Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 01, 2022 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 16,646,593 | |
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 $0.0001 per share | |
Trading Symbol | LIXTW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 6,561,840 | $ 4,823,745 |
Advances on research and development contract services | 147,017 | 150,241 |
Prepaid insurance | 86,654 | 109,029 |
Other prepaid expenses and current assets | 23,957 | 10,249 |
Total current assets | 6,819,468 | 5,093,264 |
Total assets | 6,819,468 | 5,093,264 |
Current liabilities: | ||
Accounts payable and accrued expenses, including $54,972 and $32,500 to related parties at September 30, 2022 and December 31, 2021, respectively | 307,398 | 225,965 |
Research and development contract liabilities | 100,930 | 76,961 |
Total current liabilities | 408,328 | 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 at September 30, 2022 and 13,746,593 shares at December 31, 2021 | 1,664 | 1,374 |
Additional paid-in capital | 44,672,871 | 38,371,128 |
Accumulated deficit | (41,763,395) | (37,082,164) |
Total stockholders’ equity | 6,411,140 | 4,790,338 |
Total liabilities and stockholders’ equity | $ 6,819,468 | $ 5,093,264 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Related parties accounts payable and accrued expenses | $ 54,972 | $ 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenues | ||||
General and administrative costs: | ||||
Compensation to related parties, including stock-based compensation expense of $396,883 and $347,222 for the three months ended September 30, 2022 and 2021, respectively, and $1,160,649 and $1,854,058 for the nine months ended September 30, 2022 and 2021, respectively | 643,957 | 573,472 | 1,963,409 | 2,450,641 |
Patent and licensing legal and filing fees and costs | 271,163 | 137,114 | 944,789 | 365,466 |
Other costs and expenses | 290,993 | 299,953 | 875,016 | 946,266 |
Research and development costs | 272,388 | 227,181 | 895,649 | 933,122 |
Total costs and expenses | 1,478,501 | 1,237,720 | 4,678,863 | 4,695,495 |
Loss from operations | (1,478,501) | (1,237,720) | (4,678,863) | (4,695,495) |
Interest income | 3,911 | 161 | 4,211 | 487 |
Interest expense | (2,119) | (5,240) | (2,944) | |
Foreign currency loss | (1,300) | (1,165) | (1,339) | (1,082) |
Net loss | $ (1,478,009) | $ (1,238,724) | $ (4,681,231) | $ (4,699,034) |
Net loss per common share – basic and diluted | $ (0.09) | $ (0.09) | $ (0.30) | $ (0.35) |
Weighted average common shares outstanding – basic and diluted | 16,646,593 | 13,733,912 | 15,541,831 | 13,381,922 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Allocated share based compensation expense | $ 396,883 | $ 347,222 | $ 1,160,649 | $ 1,854,058 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock [Member] Series A Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 3,500,000 | $ 1,240 | $ 31,864,479 | $ (30,353,768) | $ 5,011,951 |
Beginning balance, shares at Dec. 31, 2020 | 350,000 | 12,402,157 | |||
Stock-based compensation expense | 1,854,058 | 1,854,058 | |||
Net loss for the period | (4,699,034) | (4,699,034) | |||
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 stock options | $ 20 | 200,980 | 201,000 | ||
Exercise of warrants, shares | 3,000 | ||||
Exercise of warrants | $ 1 | 17,099 | 17,100 | ||
Exercise of stock options, shares | 208,334 | ||||
Ending balance, value at Sep. 30, 2021 | $ 3,500,000 | $ 1,374 | 37,626,264 | (35,052,802) | 6,074,836 |
Ending balance, shares at Sep. 30, 2021 | 350,000 | 13,746,593 | |||
Beginning balance, value at Jun. 30, 2021 | $ 3,500,000 | $ 1,366 | 37,179,050 | (33,814,078) | 6,866,338 |
Beginning balance, shares at Jun. 30, 2021 | 350,000 | 13,663,260 | |||
Stock-based compensation expense | 347,222 | 347,222 | |||
Net loss for the period | (1,238,724) | (1,238,724) | |||
Exercise of stock options | $ 8 | 99,992 | 100,000 | ||
Exercise of warrants, shares | 83,333 | ||||
Ending balance, value at Sep. 30, 2021 | $ 3,500,000 | $ 1,374 | 37,626,264 | (35,052,802) | 6,074,836 |
Ending balance, shares at Sep. 30, 2021 | 350,000 | 13,746,593 | |||
Beginning balance, value at Dec. 31, 2021 | $ 3,500,000 | $ 1,374 | 38,371,128 | (37,082,164) | 4,790,338 |
Beginning balance, shares at Dec. 31, 2021 | 350,000 | 13,746,593 | |||
Stock-based compensation expense | 1,160,649 | 1,160,649 | |||
Net loss for the period | (4,681,231) | (4,681,231) | |||
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 | |||||
Ending balance, value at Sep. 30, 2022 | $ 3,500,000 | $ 1,664 | 44,672,871 | (41,763,395) | $ 6,411,140 |
Ending balance, shares at Sep. 30, 2022 | 350,000 | 16,646,593 | |||
Beginning balance, value at Jun. 30, 2022 | $ 3,500,000 | $ 1,664 | 44,275,988 | (40,285,386) | 7,492,266 |
Beginning balance, shares at Jun. 30, 2022 | 350,000 | 16,646,593 | |||
Stock-based compensation expense | 396,883 | 396,883 | |||
Net loss for the period | (1,478,009) | (1,478,009) | |||
Ending balance, value at Sep. 30, 2022 | $ 3,500,000 | $ 1,664 | $ 44,672,871 | $ (41,763,395) | $ 6,411,140 |
Ending balance, shares at Sep. 30, 2022 | 350,000 | 16,646,593 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (4,681,231) | $ (4,699,034) |
Stock-based compensation expense included in - | ||
General and administrative costs | 1,160,649 | 1,854,058 |
Increase in - | ||
Advances on research and development contract services | 3,224 | (139,120) |
Prepaid insurance | 22,375 | (31,012) |
Other prepaid expenses and current assets | (13,708) | (17,224) |
Accounts payable and accrued expenses | 81,433 | 25,348 |
Research and development contract liabilities | 23,969 | 10,918 |
Net cash used in operating activities | (3,403,289) | (2,996,066) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock in direct equity offering, 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 deferred offering costs | (20,467) | |
Net cash provided by financing activities | 5,141,384 | 3,887,394 |
Cash: | ||
Net increase | 1,738,095 | 891,328 |
Balance at beginning of period | 4,823,745 | 5,069,266 |
Balance at end of period | 6,561,840 | 5,960,594 |
Supplemental disclosures of cash flow information: | ||
Interest | 5,240 | 2,944 |
Income taxes | ||
Non-cash investing and financing activities: | ||
Accrual of deferred offering costs | $ 16,376 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (“Lixte”) (collectively, the “Company”), at September 30, 2022, and for the three months and nine months ended September 30, 2022 and 2021, are unaudited. In the opinion of management of the Company, all adjustments, including normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of September 30, 2022, and the results of its operations for the three months and nine months ended September 30, 2022 and 2021, and its cash flows for the nine months ended September 30, 2022 and 2021. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The consolidated balance sheet at December 31, 2021 has been derived from the Company’s audited consolidated financial statements at such date. The condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC. Listing of the Company’s Common Stock on The Nasdaq Capital Market The Company’s common stock and the warrants issued in its public offering 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 has 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 is 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. If the Company does not regain compliance during the compliance period ending December 21, 2022, the Company may be afforded a second 180 calendar day period to regain compliance. To qualify for the second compliance period, the Company must (i) meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum closing bid price requirement, and (ii) notify Nasdaq of its intent to cure the deficiency. The Company can achieve compliance with the minimum closing bid price requirement if, during either compliance period, 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. The Company anticipates that its shares of common stock will continue to be listed and traded on The Nasdaq Capital Market during the compliance period(s). The Company is continuing to assess potential actions to regain compliance. However, the Company may be unable to regain compliance with the minimum closing bid price requirement during the compliance period(s), in which case the Company anticipates Nasdaq would provide a notice to the Company that its shares of common stock are subject to delisting, and the Company’s common shares would thereupon be delisted. |
Business
Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business | 2. Business 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 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, and encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. 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, and is dependent on periodic infusions of equity capital to fund its operating requirements. Going Concern At September 30, 2022, the Company had cash of $ 6,561,840 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 primarily 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 independent registered public accounting firm, in its report on the Company’s consolidated financial statements for the year ended December 31, 2021, has also expressed 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 and design 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 September 30, 2023. However, existing cash resources will not be sufficient to complete development of and obtain regulatory approval for the Company’s product candidate, and the Company will need to raise significant additional capital to do so. In addition, the Company’s operating plan may change as a result of many factors currently unknown, 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 assurances that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations. There is also significant uncertainty as to the effect that the coronavirus pandemic may have on the Company’s clinical trial schedule and the amount and type of financing available to the Company in the future. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Principles of Consolidation The accompanying condensed 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 Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. 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 accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash Cash is primarily held in a cash bank deposit program maintained by a major financial institution. 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 may periodically have 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 compounds and product candidates. Research and development costs also include the costs to produce the compounds used in research and clinical trials, which are charged to operations as incurred. 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 research 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 agreement. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the 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 research and development 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 research and development 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 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 amortization is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy periods. As the policy premiums incurred are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and 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 its intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs were $ 271,163 137,114 944,789 365,466 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% or more of general and administrative costs or research and development costs for the three months and nine months ended September 30, 2022 and 2021 are described as follows. General and administrative costs for the three months ended September 30, 2022 and 2021 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 22.5 13.6 Research and development costs for the three months ended September 30, 2022 include charges from four vendors and consultants representing 32.0 23.2 16.9% 11.0 13.5 13.2 12.7 General and administrative costs for the nine months ended September 30, 2022 and 2021 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 25.0 9.7 Research and development costs for the nine months ended September 30, 2022 include charges from two vendors and consultants representing 31.0 16.7 33.2 26.9 10.5 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 unrecognized tax benefits as of September 30, 2022 or 2021 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2022. 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 September 30, 2022 or December 31, 2021. Subsequent to September 30, 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 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 shares of common stock 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 September 30, 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 September 30, 2022 2021 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,400,310 3,110,310 Common stock options, including options issued in the form of warrants 3,325,000 2,466,667 Total 7,454,477 6,306,144 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 August 2020, the Financial Accounting Standards Board (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. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 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 April 12, 2022, the Company completed the sale of 2,900,000 2.00 5,800,000 658,616 5,141,384 290,000 April 14, 2027 2.00 During February and March 2021, the Company issued 3,000 3,000 5.70 17,100 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 March 2, 2026 3.70 On April 22, 2021, the Company issued 125,001 75,000 0.72 16,667 0.90 33,334 0.96 101,000 Effective July 14, 2021, a stock option held by a consultant of the Company for 83,333 1.20 100,000 83,333 Common Stock Warrants A summary of common stock warrant activity during the nine months ended September 30, 2022 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, 2021 3,110,310 $ 5.772 Issued 290,000 2.000 Exercised — — Expired — — Warrants outstanding at September 30, 2022 3,400,310 $ 5.450 1.97 At September 30, 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 $ 6.000 1,500,000 3,400,310 Based on a fair market value of $ 0.55 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 | 9 Months Ended |
Sep. 30, 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 an additional one-year period 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 62,500 62,500 187,500 187,500 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 43,750 43,750 131,250 122,917 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 43,750 43,750 131,250 112,917 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 43,750 43,750 131,250 112,917 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. 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 $ 53,324 32,500 221,510 60,332 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 three months and nine months ended September 30, 2022 and 2021 is presented below. Summary of Related Party Costs 2022 2021 2022 2021 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Compensation to related parties: Cash-based $ 247,074 $ 226,250 $ 802,760 $ 596,583 Stock-based 396,883 347,222 1,160,649 1,854,058 Total $ 643,957 $ 573,472 $ 1,963,409 $ 2,450,641 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation The Company 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 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 for up to 2,333,333 As of September 30, 2022, unexpired stock options for 2,100,000 233,333 1,800,000 4,133,333 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 nine months ended September 30, 2022, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Schedule of Fair Value of Each Option Award Estimated Assumption Risk-free interest rate 3.03 % Expected dividend yield 0 % Expected volatility 153.17 % Expected life 3.5 For stock options requiring an assessment of value during the nine months ended September 30, 2021, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 0.89 % Expected dividend yield 0 % Expected volatility 198.79 % Expected life 3.5 3.6 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 options for 58,333 five years 7.14 400,855 6.8718 100,214 25,259 25,259 74,954 74,954 On August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted options for 83,334 7.14 572,650 6.8718 143,163 36,085 36,085 107,078 107,078 On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 58,333 7.14 400,855 6.8718 100,214 25,259 25,259 74,954 74,954 Effective January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted fully-vested 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 options exercisable for a period of five years 250,000 3.20 753,611 3.0144 376,800 42,692 42,692 126,684 457,543 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 options exercisable for a period of five years 250,000 2.80 658,363 2.6335 329,188 38,827 38,827 115,215 389,117 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 exercisable for a period of five years 100,000 500,000 3.03 500,000 1,421,095 2.84225 179,100 179,100 531,455 179,100 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 options exercisable for a period of five years 250,000 0.74 158,525 0.6341 79,263 9,801 90,449 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 exercisable for a period of five years 100,000 500,000 0.74 500,000 316,700 0.6334 39,860 39,860 A summary of stock-based compensation costs for the three months and nine months ended September 30, 2022 and 2021 is as follows: Summary of Stock-based Compensation Costs 2022 2021 2022 2021 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Related parties $ 396,883 $ 347,222 $ 1,160,649 $ 1,854,058 Non-related parties — — — — Total stock-based compensation costs $ 396,883 $ 347,222 $ 1,160,649 $ 1,854,058 A summary of stock option activity, including options issued in the form of warrants, during the nine months ended September 30, 2022 is presented below. 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, 2021 2,666,667 $ 3.738 Granted 750,000 0.740 Exercised — — Expired/Forfeited (91,667 ) 2.962 Stock options outstanding at September 30, 2022 3,325,000 $ 3.083 3.23 Stock options exercisable at September 30, 2022 2,446,875 $ 3.532 2.84 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $ 1,411,000 The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at September 30, 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) $ 0.740 750,000 203,125 $ 0.900 33,333 33,333 $ 1.680 33,333 33,333 $ 2.060 200,000 200,000 $ 2.800 250,000 203,125 $ 3.000 666,667 666,667 $ 3.030 500,000 312,500 $ 3.200 250,000 203,125 $ 3.210 150,000 150,000 $ 6.000 166,667 166,667 $ 6.600 41,667 41,667 $ 7.140 200,000 150,000 $ 12.000 83,333 83,333 3,325,000 2,446,875 Based on a fair market value of $ 0.55 Outstanding stock options to acquire 878,125 The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes During the three months and nine months ended September 30, 2022 and 2021, the Company did not record any provision for income taxes as the Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company has recorded a full valuation allowance against its deferred tax assets for all periods presented as the Company believes it is more likely than not the deferred tax assets will not be realized. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 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 September 30, 2022 and December 31, 2021, the Company was not subject to any pending or threatened legal claims or actions. Principal Commitments Clinical Trial Agreements At September 30, 2022, the Company’s unpaid remaining contractual commitments pursuant to clinical trial agreements, and clinical trial monitoring agreements, as described below, aggregated $ 8,002,000 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 three months ended September 30, 2022 and 2021, the Company incurred costs of $ 9,218 0 18,623 17,693 123,300 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 was 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 include 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 September 30, 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 $ 1,144,041 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 now scheduled to commence during late 2022 or the first quarter of 2023 and to be completed by June 30, 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 December 31, 2023, 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 September 30, 2022, the Company has paid GEIS an aggregate of $ 67,582 During the three months ended September 30, 2022 and 2021, the Company did not incur any costs pursuant to this agreement. During the nine months ended September 30, 2022 and 2021, the Company incurred costs of $ 0 24,171 155,053 3,836,000 On October 7, 2022, the third milestone pursuant to this agreement was achieved. Accordingly, as of that date, the balance remaining pursuant to the second milestone of $ 18,244 254,543 City of Hope. The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, patient accrual has been slower than expected. The Company is currently seeking to add two additional centers to increase the rate of patient accrual. With the additional sites, the Company expects this clinical trial to be completed by December 31, 2024. Without additional sites, the completion date for this clinical trial will be no sooner than December 31, 2025. During the three months ended September 30, 2022 and 2021, the Company did not incur any costs pursuant to this agreement. During the nine months ended September 30, 2022 and 2021, the Company incurred costs of $ 0 525,528 2,433,000 800,000 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 neurosurgical unit at the NCI, which had been closed to research studies due to the Covid-19 epidemic, was reopened and patient accrual has been completed, and the Company is awaiting the resulting data. There is an urgent need to improve therapy for this type of aggressive brain tumor. If the NCI study shows that LB-100 does penetrate the brain, a clinical study of LB-100 in combination with standard therapy for GBM, the drug temozolomide and radiation, both of which have been well documented in pre-clinical studies to be significantly enhanced by LB-100, would be of significant interest to neuro-oncologists frustrated by decades of limited advances in therapy for this common brain tumor in adults. 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. Clinical Trial Monitoring Agreements Moffitt. Costs under this work order agreement are estimated to be approximately $ 954,000 11,953 869 19,791 9,350 111,676 853,000 City of Hope. 335,000 7,731 6,857 23,466 21,170 48,092 290,000 Patent and License Agreements INSERM. 1,750,000 upon achievement of development milestones and up to $ 6,500,000 upon achievement of commercial milestones. The Company also agreed to pay INSERM certain commercial royalties on net sales of products attributed to the Agreement. The Company’s initial plan was to complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans within three years; however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will require substantial additional capital and/or a joint venture or other type of business arrangement with a pharmaceutical company with substantially greater capital and business resources than those available to the Company. As there can be no assurances that the Company will be able to obtain the capital or business resources necessary to focus on the exploitation of this patent, it is uncertain as to when, if at all, the Company may reach any of the development or commercialization milestones under the Agreement. As of September 30, 2022 and December 31, 2021, no amounts were due under this agreement. Moffitt. Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $ 25,000 after the first patient is entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. The Company is also obligated to pay Moffitt an annual license maintenance fee of $ 25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences payment of minimum royalty payments. The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $ 1,897,000 , subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. During the three months ended September 30, 2022 and 2021, the Company recorded charges to operations of $ 6,301 and $ 6,301 , respectively, in connection with its obligations under the License Agreement. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to operations of $ 18,699 and $ 18,698 , respectively, in connection with its obligations under the License Agreement. As of September 30, 2022, no milestones had yet been attained. 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, the Company’s Chief Administrative Officer, Dr. James S. Miser, the Company’s Chief Medical Officer, and Robert N. Weingarten, the Company’s Chief Financial Officer, under the employment agreements, such that the total aggregate annual compensation of all officers increased to $ 775,000 Other Significant Agreements and Contracts On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year and provided for a quarterly cash fee of $ 4,000 4,000 4,000 12,000 12,000 Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company. Those services included, among other things: (a) assisting the Company to (i) commercialize its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products; (b) at the request of the Board of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader be temporarily unable to carry out his duties; (c) being available for consultation in drug discovery and development; and (d) identifying providers and overseeing tasks relating to clinical use and commercialization of new compounds. 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 30,000 30,000 90,000 90,000 Effective August 12, 2020, the Company entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST) to collaborate in supporting pre-clinical studies of the potential benefit of LB-100 in a mouse model of Angelman Syndrome (AS) as reported in The Proceedings of The National Academy of Science (Wang et al, June 3, 2019). The pre-clinical studies were to be conducted at The University of California - Davis under the direction of Dr. David Segal, an internationally recognized leader in AS research. If the pre-clinical studies confirm that LB-100 reduces AS signs in rodent models, the Company has agreed to enter into discussions with FAST with respect to possible collaborations to most efficiently assess the benefit of LB-100 in patients with AS, which is a rare disease affecting an estimated one out of 12,000 to one out of 20,000 persons in the United States. The genetic cause of AS, reduced function of a specific maternal gene called Ube3, has been understood for some time, but the molecular abnormality resulting from the genetic lesion has now been shown to be increased concentrations of protein phosphatase 2A (PP2A), a molecular target of the Company’s investigational compound, LB-100. The Company has agreed to provide FAST with a supply of LB-100 to be utilized in the conduct of this study, which was initially expected to be completed within three years. Conditioned on FAST’s completion of this study, the Company has agreed to pay FAST five percent ( 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, and the results are currently under review by FAST. 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. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam (NKI), 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. The Company has agreed to fund the study and provide a sufficient supply of LB-100 to conduct the study. The study is expected to take approximately two years to conduct. During the three months ended September 30, 2022, the Company incurred charges in the amount of $ 46,068 149,184 204,433 250,000 On February 2, 2012, the Company entered into a contract with MRI Global for the analysis and stability testing of LB-100. On June 10, 2022, the contract was amended to reflect a new total contract price of $ 273,980 6,749 0 27,102 17,432 212,778 61,000 External Risks Associated with the Company’s Business Activities Covid-19 Virus The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials are conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indications from the clinical research organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several months or more as a result of the coronavirus pandemic. 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 | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events The Company performed an evaluation of subsequent events through the date of filing of these condensed consolidated financial statements with the SEC. Other than the matters noted below, there were no material subsequent events which affected, or could affect, the amounts or disclosures in the condensed consolidated financial statements. On November 6, 2022, the Board of Directors of the Company approved the following actions: (1) Promoted Eric Forman, the Company’s Chief Administrative Officer, to Vice President and Chief Operating Officer, and increased his annual salary from $ 175,000 200,000 (2) Authorized the issuance of warrants to BioPharmaWorks, which has provided consulting services to the Company since September 2015, to purchase 100,000 5 years 0.5025 (3) Authorized the issuance of stock options under the Company’s 2020 Stock Incentive Plan to Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser and Robert N. Weingarten to each purchase 200,000 five years 2.00 vesting 25% on the issuance date and 25% on each anniversary date thereafter until fully vested, subject to continued service. 0.5025 (4) Approved an amendment to the Company’s Amended and Restated Bylaws to reduce the quorum requirement to hold a meeting of stockholders from 50% to 33-1/3% of the total number of outstanding shares of the Company entitled to vote at the meeting, present in person or represented by proxy |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying condensed 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 Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. |
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 accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash | Cash Cash is primarily held in a cash bank deposit program maintained by a major financial institution. 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 may periodically have 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 compounds and product candidates. Research and development costs also include the costs to produce the compounds used in research and clinical trials, which are charged to operations as incurred. 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 research 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 agreement. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the 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 research and development 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 research and development 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 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 amortization is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy periods. As the policy premiums incurred are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and 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 its intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs were $ 271,163 137,114 944,789 365,466 |
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% or more of general and administrative costs or research and development costs for the three months and nine months ended September 30, 2022 and 2021 are described as follows. General and administrative costs for the three months ended September 30, 2022 and 2021 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 22.5 13.6 Research and development costs for the three months ended September 30, 2022 include charges from four vendors and consultants representing 32.0 23.2 16.9% 11.0 13.5 13.2 12.7 General and administrative costs for the nine months ended September 30, 2022 and 2021 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 25.0 9.7 Research and development costs for the nine months ended September 30, 2022 include charges from two vendors and consultants representing 31.0 16.7 33.2 26.9 10.5 |
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 unrecognized tax benefits as of September 30, 2022 or 2021 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2022. 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 September 30, 2022 or December 31, 2021. Subsequent to September 30, 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 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 shares of common stock 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 September 30, 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 September 30, 2022 2021 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,400,310 3,110,310 Common stock options, including options issued in the form of warrants 3,325,000 2,466,667 Total 7,454,477 6,306,144 |
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 August 2020, the Financial Accounting Standards Board (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) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At September 30, 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 September 30, 2022 2021 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,400,310 3,110,310 Common stock options, including options issued in the form of warrants 3,325,000 2,466,667 Total 7,454,477 6,306,144 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding | A summary of common stock warrant activity during the nine months ended September 30, 2022 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, 2021 3,110,310 $ 5.772 Issued 290,000 2.000 Exercised — — Expired — — Warrants outstanding at September 30, 2022 3,400,310 $ 5.450 1.97 |
Schedule of Warrants Outstanding and Exercisable | At September 30, 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 $ 6.000 1,500,000 3,400,310 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 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 three months and nine months ended September 30, 2022 and 2021 is presented below. Summary of Related Party Costs 2022 2021 2022 2021 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Compensation to related parties: Cash-based $ 247,074 $ 226,250 $ 802,760 $ 596,583 Stock-based 396,883 347,222 1,160,649 1,854,058 Total $ 643,957 $ 573,472 $ 1,963,409 $ 2,450,641 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 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 nine months ended September 30, 2022, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Schedule of Fair Value of Each Option Award Estimated Assumption Risk-free interest rate 3.03 % Expected dividend yield 0 % Expected volatility 153.17 % Expected life 3.5 For stock options requiring an assessment of value during the nine months ended September 30, 2021, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 0.89 % Expected dividend yield 0 % Expected volatility 198.79 % Expected life 3.5 3.6 |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the three months and nine months ended September 30, 2022 and 2021 is as follows: Summary of Stock-based Compensation Costs 2022 2021 2022 2021 Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Related parties $ 396,883 $ 347,222 $ 1,160,649 $ 1,854,058 Non-related parties — — — — Total stock-based compensation costs $ 396,883 $ 347,222 $ 1,160,649 $ 1,854,058 |
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 nine months ended September 30, 2022 is presented below. 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, 2021 2,666,667 $ 3.738 Granted 750,000 0.740 Exercised — — Expired/Forfeited (91,667 ) 2.962 Stock options outstanding at September 30, 2022 3,325,000 $ 3.083 3.23 Stock options exercisable at September 30, 2022 2,446,875 $ 3.532 2.84 |
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 September 30, 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) $ 0.740 750,000 203,125 $ 0.900 33,333 33,333 $ 1.680 33,333 33,333 $ 2.060 200,000 200,000 $ 2.800 250,000 203,125 $ 3.000 666,667 666,667 $ 3.030 500,000 312,500 $ 3.200 250,000 203,125 $ 3.210 150,000 150,000 $ 6.000 166,667 166,667 $ 6.600 41,667 41,667 $ 7.140 200,000 150,000 $ 12.000 83,333 83,333 3,325,000 2,446,875 |
Business (Details Narrative)
Business (Details Narrative) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 6,561,840 | $ 4,823,745 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 7,454,477 | 6,306,144 |
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 | 3,400,310 | 3,110,310 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,325,000 | 2,466,667 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Product Information [Line Items] | |||||
Cash FDIC insurance | $ 250,000 | $ 250,000 | $ 500,000 | ||
Patent and licensing legal and filing fees and costs | $ 271,163 | $ 137,114 | $ 944,789 | $ 365,466 | |
Revenue Benchmark [Member] | Product Concentration Risk [Member] | General and Administrative Expense [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 22.50% | 13.60% | 25% | 9.70% | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Research and Development Expense [Member] | Vendor One [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 32% | 13.50% | 31% | 33.20% | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Research and Development Expense [Member] | Vendor Two [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 23.20% | 13.20% | 16.70% | 26.90% | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Research and Development Expense [Member] | Vendor Three [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 16.90% | 12.70% | 10.50% | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Research and Development Expense [Member] | Vendor Four [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 11% |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Number of Shares, Warrants Outstanding, Beginning Balance | shares | 3,110,310 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ / shares | $ 5.772 |
Number of Shares, Issued | shares | 290,000 |
Weighted Average Exercise Price, Issued | $ / shares | $ 2 |
Number of Shares, Exercised | shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Number of Shares, Expired | shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Number of Shares, Warrants Outstanding, Ending Balance | shares | 3,400,310 |
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ / shares | $ 5.450 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 1 year 11 months 19 days |
Schedule of Warrants Outstand_2
Schedule of Warrants Outstanding and Exercisable (Details) - $ / shares | Sep. 30, 2022 | Mar. 02, 2021 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.70 | |
Warrants Outstanding Shares | 3,400,310 | |
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 | |
Exercise Price Four [Member] | ||
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 6 | |
Warrants Outstanding Shares | 1,500,000 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
Apr. 12, 2022 | Jul. 14, 2021 | Apr. 22, 2021 | Mar. 02, 2021 | Mar. 17, 2015 | Mar. 30, 2021 | Feb. 28, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Mar. 02, 2022 | Dec. 30, 2021 | Jan. 06, 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 | 100,000,000 | ||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||||||||
Common stock, shares issued | 16,646,593 | 13,746,593 | |||||||||||
Common stock, shares outstanding | 16,646,593 | 13,746,593 | |||||||||||
Number of common stock shares issued during period | 1,133,102 | ||||||||||||
Proceeds from issuance initial public offering | $ 5,141,384 | $ 3,689,761 | |||||||||||
Costs of public offering | $ 502,717 | ||||||||||||
Net proceeds from issuance of stock | $ 3,689,761 | ||||||||||||
Warrants to purchase of common stock, shares | 113,310 | ||||||||||||
Warrants expiration date | Mar. 02, 2026 | ||||||||||||
Warrants exercise price | $ 3.70 | ||||||||||||
Proceeds from warrant exercises | 17,100 | ||||||||||||
Proceeds from issuance initial public offering | $ 4,192,478 | ||||||||||||
Total cash proceeds | $ 100,000 | $ 101,000 | $ 201,000 | ||||||||||
Common stock issuance, shares | 83,333 | ||||||||||||
Placement Agents [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrants to purchase of common stock, shares | 290,000 | ||||||||||||
Warrants expiration date | Apr. 14, 2027 | ||||||||||||
Warrants exercise price | $ 2 | ||||||||||||
Common Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Conversion of stock | 729,167 | 729,167 | |||||||||||
Number of common stock shares issued during period | 2,900,000 | ||||||||||||
Sale of stock price per share | $ 2 | $ 3.70 | |||||||||||
Proceeds from issuance initial public offering | $ 5,800,000 | ||||||||||||
Costs of public offering | 658,616 | ||||||||||||
Net proceeds from issuance of stock | $ 5,141,384 | ||||||||||||
Stock issued new issue shares | 3,000 | 3,000 | 2,900,000 | 1,133,102 | |||||||||
Warrant [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrants exercise price | $ 5.70 | $ 5.70 | |||||||||||
Stock issued new issue shares | 3,000 | 3,000 | |||||||||||
Proceeds from warrant exercises | $ 17,100 | $ 17,100 | |||||||||||
Common Stock Warrant [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Fair market value of stock | $ 0.55 | ||||||||||||
Officer And Directors [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock upon the exercise of options | 125,001 | ||||||||||||
Director [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock upon the exercise of options | 75,000 | ||||||||||||
Weighted Average Exercise Price, Exercised | $ 0.72 | ||||||||||||
Fair market value of stock | $ 2.8566 | ||||||||||||
Director One [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock upon the exercise of options | 16,667 | ||||||||||||
Weighted Average Exercise Price, Exercised | $ 0.90 | ||||||||||||
Director Two [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock upon the exercise of options | 33,334 | ||||||||||||
Weighted Average Exercise Price, Exercised | $ 0.96 | ||||||||||||
Consultant [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock upon the exercise of options | 83,333 | ||||||||||||
Weighted Average Exercise Price, Exercised | $ 1.20 | ||||||||||||
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, 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 | ||||||||||||
Conversion of stock | 350,000 | 350,000 | |||||||||||
Gross proceeds from sale of transaction | $ 21,875,000 | ||||||||||||
Series A Convertible Preferred Stock [Member] | Holder [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Conversion of 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 ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Related Party Transaction [Line Items] | ||||
Total | $ 643,957 | $ 573,472 | $ 1,963,409 | $ 2,450,641 |
Cash Based [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total | 247,074 | 226,250 | 802,760 | 596,583 |
Stock Based [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total | $ 396,883 | $ 347,222 | $ 1,160,649 | $ 1,854,058 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
May 01, 2021 | Apr. 09, 2021 | Oct. 01, 2020 | Aug. 12, 2020 | Aug. 01, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Related Party Transaction [Line Items] | |||||||||
Share-based payment award, award vesting period | 12.50% | ||||||||
Annual cash fee | $ 643,957 | $ 573,472 | $ 1,963,409 | $ 2,450,641 | |||||
Stock based compensation | 396,883 | 347,222 | 1,160,649 | 1,854,058 | |||||
Independent Director [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock based compensation | $ 53,324 | 32,500 | $ 221,510 | 60,332 | |||||
New Independent Director [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Options, grants in period, gross | 250,000 | ||||||||
Share-based payment award, award vesting period | 50% | 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 | ||||||||
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 | $ 62,500 | 62,500 | 187,500 | 187,500 | |||||
Employment Agreement [Member] | Dr. James S. Miser, M.D [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Annual salary | $ 150,000 | ||||||||
Compensation | 43,750 | 43,750 | 131,250 | 122,917 | |||||
Increase in annual salary | $ 175,000 | ||||||||
Employment Agreement [Member] | Eric J. Forman [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Annual salary | $ 120,000 | ||||||||
Compensation | 43,750 | 43,750 | 131,250 | 112,917 | |||||
Increase in annual salary | 175,000 | ||||||||
Employment Agreement [Member] | Robert N. Weingarten [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Annual salary | $ 120,000 | ||||||||
Compensation | $ 43,750 | $ 43,750 | $ 131,250 | $ 112,917 | |||||
Increase in annual salary | $ 175,000 |
Schedule of Fair Value of Each
Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.03% | 0.89% |
Expected dividend yield | 0% | 0% |
Expected volatility | 153.17% | 198.79% |
Expected life | 3 years 6 months | |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected life | 3 years 6 months | |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected life | 3 years 7 months 6 days |
Summary of Stock-based Compensa
Summary of Stock-based Compensation Costs (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | ||||
Total stock-based compensation costs | $ 396,883 | $ 347,222 | $ 1,160,649 | $ 1,854,058 |
Related Parties [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Total stock-based compensation costs | 396,883 | 347,222 | 1,160,649 | 1,854,058 |
Non Related Parties [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Total stock-based compensation costs |
Summary of Stock Option Activit
Summary of Stock Option Activity Including Options Form of Warrants (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Number of shares, stock options outstanding, at the beginning | shares | 2,666,667 |
Weighted average exercise price, stock options outstanding, at the beginning | $ / shares | $ 3.738 |
Number of shares, Granted | shares | 750,000 |
Weighted average exercise price, granted | $ / shares | $ 0.740 |
Number of shares, Exercised | shares | |
Weighted average exercise price, exercised | $ / shares | |
Number of shares, Expired | shares | (91,667) |
Weighted average exercise price, expired | $ / shares | $ 2.962 |
Number of shares, stock options outstanding, at the end | shares | 3,325,000 |
Weighted average exercise price, stock options outstanding, at the end | $ / shares | $ 3.083 |
Weighted average remaining contractual life (in years), stock options outstanding | 3 years 2 months 23 days |
Number of shares, stock options exercisable, at the end | shares | 2,446,875 |
Weighted average exercise price, stock options exercisable, at the end | $ / shares | $ 3.532 |
Weighted average remaining contractual life (in years), stock options exercisable | 2 years 10 months 2 days |
Schedule of Exercise Prices of
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options Outstanding (Shares) | 3,325,000 |
Options Exercisable (Shares) | 2,446,875 |
Exercise Price One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 0.740 |
Options Outstanding (Shares) | 750,000 |
Options Exercisable (Shares) | 203,125 |
Exercise Price Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 0.900 |
Options Outstanding (Shares) | 33,333 |
Options Exercisable (Shares) | 33,333 |
Exercise Price Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 1.680 |
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 | $ / shares | $ 2.060 |
Options Outstanding (Shares) | 200,000 |
Options Exercisable (Shares) | 200,000 |
Exercise Price Five [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 2.800 |
Options Outstanding (Shares) | 250,000 |
Options Exercisable (Shares) | 203,125 |
Exercise Price Six [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3 |
Options Outstanding (Shares) | 666,667 |
Options Exercisable (Shares) | 666,667 |
Exercise Price Seven [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3.030 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | 312,500 |
Exercise Price Eight [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3.200 |
Options Outstanding (Shares) | 250,000 |
Options Exercisable (Shares) | 203,125 |
Exercise Price Nine [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3.210 |
Options Outstanding (Shares) | 150,000 |
Options Exercisable (Shares) | 150,000 |
Exercise Price Ten [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 6 |
Options Outstanding (Shares) | 166,667 |
Options Exercisable (Shares) | 166,667 |
Exercise Price Eleven [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 6.600 |
Options Outstanding (Shares) | 41,667 |
Options Exercisable (Shares) | 41,667 |
Exercise Price Twelve [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 7.140 |
Options Outstanding (Shares) | 200,000 |
Options Exercisable (Shares) | 150,000 |
Exercise Price Thirteen [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 12 |
Options Outstanding (Shares) | 83,333 |
Options Exercisable (Shares) | 83,333 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||||
Oct. 07, 2022 | Jun. 30, 2022 | Jun. 17, 2022 | 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, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Shares outstanding | 3,325,000 | 3,325,000 | 2,666,667 | ||||||||||||||
Stock based compensation | $ 396,883 | $ 347,222 | $ 1,160,649 | $ 1,854,058 | |||||||||||||
Number of fully vested option exercisable | 2,446,875 | 2,446,875 | |||||||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | $ 1,411,000 | ||||||||||||||||
Fair market value, per share | $ 0.55 | ||||||||||||||||
Outstanding stock options to acquire shares of common stock not vested | 878,125 | 878,125 | |||||||||||||||
Director [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Stock options are exercisable price per share | $ 3.21 | ||||||||||||||||
Fair value of stock options | $ 571,312 | ||||||||||||||||
Stock price per share | $ 2.8566 | ||||||||||||||||
Number of fully vested option issued | 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 exercisable for a period of five years to purchase 100,000 shares (a total of 500,000 shares) of the Company’s common stock 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. The total fair value of the 500,000 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 three months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $179,100 and $179,100, respectively, with respect to these stock options. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $531,455 and $179,100, respectively, with respect to these stock options | ||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||
Stock options are exercisable price per share | $ 3.03 | $ 3.03 | |||||||||||||||
Fair value of stock options | $ 1,421,095 | ||||||||||||||||
Stock price per share | $ 2.84225 | $ 2.84225 | |||||||||||||||
Stock based compensation | $ 179,100 | 179,100 | $ 531,455 | 179,100 | |||||||||||||
Number of fully vested option exercisable | 100,000 | 100,000 | 100,000 | ||||||||||||||
Stock options granted to purchase common stock, issued | 500,000 | ||||||||||||||||
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 exercisable for a period of five years to purchase 100,000 shares (a total of 500,000 shares) of the Company’s common stock 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. The total fair value of the 500,000 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 three months and nine months ended September 30, 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $39,860 and $39,860, respectively, with respect to these stock options | ||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||
Stock options are exercisable price per share | $ 0.74 | ||||||||||||||||
Fair value of stock options | $ 316,700 | ||||||||||||||||
Stock price per share | $ 0.6334 | ||||||||||||||||
Stock based compensation | 39,860 | 39,860 | |||||||||||||||
Number of fully vested option exercisable | 500,000 | 500,000 | 500,000 | ||||||||||||||
Stock options granted to purchase common stock, issued | 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 options exercisable for a period of five years to purchase 250,000 shares of the Company’s common stock 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. 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 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 three months and nine months ended September 30, 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $9,801 and $90,449, respectively, with respect to these stock options | ||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||
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 | 9,801 | 90,449 | |||||||||||||||
Number of fully vested option exercisable | 250,000 | ||||||||||||||||
Stock options granted to purchase common stock, issued | 79,263 | ||||||||||||||||
DrWinson SzeChunHo [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 options for 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and 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 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 three months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $25,259 and $25,259, respectively, with respect to these stock options. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $74,954 and $74,954, 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 | 25,259 | 25,259 | 74,954 | 74,954 | |||||||||||||
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 options for 83,334 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and 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 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 three months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $36,085 and $36,085, respectively, with respect to these stock options. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $107,078 and $107,078, 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 | 36,085 | 36,085 | 107,078 | 107,078 | |||||||||||||
Robert N. Weingarten [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 August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and 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 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 three months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $25,259 and $25,259, respectively, with respect to these stock options. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $74,954 and $74,954, 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 | 25,259 | 25,259 | 74,954 | 74,954 | |||||||||||||
DrWinson SzeChunHo [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 options exercisable for a period of five years to purchase 250,000 shares of the Company’s common stock 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. 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 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 is being charged to operations ratably from April 9, 2021 through June 30, 2023. During the three months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $42,692 and $42,692, respectively, with respect to these stock options. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $126,684 and $457,543, respectively, with respect to these stock options | ||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||
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 | 42,692 | 42,692 | 126,684 | 457,543 | |||||||||||||
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 options exercisable for a period of five years to purchase 250,000 shares of the Company’s common stock 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. 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 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 three months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $38,827 and $38,827, respectively, with respect to these stock options. During the nine months ended September 30, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $115,215 and $389,117, respectively, with respect to these stock options | ||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||
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 | $ 38,827 | $ 38,827 | $ 115,215 | $ 389,117 | |||||||||||||
Number of fully vested option exercisable | 250,000 | ||||||||||||||||
2020 Stock Incentive Plan [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Shares issued | 2,100,000 | ||||||||||||||||
Shares outstanding | 2,100,000 | 2,100,000 | |||||||||||||||
Shares were available for issuance | 233,333 | 233,333 | |||||||||||||||
Stock options granted to purchase common stock, issued | 4,133,333 | ||||||||||||||||
2020 Stock Incentive Plan [Member] | Subsequent Event [Member] | |||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||
Common shares avaliable for issuable | 1,800,000 | ||||||||||||||||
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 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 2 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||
Oct. 07, 2022 | Jun. 10, 2022 | Apr. 09, 2021 | Feb. 05, 2021 | Aug. 12, 2020 | Sep. 12, 2018 | Aug. 20, 2018 | Mar. 22, 2018 | Sep. 14, 2015 | Dec. 24, 2013 | Aug. 31, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Loss Contingencies [Line Items] | |||||||||||||||
Contractual commitment | $ 8,002,000 | $ 8,002,000 | |||||||||||||
Research and development costs | 272,388 | $ 227,181 | 895,649 | $ 933,122 | |||||||||||
City of Hope [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Aggregate commitments expected | 290,000 | 290,000 | |||||||||||||
GEIS [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Amount related to milestone payment | 67,582 | ||||||||||||||
NDA Consulting Corp [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Consulting and advisory fee | $ 4,000 | 4,000 | 4,000 | 12,000 | 12,000 | ||||||||||
Clinical Trial Research Agreement [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Advance amount related to milestone payment | 9,218 | 0 | |||||||||||||
Research and development costs | 18,623 | 17,693 | |||||||||||||
Research and development costs | $ 123,300 | ||||||||||||||
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 September 30, 2022, which is expected to be incurred through December 31, 2025 | ||||||||||||||
Aggregate commitments expected | 590,000 | $ 590,000 | |||||||||||||
Other Clinical Agreements [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Research and development costs | 1,144,041 | ||||||||||||||
Collaboration Agreement [Member] | GEIS [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Advance amount related to milestone payment | 0 | 24,171 | |||||||||||||
Research and development costs | 155,053 | ||||||||||||||
Aggregate commitments expected | 3,836,000 | 3,836,000 | |||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks LLC [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Consulting and advisory fee | $ 10,000 | ||||||||||||||
Reimbursed expense | 30,000 | 30,000 | 90,000 | 90,000 | |||||||||||
Second Milestone [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Amount related to milestone payment | $ 18,244 | ||||||||||||||
Third Milestone [Member] | Subsequent Event [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Amount related to milestone payment | $ 254,543 | ||||||||||||||
Clinical Research Support Agreement [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Aggregate commitments expected | 800,000 | 800,000 | |||||||||||||
Clinical Research Support Agreement [Member] | City of Hope [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Research and development costs | 0 | 525,528 | |||||||||||||
Aggregate commitments expected | 2,433,000 | 2,433,000 | |||||||||||||
Work Order Agreement [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Research and development costs | 111,676 | ||||||||||||||
Aggregate commitments expected | 853,000 | 853,000 | |||||||||||||
Work Order Agreement [Member] | City of Hope [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Advance amount related to milestone payment | 7,731 | 6,857 | 23,466 | 21,170 | |||||||||||
Research and development costs | $ 335,000 | ||||||||||||||
Aggregate commitments expected | 48,092 | 48,092 | |||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc. [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Research and development costs | $ 954,000 | 11,953 | 869 | 19,791 | 9,350 | ||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Development Milestones [Member] | Maximum [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Milestone payments | $ 1,750,000 | ||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Commercial Milestones [Member] | Maximum [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Milestone payments | $ 6,500,000 | ||||||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Minimum payments for royalties | 50,000 | ||||||||||||||
Exclusive License Agreement [Member] | Five Years And Thereafter [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Minimum payments for royalties | 100,000 | ||||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Non refundable license issue fee | $ 25,000 | ||||||||||||||
Annual license maintenance fee | 25,000 | ||||||||||||||
[custom:PaymentsOnNonrefundableMilestone] | $ 1,897,000 | ||||||||||||||
Operating Costs and Expenses | 6,301 | 6,301 | 18,699 | 18,698 | |||||||||||
Employment Agreement [Member] | Executive Officers [Member] | |||||||||||||||
Loss Contingencies [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] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Annual compensation | $ 775,000 | ||||||||||||||
Master Service Agreement [Member] | Foundation for Angelman Syndrome Therapy [Member] | |||||||||||||||
Loss Contingencies [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] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Advance amount related to milestone payment | 46,068 | 149,184 | |||||||||||||
Research and development costs | 204,433 | ||||||||||||||
Aggregate commitments expected | 250,000 | 250,000 | |||||||||||||
MRI Global [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Advance amount related to milestone payment | 6,749 | $ 0 | 27,102 | $ 17,432 | |||||||||||
Research and development costs | 212,778 | ||||||||||||||
Contract price | $ 273,980 | ||||||||||||||
Clinical Trial Monitoring Agreement [Member] | |||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||
Aggregate commitments expected | $ 61,000 | $ 61,000 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | ||||
Nov. 06, 2022 | Nov. 04, 2022 | Mar. 30, 2021 | Feb. 28, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Subsequent Event [Line Items] | ||||||
Exercisable period | 2 years 10 months 2 days | |||||
Exercisable price per share | $ 3.532 | |||||
Common Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares purchased | 3,000 | 3,000 | 2,900,000 | 1,133,102 | ||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Description of voting rights of shareholders | Approved an amendment to the Company’s Amended and Restated Bylaws to reduce the quorum requirement to hold a meeting of stockholders from 50% to 33-1/3% of the total number of outstanding shares of the Company entitled to vote at the meeting, present in person or represented by proxy | |||||
Subsequent Event [Member] | Common Stock [Member] | 2020 Stock Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Description of vesting percentage | vesting 25% on the issuance date and 25% on each anniversary date thereafter until fully vested, subject to continued service. | |||||
Market price per share | $ 0.5025 | |||||
Subsequent Event [Member] | Common Stock [Member] | BioPharma Works [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares purchased | 100,000 | |||||
Exercisable period | 5 years | |||||
Exercisable price per share | $ 0.5025 | |||||
Subsequent Event [Member] | Eric Forman [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Annual salary per year | $ 200,000 | $ 175,000 | ||||
Subsequent Event [Member] | Dr. John S. Kovach [Member] | Common Stock [Member] | 2020 Stock Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares purchased | 200,000 | |||||
Exercisable period | 5 years | |||||
Exercisable price per share | $ 2 | |||||
Subsequent Event [Member] | Eric J. Forman [Member] | Common Stock [Member] | 2020 Stock Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares purchased | 200,000 | |||||
Exercisable period | 5 years | |||||
Exercisable price per share | $ 2 | |||||
Subsequent Event [Member] | Dr. James S. Miser [Member] | Common Stock [Member] | 2020 Stock Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares purchased | 200,000 | |||||
Exercisable period | 5 years | |||||
Exercisable price per share | $ 2 | |||||
Subsequent Event [Member] | Robert N. Weingarten [Member] | Common Stock [Member] | 2020 Stock Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares purchased | 200,000 | |||||
Exercisable period | 5 years | |||||
Exercisable price per share | $ 2 |