants exercise term description | The Company’s previously issued warrants carrying an exercise price of $45.00 have expired by their terms. As a result, no additional consideration will be due to the former sole shareholder of NTI relating to these warrants | ||||
Noachis Terra Inc. [Member] | Warrant [Member] | Minimum [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 45 | ||||
Noachis Terra Inc. [Member] | Warrant [Member] | Maximum [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrant exercise price | $ 54 | ||||
Noachis Terra Inc. [Member] | Warrant One [Member] | |||||
Loss Contingencies [Line Items] | |||||
Percentage of warrant exercise | 45% | ||||
Warrant exercise price | $ 60 |
Schedule of Other Information R
Schedule of Other Information Related to Leases (Details) | Jun. 30, 2023 | Dec. 31, 2022 |
Leases | ||
Operating Lease, Weighted Average Remaining Lease Term | 1 year 2 months 15 days | 1 year 8 months 19 days |
Weighted Average Discount Rate, Operating leases | 5.77% | 5.78% |
Schedule of Maturities of Opera
Schedule of Maturities of Operating Lease Liabilities (Details) | Jun. 30, 2023 USD ($) |
Leases | |
2023 | $ 109,690 |
2024 | 156,605 |
2025 | |
Total | 266,295 |
Less: effect of discounting | (10,301) |
Present value of lease liabilities | $ 255,994 |
Schedule of Cost Component of O
Schedule of Cost Component of Operating Leases (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Leases | ||
Operating lease cost | $ 116,098 | $ 114,259 |
Short-term lease cost | 1,965 | |
Total lease cost | $ 116,098 | $ 116,224 |
Schedule of Supplemental Cash F
Schedule of Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Leases | ||
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases | $ 118,807 | $ 117,350 |
Leases (Details Narrative)
Leases (Details Narrative) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 USD ($) | Nov. 30, 2016 USD ($) ft² | Jun. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2014 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Operating lease payments | $ 118,807 | $ 117,350 | ||||
Alachua Facility [Member] | Minimum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Rent expense | $ 12,870 | |||||
Tampa Facility [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Lease term | 36 months | |||||
Rent expense | $ 16,878 | 33,578 | ||||
Lease area | ft² | 2,207 | |||||
Lease expiration date | Feb. 29, 2024 | |||||
Operating lease payments | $ 4,944 | |||||
Alachua Facility [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Lease term | 5 years | 5 years | ||||
Rent expense | $ 85,230 | |||||
Alachua Facility [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Rent expense | $ 13,338 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Aug. 04, 2023 | Jun. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | ||||
Number of shares issued | 0 | 0 | ||
Common stock par value | $ 0.001 | $ 0.001 | $ 0.001 | |
Subsequent Event [Member] | Security Purchase Agreement [Member] | Series E Mirroring Preferred Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Preferred Stock, Shares Subscribed but Unissued | 404,728 | |||
Subsequent Event [Member] | Security Purchase Agreement [Member] | Private Placement [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued | 404,728 | |||
Common stock par value | $ 0.001 | |||
Gross proceeds from offering | $ 850,000 | |||
Subsequent Event [Member] | Security Purchase Agreement [Member] | Private Placement [Member] | Series E Mirroring Preferred Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued | 404,728 |