Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 07, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-39717 | |
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 | 2,249,290 | |
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 $0.0001 per share | |
Trading Symbol | LIXTW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 2,912,920 | $ 5,353,392 |
Advances on research and development contract services | 78,015 | 147,017 |
Prepaid insurance | 54,650 | 49,224 |
Other prepaid expenses and current assets | 49,563 | 10,380 |
Total current assets | 3,095,148 | 5,560,013 |
Total assets | 3,095,148 | 5,560,013 |
Current liabilities: | ||
Accounts payable and accrued expenses, including $42,500 and $46,982 to related parties at June 30, 2023 and December 31, 2022, respectively | 366,528 | 229,764 |
Research and development contract liabilities | 36,086 | 165,022 |
Total current liabilities | 402,614 | 394,786 |
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 – 72,917 shares | 3,500,000 | 3,500,000 |
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 1,665,956 shares and 1,664,706 shares at June 30, 2023 and December 31, 2022, respectively | 166 | 166 |
Additional paid-in capital | 45,623,081 | 45,059,760 |
Accumulated deficit | (46,430,713) | (43,394,699) |
Total stockholders’ equity | 2,692,534 | 5,165,227 |
Total liabilities and stockholders’ equity | $ 3,095,148 | $ 5,560,013 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
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 | 1,665,956 | 1,664,706 |
Common stock, shares outstanding | 1,665,956 | 1,664,706 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, shares issued | 350,000 | 350,000 |
Preferred stock, shares outstanding | 350,000 | 350,000 |
Preferred stock liquidation preference per share | $ 10 | $ 10 |
Preferred stock, issuable upon conversion | 72,917 | 72,917 |
Related Party [Member] | ||
Related parties accounts payable and accrued expenses | $ 42,500 | $ 46,982 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenues | ||||
General and administrative costs: | ||||
Compensation to related parties, including stock-based compensation expense of $280,060 and $424,094 for the three months ended June 30, 2023 and 2022, respectively, and $557,040 and $763,766 for the six months ended June 30, 2023 and 2022, respectively | 522,561 | 753,530 | 1,042,041 | 1,319,452 |
Patent and licensing legal and filing fees and costs | 340,010 | 358,389 | 657,350 | 673,626 |
Other costs and expenses | 379,970 | 269,281 | 724,212 | 584,023 |
Research and development costs | 427,457 | 164,810 | 616,542 | 623,261 |
Total costs and expenses | 1,669,998 | 1,546,010 | 3,040,145 | 3,200,362 |
Loss from operations | (1,669,998) | (1,546,010) | (3,040,145) | (3,200,362) |
Interest income | 2,714 | 191 | 7,729 | 300 |
Interest expense | (1,948) | (627) | (5,809) | (3,121) |
Foreign currency gain (loss) | 877 | 142 | 2,211 | (39) |
Net loss | $ (1,668,355) | $ (1,546,304) | $ (3,036,014) | $ (3,203,222) |
Net loss per common share - basic | $ (1) | $ (0.95) | $ (1.82) | $ (2.14) |
Net loss per common share - diluted | $ (1) | $ (0.95) | $ (1.82) | $ (2.14) |
Weighted average common shares outstanding - basic | 1,665,956 | 1,620,091 | 1,665,479 | 1,498,076 |
Weighted average common shares outstanding - diluted | 1,665,956 | 1,620,091 | 1,665,479 | 1,498,076 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Allocated share based compensation expense | $ 280,060 | $ 424,094 | $ 557,040 | $ 763,766 |
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 |
Balance at Dec. 31, 2021 | $ 3,500,000 | $ 137 | $ 38,372,365 | $ (37,082,164) | $ 4,790,338 |
Balance, shares at Dec. 31, 2021 | 350,000 | 1,374,706 | |||
Stock-based compensation expense | 763,766 | 763,766 | |||
Net loss | (3,203,222) | (3,203,222) | |||
Proceeds from sale of common stock in registered direct offering, net of offering costs | $ 29 | 5,141,355 | 5,141,384 | ||
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares | 290,000 | ||||
Balance at Jun. 30, 2022 | $ 3,500,000 | $ 166 | 44,277,486 | (40,285,386) | 7,492,266 |
Balance, shares at Jun. 30, 2022 | 350,000 | 1,664,706 | |||
Balance at Mar. 31, 2022 | $ 3,500,000 | $ 137 | 38,712,037 | (38,739,082) | 3,473,092 |
Balance, shares at Mar. 31, 2022 | 350,000 | 1,374,706 | |||
Stock-based compensation expense | 424,094 | 424,094 | |||
Net loss | (1,546,304) | (1,546,304) | |||
Proceeds from sale of common stock in registered direct offering, net of offering costs | $ 29 | 5,141,355 | 5,141,384 | ||
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares | 290,000 | ||||
Balance at Jun. 30, 2022 | $ 3,500,000 | $ 166 | 44,277,486 | (40,285,386) | 7,492,266 |
Balance, shares at Jun. 30, 2022 | 350,000 | 1,664,706 | |||
Balance at Dec. 31, 2022 | $ 3,500,000 | $ 166 | 45,059,760 | (43,394,699) | 5,165,227 |
Balance, shares at Dec. 31, 2022 | 350,000 | 1,664,706 | |||
Stock-based compensation expense | 557,040 | 557,040 | |||
Net loss | (3,036,014) | (3,036,014) | |||
Exercise of options | 6,281 | $ 6,281 | |||
Exercise of stock options, shares | 1,250 | 1,250 | |||
Balance at Jun. 30, 2023 | $ 3,500,000 | $ 166 | 45,623,081 | (46,430,713) | $ 2,692,534 |
Balance, shares at Jun. 30, 2023 | 350,000 | 1,665,956 | |||
Balance at Mar. 31, 2023 | $ 3,500,000 | $ 166 | 45,343,021 | (44,762,358) | 4,080,829 |
Balance, shares at Mar. 31, 2023 | 350,000 | 1,665,956 | |||
Stock-based compensation expense | 280,060 | 280,060 | |||
Net loss | (1,668,355) | (1,668,355) | |||
Balance at Jun. 30, 2023 | $ 3,500,000 | $ 166 | $ 45,623,081 | $ (46,430,713) | $ 2,692,534 |
Balance, shares at Jun. 30, 2023 | 350,000 | 1,665,956 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities: | |||||
Net loss | $ (1,668,355) | $ (1,546,304) | $ (3,036,014) | $ (3,203,222) | |
Stock-based compensation expense included in - | |||||
Stock-based compensation expense | 280,060 | 424,094 | 557,040 | 763,766 | |
Increase (decrease) in - | |||||
Advances on research and development contract services | 69,002 | 3,224 | |||
Prepaid insurance | (5,426) | 8,574 | |||
Other prepaid expenses and current assets | (39,183) | (30,313) | |||
Accounts payable and accrued expenses | 136,764 | 146,743 | |||
Research and development contract liabilities | (128,936) | 81,871 | |||
Net cash used in operating activities | (2,446,753) | (2,229,357) | |||
Cash flows from financing activities: | |||||
Exercise of common stock options | 6,281 | ||||
Proceeds from sale of common stock in registered direct offering, net of offering costs | 5,141,384 | ||||
Net cash provided by financing activities | 6,281 | 5,141,384 | |||
Cash: | |||||
Net increase (decrease) | (2,440,472) | 2,912,027 | |||
Balance at beginning of period | 5,353,392 | 4,823,745 | $ 4,823,745 | ||
Balance at end of period | $ 2,912,920 | $ 7,735,772 | 2,912,920 | 7,735,772 | $ 5,353,392 |
Supplemental disclosures of cash flow information: | |||||
Interest | 5,809 | 3,121 | |||
Income taxes | |||||
General and Administrative Expense [Member] | |||||
Stock-based compensation expense included in - | |||||
Stock-based compensation expense | 557,040 | 763,766 | |||
Research and Development Expense [Member] | |||||
Stock-based compensation expense included in - | |||||
Stock-based compensation expense |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
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), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at June 30, 2023, and for the three months and six months ended June 30, 2023 and 2022, 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 June 30, 2023, and the results of its operations for the three months and six months ended June 30, 2023 and 2022, and its cash flows for the six months ended June 30, 2023 and 2022. 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, 2022 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, 2022, as filed with the SEC. Reverse Stock Split On June 2, 2023, the Company effected a 1-for-10 All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented. Nasdaq Notification of Failure to Satisfy a Continued Listing Rule The Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively. On June 24, 2022, the Company received a written notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company had not been in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a period of 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. The Notice had no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of the Notice, or until December 21, 2022, to regain compliance with the minimum closing bid price requirement. On December 22, 2022, the Company received a written notice from Nasdaq that the Company was eligible for a second 180 calendar day compliance period, or until June 19, 2023, in order to regain compliance with the $1.00 minimum bid price requirement. Nasdaq’s determination to grant the second compliance period was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. A company can generally achieve compliance with the minimum closing bid price requirement if the minimum closing bid price of a company’s common stock is at least $1.00 per share for a minimum of 10 consecutive business days during the 180-day compliance period. However, under certain circumstances, Nasdaq can extend this 10-day trading period up to a maximum of 20 days. In order to achieve compliance with the minimum closing bid price requirement, the Company filed a proxy statement with the SEC to hold a special meeting of stockholders on May 26, 2023 to seek stockholder approval to approve an amendment to the Company’s Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of the Company’s common stock at a split ratio of up to a maximum of a 1-for-10 The stockholders approved an amendment to the Company’s Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of the Company’s common stock, as a result of which the Company effected a 1-for-10 However, there can be no assurances that the Company will be able to remain in compliance with the minimum bid price requirement over time, or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements. |
Business
Business | 6 Months Ended |
Jun. 30, 2023 | |
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 corporate office is located in Pasadena, California. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its operating requirements. Sale of Common Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants; Exercise of Pre-Funded Common Stock Purchase Warrants Subsequent to June 30, 2023, on July 20, 2023, in a registered direct offering to an institutional investor, the Company sold 180,000 6.00 403,334 5.9999 0.0001 In a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 6.00 The registered direct offering and the concurrent private placement generated gross proceeds of approximately $ 3,500,000 375,000 3,125,000 35,000 6.60 During the period from July 24, 2023 through August 7, 2023, the 403,334 0.0001 40 403,334 Going Concern At June 30, 2023, the Company had cash of $ 2,912,920 6,389,000 The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities. Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the accompanying interim condensed consolidated financial statements are being issued. The Company’s interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities. Based on current operating plans, the Company estimates that existing cash resources, together with the proceeds from the July 20, 2023 registered direct offering and concurrent private placement, will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately December 31, 2024. However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments, no later than the latter half of the fiscal year ending December 31, 2024. However, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned. As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
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 Lixte Biotechnology Holdings, Inc. and its wholly-owned subsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation. Segment Information The Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President, Chief Executive Officer and Chief Scientific Officer. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $ 250,000 500,000 Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation, design, development and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union in accordance with the laws and regulations of such jurisdictions. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred. Obligations incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research and development contracts on a quarterly basis. Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each reporting period. Patent and Licensing Legal and Filing Fees and Costs Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs were $ 340,010 358,389 657,350 673,626 Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10 General and administrative costs for the three months ended June 30, 2023 and 2022 included charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.3 25.9 22.5 30.7 Research and development costs for the three months ended June 30, 2023 included charges from two vendors and consultants representing 62.9 12.4 29.7 18.2 17.4 12.6 10.2 General and administrative costs for the six months ended June 30, 2023 and 2022 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.1 26.1 23.0 29.6 Research and development costs for the six months ended June 30, 2023 include charges from three vendors and consultants representing 43.9 17.1 11.2 44.6 16.5 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 June 30, 2023 or December 31, 2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023. 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 June 30, 2023 or December 31, 2022. Subsequent to June 30, 2023, 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. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero. The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS, but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At June 30, 2023 and 2022, 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 2023 2022 June 30, 2023 2022 Series A Convertible Preferred Stock 72,917 72,917 Common stock warrants 190,031 340,031 Common stock options, including options issued in the form of warrants 428,229 332,500 Total 691,177 745,448 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 May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 was 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 related disclosures. In July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation (Topic 718) Presentation of Financial Statements (“ASU 2023-03”). ASU 2023-03 amends the FASB Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 — General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. As the ASU does not provide any new guidance, there is no transition or effective date associated with its adoption. Accordingly, the Company adopted ASU 2023-03 immediately upon its issuance. The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial statement presentation or related disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Research and Development Costs
Research and Development Costs | 6 Months Ended |
Jun. 30, 2023 | |
Research and Development [Abstract] | |
Research and Development Costs | 4. Research and Development Costs A summary of research and development costs for the three months and six months ended June 30, 2023 and 2022, including costs associated with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical regions where such costs have been incurred. Schedule of Research and Development Costs 2023 2022 2023 2022 Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 United States $ 87,625 $ 80,290 $ 223,531 $ 154,821 Spain 272,564 18,774 273,539 347,604 China 14,090 16,860 14,090 17,720 Netherlands 53,178 48,886 105,382 103,116 Total $ 427,457 $ 164,810 $ 616,542 $ 623,261 Research and development expense $ 427,457 $ 164,810 $ 616,542 $ 623,261 |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | 5. 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 0.20833 21,875,000 350,000 72,917 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 1,665,956 1,664,706 On June 2, 2023, the Company effected a 1-for-10 Effective April 12, 2022, the Company completed the sale of 290,000 20.00 5,800,000 658,616 5,141,384 29,000 20.00 Effective March 10, 2023, the Company issued 1,250 1,250 5.025 6,281 Common Stock Warrants A summary of common stock warrant activity during the six months ended June 30, 2023 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, 2022 190,031 $ 50.161 Issued — — Exercised — — Expired — — Warrants outstanding at June 30, 2023 190,031 $ 50.161 2.65 Warrants exercisable at December 31, 2022 190,031 $ 50.161 Warrants exercisable at June 30, 2023 190,031 $ 50.161 2.65 At June 30, 2023, the outstanding warrants are exercisable at the following prices per common share: Schedule of Warrants Outstanding and Exercisable Exercise Prices Warrants Outstanding (Shares) $ 20.000 29,000 $ 37.000 11,331 $ 57.000 149,700 190,031 The warrants exercisable at $ 57.00 1-for-10 5.70 5.70 57.00 Based on a fair market value of $ 5.88 Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 7. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 6. Related Party Transactions Related party transactions include transactions with the Company’s officers, directors and affiliates. Employment Agreements with Officers During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, payable monthly, as described below. The employment agreements are automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021 and 2022. The Company entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, for Dr. Kovach to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $ 250,000 62,500 62,500 125,000 125,000 The Company entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020 to act as the Company’s Chief Medical Officer, with an annual salary of $ 150,000 175,000 43,750 43,750 87,500 87,500 The Company entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as the Company’s Chief Administrative Officer, with an annual salary of $ 120,000 175,000 200,000 1,530 4,113 50,000 43,750 100,000 87,500 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 87,500 87,500 Appointment of Dr. René Bernards to the Board of Directors Effective as of June 15, 2022, Dr. René Bernards was appointed to the Company’s Board of Directors as an independent director. Dr. Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam. As a new director, in lieu of a grant of stock options, Dr. Bernards received a one-time cash board fee of $ 100,000 40,000 Previously, on October 8, 2021, the Company had 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 9. 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 grants options to purchase 25,000 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 grants options to purchase 10,000 12.5 40,000 Total cash compensation paid to independent directors was $ 42,501 135,686 85,001 168,186 Stock-based compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 7. 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 six months ended June 30, 2023 and 2022, is presented below. Summary of Related Party Costs 2023 2022 2023 2022 Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Related party costs: Cash-based $ 242,501 $ 329,436 $ 485,001 $ 555,686 Stock-based 280,060 424,094 557,040 763,766 Total $ 522,561 $ 753,530 $ 1,042,041 $ 1,319,452 Related party costs $ 522,561 $ 753,530 $ 1,042,041 $ 1,319,452 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation The Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees, contractors, and consultants of the Company. On July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently approved by the stockholders of the Company. The 2020 Plan provides for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates, initially for a total of 233,333 180,000 413,333 As of June 30, 2023, unexpired stock options for 300,313 113,020 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 six months ended June 30, 2023, 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 4.565 % Expected dividend yield 0 % Expected volatility 138.05 % Expected life 3.5 For stock options requiring an assessment of value during the six months ended June 30, 2022, 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 3.03 % Expected dividend yield 0 % Expected volatility 153.17 % Expected life 3.5 On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted stock options to purchase 5,833 five years 400,855 68.718 100,214 24,985 24,985 49,695 49,695 On August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted stock options to purchase 8,333 71.40 572,650 68.718 143,163 35,693 35,693 70,993 70,993 On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $ 71.40 400,855 68.718 100,214 24,985 24,985 49,695 49,695 On April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 25,000 32.00 753,611 30.144 376,800 42,228 83,992 On May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Ms. Brown was granted stock options to purchase 25,000 28.00 658,363 26.335 329,188 38,405 38,405 76,388 76,388 On June 30, 2021, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 50,000 30.30 1,421,095 28.423 106,290 177,150 211,412 352,355 On June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Baan was granted stock options to purchase 25,000 7.40 158,525 6.341 79,263 9,695 80,647 19,284 80,647 On June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 50,000 five years 316,700 6.334 47,049 0 On November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 80,000 20.00 25 25 80,000 262,560 3.282 16,352 32,524 On November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 10,000 5.025 43,264 4.326 On June 30, 2023, 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 four non-officer directors of the Company stock options to purchase 10,000 40,000 5.88 12.5 192,593 4.8131 Dr. Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the Company’s Annual Meeting of Stockholders held on October 7, 2022, and Gil Schwartzberg, a director of the Company, died on October 30, 2022. Accordingly, the unvested stock options for each such person ceased vesting effective as of the respective dates that their service on the Company’s Board of Directors terminated. Furthermore, the expiration date of all vested stock options owned by such persons are contractually scheduled to expire one year from the respective dates that their service on the Company’s Board of Directors terminated. A summary of stock-based compensation costs for the three months and six months ended June 30, 2023 and 2022 is as follows: Summary of Stock-based Compensation Costs 2023 2022 2023 2022 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Related parties $ 280,060 $ 424,094 $ 557,040 $ 763,766 Non-related parties — — — — Total stock-based compensation costs $ 280,060 $ 424,094 $ 557,040 $ 763,766 A summary of stock option activity, including options issued in the form of warrants, during the six months ended June 30, 2023 is as follows: Summary of Stock Option Activity Including Options Form of Warrants Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2022 389,479 $ 29.1826 Granted 40,000 5.8800 Exercised (1,250 ) 5.0250 Expired — — Stock options outstanding at June 30, 2023 428,229 $ 27.0764 2.77 Stock options exercisable at December 31, 2022 281,979 $ 32.8335 Stock options exercisable at June 30, 2023 301,979 $ 31.9708 2.75 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $ 517,000 21 The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at June 30, 2023 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) $ 5.025 8,750 8,750 $ 5.880 40,000 — $ 7.400 57,500 36,250 $ 16.800 3,333 3,333 $ 20.000 80,000 20,000 $ 20.600 20,000 20,000 $ 28.000 25,000 25,000 $ 30.000 66,667 66,667 $ 30.300 42,500 42,500 $ 32.000 20,313 20,313 $ 32.100 15,000 15,000 $ 60.000 16,667 16,667 $ 66.000 4,167 4,167 $ 71.400 20,000 15,000 $ 120.000 8,332 8,332 428,229 301,979 The intrinsic value of exercisable but unexercised in-the-money stock options at June 30, 2023 was approximately $ 7,500 5.88 Outstanding stock options to acquire 126,250 The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes During the three months and six months ended June 30, 2023 and 2022, 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 currently believes it is more likely than not that the deferred tax assets will not be realized. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. 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 June 30, 2023 and December 31, 2022, the Company was not subject to any pending or threatened legal claims or actions. Principal Commitments Clinical Trial Agreements At June 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $ 6,389,000 Moffitt. In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and 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 utilized 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. During the three months ended June 30, 2023, the Phase 1b/2 clinical trial at the Moffitt Cancer Center evaluating LB-100 in patients with MDS was closed by the principal investigator. In this clinical trial, single agent LB-100 was used on a new schedule of days 1, 3, and 5 every 3 weeks. It was determined that patients found it too challenging to go for an infusion given on this schedule. The Company is not employing this schedule in its other clinical trials. Although the Maximally Tolerated Dose (MTD) was not achieved, there was no dose-limiting toxicity on this schedule at doses that were even greater than those which were above the MTD in the Phase 1 clinical trial of LB-100 on the Monday, Tuesday, Wednesday schedule. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $ 6,000 6,073 12,000 9,405 143,074 The Company has decided not to pursue further studies in MDS, as other opportunities in much more common diseases have become available. For example, the Company is now focusing on documenting clear-cut potentiation of cytotoxic treatment as in the ongoing study of advanced soft tissue sarcoma and small cell lung cancer. In addition, new pre-clinical data demonstrate the potentiation of immunotherapy by LB-100 in other common cancers. GEIS. GEIS has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over a period of two years. As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival (PFS, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required for final analysis is reached. The Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July 2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol, it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These standards were adopted subsequent to the production of the Company’s existing LB-100 inventory. In order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility, provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory authorities for review and approval before being used in a clinical trial. As of June 30, 2023, 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 approximately $ 1,144,000 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 commenced during the quarter ending June 30, 2023 and is expected to be completed by December 31, 2025. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The Phase 1b section of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on both response and toxicity from this portion of the clinical trial. The interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone. The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $ 268,829 0 268,829 0 684,652 The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 3,536,000 City of Hope. The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, as patient accrual was slower than expected, the Company has been seeking to add two additional sites to increase the rate of patient accrual. Effective March 6, 2023, the Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, joined the City of Hope’s ongoing Phase 1b clinical trial. The Company is continuing its efforts to add a third site. The addition of SCRI is expected to expedite and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability and efficacy of adding LB-100 to the current standard treatment regimen. With the addition of SCRI, the Company currently expects that this clinical trial will be completed by December 31, 2024. During the three months ended June 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the six months ended June 30, 2023 and 2022, the Company incurred costs of $ 69,001 0 447,512 The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 2,433,000 800,000 The Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment of a very aggressive disease. Theradex. Costs under this work order agreement are estimated to be approximately $ 153,000 72 28 6,250 6,250 The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $ 153,000 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 NCI study was 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 has proceeded. 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. Results of this study are currently being reviewed by NCI and a report is expected by the end of 2023. Clinical Trial Monitoring Agreements Moffitt. The costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic documentation provided by the CRO. During the three months ended June 30, 2023 and 2022, the Company incurred costs of $ 10,997 4,558 20,284 7,839 147,572 During the three months ended June 30, 2023, concurrent with the closure of the Company’s Clinical Trial Research Agreement with Moffitt, this work order agreement with Theradex to monitor the Clinical Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to June 30, 2023 are expected to be incurred relating to the closure of the Moffitt study. City of Hope. 335,000 5,687 11,235 11,240 15,735 69,681 The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $ 267,000 Patent and License Agreements Moffitt. 25,000 25,000 1,897,000 6,233 6,233 12,398 12,398 The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $ 50,000 100,000 Employment Agreements with Officers During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual compensation of $ 640,000 one-year periods On April 9, 2021, the Board of Directors increased the annual compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten under the employment agreements, such that the total aggregate annual compensation of all officers increased to $ 775,000 Effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $ 200,000 1,500 The total aggregate annual compensation of all officers increased to $ 800,000 Other Significant Agreements and Contracts NDA Consulting Corp. 4,000 4,000 4,000 8,000 8,000 BioPharmaWorks BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $ 10,000 30,000 30,000 60,000 60,000 Netherlands Cancer Institute 53,178 48,886 105,381 103,116 364,788 53,000 MRI Global. 273,980 326,274 4,010 19,597 7,183 20,353 225,924 The Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $ 100,000 External Risks Associated with the Company’s Business Activities Covid-19 Virus Inflation Risk. Supply Chain Issues. Potential Recession. The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance become available. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. 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 those matters described below, there were no material subsequent events which affected, or could affect, the amounts or disclosures in the condensed consolidated financial statements. Sale of Common Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants; Exercise of Pre-Funded Common Stock Purchase Warrants On July 20, 2023, in a registered direct offering to an institutional investor, the Company sold 180,000 6.00 403,334 5.9999 0.0001 In a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 6.00 The registered direct offering and the concurrent private placement generated gross proceeds of approximately $ 3,500,000 375,000 3,125,000 35,000 6.60 During the period from 403,334 0.0001 40 403,334 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
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 Lixte Biotechnology Holdings, Inc. and its wholly-owned subsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation. |
Segment Information | Segment Information The Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President, Chief Executive Officer and Chief Scientific Officer. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash | Cash Cash is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC (“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $ 250,000 500,000 |
Research and Development | Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation, design, development and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union in accordance with the laws and regulations of such jurisdictions. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred. Obligations incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research and development contracts on a quarterly basis. |
Prepaid Insurance | Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each reporting period. |
Patent and Licensing Legal and Filing Fees and Costs | Patent and Licensing Legal and Filing Fees and Costs Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs were $ 340,010 358,389 657,350 673,626 |
Concentration of Risk | Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10 General and administrative costs for the three months ended June 30, 2023 and 2022 included charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.3 25.9 22.5 30.7 Research and development costs for the three months ended June 30, 2023 included charges from two vendors and consultants representing 62.9 12.4 29.7 18.2 17.4 12.6 10.2 General and administrative costs for the six months ended June 30, 2023 and 2022 include charges from legal firms and other vendors for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.1 26.1 23.0 29.6 Research and development costs for the six months ended June 30, 2023 include charges from three vendors and consultants representing 43.9 17.1 11.2 44.6 16.5 |
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 June 30, 2023 or December 31, 2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023. 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 June 30, 2023 or December 31, 2022. Subsequent to June 30, 2023, 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. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero. The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS, but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At June 30, 2023 and 2022, 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 2023 2022 June 30, 2023 2022 Series A Convertible Preferred Stock 72,917 72,917 Common stock warrants 190,031 340,031 Common stock options, including options issued in the form of warrants 428,229 332,500 Total 691,177 745,448 |
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 May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 was 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 related disclosures. In July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation (Topic 718) Presentation of Financial Statements (“ASU 2023-03”). ASU 2023-03 amends the FASB Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 — General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. As the ASU does not provide any new guidance, there is no transition or effective date associated with its adoption. Accordingly, the Company adopted ASU 2023-03 immediately upon its issuance. The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial statement presentation or related 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) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At June 30, 2023 and 2022, 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 2023 2022 June 30, 2023 2022 Series A Convertible Preferred Stock 72,917 72,917 Common stock warrants 190,031 340,031 Common stock options, including options issued in the form of warrants 428,229 332,500 Total 691,177 745,448 |
Research and Development Costs
Research and Development Costs (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Research and Development [Abstract] | |
Schedule of Research and Development Costs | A summary of research and development costs for the three months and six months ended June 30, 2023 and 2022, including costs associated with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical regions where such costs have been incurred. Schedule of Research and Development Costs 2023 2022 2023 2022 Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 United States $ 87,625 $ 80,290 $ 223,531 $ 154,821 Spain 272,564 18,774 273,539 347,604 China 14,090 16,860 14,090 17,720 Netherlands 53,178 48,886 105,382 103,116 Total $ 427,457 $ 164,810 $ 616,542 $ 623,261 Research and development expense $ 427,457 $ 164,810 $ 616,542 $ 623,261 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding | A summary of common stock warrant activity during the six months ended June 30, 2023 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, 2022 190,031 $ 50.161 Issued — — Exercised — — Expired — — Warrants outstanding at June 30, 2023 190,031 $ 50.161 2.65 Warrants exercisable at December 31, 2022 190,031 $ 50.161 Warrants exercisable at June 30, 2023 190,031 $ 50.161 2.65 |
Schedule of Warrants Outstanding and Exercisable | At June 30, 2023, the outstanding warrants are exercisable at the following prices per common share: Schedule of Warrants Outstanding and Exercisable Exercise Prices Warrants Outstanding (Shares) $ 20.000 29,000 $ 37.000 11,331 $ 57.000 149,700 190,031 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 six months ended June 30, 2023 and 2022, is presented below. Summary of Related Party Costs 2023 2022 2023 2022 Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Related party costs: Cash-based $ 242,501 $ 329,436 $ 485,001 $ 555,686 Stock-based 280,060 424,094 557,040 763,766 Total $ 522,561 $ 753,530 $ 1,042,041 $ 1,319,452 Related party costs $ 522,561 $ 753,530 $ 1,042,041 $ 1,319,452 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 six months ended June 30, 2023, 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 4.565 % Expected dividend yield 0 % Expected volatility 138.05 % Expected life 3.5 For stock options requiring an assessment of value during the six months ended June 30, 2022, 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 3.03 % Expected dividend yield 0 % Expected volatility 153.17 % Expected life 3.5 |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the three months and six months ended June 30, 2023 and 2022 is as follows: Summary of Stock-based Compensation Costs 2023 2022 2023 2022 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Related parties $ 280,060 $ 424,094 $ 557,040 $ 763,766 Non-related parties — — — — Total stock-based compensation costs $ 280,060 $ 424,094 $ 557,040 $ 763,766 |
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 six months ended June 30, 2023 is as follows: Summary of Stock Option Activity Including Options Form of Warrants Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2022 389,479 $ 29.1826 Granted 40,000 5.8800 Exercised (1,250 ) 5.0250 Expired — — Stock options outstanding at June 30, 2023 428,229 $ 27.0764 2.77 Stock options exercisable at December 31, 2022 281,979 $ 32.8335 Stock options exercisable at June 30, 2023 301,979 $ 31.9708 2.75 |
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 June 30, 2023 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) $ 5.025 8,750 8,750 $ 5.880 40,000 — $ 7.400 57,500 36,250 $ 16.800 3,333 3,333 $ 20.000 80,000 20,000 $ 20.600 20,000 20,000 $ 28.000 25,000 25,000 $ 30.000 66,667 66,667 $ 30.300 42,500 42,500 $ 32.000 20,313 20,313 $ 32.100 15,000 15,000 $ 60.000 16,667 16,667 $ 66.000 4,167 4,167 $ 71.400 20,000 15,000 $ 120.000 8,332 8,332 428,229 301,979 |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details Narrative) | Jun. 02, 2023 |
Common Stock [Member] | |
Reverse stock split | 1-for-10 |
Business (Details Narrative)
Business (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||||||
Jul. 24, 2023 | Jul. 20, 2023 | Mar. 10, 2023 | Apr. 12, 2022 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 02, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | |||||||||
Proceeds from Stock Options Exercised | $ 6,281 | ||||||||
Cash and Cash Equivalents, at Carrying Value | 2,912,920 | $ 5,353,392 | |||||||
Contractual commitment | $ 6,389,000 | ||||||||
Placement Agents [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Warrant exercise price | $ 6.60 | $ 20 | |||||||
Warrants to purchase shares | 35,000 | 29,000 | |||||||
Common Stock [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Shares issued during period | 1,250 | 290,000 | 290,000 | ||||||
Warrant exercise price | $ 5.70 | ||||||||
Costs of public offering | $ 658,616 | ||||||||
Net proceeds from issuance of stock | $ 5,141,384 | ||||||||
Warrant [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Shares issued during period | 1,250 | ||||||||
Warrant exercise price | $ 5.025 | ||||||||
Subsequent Event [Member] | Common Stock [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Shares issued during period | 180,000 | ||||||||
Share issued price per share | $ 6 | ||||||||
Proceeds from issuance of private placement | $ 3,500,000 | ||||||||
Costs of public offering | 375,000 | ||||||||
Net proceeds from issuance of stock | $ 3,125,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 403,334 | ||||||||
Subsequent Event [Member] | Prefunded Warrant [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Shares issued during period | 403,334 | ||||||||
Share issued price per share | $ 5.9999 | ||||||||
Warrant exercise price | $ 0.0001 | $ 0.0001 | |||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 403,334 | ||||||||
Proceeds from Stock Options Exercised | $ 40 | ||||||||
Subsequent Event [Member] | Warrant [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Shares issued during period | 583,334 | ||||||||
Share issued price per share | $ 6 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 691,177 | 745,448 |
Series A Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 72,917 | 72,917 |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 190,031 | 340,031 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 428,229 | 332,500 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Product Information [Line Items] | ||||
Cash FDIC insurance | $ 250,000 | $ 250,000 | ||
Cash SIPC insurance | 500,000 | 500,000 | ||
Patent and licensing legal and filing fees and costs | $ 340,010 | $ 358,389 | $ 657,350 | $ 673,626 |
Cost of Sales [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 10% | 10% | 10% | 10% |
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 27.30% | 25.90% | 27.10% | 26.10% |
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Stock Options Granted to Directors and Corporate Officers [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 22.50% | 30.70% | 23% | 29.60% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant One [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 62.90% | 29.70% | 43.90% | 44.60% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant Two [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 12.40% | 18.20% | 17.10% | 16.50% |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant Three [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 17.40% | 11.20% | ||
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant Four [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 12.60% | |||
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant Five [Member] | ||||
Product Information [Line Items] | ||||
Concentration risk percentage | 10.20% |
Schedule of Research and Develo
Schedule of Research and Development Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Research and development expense | $ 427,457 | $ 164,810 | $ 616,542 | $ 623,261 |
UNITED STATES | ||||
Research and development expense | 87,625 | 80,290 | 223,531 | 154,821 |
SPAIN | ||||
Research and development expense | 272,564 | 18,774 | 273,539 | 347,604 |
CHINA | ||||
Research and development expense | 14,090 | 16,860 | 14,090 | 17,720 |
NETHERLANDS | ||||
Research and development expense | $ 53,178 | $ 48,886 | $ 105,382 | $ 103,116 |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of Shares, Warrants Outstanding, Beginning Balance | 190,031 | |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ 50.161 | |
Number of Shares, Issued | ||
Weighted Average Exercise Price, Issued | ||
Number of Shares, Exercised | ||
Weighted Average Exercise Price, Exercised | ||
Number of Shares, Expired | ||
Weighted Average Exercise Price, Expired | ||
Number of Shares, Warrants Outstanding, Ending Balance | 190,031 | |
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ 50.161 | |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 2 years 7 months 24 days | |
Number of Shares, Warrants exercisable, Ending Balance | 190,031 | 190,031 |
Weighted Average Exercise Price, Warrants exercisable, Beginning Balance | $ 50.161 | $ 50.161 |
Weighted Average Remaining Contractual Life (in Years), Exercisable | 2 years 7 months 24 days |
Schedule of Warrants Outstand_2
Schedule of Warrants Outstanding and Exercisable (Details) | Jun. 30, 2023 $ / shares shares |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Warrants Outstanding Shares | 190,031 |
Exercise Price One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 20 |
Warrants Outstanding Shares | 29,000 |
Exercise Price Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 37 |
Warrants Outstanding Shares | 11,331 |
Exercise Price Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 57 |
Warrants Outstanding Shares | 149,700 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | 96 Months Ended | ||||||
Jun. 02, 2023 | Mar. 10, 2023 | Apr. 12, 2022 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Mar. 17, 2023 | Jul. 20, 2023 | Mar. 17, 2015 | |
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||||||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | ||||||||
Common stock, shares issued | 1,665,956 | 1,664,706 | ||||||||
Common stock, shares outstanding | 1,665,956 | 1,664,706 | ||||||||
Proceeds from issuance of common stock | $ 5,141,384 | |||||||||
Placement Agents [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants to purchase shares | 29,000 | 35,000 | ||||||||
Exercise price | $ 20 | $ 6.60 | ||||||||
Common Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Reverse stock split | 1-for-10 | |||||||||
Number of common stock shares issued during period | 290,000 | |||||||||
Sale of stock price per share | $ 20 | |||||||||
Proceeds from issuance of common stock | $ 5,800,000 | |||||||||
Costs of public offering | 658,616 | |||||||||
Net proceeds from issuance of stock | $ 5,141,384 | |||||||||
Exercise price | $ 5.70 | |||||||||
Stock issued new issue shares | 1,250 | 290,000 | 290,000 | |||||||
Fair market value of stock | $ 57 | |||||||||
Warrant [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price | $ 5.025 | |||||||||
Stock issued new issue shares | 1,250 | |||||||||
Proceeds from warrant exercises | $ 6,281 | |||||||||
Fair market value of stock | 5.70 | |||||||||
Warrants and rights outstanding | $ 57 | |||||||||
Common Stock Warrant [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Fair market value of stock | $ 5.88 | |||||||||
Series A Convertible Preferred Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares authorized | 350,000 | |||||||||
Principal Cash Obligations and Commitments | 175,000 | |||||||||
Preferred stock dividend, percentage | 100% | |||||||||
Annual net revenue | 175,000 | |||||||||
Preferred stock convertible into common stock | 72,917 | 72,917 | ||||||||
Gross proceeds from sale of transaction | $ 21,875,000 | |||||||||
Preferred stock, shares outstanding | 350,000 | 350,000 | ||||||||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 0.20833 shares of common stock (subject to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. | |||||||||
Preferred stock convertible into common stock | 0.20833 | |||||||||
Undesignated Preferred Stock [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares authorized | 9,650,000 |
Summary of Related Party Costs
Summary of Related Party Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Related Party Transaction [Line Items] | ||||
Related party costs | $ 522,561 | $ 753,530 | $ 1,042,041 | $ 1,319,452 |
Related Party [Member] | ||||
Related Party Transaction [Line Items] | ||||
Related party costs | 242,501 | 329,436 | 485,001 | 555,686 |
Stock Based [Member] | ||||
Related Party Transaction [Line Items] | ||||
Related party costs | $ 280,060 | $ 424,094 | $ 557,040 | $ 763,766 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||
Nov. 06, 2022 | Oct. 01, 2022 | May 01, 2021 | Apr. 09, 2021 | Oct. 01, 2020 | Aug. 12, 2020 | Aug. 01, 2020 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jun. 15, 2022 | |
Related Party Transaction [Line Items] | |||||||||||||
Cash board fee payable | $ 100,000 | ||||||||||||
Cash board fee payable | $ 40,000 | ||||||||||||
Share-based payment award, award vesting period | 12.50% | ||||||||||||
Annual cash fee | $ 522,561 | $ 753,530 | $ 1,042,041 | $ 1,319,452 | |||||||||
Stock based compensation | 280,060 | 424,094 | 557,040 | 763,766 | |||||||||
Related Party [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual cash fee | 242,501 | 329,436 | 485,001 | 555,686 | |||||||||
Independent Director [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Stock based compensation | 42,501 | 135,686 | $ 85,001 | 168,186 | |||||||||
New Independent Director [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Options, grants in period, gross | 25,000 | ||||||||||||
Share-based payment award, award vesting period | 50% | ||||||||||||
New Independent Director [Member] | Related Party [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual cash fee | $ 100,000 | ||||||||||||
Annual Grant of Options [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Options, grants in period, gross | 10,000 | ||||||||||||
Share-based payment award, award vesting period | 12.50% | ||||||||||||
Annual Grant of Options [Member] | Related Party [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual cash fee | $ 40,000 | ||||||||||||
Forman [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Compensation | $ 200,000 | ||||||||||||
Paid office rent | $ 1,500 | 1,530 | 4,113 | ||||||||||
Director [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Compensation | $ 20,000 | ||||||||||||
Stock based compensation | 47,049 | $ 0 | |||||||||||
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 | 125,000 | 125,000 | |||||||||
Employment Agreement [Member] | Dr. James S. Miser, M.D [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual salary | $ 150,000 | ||||||||||||
Compensation | 43,750 | 43,750 | 87,500 | 87,500 | |||||||||
Increase in annual salary | $ 175,000 | ||||||||||||
Employment Agreement [Member] | Eric J. Forman [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual salary | $ 120,000 | ||||||||||||
Compensation | 50,000 | 43,750 | 100,000 | 87,500 | |||||||||
Increase in annual salary | 175,000 | ||||||||||||
Employment Agreement [Member] | Chief Operating Officer [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Compensation | $ 200,000 | ||||||||||||
Employment Agreement [Member] | Robert N. Weingarten [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Annual salary | $ 120,000 | ||||||||||||
Compensation | $ 43,750 | $ 43,750 | $ 87,500 | $ 87,500 | |||||||||
Increase in annual salary | $ 175,000 |
Schedule of Fair Value of Each
Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Risk-free interest rate | 4.565% | 3.03% |
Expected dividend yield | 0% | 0% |
Expected volatility | 138.05% | 153.17% |
Expected life | 3 years 6 months | 3 years 6 months |
Summary of Stock-based Compensa
Summary of Stock-based Compensation Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||||
Total stock-based compensation costs | $ 280,060 | $ 424,094 | $ 557,040 | $ 763,766 |
Related Parties [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Total stock-based compensation costs | 280,060 | 424,094 | 557,040 | 763,766 |
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) - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Number of shares, stock options outstanding, at the beginning | 389,479 | |
Weighted average exercise price, stock options outstanding, at the beginning | $ 29.1826 | |
Number of shares, Granted | 40,000 | |
Weighted average exercise price, granted | $ 5.8800 | |
Number of shares, Exercised | (1,250) | |
Weighted average exercise price, exercised | $ 5.0250 | |
Number of shares, Expired | ||
Weighted average exercise price, expired | ||
Number of shares, stock options outstanding, at the end | 428,229 | |
Weighted average exercise price, stock options outstanding, at the end | $ 27.0764 | |
Weighted average remaining contractual life (in years), stock options outstanding | 2 years 9 months 7 days | |
Number of shares, stock options exercisable, at the end | 301,979 | 281,979 |
Weighted average exercise price, stock options exercisable, at the end | $ 31.9708 | $ 32.8335 |
Weighted average remaining contractual life (in years), stock options exercisable | 2 years 9 months |
Schedule of Exercise Prices of
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options Outstanding (Shares) | 428,229 |
Options Exercisable (Shares) | 301,979 |
Exercise Price One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 5.025 |
Options Outstanding (Shares) | 8,750 |
Options Exercisable (Shares) | 8,750 |
Exercise Price Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 5.880 |
Options Outstanding (Shares) | 40,000 |
Options Exercisable (Shares) | |
Exercise Price Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 7.400 |
Options Outstanding (Shares) | 57,500 |
Options Exercisable (Shares) | 36,250 |
Exercise Price Four [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 16.800 |
Options Outstanding (Shares) | 3,333 |
Options Exercisable (Shares) | 3,333 |
Exercise Price Five [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 20 |
Options Outstanding (Shares) | 80,000 |
Options Exercisable (Shares) | 20,000 |
Exercise Price Six [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 20.600 |
Options Outstanding (Shares) | 20,000 |
Options Exercisable (Shares) | 20,000 |
Exercise Price Seven [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 28 |
Options Outstanding (Shares) | 25,000 |
Options Exercisable (Shares) | 25,000 |
Exercise Price Eight [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 30 |
Options Outstanding (Shares) | 66,667 |
Options Exercisable (Shares) | 66,667 |
Exercise Price Nine [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 30.300 |
Options Outstanding (Shares) | 42,500 |
Options Exercisable (Shares) | 42,500 |
Exercise Price Ten [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 32 |
Options Outstanding (Shares) | 20,313 |
Options Exercisable (Shares) | 20,313 |
Exercise Price Eleven [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 32.100 |
Options Outstanding (Shares) | 15,000 |
Options Exercisable (Shares) | 15,000 |
Exercise Price Twelve [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 60 |
Options Outstanding (Shares) | 16,667 |
Options Exercisable (Shares) | 16,667 |
ExercisePriceThirteen [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 66 |
Options Outstanding (Shares) | 4,167 |
Options Exercisable (Shares) | 4,167 |
Exercise Price Fourteen [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 71.400 |
Options Outstanding (Shares) | 20,000 |
Options Exercisable (Shares) | 15,000 |
Exercise Price Fifteen [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 120 |
Options Outstanding (Shares) | 8,332 |
Options Exercisable (Shares) | 8,332 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||||||
Jun. 30, 2023 | Nov. 06, 2022 | Oct. 07, 2022 | Jun. 30, 2022 | Jun. 17, 2022 | Jun. 30, 2021 | May 11, 2021 | Apr. 09, 2021 | Aug. 12, 2020 | Aug. 01, 2020 | Jul. 15, 2020 | Jul. 14, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jun. 06, 2023 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Shares outstanding | 428,229 | 428,229 | 428,229 | 389,479 | |||||||||||||||||
Stock option vested exercisable term | 21 months | ||||||||||||||||||||
Stock based compensation | $ 280,060 | $ 424,094 | $ 557,040 | $ 763,766 | |||||||||||||||||
Number of fully vested option exercisable | 301,979 | 301,979 | 301,979 | 281,979 | |||||||||||||||||
Share based compensation vesting rights, percentage | 12.50% | ||||||||||||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | $ 517,000 | ||||||||||||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 7,500 | $ 7,500 | $ 7,500 | ||||||||||||||||||
Fair market value, per share | $ 5.88 | ||||||||||||||||||||
Outstanding stock options to acquire shares of common stock not vested | 126,250 | ||||||||||||||||||||
Common Stock [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock price per share | $ 57 | $ 57 | 57 | ||||||||||||||||||
Director [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock options description | the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $316,700 ($6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $23,655 and $0, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $47,049 and $0, respectively, with respect to these stock options. | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Fair value of stock options | $ 10,000 | ||||||||||||||||||||
Stock price per share | $ 5.88 | $ 20 | $ 50,000 | $ 6.334 | $ 50,000 | $ 6.334 | $ 5.88 | $ 50,000 | $ 5.88 | $ 50,000 | |||||||||||
Stock based compensation | $ 47,049 | $ 0 | |||||||||||||||||||
Stock options are exercisable price per share | $ 5.025 | ||||||||||||||||||||
Number of fully vested option exercisable | 10,000 | 10,000 | 10,000 | 10,000 | |||||||||||||||||
Director [Member] | Common Stock [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Number of fully vested option exercisable | 20,000 | ||||||||||||||||||||
Five Non Officer Directors [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock options description | the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $30.30 per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $1,421,095 ($28.423 per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $106,290 and $177,150, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $211,412 and $352,355, respectively, with respect to these stock options | ||||||||||||||||||||
Fair value of stock options | $ 43,264 | $ 316,700 | $ 1,421,095 | ||||||||||||||||||
Stock price per share | $ 4.326 | $ 28.423 | $ 28.423 | ||||||||||||||||||
Stock based compensation | $ 106,290 | $ 177,150 | $ 211,412 | $ 352,355 | |||||||||||||||||
Stock options are exercisable price per share | $ 30.30 | $ 30.30 | |||||||||||||||||||
Number of fully vested option exercisable | 10,000 | 10,000 | |||||||||||||||||||
Non Officer Directors [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Number of fully vested option exercisable | 50,000 | 50,000 | |||||||||||||||||||
BasvanderBaan [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock options description | the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341 per share), of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from June 17, 2022 through June 30, 2024. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $9,695 and $80,647, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $19,284 and $80,647, respectively, with respect to these stock options. | ||||||||||||||||||||
Fair value of stock options | $ 158,525 | ||||||||||||||||||||
Stock price per share | $ 6.341 | ||||||||||||||||||||
Stock based compensation | 9,695 | 80,647 | 19,284 | 80,647 | |||||||||||||||||
Stock options are exercisable price per share | $ 7.40 | ||||||||||||||||||||
Number of fully vested option exercisable | 25,000 | ||||||||||||||||||||
Stock options granted to purchase common stock, issued | $ 79,263 | ||||||||||||||||||||
Four Officers [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Fair value of stock options | $ 262,560 | ||||||||||||||||||||
Stock price per share | $ 3.282 | ||||||||||||||||||||
Stock based compensation | $ 16,352 | $ 32,524 | |||||||||||||||||||
Number of fully vested option exercisable | 80,000 | 40,000 | |||||||||||||||||||
Share based compensation vesting rights, percentage | 25% | ||||||||||||||||||||
Share based compensation issuance, percentage | 25% | ||||||||||||||||||||
Stock options granted to purchase common stock, issued | 80,000 | ||||||||||||||||||||
Four Non Officers[Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Fair value of stock options | $ 192,593 | ||||||||||||||||||||
Stock price per share | $ 4.8131 | $ 4.8131 | $ 4.8131 | ||||||||||||||||||
Share based compensation vesting rights, percentage | 12.50% | ||||||||||||||||||||
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 | 5,833 | ||||||||||||||||||||
Stock options description | On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $71.40 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 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $24,985 and $24,985, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $49,695 and $49,695, respectively, with respect to these stock options | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Fair value of stock options | $ 400,855 | ||||||||||||||||||||
Stock price per share | $ 68.718 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | ||||||||||||||||||||
Stock based compensation | $ 24,985 | 24,985 | $ 49,695 | 49,695 | |||||||||||||||||
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 | 8,333 | ||||||||||||||||||||
Stock options description | Dr. James S. Miser, M.D., Dr. Miser was granted stock options to purchase 8,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $71.40 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 ($68.718 per share), of which $143,163 was attributable to the portion of the stock options fully vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 1, 2020 through August 1, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $35,693 and $35,693, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $70,993 and $70,993, respectively, with respect to these stock options | ||||||||||||||||||||
Fair value of stock options | $ 572,650 | ||||||||||||||||||||
Stock price per share | $ 68.718 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 143,163 | ||||||||||||||||||||
Stock based compensation | 35,693 | 35,693 | 70,993 | 70,993 | |||||||||||||||||
Stock options are exercisable price per share | $ 71.40 | ||||||||||||||||||||
Robert N. Weingarten [Member] | Employment Agreement [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock options description | On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable for a period of five years at an exercise price of $71.40 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 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $24,985 and $24,985, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $49,695 and $49,695, respectively, with respect to these stock options | ||||||||||||||||||||
Fair value of stock options | $ 400,855 | ||||||||||||||||||||
Stock price per share | $ 68.718 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | ||||||||||||||||||||
Stock based compensation | 24,985 | 24,985 | 49,695 | 49,695 | |||||||||||||||||
Stock options are exercisable price per share | $ 71.40 | ||||||||||||||||||||
Mr Schwartberg [Member] | Director [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock options description | On April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation. In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $32.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $753,611 ($30.144 per share), of which $376,800 was attributable to the portion of the stock options fully vested on April 9, 2021 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options was being charged to operations ratably from April 9, 2021 through June 30, 2023. However, vesting of these stock options terminated on October 30, 2022, the date that Mr. Schwartzberg died. During the three months and six months ended June 30, 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $42,228 and $83,992, respectively, with respect to these stock options | ||||||||||||||||||||
Fair value of stock options | $ 753,611 | ||||||||||||||||||||
Stock price per share | $ 30.144 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 376,800 | ||||||||||||||||||||
Stock based compensation | 42,228 | 83,992 | |||||||||||||||||||
Stock options are exercisable price per share | $ 32 | ||||||||||||||||||||
Number of fully vested option exercisable | 25,000 | ||||||||||||||||||||
Ms.Regina Brown [Member] | Director [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Stock options description | the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors, Ms. Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $28.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($26.335 per share), of which $329,188 was attributable to the portion of the stock options fully vested on May 11, 2021 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from May 11, 2021 through June 30, 2023. During the three months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $38,405 and $38,405, respectively, with respect to these stock options. During the six months ended June 30, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $76,388 and $76,388, respectively, with respect to these stock options. | ||||||||||||||||||||
Fair value of stock options | $ 658,363 | ||||||||||||||||||||
Stock price per share | $ 26.335 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 329,188 | ||||||||||||||||||||
Stock based compensation | $ 38,405 | $ 38,405 | $ 76,388 | $ 76,388 | |||||||||||||||||
Stock options are exercisable price per share | $ 28 | ||||||||||||||||||||
Number of fully vested option exercisable | 25,000 | ||||||||||||||||||||
2020 Stock Incentive Plan [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Common shares avaliable for issuable | 180,000 | ||||||||||||||||||||
Stock options granted to purchase common stock, issued | 413,333 | ||||||||||||||||||||
Shares outstanding | 300,313 | 300,313 | 300,313 | ||||||||||||||||||
Shares were available for issuance | 113,020 | 113,020 | 113,020 | ||||||||||||||||||
2020 Stock Incentive Plan [Member] | Maximum [Member] | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||
Number of restricted stock issued | 233,333 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 2 Months Ended | 3 Months Ended | 5 Months Ended | 6 Months Ended | ||||||||||||
Jun. 22, 2023 | Apr. 17, 2023 | Nov. 06, 2022 | Oct. 01, 2022 | Jun. 10, 2022 | Apr. 09, 2021 | Feb. 05, 2021 | Aug. 20, 2018 | Sep. 14, 2015 | Dec. 24, 2013 | Aug. 31, 2020 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Contractual commitment | $ 6,389,000 | $ 6,389,000 | $ 6,389,000 | |||||||||||||
Research and development costs | 427,457 | $ 164,810 | 616,542 | $ 623,261 | ||||||||||||
Aggregate commitments expected | 100,000 | 100,000 | 100,000 | |||||||||||||
Forman [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Compensation | $ 200,000 | |||||||||||||||
Paid office rent | $ 1,500 | 1,530 | 4,113 | |||||||||||||
Officer [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Compensation | $ 800,000 | |||||||||||||||
City of Hope [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Aggregate commitments expected | 69,681 | 69,681 | 69,681 | |||||||||||||
Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 147,572 | |||||||||||||||
GEIS [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Amount related to milestone payment | 684,652 | |||||||||||||||
NDA Consulting Corp [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Consulting and advisory fee | $ 4,000 | 4,000 | 4,000 | 8,000 | 8,000 | |||||||||||
Clinical Trial Research Agreement [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Advance amount related to milestone payment | 6,000 | 6,073 | ||||||||||||||
Research and development costs | 12,000 | 9,405 | ||||||||||||||
Clinical Trial Research Agreements [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 143,074 | |||||||||||||||
Other Clinical Agreements [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 1,144,000 | |||||||||||||||
Collaboration Agreement [Member] | GEIS [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 268,829 | 0 | 268,829 | 0 | ||||||||||||
Aggregate commitments expected | 3,536,000 | 3,536,000 | 3,536,000 | |||||||||||||
Collaboration Agreement [Member] | Bio Pharma Works LLC [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Consulting and advisory fee | $ 10,000 | |||||||||||||||
Reimbursed expense | 30,000 | 30,000 | 60,000 | 60,000 | ||||||||||||
Clinical Research Support Agreement [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Aggregate commitments expected | 800,000 | 800,000 | 800,000 | |||||||||||||
Clinical Research Support Agreement [Member] | City of Hope [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 69,001 | 0 | ||||||||||||||
Aggregate commitments expected | 2,433,000 | 2,433,000 | 2,433,000 | |||||||||||||
Total costs | 447,512 | 447,512 | 447,512 | |||||||||||||
Work Order Agreement [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Aggregate commitments expected | 153,000 | 153,000 | 153,000 | |||||||||||||
Total costs | 6,250 | 6,250 | 6,250 | |||||||||||||
Work Order Agreement [Member] | City of Hope [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Advance amount related to milestone payment | 5,687 | 11,235 | 11,240 | 15,735 | ||||||||||||
Research and development costs | $ 335,000 | |||||||||||||||
Aggregate commitments expected | 267,000 | 267,000 | 267,000 | |||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc. [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 4,558 | 6,250 | 7,839 | |||||||||||||
Work cost | $ 153,000 | |||||||||||||||
Percentage of payment through services | 7,200% | |||||||||||||||
Percentage of payment through software | 2,800% | |||||||||||||||
Work Order Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Research and development costs | 10,997 | 20,284 | ||||||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Minimum payments for royalties | 50,000 | |||||||||||||||
Exclusive License Agreement [Member] | Five Years And Thereafter [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Minimum payments for royalties | 100,000 | |||||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Non refundable license issue fee | $ 25,000 | |||||||||||||||
Maintenance fee | 25,000 | |||||||||||||||
Payment on non refundable milestone | $ 1,897,000 | |||||||||||||||
Operating costs and expenses | 6,233 | 6,233 | 12,398 | 12,398 | ||||||||||||
Employment Agreement [Member] | Executive Officers [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Salary and compensation | $ 640,000 | |||||||||||||||
Agreement term description | one-year periods | |||||||||||||||
Employment Agreement [Member] | Dr.James [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Annual compensation | $ 775,000 | |||||||||||||||
Development Collaboration Agreement [Member] | Netherlands Cancer Institute [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Advance amount related to milestone payment | 53,178 | 48,886 | 105,381 | 103,116 | ||||||||||||
Research and development costs | 364,788 | |||||||||||||||
Aggregate commitments expected | 53,000 | $ 53,000 | 53,000 | |||||||||||||
MRI Global [Member] | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Advance amount related to milestone payment | $ 4,010 | $ 19,597 | 7,183 | $ 20,353 | ||||||||||||
Research and development costs | $ 225,924 | |||||||||||||||
Contract price | $ 326,274 | $ 273,980 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
Jul. 24, 2023 | Jul. 20, 2023 | Mar. 10, 2023 | Apr. 12, 2022 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 02, 2023 | |
Subsequent Event [Line Items] | ||||||||
Proceeds from Stock Options Exercised | $ 6,281 | |||||||
Placement Agents [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Warrant exercise price | $ 6.60 | $ 20 | ||||||
Warrants to purchase shares | 35,000 | 29,000 | ||||||
Common Stock [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Shares issued during period | 1,250 | 290,000 | 290,000 | |||||
Warrant exercise price | $ 5.70 | |||||||
Costs of public offering | $ 658,616 | |||||||
Net proceeds from issuance of stock | $ 5,141,384 | |||||||
Warrant [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Shares issued during period | 1,250 | |||||||
Warrant exercise price | $ 5.025 | |||||||
Subsequent Event [Member] | Common Stock [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Shares issued during period | 180,000 | |||||||
Share issued price per share | $ 6 | |||||||
Proceeds from issuance of private placement | $ 3,500,000 | |||||||
Costs of public offering | 375,000 | |||||||
Net proceeds from issuance of stock | $ 3,125,000 | |||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 403,334 | |||||||
Subsequent Event [Member] | Prefunded Warrant [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Shares issued during period | 403,334 | |||||||
Share issued price per share | $ 5.9999 | |||||||
Warrant exercise price | $ 0.0001 | $ 0.0001 | ||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 403,334 | |||||||
Proceeds from Stock Options Exercised | $ 40 | |||||||
Subsequent Event [Member] | Warrant [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Shares issued during period | 583,334 | |||||||
Share issued price per share | $ 6 |