Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 10, 2023 | Jun. 30, 2022 | |
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-39717 | ||
Entity Registrant Name | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | ||
Entity Central Index Key | 0001335105 | ||
Entity Tax Identification Number | 20-2903526 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 680 East Colorado Boulevard | ||
Entity Address, Address Line Two | Suite 180 | ||
Entity Address, City or Town | Pasadena | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 91101 | ||
City Area Code | (631) | ||
Local Phone Number | 830-7092 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 2,400,000 | ||
Entity Common Stock, Shares Outstanding | 16,659,093 | ||
Documents Incorporated by Reference [Text Block] | None | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 572 | ||
Auditor Name | Weinberg & Company, P.A | ||
Auditor Location | Los Angeles, California | ||
Common Stock, par value $0.0001 per share | |||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | LIXT | ||
Security Exchange Name | NASDAQ | ||
Warrants to Purchase Common Stock, par value $0.0001 per share | |||
Title of 12(b) Security | Warrants to Purchase Common Stock, par value $0.0001 per share | ||
Trading Symbol | LIXTW | ||
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 5,353,392 | $ 4,823,745 |
Advances on research and development contract services | 147,017 | 150,241 |
Prepaid insurance | 49,224 | 109,029 |
Other prepaid expenses and current assets | 10,380 | 10,249 |
Total current assets | 5,560,013 | 5,093,264 |
Total assets | 5,560,013 | 5,093,264 |
Current liabilities: | ||
Accounts payable and accrued expenses, including $46,982 and $32,500 to related parties at December 31, 2022 and 2021, respectively | 229,764 | 225,965 |
Research and development contract liabilities | 165,022 | 76,961 |
Total current liabilities | 394,786 | 302,926 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred Stock, $0.0001 par value; authorized – 10,000,000 shares; issued and outstanding – 350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, liquidation preference based on assumed conversion into common shares – 729,167 shares | 3,500,000 | 3,500,000 |
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 16,646,593 shares and 13,746,593 shares at December 31, 2022 and 2021, respectively | 1,664 | 1,374 |
Additional paid-in capital | 45,058,262 | 38,371,128 |
Accumulated deficit | (43,394,699) | (37,082,164) |
Total stockholders’ equity | 5,165,227 | 4,790,338 |
Total liabilities and stockholders’ equity | $ 5,560,013 | $ 5,093,264 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Related parties accounts payable and accrued expenses | $ 46,982 | $ 32,500 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 16,646,593 | 13,746,593 |
Common stock, shares outstanding | 16,646,593 | 13,746,593 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 10 | $ 10 |
Preferred stock, shares issued | 350,000 | 350,000 |
Preferred stock, shares outstanding | 350,000 | 350,000 |
Preferred stock, issuable upon conversion | 729,167 | 729,167 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Revenues | ||
General and administrative costs: | ||
Compensation to related parties, including stock-based compensation of $1,502,776 and $2,201,280 for the years ended December 31, 2022 and 2021, respectively | 2,547,615 | 3,024,113 |
Patent and licensing legal and filing fees and costs | 1,268,308 | 729,171 |
Other costs and expenses | 1,146,289 | 1,230,385 |
Research and development costs, including $43,264 and $397,642 of stock-based compensation costs to a consultant for the years ended December 31, 2022 and 2021, respectively | 1,349,269 | 1,736,776 |
Total costs and expenses | 6,311,481 | 6,720,445 |
Loss from operations | (6,311,481) | (6,720,445) |
Interest income | 11,195 | 626 |
Interest expense | (8,875) | (7,414) |
Foreign currency loss | (3,374) | (1,163) |
Net loss | $ (6,312,535) | $ (6,728,396) |
Net loss per common share – basic and diluted | $ (0.40) | $ (0.50) |
Weighted average common shares outstanding – basic and diluted | 15,820,292 | 13,473,839 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Allocated share based, compensation expense | $ 1,502,776 | $ 2,201,280 |
Consultant [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Allocated share based, compensation expense | $ 43,264 | $ 397,642 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Series A Convertible Preferred Stock [Member] Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance, value at Dec. 31, 2020 | $ 3,500,000 | $ 1,240 | $ 31,864,479 | $ (30,353,768) | $ 5,011,951 |
Balance, shares at Dec. 31, 2020 | 350,000 | 12,402,157 | |||
Proceeds from sale of common stock in direct equity offering, net of offering costs | $ 113 | 3,689,648 | 3,689,761 | ||
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares | 1,133,102 | ||||
Exercise of warrants | $ 1 | 17,099 | 17,100 | ||
Exercise of warrants, shares | 3,000 | ||||
Exercise of options | $ 20 | 200,980 | $ 201,000 | ||
Exercise of stock options, shares | 208,334 | 208,334 | |||
Stock-based compensation expense | 2,598,922 | $ 2,598,922 | |||
Net loss | (6,728,396) | (6,728,396) | |||
Balance, value at Dec. 31, 2021 | $ 3,500,000 | $ 1,374 | 38,371,128 | (37,082,164) | 4,790,338 |
Balance, shares at Dec. 31, 2021 | 350,000 | 13,746,593 | |||
Proceeds from sale of common stock in direct equity offering, net of offering costs | $ 290 | 5,141,094 | $ 5,141,384 | ||
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares | 2,900,000 | ||||
Exercise of stock options, shares | |||||
Stock-based compensation expense | 1,546,040 | $ 1,546,040 | |||
Net loss | (6,312,535) | (6,312,535) | |||
Balance, value at Dec. 31, 2022 | $ 3,500,000 | $ 1,664 | $ 45,058,262 | $ (43,394,699) | $ 5,165,227 |
Balance, shares at Dec. 31, 2022 | 350,000 | 16,646,593 |
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 | $ (6,312,535) | $ (6,728,396) |
Stock-based compensation expense included in - | ||
General and administrative costs | 1,502,776 | 2,201,280 |
Research and development costs | 43,264 | 397,642 |
Increase in - | ||
Advances on research and development contract services | 3,224 | (73,343) |
Prepaid insurance | 59,805 | (41,718) |
Other prepaid expenses and current assets | (131) | 4,751 |
Accounts payable and accrued expenses | 3,799 | 35,673 |
Research and development contract liabilities | 88,061 | 61,196 |
Net cash used in operating activities | (4,611,737) | (4,142,915) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock in direct equity offerings, net of offering costs | 5,141,384 | 3,689,761 |
Exercise of common stock warrants | 17,100 | |
Exercise of common stock options | 201,000 | |
Payment of costs incurred in connection with sale of common stock units in November 2020 | (10,467) | |
Net cash provided by financing activities | 5,141,384 | 3,897,394 |
Cash: | ||
Net increase (decrease) | 529,647 | (245,521) |
Balance at beginning of period | 4,823,745 | 5,069,266 |
Balance at end of period | 5,353,392 | 4,823,745 |
Supplemental disclosures of cash flow information: | ||
Interest | 8,875 | 7,414 |
Income taxes |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Lixte Biotechnology Holdings, Inc., a Delaware corporation, including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s corporate office is located in Pasadena, California. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its operating requirements. Nasdaq Notification of Failure to Satisfy a Continued Listing Rule The Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively. On June 24, 2022, the Company received a written notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company had not been in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a period of 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. The Notice had no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of the Notice, or until December 21, 2022, to regain compliance with the minimum closing bid price requirement. On December 22, 2022, the Company received a written notice from Nasdaq that the Company was eligible for a second 180 calendar day compliance period, or until June 19, 2023, in order to regain compliance with the $1.00 minimum bid price requirement. Nasdaq’s determination to grant the second compliance period was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. The Company can generally achieve compliance with the minimum closing bid price requirement if the minimum closing bid price per share of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days during the 180-day compliance period. However, under certain circumstances, Nasdaq can extend this 10-day trading period to a maximum of 20 days. The Company anticipates that its shares of common stock and warrants will continue to be listed and traded on The Nasdaq Capital Market during the compliance period ending June 19, 2023. In order to achieve compliance with the minimum closing bid price per share requirement, the Company intends to file a proxy statement to hold a special meeting of stockholders to seek approval to effect a reverse stock split of its issued and outstanding shares of common stock. However, there can be no assurance that the Company will be successful in this regard and will be able to regain compliance with the minimum closing bid price requirement by June 19, 2023, in which case the Company anticipates Nasdaq would provide a notice to the Company that its shares of common stock and warrants are subject to delisting, and the Company’s common shares and warrants would then be delisted. Going Concern At December 31, 2022, the Company had cash of $ 5,353,392 The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities. Based on current operating plans, the Company estimates that existing cash resources will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately December 31, 2023. However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate, as a result of which the Company will need to raise significant additional capital to do so. The Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments, during the latter part of the fiscal year ending December 31, 2023. In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned. As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely. Reverse Stock Split On November 18, 2020, the Company effected a 1-for-6 All share and per share amounts and information presented herein has been retroactively adjusted to reflect the reverse stock split for all periods presented. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its wholly-owned subsidiary, Lixte Biotechnology, Inc.. Intercompany balances and transactions have been eliminated in consolidation. Segment Information The Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President, Chief Executive Officer and Chief Scientific Officer. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $ 250,000 500,000 Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition, design, development and clinical trials with respect to the Company’s clinical compound and product candidate. Research and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union in accordance with the laws and regulations of such jurisdictions. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred. Obligations incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research and development contracts on a quarterly basis. Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each reporting period. Patent and Licensing Legal and Filing Fees and Costs Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs were $ 1,268,308 729,171 Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10 General and administrative costs for the years ended December 31, 2022 and 2021 included charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 26.5 14.6 30.3 44.2 Research and development costs for the year ended December 30, 2022 included charges from four vendors and consultants representing 21.0 19.3 15.1 12.1 30.3 21.8 14.4 Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of December 31, 2022 or 2021. Subsequent to December 31, 2022, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero. The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS, but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At December 31, 2022 and 2021, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2022 2021 December 31, 2022 2021 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 1,900,310 3,110,310 Common stock options, including options issued in the form of warrants 3,894,792 2,666,667 Total 6,524,269 6,506,144 Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. The carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of ASU 2019-12 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06 are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider whether collateral is required to be posted, and (iii) assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if adopted as of the beginning of such fiscal year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. The Company adopted ASU 2021-04 effective January 1, 2022. The adoption of ASU 2021-04 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Research and Development Costs
Research and Development Costs | 12 Months Ended |
Dec. 31, 2022 | |
Research and Development [Abstract] | |
Research and Development Costs | 3. Research and Development Costs Research and development costs, including costs associated with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical regions where such costs are incurred. Schedule of Research and Development Costs 2022 2021 Years Ended December 31, 2022 2021 United States $ 418,221 $ 1,109,058 Spain 559,438 269,532 France 91,532 248,908 China 75,920 54,030 Netherlands 204,158 55,248 Total $ 1,349,269 $ 1,736,776 |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | 4. Stockholders’ Equity Preferred Stock The Company is authorized to issue a total of 10,000,000 0.0001 350,000 175,000 1 175,000 9,650,000 Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 2.0833 21,875,000 If fully converted, the 350,000 729,167 Based on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible Preferred Stock as a permanent component of stockholders’ equity. Common Stock The Company is authorized to issue a total of 100,000,000 0.0001 16,646,593 13,746,593 Effective November 30, 2020, the Company raised gross proceeds of $ 5,700,000 1,200,000 4.75 180,000 1,800 5.70 1,110,451 4,591,349 120,000 5.70 Effective March 2, 2021, the Company completed the sale of 1,133,102 3.70 4,192,478 502,717 3,689,761 113,310 3.70 During February and March 2021, the Company issued 3,000 3,000 5.70 17,100 On April 22, 2021, the Company issued 125,001 101,000 75,000 0.72 16,667 0.90 33,334 0.96 Effective July 14, 2021, the Company issued 83,333 83,333 1.20 100,000 Effective April 12, 2022, the Company completed the sale of 2,900,000 2.00 5,800,000 658,616 5,141,384 290,000 2.00 Common Stock Warrants A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s November 2020 public offering of its securities, during the years ended December 31, 2022 and 2021 is presented below. Schedule of Warrants Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2020 3,000,000 $ 5.850 Issued 113,310 3.700 Exercised (3,000 ) 5.700 Expired — — Warrants outstanding at December 31, 2021 3,110,310 $ 5.772 Issued 290,000 2.000 Exercised — — Expired (1,500,000 ) 6.000 Warrants outstanding at December 31, 2022 1,900,310 $ 5.016 3.14 Warrants exercisable at December 31, 2021 3,110,310 $ 5.772 Warrants exercisable at December 31, 2022 1,900,310 $ 5.016 3.14 At December 31, 2022, the outstanding warrants are exercisable at the following prices per common share: Schedule of Warrants Outstanding and Exercisable Exercise Prices Warrants Outstanding (Shares) $ 2.000 290,000 $ 3.700 113,310 $ 5.700 1,497,000 1,900,310 Based on a fair market value of $ 0.50 Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 6. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions Related party transactions include transactions with the Company’s officers, directors and affiliates. Employment Agreements with Officers During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, payable monthly, as described below. The employment agreements are automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021 and 2022. The Company entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, for Dr. Kovach to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $ 250,000 250,000 250,000 The Company entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020 to act as the Company’s Chief Medical Officer, with an annual salary of $ 150,000 175,000 175,000 166,667 The Company entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as the Company’s Chief Administrative Officer, with an annual salary of $ 120,000 175,000 200,000 178,819 156,667 The Company entered into an employment agreement with Robert N. Weingarten effective August 12, 2020 to act as the Company’s Vice President and Chief Financial Officer, with an annual salary of $ 120,000 175,000 175,000 156,667 Appointment of Dr. René Bernards to the Board of Directors Effective as of June 15, 2022, Dr. René Bernards was appointed to the Company’s Board of Directors as an independent director. Dr. Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam. As a new director, in lieu of a grant of stock options, Dr. Bernards received a one-time cash board fee of $ 100,000 40,000 On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations, as described at Note 8. Compensatory Arrangements for Members of the Board of Directors Effective April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation program for the independent members of the Board of Directors and committee members. Effective May 25, 2022, the Board of Directors approved an amendment to the program. Officers who also serve on the Board of Directors are not compensated separately for their service on the Board of Directors. Cash compensation for independent directors, payable quarterly, is as follows: Base director compensation - $ 20,000 Chairman of audit committee - additional $ 10,000 Chairman of any other committees - additional $ 5,000 Member of audit committee - additional $ 5,000 Member of any other committees - additional $ 2,500 Equity compensation for independent directors is as follows: Appointment of new independent directors - The Company will grant options to purchase 250,000 50 50 12.5 100,000 Annual grant of options to independent directors - Effective on the last business day of the month of June, the Company will grant options to purchase 100,000 12.5 40,000 Total cash compensation paid to independent directors was $ 266,020 92,833 Stock-based compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 6. A summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors for their services on the Board of Directors, for the years ended December 31, 2022 and 2021 is as follows: Summary of Related Party Costs Years Ended December 31, 2022 2021 Related party costs: Cash-based $ 1,044,839 $ 822,833 Stock-based 1,502,776 2,201,280 Total $ 2,547,615 $ 3,024,113 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation The Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees, contractors, and consultants of the Company. On July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently approved by the stockholders of the Company. The 2020 Plan provides for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates, initially for a total of 2,333,333 1,800,000 4,133,333 As of December 31, 2022, unexpired stock options for 2,603,125 1,530,208 The fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts and is assumed to be zero. The estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of the common stock is determined by reference to the quoted market price of the common stock on the grant date. For stock options requiring an assessment of value during the year ended December 31, 2022, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: Schedule of Fair Value of Each Option Award Estimated Assumption Risk-free interest rate 3.03 3.63 % Expected dividend yield 0 % Expected volatility 128.03 153.17 % Expected life 3.5 5 For stock options requiring an assessment of value during the year ended December 31, 2021, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: Risk-free interest rate 0.89 1.13 % Expected dividend yield 0 % Expected volatility 187.7 198.79 % Expected life 3.5 5 On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted stock options to purchase 58,333 five years 7.14 400,855 6.8718 100,214 100,213 100,213 On August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted stock options to purchase 83,334 7.14 572,650 6.8718 143,163 143,163 143,163 On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock options to purchase 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $ 7.14 400,855 6.8718 100,214 100,213 100,213 Effective January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted stock options to purchase 50,000 200,000 3.21 571,312 2.8566 On April 9, 2021, Winson Sze Chun Ho resigned from the Company’s Board of Directors to focus on clinical and pre-clinical cancer research in academic medicine. Concurrent with his resignation, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by Dr. Ho’s resignation. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 250,000 3.20 753,611 3.0144 376,800 126,684 500,235 On May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Ms. Brown was granted stock options to purchase 250,000 2.80 658,363 2.6335 329,188 154,042 427,944 On June 30, 2021, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 100,000 500,000 3.03 1,421,095 2.84225 638,915 358,200 On November 8, 2021, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 200,000 2.06 397,642 1.9882 On June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Baan was granted stock options to purchase 250,000 0.74 158,525 0.6341 79,263 100,249 On June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 100,000 500,000 five years 0.74 316,700 0.6334 63,777 On November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 200,000 800,000 five years 2.00 25% 25% 800,000 262,560 0.3282 75,520 On November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 100,000 0.5025 43,264 0.4326 Dr. Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the Company’s Annual Meeting of Stockholders held on October 7, 2022, and Gil Schwartzberg, a director of the Company, died on October 30, 2022. Accordingly, the unvested stock options for each such person ceased vesting effective as of the respective dates that their service on the Company’s Board of Directors terminated. Furthermore, the expiration date of all vested stock options owned by such persons are contractually scheduled to expire one year from the respective dates that their service on the Company’s Board of Directors terminated. A summary of stock-based compensation costs for the years ended December 31, 2022 and 2021 is as follows: Summary of Stock-based Compensation Costs Years Ended December 31, 2022 2021 Related parties $ 1,502,776 $ 2,201,280 Non-related parties 43,264 397,642 Total stock-based compensation costs $ 1,546,040 $ 2,598,922 A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2022 and 2021 is as follows: Summary of Stock Option Activity Including Options Form of Warrants Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2020 1,475,000 $ 4.136 Granted 1,400,000 2.906 Exercised (208,334 ) 0.965 Expired — — Rounding adjustment attributable to reverse stock split 1 — Stock options outstanding at December 31, 2021 2,666,667 3.738 Granted 1,650,000 1.337 Exercised — — Expired (421,875 ) 1.916 Stock options outstanding at December 31, 2022 3,894,792 $ 2.918 3.04 Stock options exercisable at December 31, 2021 2,004,167 $ 3.777 Stock options exercisable at December 31, 2022 2,819,792 $ 3.283 2.49 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $ 882,000 15 The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31, 2022 are as follows: Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants Exercise Prices Options Outstanding (Shares) Options Exercisable (Shares) $ 0.5025 100,000 100,000 $ 0.7400 575,000 256,250 $ 1.6800 33,333 33,333 $ 2.0000 800,000 200,000 $ 2.0600 200,000 200,000 $ 2.8000 250,000 218,750 $ 3.0000 666,667 666,667 $ 3.0300 425,000 350,000 $ 3.2000 203,125 203,125 $ 3.2100 150,000 150,000 $ 6.0000 166,667 166,667 $ 6.6000 41,667 41,667 $ 7.1400 200,000 150,000 $ 12.0000 83,333 83,333 3,894,792 2,819,792 The intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2022 was approximately $ 750 0.51 Outstanding stock options to acquire 1,075,000 The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are as follows: Schedule of Components of Deferred Tax Assets 2022 2021 December 31, 2022 2021 Research credits $ 574,000 $ 451,000 Stock-based compensation 2,137,000 1,821,000 Net operating loss carryforwards 8,135,000 6,723,000 Total deferred tax assets 10,846,000 8,995,000 Valuation allowance (10,846,000 ) (8,995,000 ) Net deferred tax assets $ — $ — In assessing the potential realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during the periods in which those temporary differences become deductible. As of December 31, 2022 and 2021, management was unable to determine if it is more likely than not that the Company’s deferred tax assets will be realized and has therefore recorded an appropriate valuation allowance against deferred tax assets at such dates. No Schedule of Effective Income Tax Rate Years Ended December 31, 2022 2021 U. S. federal statutory tax rate (21.0 )% (21.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 1.7 % 0.6 % Adjustment to deferred tax asset (1.5 )% (0.4 )% Change in valuation allowance 26.8 % 26.8 % Effective tax rate 0.0 % 0.0 % At December 31, 2022, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately $ 27,803,000 28,040,000 expire through 2038 The state net operating loss carryovers include approximately $ 19,141,000 The Company may utilize up to 1/10 of the PNOLC subtraction pool, or $ 928,313 8,899,000 In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the ownership of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income might be limited. As the Company’s net operating losses have yet to be utilized, all previous tax years since 2006 remain subject to adjustment by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Legal Claims The Company may be subject to legal claims and actions from time to time as part of its business activities. As of December 31, 2022 and 2021, the Company was not subject to any pending or threatened legal claims or actions. Principal Commitments Clinical Trial Agreements At December 31, 2022, the Company’s unpaid remaining contractual commitments pursuant to clinical trial agreements, and clinical trial monitoring agreements, as described below, aggregated $ 7,892,000 Moffitt. In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application (“IND”) to conduct a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilizes LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy. The bone marrow cells of patients with del5qMDS are deficient in PP2A by virtue of an acquired mutation and are especially vulnerable to further inhibition of PP2A by LB-100. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. A total enrollment of 41 patients is planned. An interim analysis will be done after the first 21 patients are entered. If there are 3 or more responders but fewer than 7, an additional 20 patients will be entered. If at any point there are 7 or more responders, this will be sufficient evidence to support continued development of LB-100 for the treatment of low and intermediate-1 risk MDS. Recruitment has been slow and the Covid-19 pandemic has further reduced recruitment of patients into the protocol. At the current rate of accrual, the clinical trial is expected to be completed by June 30, 2025. However, with additional funds, the Company would consider adding two additional MDS centers to the Phase 2 portion of the study to accelerate patient accrual. During the years ended December 31, 2022 and 2021, the Company incurred costs of $ 26,397 18,443 131,074 The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 590,000 GEIS. GEIS has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as well as to provide funding for the clinical trial. The goal is to enter approximately 150 patients in this clinical trial over a period of two years. As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival (PFS, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required for final analysis is reached. The Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July 2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol, it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These standards were adopted subsequent to the production of the Company’s existing LB-100 inventory. In order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility, provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal application documenting all steps taken to prepare the clinical drug product for clinical use must be submitted to the appropriate regulatory authorities for review and approval before being used in a clinical trial. As of December 31, 2022, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially for subsequent multiple trials within the European Union, had cost $ 1,144,169 On October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS). Consequently, the GEIS clinical trial is currently scheduled to commence during the quarter ending June 30, 2023 and to be completed by December 31, 2025. Up to 170 patents will be entered into the clinical trial. The Phase 1b section of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on both response and toxicity from this portion of the clinical trial. The interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone. The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. Through December 31, 2022, the Company has paid GEIS an aggregate of $ 415,823 During the years ended December 31, 2022 and 2021, the Company incurred costs of $ 260,770 24,171 415,823 3,743,000 City of Hope. The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, as patient accrual has been slower than expected, the Company is currently seeking to add two additional sites to increase the rate of patient accrual, with at least one major site expected to be added by June 30, 2023. With the additional sites, the Company expects that this clinical trial will be completed by December 31, 2024. Without the additional sites, the Company expects that this clinical trial will be completed no sooner than December 31, 2025. Effective March 6, 2023, Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, joined the City of Hope’s ongoing Phase 1b clinical trial to assess the combination of the Company’s first-in-class protein phosphatase 2A (PP2A) inhibitor, LB-100, with a standard regimen for previously untreated, extensive stage small cell lung cancer disease. SCRI, one of the largest community-based cancer trial centers in the United States, is expected to expedite and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability and efficacy of adding LB-100 to the current standard treatment regimen. During the years ended December 31, 2022 and 2021, the Company incurred costs of $ 0 378,511 2,433,000 800,000 The Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment of a very aggressive disease. National Cancer Institute Pharmacologic Clinical Trial. Primary malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation, temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain is not known. Unfortunately, many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action. The NCI study is designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove one or more tumors will receive one dose of LB-100 prior to surgery and have blood and tumor tissue analyzed to determine the amount of LB-100 present and to determine whether the cells in the tumors show the biochemical changes expected to be present if LB-100 reaches its molecular target. As a result of the innovative design of the NCI study, data from a few patients should be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs. Five patients have been entered and analysis of the blood and tissue will now proceed. If there is evidence in at least two of the patients of penetration of LB 100 into tumor tissue, the study will be deemed as successful. The results of this study are expected during 2023. Clinical Trial Monitoring Agreements Moffitt. Costs under this work order agreement are estimated to be approximately $ 954,000 35,403 9,730 127,288 842,000 City of Hope. 335,000 33,815 24,626 58,441 284,000 Patent and License Agreements Moffitt. 25,000 25,000 1,897,000 25,000 25,000 The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $ 50,000 100,000 Employment Agreements with Officers During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual compensation of $ 640,000 one-year periods On April 9, 2021, the Board of Directors increased the annual compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten under the employment agreements, such that the total aggregate annual compensation of all officers increased to $ 775,000 Effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $ 200,000 800,000 600 The total aggregate annual compensation of all officers increased to $ 800,000 Other Significant Agreements and Contracts NDA Consulting Corp. 4,000 16,000 16,000 BioPharmaWorks BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $ 10,000 120,000 120,000 Foundation for Angelman Syndrome Therapy. 5 250,000 The research team at the University of California - Davis recently completed their pre-clinical study of the potential benefit of LB-100 in a mouse model of AS. The preliminary analysis indicates that the positive results previously reported by Chinese investigators were not confirmed in the US model. The Company is currently awaiting input from FAST as to whether it intends to continue to pursue pre-clinical studies of LB 100. To date, FAST has not indicated whether it desires to pursue further studies of LB-100, but in light of the failure to confirm the Chinese study results, the Company does not plan to pursue further studies of AS. Netherlands Cancer Institute 204,158 55,248 259,406 262,000 MRI Global. 273,980 27,702 17,782 219,611 55,000 External Risks Associated with the Company’s Business Activities Covid-19 Virus Inflation Risk. Supply Chain Issues. Potential Recession. The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance become available. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events The Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC. Other than the matter noted below, there were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements. Effective March 10, 2023, the Company issued 12,500 12,500 0.5025 6,281 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its wholly-owned subsidiary, Lixte Biotechnology, Inc.. Intercompany balances and transactions have been eliminated in consolidation. |
Segment Information | Segment Information The Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President, Chief Executive Officer and Chief Scientific Officer. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash | Cash Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $ 250,000 500,000 |
Research and Development | Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition, design, development and clinical trials with respect to the Company’s clinical compound and product candidate. Research and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union in accordance with the laws and regulations of such jurisdictions. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred. Obligations incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research and development contracts on a quarterly basis. |
Prepaid Insurance | Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each reporting period. |
Patent and Licensing Legal and Filing Fees and Costs | Patent and Licensing Legal and Filing Fees and Costs Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs were $ 1,268,308 729,171 |
Concentration of Risk | Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10 General and administrative costs for the years ended December 31, 2022 and 2021 included charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 26.5 14.6 30.3 44.2 Research and development costs for the year ended December 30, 2022 included charges from four vendors and consultants representing 21.0 19.3 15.1 12.1 30.3 21.8 14.4 |
Income Taxes | Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of December 31, 2022 or 2021. Subsequent to December 31, 2022, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero. The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS, but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At December 31, 2022 and 2021, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2022 2021 December 31, 2022 2021 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 1,900,310 3,110,310 Common stock options, including options issued in the form of warrants 3,894,792 2,666,667 Total 6,524,269 6,506,144 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. The carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of ASU 2019-12 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06 are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider whether collateral is required to be posted, and (iii) assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if adopted as of the beginning of such fiscal year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. The Company adopted ASU 2021-04 effective January 1, 2022. The adoption of ASU 2021-04 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At December 31, 2022 and 2021, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share 2022 2021 December 31, 2022 2021 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 1,900,310 3,110,310 Common stock options, including options issued in the form of warrants 3,894,792 2,666,667 Total 6,524,269 6,506,144 |
Research and Development Costs
Research and Development Costs (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Research and Development [Abstract] | |
Schedule of Research and Development Costs | Research and development costs, including costs associated with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical regions where such costs are incurred. Schedule of Research and Development Costs 2022 2021 Years Ended December 31, 2022 2021 United States $ 418,221 $ 1,109,058 Spain 559,438 269,532 France 91,532 248,908 China 75,920 54,030 Netherlands 204,158 55,248 Total $ 1,349,269 $ 1,736,776 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding | A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s November 2020 public offering of its securities, during the years ended December 31, 2022 and 2021 is presented below. Schedule of Warrants Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2020 3,000,000 $ 5.850 Issued 113,310 3.700 Exercised (3,000 ) 5.700 Expired — — Warrants outstanding at December 31, 2021 3,110,310 $ 5.772 Issued 290,000 2.000 Exercised — — Expired (1,500,000 ) 6.000 Warrants outstanding at December 31, 2022 1,900,310 $ 5.016 3.14 Warrants exercisable at December 31, 2021 3,110,310 $ 5.772 Warrants exercisable at December 31, 2022 1,900,310 $ 5.016 3.14 |
Schedule of Warrants Outstanding and Exercisable | At December 31, 2022, the outstanding warrants are exercisable at the following prices per common share: Schedule of Warrants Outstanding and Exercisable Exercise Prices Warrants Outstanding (Shares) $ 2.000 290,000 $ 3.700 113,310 $ 5.700 1,497,000 1,900,310 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Summary of Related Party Costs | A summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors for their services on the Board of Directors, for the years ended December 31, 2022 and 2021 is as follows: Summary of Related Party Costs Years Ended December 31, 2022 2021 Related party costs: Cash-based $ 1,044,839 $ 822,833 Stock-based 1,502,776 2,201,280 Total $ 2,547,615 $ 3,024,113 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Fair Value of Each Option Award Estimated Assumption | For stock options requiring an assessment of value during the year ended December 31, 2022, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: Schedule of Fair Value of Each Option Award Estimated Assumption Risk-free interest rate 3.03 3.63 % Expected dividend yield 0 % Expected volatility 128.03 153.17 % Expected life 3.5 5 For stock options requiring an assessment of value during the year ended December 31, 2021, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: Risk-free interest rate 0.89 1.13 % Expected dividend yield 0 % Expected volatility 187.7 198.79 % Expected life 3.5 5 |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the years ended December 31, 2022 and 2021 is as follows: Summary of Stock-based Compensation Costs Years Ended December 31, 2022 2021 Related parties $ 1,502,776 $ 2,201,280 Non-related parties 43,264 397,642 Total stock-based compensation costs $ 1,546,040 $ 2,598,922 |
Summary of Stock Option Activity Including Options Form of Warrants | A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2022 and 2021 is as follows: Summary of Stock Option Activity Including Options Form of Warrants Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2020 1,475,000 $ 4.136 Granted 1,400,000 2.906 Exercised (208,334 ) 0.965 Expired — — Rounding adjustment attributable to reverse stock split 1 — Stock options outstanding at December 31, 2021 2,666,667 3.738 Granted 1,650,000 1.337 Exercised — — Expired (421,875 ) 1.916 Stock options outstanding at December 31, 2022 3,894,792 $ 2.918 3.04 Stock options exercisable at December 31, 2021 2,004,167 $ 3.777 Stock options exercisable at December 31, 2022 2,819,792 $ 3.283 2.49 |
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants | The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31, 2022 are as follows: Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants Exercise Prices Options Outstanding (Shares) Options Exercisable (Shares) $ 0.5025 100,000 100,000 $ 0.7400 575,000 256,250 $ 1.6800 33,333 33,333 $ 2.0000 800,000 200,000 $ 2.0600 200,000 200,000 $ 2.8000 250,000 218,750 $ 3.0000 666,667 666,667 $ 3.0300 425,000 350,000 $ 3.2000 203,125 203,125 $ 3.2100 150,000 150,000 $ 6.0000 166,667 166,667 $ 6.6000 41,667 41,667 $ 7.1400 200,000 150,000 $ 12.0000 83,333 83,333 3,894,792 2,819,792 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets | Schedule of Components of Deferred Tax Assets 2022 2021 December 31, 2022 2021 Research credits $ 574,000 $ 451,000 Stock-based compensation 2,137,000 1,821,000 Net operating loss carryforwards 8,135,000 6,723,000 Total deferred tax assets 10,846,000 8,995,000 Valuation allowance (10,846,000 ) (8,995,000 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate | Schedule of Effective Income Tax Rate Years Ended December 31, 2022 2021 U. S. federal statutory tax rate (21.0 )% (21.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 1.7 % 0.6 % Adjustment to deferred tax asset (1.5 )% (0.4 )% Change in valuation allowance 26.8 % 26.8 % Effective tax rate 0.0 % 0.0 % |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details Narrative) - USD ($) | Nov. 18, 2020 | Dec. 31, 2022 | Dec. 31, 2021 |
Cash and cash equivalents | $ 5,353,392 | $ 4,823,745 | |
Common Stock [Member] | |||
Reverse stock split | 1-for-6 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 6,524,269 | 6,506,144 |
Series A Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 729,167 | 729,167 |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,900,310 | 3,110,310 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,894,792 | 2,666,667 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Product Information [Line Items] | ||
Cash FDIC insurance | $ 250,000 | |
Cash SIPC insurance | 500,000 | |
Patent and licensing legal and filing fees and costs | 1,268,308 | $ 729,171 |
Unrecognized tax benefits | $ 0 | $ 0 |
Cost of Sales [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 10% | 10% |
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 26.50% | 14.60% |
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Stock Options Granted to Directors and Corporate Officers [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 30.30% | 44.20% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor One [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 21% | 30.30% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor Two [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 19.30% | 21.80% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor Three [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 15.10% | 14.40% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor Four [Member] | ||
Product Information [Line Items] | ||
Concentration of risk, percentage | 12.10% |
Schedule of Research and Develo
Schedule of Research and Development Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Total | $ 1,349,269 | $ 1,736,776 |
UNITED STATES | ||
Total | 418,221 | 1,109,058 |
SPAIN | ||
Total | 559,438 | 269,532 |
FRANCE | ||
Total | 91,532 | 248,908 |
CHINA | ||
Total | 75,920 | 54,030 |
NETHERLANDS | ||
Total | $ 204,158 | $ 55,248 |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of Shares, Warrants Outstanding, Beginning Balance | 3,110,310 | 3,000,000 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ 5.772 | $ 5.850 |
Number of Shares, Issued | 290,000 | 113,310 |
Weighted Average Exercise Price, Issued | $ 2 | $ 3.700 |
Number of Shares, Exercised | (3,000) | |
Weighted Average Exercise Price, Exercised | $ 5.700 | |
Number of Shares, Expired | 1,500,000 | |
Weighted average exercise price, expired | $ 6 | |
Number of Shares, Expired | (1,500,000) | |
Number of Shares, Warrants Outstanding, Ending Balance | 1,900,310 | 3,110,310 |
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ 5.016 | $ 5.772 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 3 years 1 month 20 days | |
Number of Shares, Warrants exercisable, Ending Balance | 1,900,310 | 3,110,310 |
Weighted Average Exercise Price, Warrants exercisable, Ending Balance | $ 5.016 | $ 5.772 |
Weighted Average Remaining Contractual Life (in Years), Exercisable | 3 years 1 month 20 days |
Schedule of Warrants Outstand_2
Schedule of Warrants Outstanding and Exercisable (Details) - $ / shares | Dec. 31, 2022 | Mar. 02, 2021 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.70 | |
Warrants Outstanding Shares | 1,900,310 | |
Exercise Price One [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 2 | |
Warrants Outstanding Shares | 290,000 | |
Exercise Price Two [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.700 | |
Warrants Outstanding Shares | 113,310 | |
Exercise Price Three [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 5.700 | |
Warrants Outstanding Shares | 1,497,000 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||||
Apr. 12, 2022 | Jul. 14, 2021 | Apr. 22, 2021 | Mar. 02, 2021 | Dec. 07, 2020 | Nov. 30, 2020 | Mar. 17, 2015 | Mar. 30, 2021 | Feb. 28, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | |
Class of Stock [Line Items] | ||||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||||||||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | ||||||||||
Common stock, shares outstanding | 16,646,593 | 13,746,593 | ||||||||||
Common stock, shares issued | 16,646,593 | 13,746,593 | ||||||||||
Net proceeds from issuance of stock | $ 5,700,000 | |||||||||||
Number of common stock shares issued during period | 1,200,000 | |||||||||||
Sale of stock price per share | $ 4.75 | |||||||||||
Warrant exercise price | $ 3.70 | |||||||||||
Estimated gross proceeds from offering of shares | $ 502,717 | |||||||||||
Warrants to purchase shares | 113,310 | |||||||||||
Stock issued new issue shares | 1,133,102 | |||||||||||
Share issued per share | $ 3.70 | |||||||||||
Proceeds from issuance of common stock gross | $ 4,192,478 | |||||||||||
Proceeds from issuance initial public offering | $ 3,689,761 | $ 5,141,384 | $ 3,689,761 | |||||||||
Proceeds from warrant exercises | 17,100 | |||||||||||
Total cash proceeds | $ 100,000 | $ 101,000 | $ 201,000 | |||||||||
Stock Repurchased During Period, Shares | 83,333 | |||||||||||
Officer and Directors [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock upon the exercise of options | 125,001 | |||||||||||
Officer [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock upon the exercise of options | 75,000 | |||||||||||
Exercise price | $ 0.72 | |||||||||||
Director One [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock upon the exercise of options | 16,667 | |||||||||||
Exercise price | $ 0.90 | |||||||||||
Director Two [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock upon the exercise of options | 33,334 | |||||||||||
Exercise price | $ 0.96 | |||||||||||
Consultant [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock upon the exercise of options | 83,333 | |||||||||||
Exercise price | $ 1.20 | |||||||||||
Placement Agents [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrant exercise price | $ 2 | |||||||||||
Warrants to purchase shares | 290,000 | |||||||||||
Common Stock [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Net proceeds from issuance of stock | $ 5,141,384 | |||||||||||
Number of common stock shares issued during period | 2,900,000 | |||||||||||
Sale of stock price per share | $ 2 | |||||||||||
Costs of public offering | $ 658,616 | |||||||||||
Stock issued new issue shares | 3,000 | 3,000 | 2,900,000 | 1,133,102 | ||||||||
Proceeds from issuance initial public offering | $ 5,800,000 | |||||||||||
Warrant [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Net proceeds from issuance of stock | $ 180,000 | |||||||||||
Warrant exercise price | $ 5.70 | $ 5.70 | $ 5.70 | $ 5.70 | ||||||||
Costs of public offering | $ 1,110,451 | |||||||||||
Estimated gross proceeds from offering of shares | $ 4,591,349 | |||||||||||
Stock issued new issue shares | 3,000 | 3,000 | ||||||||||
Proceeds from warrant exercises | $ 17,100 | $ 17,100 | ||||||||||
Warrant [Member] | Underwriting Agreement [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants to purchase shares | 120,000 | |||||||||||
Warrant [Member] | Over-Allotment Option [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Net proceeds from issuance of stock | $ 1,800 | |||||||||||
Common Stock Warrant [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Fair market value of stock | 0.50 | |||||||||||
Series A Convertible Preferred Stock [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Preferred stock, shares authorized | 350,000 | |||||||||||
Preferred stock, par value | $ 10 | $ 10 | ||||||||||
Principal Cash Obligations and Commitments | 175,000 | |||||||||||
Preferred stock dividend, percentage | 1% | |||||||||||
Annual net revenue | 175,000 | |||||||||||
Preferred stock convertible into common stock | 729,167 | 729,167 | ||||||||||
Gross proceeds from sale of transaction | $ 21,875,000 | |||||||||||
Preferred stock, shares outstanding | 350,000 | 350,000 | ||||||||||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 2.0833 shares of common stock (subject to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000 | |||||||||||
Preferred stock convertible into common stock | 2.0833 | |||||||||||
Undesignated Preferred Stock [Member] | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Preferred stock, shares authorized | 9,650,000 | 9,650,000 |
Summary of Related Party Costs
Summary of Related Party Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | ||
Total | $ 2,547,615 | $ 3,024,113 |
Cash Based [Member] | ||
Related Party Transaction [Line Items] | ||
Total | 1,044,839 | 822,833 |
Stock Based [Member] | ||
Related Party Transaction [Line Items] | ||
Total | $ 1,502,776 | $ 2,201,280 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 12 Months Ended | |||||||
May 01, 2021 | Apr. 09, 2021 | Oct. 01, 2020 | Aug. 12, 2020 | Aug. 01, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 15, 2022 | |
Related Party Transaction [Line Items] | ||||||||
Cash board fee payable | $ 100,000 | |||||||
Cash board fee payable | $ 40,000 | |||||||
Share-based payment award, award vesting period | 12.50% | |||||||
Annual cash fee | $ 2,547,615 | $ 3,024,113 | ||||||
Stock based compensation | 1,546,040 | 2,598,922 | ||||||
Independent Director [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Stock based compensation | $ 266,020 | 92,833 | ||||||
New Independent Director [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Options, grants in period, gross | 250,000 | |||||||
Share-based payment award, award vesting period | 50% | |||||||
Annual cash fee | $ 100,000 | |||||||
Annual Grant of Options [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Options, grants in period, gross | 100,000 | |||||||
Share-based payment award, award vesting period | 12.50% | |||||||
Annual cash fee | $ 40,000 | |||||||
Director [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | $ 20,000 | |||||||
Stock based compensation | 63,777 | |||||||
Chairman of Audit Committee [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | 10,000 | |||||||
Chairman of Other Committees [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | 5,000 | |||||||
Member of Audit Committee [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | 5,000 | |||||||
Member of Other Committees [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | $ 2,500 | |||||||
Employment Agreement [Member] | Dr. Kovach [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Annual salary | $ 250,000 | |||||||
Compensation | 250,000 | |||||||
Employment Agreement [Member] | Dr. James S. Miser, M.D [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Annual salary | $ 150,000 | |||||||
Compensation | 175,000 | 166,667 | ||||||
Increase in annual salary | $ 175,000 | |||||||
Employment Agreement [Member] | Eric J. Forman [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Annual salary | $ 120,000 | |||||||
Compensation | 178,819 | 156,667 | ||||||
Increase in annual salary | 175,000 | |||||||
Employment Agreement [Member] | Vice President [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | 200,000 | |||||||
Employment Agreement [Member] | Chief Operating Officer [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Compensation | 200,000 | |||||||
Employment Agreement [Member] | Robert N. Weingarten [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Annual salary | $ 120,000 | |||||||
Compensation | $ 175,000 | $ 156,667 | ||||||
Increase in annual salary | $ 175,000 |
Schedule of Fair Value of Each
Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.03% | 0.89% |
Expected volatility | 128.03% | 187.70% |
Expected life | 3 years 6 months | 3 years 6 months |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.63% | 1.13% |
Expected volatility | 153.17% | 198.79% |
Expected life | 5 years | 5 years |
Summary of Stock-based Compensa
Summary of Stock-based Compensation Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Total stock-based compensation costs | $ 1,546,040 | $ 2,598,922 |
Related Parties [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Total stock-based compensation costs | 1,502,776 | 2,201,280 |
Non Related Parties [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Total stock-based compensation costs | $ 43,264 | $ 397,642 |
Summary of Stock Option Activit
Summary of Stock Option Activity Including Options Form of Warrants (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Nov. 06, 2022 | Nov. 08, 2021 | |
Share-Based Payment Arrangement [Abstract] | ||||
Number of shares, stock options outstanding, at the beginning | 2,666,667 | 1,475,000 | ||
Weighted average exercise price, stock options outstanding, at the beginning | $ 3.738 | $ 4.136 | ||
Number of shares, Granted | 1,650,000 | 1,400,000 | ||
Weighted average exercise price, granted | $ 1.337 | $ 2.906 | ||
Number of shares, Exercised | (208,334) | |||
Weighted average exercise price, exercised | $ 0.965 | |||
Number of shares, Expired | (421,875) | |||
Weighted average exercise price, expired | ||||
Number of shares, rounding adjustment attributable to reverse stock split | 1 | |||
Weighted average exercise price, reverse stock split | $ 1.916 | |||
Number of shares, stock options outstanding, at the end | 3,894,792 | 2,666,667 | ||
Weighted average exercise price, stock options outstanding, at the end | $ 2.918 | $ 3.738 | ||
Weighted average remaining contractual life (in years), stock options outstanding | 3 years 14 days | |||
Number of shares, stock options exercisable, at the end | 2,819,792 | 2,004,167 | 100,000 | 200,000 |
Weighted average exercise price, stock options exercisable, at the end | $ 3.283 | $ 3.777 | ||
Weighted average remaining contractual life (in years), stock options exercisable | 2 years 5 months 26 days |
Schedule of Exercise Prices of
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Options Outstanding (Shares) | 3,894,792 | |
Options Exercisable (Shares) | 2,819,792 | |
Exercise Price One [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 0.5025 | |
Options Outstanding (Shares) | 100,000 | |
Options Exercisable (Shares) | 100,000 | |
Exercise Price Two [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 0.7400 | |
Options Outstanding (Shares) | 575,000 | |
Options Exercisable (Shares) | 256,250 | |
Exercise Price Three [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 1.6800 | |
Options Outstanding (Shares) | 33,333 | |
Options Exercisable (Shares) | 33,333 | |
Exercise Price Four [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 2 | |
Options Outstanding (Shares) | 800,000 | |
Options Exercisable (Shares) | 200,000 | |
Exercise Price Five [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 2.0600 | |
Options Outstanding (Shares) | 200,000 | |
Options Exercisable (Shares) | 200,000 | |
Exercise Price Six [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 2.8000 | |
Options Outstanding (Shares) | 250,000 | |
Options Exercisable (Shares) | 218,750 | |
Exercise Price Seven [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3 | |
Options Outstanding (Shares) | 666,667 | |
Options Exercisable (Shares) | 666,667 | |
Exercise Price Eight [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.0300 | |
Options Outstanding (Shares) | 425,000 | |
Options Exercisable (Shares) | 350,000 | |
Exercise Price Nine [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.2000 | |
Options Outstanding (Shares) | 203,125 | |
Options Exercisable (Shares) | 203,125 | |
Exercise Price Ten [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.2100 | |
Options Outstanding (Shares) | 150,000 | |
Options Exercisable (Shares) | 150,000 | |
Exercise Price Eleven [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 6 | |
Options Outstanding (Shares) | 166,667 | |
Options Exercisable (Shares) | 166,667 | |
Exercise Price Twelve [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 6.6000 | |
Options Outstanding (Shares) | 41,667 | |
Options Exercisable (Shares) | 41,667 | |
Exercise Price Thirteen [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 7.1400 | |
Options Outstanding (Shares) | 200,000 | |
Options Exercisable (Shares) | 150,000 | |
Exercise Price Fourteen [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 12 | |
Options Outstanding (Shares) | 83,333 | |
Options Exercisable (Shares) | 83,333 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||||||||||||
Nov. 06, 2022 | Nov. 06, 2022 | Oct. 07, 2022 | Jun. 30, 2022 | Jun. 17, 2022 | Nov. 08, 2021 | Jun. 30, 2021 | May 11, 2021 | Apr. 09, 2021 | Jan. 06, 2021 | Aug. 12, 2020 | Aug. 01, 2020 | Jul. 15, 2020 | Jul. 14, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Shares outstanding | 3,894,792 | 2,666,667 | 1,475,000 | ||||||||||||||||
Stock option vested exercisable term | 15 months | ||||||||||||||||||
Stock options are exercisable price per share | $ 2.06 | ||||||||||||||||||
Stock based compensation | $ 1,546,040 | $ 2,598,922 | |||||||||||||||||
Number of fully vested option exercisable | 100,000 | 100,000 | 200,000 | 2,819,792 | 2,004,167 | ||||||||||||||
Share based compensation vesting rights, percentage | 12.50% | ||||||||||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | $ 882,000 | ||||||||||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 750 | ||||||||||||||||||
Fair market value, per share | $ 0.51 | ||||||||||||||||||
Outstanding stock options to acquire shares of common stock not vested | 1,075,000 | ||||||||||||||||||
Director [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options description | the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 100,000 shares (a total of 500,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $0.74 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $316,700 ($0.6334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024. During the year ended December 31, 2022, the Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $63,777 with respect to these stock options | ||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||
Stock options are exercisable price per share | $ 0.5025 | $ 0.5025 | $ 0.74 | $ 3.21 | $ 0.74 | ||||||||||||||
Fair value of stock options | $ 571,312 | $ 100,000 | |||||||||||||||||
Stock price per share | $ 2 | $ 2 | $ 500,000 | $ 0.6334 | $ 2.8566 | $ 500,000 | $ 0.6334 | ||||||||||||
Stock based compensation | $ 63,777 | ||||||||||||||||||
Number of fully vested option issued | 200,000 | ||||||||||||||||||
Number of fully vested option exercisable | 200,000 | 200,000 | |||||||||||||||||
Five Non Officer Directors [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options description | the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 100,000 shares (a total of 500,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $3.03 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $1,421,095 ($2.84225 per share), which is being charged to operations ratably from July 1, 2021 through June 30, 2023. During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $638,915 and $358,200, respectively, with respect to these stock options | ||||||||||||||||||
Stock options are exercisable price per share | $ 3.03 | $ 3.03 | |||||||||||||||||
Fair value of stock options | $ 43,264 | $ 397,642 | $ 316,700 | $ 1,421,095 | |||||||||||||||
Stock price per share | $ 0.4326 | $ 0.4326 | $ 1.9882 | $ 2.84225 | $ 2.84225 | ||||||||||||||
Stock based compensation | 638,915 | $ 358,200 | |||||||||||||||||
Number of fully vested option exercisable | 100,000 | 100,000 | |||||||||||||||||
Non Officer Directors [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Number of fully vested option exercisable | 500,000 | 500,000 | |||||||||||||||||
BasvanderBaan [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options description | the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Baan was granted stock options to purchase 250,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $0.74 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($0.6341 per share), of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from June 17, 2022 through June 30, 2024. During the year ended December 31, 2022, the Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $100,249 with respect to these stock options | ||||||||||||||||||
Stock options are exercisable price per share | $ 0.74 | ||||||||||||||||||
Fair value of stock options | $ 158,525 | ||||||||||||||||||
Stock price per share | $ 0.6341 | ||||||||||||||||||
Stock based compensation | 100,249 | ||||||||||||||||||
Number of fully vested option exercisable | 250,000 | ||||||||||||||||||
Stock options granted to purchase common stock, issued | $ 79,263 | ||||||||||||||||||
Four Officers [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||
Fair value of stock options | $ 262,560 | ||||||||||||||||||
Stock price per share | $ 0.3282 | $ 0.3282 | |||||||||||||||||
Stock based compensation | 75,520 | ||||||||||||||||||
Number of fully vested option exercisable | 800,000 | 800,000 | |||||||||||||||||
Share based compensation vesting rights, percentage | 25% | ||||||||||||||||||
Share based compensation issuance, percentage | 25% | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 800,000 | ||||||||||||||||||
Dr Winson SzeChun Ho [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||||||||
Dr Yun Yen [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||||||||
Dr Stephen Forman [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||||||||
Philip Palmedo [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||||||||
Eric J. Forman [Member] | Employment Agreement [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options granted to purchase common stock, issued | 58,333 | ||||||||||||||||||
Stock options description | On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted stock options to purchase 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $7.14 per share, which was equal to the closing market price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 12, 2020 through August 12, 2023. During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $100,213 and $100,213, respectively, with respect to these stock options | ||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||
Stock options are exercisable price per share | $ 7.14 | ||||||||||||||||||
Fair value of stock options | $ 400,855 | ||||||||||||||||||
Stock price per share | $ 6.8718 | ||||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | ||||||||||||||||||
Stock based compensation | 100,213 | 100,213 | |||||||||||||||||
Dr. James Miser [Member] | Employment Agreement [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options granted to purchase common stock, issued | 83,334 | ||||||||||||||||||
Stock options description | Dr. James S. Miser, M.D., Dr. Miser was granted stock options to purchase 83,334 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $7.14 per share, which was equal to the closing market price of the Company’s common stock on the effective date of the employment agreement. The options vested 25% on August 1, 2020, 2021 and 2022, respectively, with the final 25% vesting on August 1, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($6.8718 per share), of which $143,163 was attributable to the portion of the stock options fully vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 1, 2020 through August 1, 2023. During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $143,163 and $143,163, respectively, with respect to these stock options | ||||||||||||||||||
Stock options are exercisable price per share | $ 7.14 | ||||||||||||||||||
Fair value of stock options | $ 572,650 | ||||||||||||||||||
Stock price per share | $ 6.8718 | ||||||||||||||||||
Stock options fully vested amount, fair value | $ 143,163 | ||||||||||||||||||
Stock based compensation | 143,163 | 143,163 | |||||||||||||||||
Robert N. Weingarten [Member] | Employment Agreement [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options description | On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock options to purchase 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $7.14 per share, which was equal to the closing market price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 12, 2020 through August 12, 2023. During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $100,213 and $100,213, respectively, with respect to these stock options | ||||||||||||||||||
Stock options are exercisable price per share | $ 7.14 | ||||||||||||||||||
Fair value of stock options | $ 400,855 | ||||||||||||||||||
Stock price per share | $ 6.8718 | ||||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | ||||||||||||||||||
Stock based compensation | 100,213 | 100,213 | |||||||||||||||||
Dr Winson SzeChun Ho [Member] | Director [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options description | Winson Sze Chun Ho resigned from the Company’s Board of Directors to focus on clinical and pre-clinical cancer research in academic medicine. Concurrent with his resignation, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by Dr. Ho’s resignation. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 250,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $3.20 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $753,611 ($3.0144 per share), of which $376,800 was attributable to the portion of the stock options fully vested on April 9, 2021 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options was being charged to operations ratably from April 9, 2021 through June 30, 2023, although vesting terminated on October 30, 2022, the date that Mr. Schwartzberg died. During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $126,684 and $500,235, respectively, with respect to these stock options | ||||||||||||||||||
Stock options are exercisable price per share | $ 3.20 | ||||||||||||||||||
Fair value of stock options | $ 753,611 | ||||||||||||||||||
Stock price per share | $ 3.0144 | ||||||||||||||||||
Stock options fully vested amount, fair value | $ 376,800 | ||||||||||||||||||
Stock based compensation | 126,684 | 500,235 | |||||||||||||||||
Number of fully vested option exercisable | 250,000 | ||||||||||||||||||
Ms.Regina Brown [Member] | Director [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Stock options description | the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Ms. Brown was granted stock options to purchase 250,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $2.80 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($2.6335 per share), of which $329,188 was attributable to the portion of the stock options fully vested on May 11, 2021 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from May 11, 2021 through June 30, 2023. During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $154,042 and $427,944, respectively, with respect to these stock options | ||||||||||||||||||
Stock options are exercisable price per share | $ 2.80 | ||||||||||||||||||
Fair value of stock options | $ 658,363 | ||||||||||||||||||
Stock price per share | $ 2.6335 | ||||||||||||||||||
Stock options fully vested amount, fair value | $ 329,188 | ||||||||||||||||||
Stock based compensation | $ 154,042 | $ 427,944 | |||||||||||||||||
Number of fully vested option exercisable | 250,000 | ||||||||||||||||||
2020 Stock Incentive Plan [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Common shares avaliable for issuable | 1,800,000 | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 4,133,333 | ||||||||||||||||||
Shares outstanding | 2,603,125 | ||||||||||||||||||
Shares were available for issuance | 1,530,208 | ||||||||||||||||||
2020 Stock Incentive Plan [Member] | Maximum [Member] | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||
Number of restricted stock issued | 2,333,333 |
Schedule of Components of Defer
Schedule of Components of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Research credits | $ 574,000 | $ 451,000 |
Stock-based compensation | 2,137,000 | 1,821,000 |
Net operating loss carryforwards | 8,135,000 | 6,723,000 |
Total deferred tax assets | 10,846,000 | 8,995,000 |
Valuation allowance | (10,846,000) | (8,995,000) |
Net deferred tax assets |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
U. S. federal statutory tax rate | (21.00%) | (21.00%) |
State income taxes, net of federal tax benefit | (6.00%) | (6.00%) |
Expirations related to stock-based compensation | 1.70% | 0.60% |
Adjustment to deferred tax asset | (1.50%) | (0.40%) |
Change in valuation allowance | 26.80% | 26.80% |
Effective tax rate | 0% | 0% |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards amount federal | $ 27,803,000 | |
Net operating loss carryovers | $ 28,040,000 | |
Operating loss carryforwards, expiration date | expire through 2038 | |
Prior net operating loss conversion utilization | The Company may utilize up to 1/10 of the PNOLC subtraction pool, or $928,313, each year. Unutilized PNOLC amounts carry forward to succeeding years until they expire in 2035. In addition, the full New York net operating losses incurred in post-2015 tax years may be utilized in future tax years. Post-2015 New York net operating losses expire through 2040 | |
Prior net operating loss conversion | $ 928,313 | |
New York State Division of Taxation and Finance [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryovers | 19,141,000 | |
California Franchise Tax Board [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryovers | 8,899,000 | |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Income Tax Expense (Benefit) | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 2 Months Ended | 12 Months Ended | |||||||||||
Nov. 06, 2022 | Oct. 01, 2022 | Jun. 10, 2022 | Apr. 09, 2021 | Feb. 05, 2021 | Aug. 12, 2020 | Sep. 12, 2018 | Aug. 20, 2018 | Sep. 14, 2015 | Dec. 24, 2013 | Aug. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Contractual commitment | $ 7,892,000 | ||||||||||||
Research and development costs | 1,349,269 | $ 1,736,776 | |||||||||||
Aggregate commitments expected | 55,000 | ||||||||||||
Forman [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Compensation | $ 200,000 | ||||||||||||
Paid office rent | $ 600 | ||||||||||||
Officer [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Compensation | $ 800,000 | ||||||||||||
City of Hope [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Aggregate commitments expected | 284,000 | ||||||||||||
GEIS [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Amount related to milestone payment | 415,823 | ||||||||||||
NDA Consulting Corp [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Consulting and advisory fee | $ 4,000 | 16,000 | 16,000 | ||||||||||
Clinical Trial Research Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Advance amount related to milestone payment | 26,397 | 18,443 | |||||||||||
Research and development costs | $ 131,074 | ||||||||||||
Aggregate commitments expected, description | The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $590,000 as of December 31, 2022, which is expected to be incurred through December 31, 2025 | ||||||||||||
Aggregate commitments expected | $ 590,000 | ||||||||||||
Other Clinical Agreements [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development costs | 1,144,169 | ||||||||||||
Collaboration Agreement [Member] | GEIS [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Advance amount related to milestone payment | 260,770 | 24,171 | |||||||||||
Research and development costs | 415,823 | ||||||||||||
Aggregate commitments expected | 3,743,000 | ||||||||||||
Collaboration Agreement [Member] | Bio Pharma Works LLC [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Consulting and advisory fee | $ 10,000 | ||||||||||||
Reimbursed expense | 120,000 | 120,000 | |||||||||||
Clinical Research Support Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Aggregate commitments expected | 800,000 | ||||||||||||
Clinical Research Support Agreement [Member] | City of Hope [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development costs | 0 | 378,511 | |||||||||||
Aggregate commitments expected | 2,433,000 | ||||||||||||
Work Order Agreement [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development costs | 127,288 | ||||||||||||
Aggregate commitments expected | 842,000 | ||||||||||||
Work Order Agreement [Member] | City of Hope [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Advance amount related to milestone payment | 33,815 | 24,626 | |||||||||||
Research and development costs | $ 335,000 | ||||||||||||
Aggregate commitments expected | 58,441 | ||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc. [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Research and development costs | $ 954,000 | 35,403 | 9,730 | ||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Minimum payments for royalties | 50,000 | ||||||||||||
Exclusive License Agreement [Member] | Five Years And Thereafter [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Minimum payments for royalties | 100,000 | ||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Non refundable license issue fee | $ 25,000 | ||||||||||||
Annual license maintenance fee | 25,000 | ||||||||||||
[custom:PaymentsOnNonrefundableMilestone] | $ 1,897,000 | ||||||||||||
Operating Costs and Expenses | 25,000 | 25,000 | |||||||||||
Employment Agreement [Member] | Executive Officers [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Salary and Wage, Excluding Cost of Good and Service Sold | $ 640,000 | ||||||||||||
Agreement term description | one-year periods | ||||||||||||
Employment Agreement [Member] | Dr.James [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Annual compensation | $ 775,000 | ||||||||||||
Master Service Agreement [Member] | Foundation for Angelman Syndrome Therapy [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Percentage of proceeds agree to pay under agreement | 5% | ||||||||||||
Maximum amount received under agreement | $ 250,000 | ||||||||||||
Development Collaboration Agreement [Member] | Netherlands Cancer Institute [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Advance amount related to milestone payment | 204,158 | 55,248 | |||||||||||
Research and development costs | 259,406 | ||||||||||||
Aggregate commitments expected | 262,000 | ||||||||||||
MRI Global [Member] | |||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||
Advance amount related to milestone payment | 27,702 | $ 17,782 | |||||||||||
Research and development costs | $ 219,611 | ||||||||||||
Contract price | $ 273,980 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 12 Months Ended | |||||
Mar. 10, 2023 | Jul. 14, 2021 | Apr. 22, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Subsequent Event [Line Items] | ||||||
Common stock issuance, shares | 83,333 | |||||
Exercisable per share price | $ 2.918 | $ 3.738 | $ 4.136 | |||
Exercise of common stock cash proceeds | $ 100,000 | $ 101,000 | $ 201,000 | |||
Consultant [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares, exercised | 83,333 | |||||
Subsequent Event [Member] | Consultant [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares, exercised | 12,500 | |||||
Common stock issuance, shares | 12,500 | |||||
Exercisable per share price | $ 0.5025 | |||||
Exercise of common stock cash proceeds | $ 6,281 |