Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2020 | |
Cover [Abstract] | |
Entity Registrant Name | LIXTE BIOTECHNOLOGY HOLDINGS, INC. |
Entity Central Index Key | 0001335105 |
Document Type | S-1/A |
Amendment Flag | true |
Amendment description | Amendment No.3 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business Flag | true |
Entity Emerging Growth Company | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | |||
Cash | $ 1,076,248 | $ 2,598,864 | $ 4,273,012 |
Advances on research and development contract services | 29,792 | ||
Accrued interest receivable | 14,367 | ||
Prepaid insurance | 69,091 | 34,508 | |
Other prepaid expenses and current assets | 13,000 | 24,294 | 61,433 |
Total current assets | 1,188,131 | 2,672,033 | 4,334,445 |
Deferred offering costs | 174,253 | ||
Prepaid expense, less current portion | 2,293 | ||
Total assets | 1,362,384 | 2,672,033 | 4,336,738 |
Current liabilities: | |||
Accounts payable and accrued expenses | 115,518 | 143,549 | 195,211 |
Accrued offering costs | 44,009 | ||
Research and development contract liabilities | 61,931 | 94,349 | 15,704 |
Total current liabilities | 221,458 | 237,898 | 210,915 |
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 - 4,375,000 shares and $50.00 per share cash redemption value; aggregate cash redemption value - $17,500,000; liquidation preference based on assumed conversion into common shares - 4,375,000 shares | 3,500,000 | 3,500,000 | 3,500,000 |
Common stock, $0.0001 par value; authorized - 100,000,000 shares; issued and outstanding - 67,045,814 shares | 6,704 | 6,704 | 6,704 |
Additional paid-in capital | 27,081,063 | 26,016,317 | 25,267,662 |
Accumulated deficit | (29,446,841) | (27,088,886) | (24,648,543) |
Total stockholders' equity | 1,140,926 | 2,434,135 | 4,125,823 |
Total liabilities and stockholders' equity | $ 1,362,384 | $ 2,672,033 | $ 4,336,738 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 67,045,814 | 67,045,814 | 67,045,814 |
Common stock, shares outstanding | 67,045,814 | 67,045,814 | 67,045,814 |
Series A Convertible Preferred Stock [Member] | |||
Preferred stock, shares issued | 350,000 | 350,000 | 350,000 |
Preferred stock, shares outstanding | 350,000 | 350,000 | 350,000 |
Preferred stock, stated value | $ 10 | $ 10 | $ 10 |
Preferred stock, per share redemption price | $ 50 | $ 50 | |
Preferred stock, aggregate cash redemption value | $ 8,750,000 | $ 17,500,000 | $ 17,500,000 |
Preferred stock, issuable upon conversion | 4,375,000 | 4,375,000 | 4,375,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | ||||||
Revenues | ||||||
Costs and expenses: | ||||||
General and administrative costs, including $464,483 and $32,030 to related parties for the three months ended September 30, 2020 and 2019, respectively, and $518,483 and $395,631 to related parties for the nine months ended September 30, 2020 and 2019, respectively, and $362,631 and $833,612 to related parties for the years ended December 31, 2019 and 2018, respectively | 802,273 | 522,360 | 1,350,201 | 1,460,551 | 1,669,160 | 2,097,348 |
Research and development costs, including $670,715 of stock-based compensation costs to consultant for the three months and nine months ended September 30, 2020 | 799,420 | 570,601 | 1,012,038 | 699,038 | 820,906 | 40,703 |
Total costs and expenses | 1,601,693 | 1,092,961 | 2,362,239 | 2,159,589 | 2,490,066 | 2,138,051 |
Loss from operations | (1,601,693) | (1,092,961) | (2,362,239) | (2,159,589) | (2,490,066) | (2,138,051) |
Interest income | 38 | 13,889 | 4,284 | 41,317 | 49,723 | 4,923 |
Net loss | $ (1,601,655) | $ (1,079,072) | $ (2,357,955) | $ (2,118,272) | $ (2,440,343) | $ (2,133,128) |
Net loss per common share - basic and diluted | $ (0.02) | $ (0.02) | $ (0.04) | $ (0.03) | $ (0.04) | $ (0.04) |
Weighted average common shares outstanding - basic and diluted | 67,045,814 | 67,045,814 | 67,045,814 | 67,045,814 | 67,045,814 | 58,796,115 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
General and administrative costs, to related parties | $ 464,483 | $ 32,030 | $ 518,483 | $ 395,631 | $ 362,631 | $ 833,612 |
Stock-based compensation costs | 464,483 | $ 32,030 | 518,483 | $ 395,631 | $ 362,631 | $ 833,612 |
Consultant [Member] | ||||||
Stock-based compensation costs | $ 670,715 | $ 670,715 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Series A Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 3,500,000 | $ 5,802 | $ 20,004,654 | $ (22,515,415) | $ 995,041 |
Balance, shares at Dec. 31, 2017 | 350,000 | 58,025,814 | |||
Sale of common stock | $ 900 | 4,499,100 | 4,500,000 | ||
Sale of common stock, shares | 9,000,000 | ||||
Costs incurred in connection with the sale of common stock units | (24,702) | (24,702) | |||
Exercise of common stock options | $ 2 | 2,998 | $ 3,000 | ||
Exercise of common stock options, shares | 20,000 | 20,000 | |||
Stock-based compensation expense, including $711,738 for extension of stock options to related party | 785,612 | $ 785,612 | |||
Net loss | (2,133,128) | (2,133,128) | |||
Balance at Dec. 31, 2018 | $ 3,500,000 | $ 6,704 | 25,267,662 | (24,648,543) | 4,125,823 |
Balance, shares at Dec. 31, 2018 | 350,000 | 67,045,814 | |||
Stock-based compensation expense | 12,936 | 12,936 | |||
Net loss | (428,736) | (428,736) | |||
Balance at Mar. 31, 2019 | $ 3,500,000 | $ 6,704 | 25,280,598 | (25,077,279) | 3,710,023 |
Balance, shares at Mar. 31, 2019 | 350,000 | 67,045,814 | |||
Balance at Dec. 31, 2018 | $ 3,500,000 | $ 6,704 | 25,267,662 | (24,648,543) | 4,125,823 |
Balance, shares at Dec. 31, 2018 | 350,000 | 67,045,814 | |||
Net loss | (2,118,272) | ||||
Balance at Sep. 30, 2019 | $ 3,500,000 | $ 6,704 | 26,016,317 | (26,766,815) | 2,756,206 |
Balance, shares at Sep. 30, 2019 | 350,000 | 67,045,814 | |||
Balance at Dec. 31, 2018 | $ 3,500,000 | $ 6,704 | 25,267,662 | (24,648,543) | 4,125,823 |
Balance, shares at Dec. 31, 2018 | 350,000 | 67,045,814 | |||
Stock-based compensation expense | 748,655 | 748,655 | |||
Net loss | (2,440,343) | (2,440,343) | |||
Balance at Dec. 31, 2019 | $ 3,500,000 | $ 6,704 | 26,016,317 | (27,088,886) | 2,434,135 |
Balance, shares at Dec. 31, 2019 | 350,000 | 67,045,814 | |||
Balance at Mar. 31, 2019 | $ 3,500,000 | $ 6,704 | 25,280,598 | (25,077,279) | 3,710,023 |
Balance, shares at Mar. 31, 2019 | 350,000 | 67,045,814 | |||
Stock-based compensation expense | 296,665 | 296,665 | |||
Net loss | (610,464) | (610,464) | |||
Balance at Jun. 30, 2019 | $ 3,500,000 | $ 6,704 | 25,577,263 | (25,687,743) | 3,396,224 |
Balance, shares at Jun. 30, 2019 | 350,000 | 67,045,814 | |||
Stock-based compensation expense | 439,054 | 439,054 | |||
Net loss | (1,079,072) | (1,079,072) | |||
Balance at Sep. 30, 2019 | $ 3,500,000 | $ 6,704 | 26,016,317 | (26,766,815) | 2,756,206 |
Balance, shares at Sep. 30, 2019 | 350,000 | 67,045,814 | |||
Balance at Dec. 31, 2019 | $ 3,500,000 | $ 6,704 | 26,016,317 | (27,088,886) | 2,434,135 |
Balance, shares at Dec. 31, 2019 | 350,000 | 67,045,814 | |||
Net loss | (383,175) | (383,175) | |||
Balance at Mar. 31, 2020 | $ 3,500,000 | $ 6,704 | 26,016,317 | (27,472,061) | 2,050,960 |
Balance, shares at Mar. 31, 2020 | 350,000 | 67,045,814 | |||
Balance at Dec. 31, 2019 | $ 3,500,000 | $ 6,704 | 26,016,317 | (27,088,886) | $ 2,434,135 |
Balance, shares at Dec. 31, 2019 | 350,000 | 67,045,814 | |||
Exercise of common stock options, shares | |||||
Net loss | $ (2,357,955) | ||||
Balance at Sep. 30, 2020 | $ 3,500,000 | $ 6,704 | 27,081,063 | (29,446,841) | 1,140,926 |
Balance, shares at Sep. 30, 2020 | 350,000 | 67,045,814 | |||
Balance at Mar. 31, 2020 | $ 3,500,000 | $ 6,704 | 26,016,317 | (27,472,061) | 2,050,960 |
Balance, shares at Mar. 31, 2020 | 350,000 | 67,045,814 | |||
Net loss | (373,125) | (373,125) | |||
Balance at Jun. 30, 2020 | $ 3,500,000 | $ 6,704 | 26,016,317 | (27,845,186) | 1,677,835 |
Balance, shares at Jun. 30, 2020 | 350,000 | 67,045,814 | |||
Stock-based compensation expense | 1,064,746 | 1,064,746 | |||
Net loss | (1,601,655) | (1,601,655) | |||
Balance at Sep. 30, 2020 | $ 3,500,000 | $ 6,704 | $ 27,081,063 | $ (29,446,841) | $ 1,140,926 |
Balance, shares at Sep. 30, 2020 | 350,000 | 67,045,814 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Extension of stock options to related party | $ 711,738 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||||
Net loss | $ (2,357,955) | $ (2,118,272) | $ (2,440,343) | $ (2,133,128) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Stock-based compensation expense included in - General and administrative costs | 394,031 | 314,631 | 314,631 | 785,612 |
Stock-based compensation expense included in - Research and development costs | 670,715 | 434,024 | 434,024 | |
(Increase) decrease in - | ||||
Advances on research and development contract services | (29,792) | |||
Accrued interest receivable | 14,367 | (2,678) | (14,367) | |
Prepaid insurance | (34,583) | (19,296) | ||
Other prepaid expenses and current assets | 11,294 | (3,415) | 4,924 | (1,409) |
Increase (decrease) in - | ||||
Accounts payable and accrued expenses | (28,031) | 78,322 | (51,662) | (116,823) |
Research and development contract liabilities | (32,418) | 20,074 | 78,645 | (45,286) |
Net cash used in operating activities | (1,392,372) | (1,296,610) | (1,674,148) | (1,511,034) |
Cash flows from financing activities: | ||||
Payment of deferred offering costs | (130,244) | |||
Exercise of common stock options | 3,000 | |||
Proceeds from sale of common stock and common stock units | 4,500,000 | |||
Costs incurred in connection with the sale of common stock units | (24,702) | |||
Net cash used in financing activities | (130,244) | 4,478,298 | ||
Cash: | ||||
Net decrease | (1,522,616) | (1,296,610) | (1,674,148) | 2,967,264 |
Balance at beginning of period | 2,598,864 | 4,273,012 | 4,273,012 | 1,305,748 |
Balance at end of period | 1,076,248 | 2,976,402 | 2,598,864 | 4,273,012 |
Supplemental disclosures of cash flow information: | ||||
Interest | ||||
Income taxes | ||||
Noncash investing and financing activities: | ||||
Accrual of deferred offering costs | $ 44,009 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (“Lixte”) (collectively, the “Company”), at September 30, 2020, and for the three months and nine months ended September 30, 2020 and 2019, are unaudited. In the opinion of management of the Company, all adjustments, including normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of September 30, 2020, and the results of its operations for the three months and nine months ended September 30, 2020 and 2019, and its cash flows for the nine months ended September 30, 2020 and 2019. 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, 2019 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, 2019, as filed with the SEC. | 1. Organization and Basis of Presentation Lixte Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (“Lixte”) (collectively, the “Company”), is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital, as described below. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, and is dependent on periodic infusions of equity capital to fund its operating requirements. The Company’s common stock is traded on the OTCQB operated by the OTC Markets under the symbol “LIXT”. Going Concern The Company’s consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future. Furthermore, the Company has experienced recurring operating losses and negative operating cash flows since inception and has financed its working capital requirements during this period primarily through the recurring sale of its equity securities and the exercise of outstanding common stock options and purchase warrants. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the consolidated financial statements are being issued. In addition, the Company’s independent registered public accounting firm, in their report on the Company’s consolidated financial statements for the year ended December 31, 2019, has also expressed substantial doubt about the Company’s ability to continue as a going concern. 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 profits. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. At December 31, 2019, the Company had cash and cash equivalents of $2,598,864 available to fund its operations. Because the Company is currently engaged in Phase 2 clinical trials, it is expected that it will take a significant amount of time to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. In addition, to the extent that the Company is able to generate revenues through licensing its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and operating cash flows. The Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical companies with major programs in cancer. The Company expects that it will need to begin to raise additional capital no later than the fourth quarter of 2020. The amount and timing of future cash requirements will depend on the pace and design of the Company’s clinical trial program. As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, or at all, as and when necessary to continue to conduct operations. There is also significant uncertainty as to the affect that the coronavirus may have on the availability, amount and type of financing in the future. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program and its technology and product development efforts, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain of its compounds, or to discontinue its operations entirely. |
Business
Business | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business | 2. Business The Company is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, and is dependent on periodic infusions of equity capital to fund its operating requirements. Going Concern At September 30, 2020, the Company had cash and cash equivalents of $1,076,248 available to fund its operations. Because the Company is currently engaged in Phase 2 clinical trials, it is expected that it will take a significant amount of time to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. In addition, to the extent that the Company is able to generate revenues through licensing its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and operating cash flows. The Company’s consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future. Furthermore, the Company has experienced recurring operating losses and negative operating cash flows since inception and has financed its working capital requirements during this period primarily through the recurring sale of its equity securities and the exercise of outstanding common stock options and purchase warrants. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the consolidated financial statements are being issued. In addition, the Company’s independent registered public accounting firm, in their report on the Company’s consolidated financial statements for the year ended December 31, 2019, has also expressed substantial doubt about the Company’s ability to continue as a going concern. 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 Company’s consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. The amount and timing of future cash requirements depends on the pace and design of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities. If the Company is able to complete the proposed public offering as discussed below in the approximate amount indicated, the Company estimates that such funding would provide sufficient working capital resources to fund the Company’s clinical trial program with respect to the development of its lead anti-cancer clinical compound LB-100 through at least December 2022. If the Company is not able to complete the proposed public offering as discussed below, the Company would attempt to raise additional capital to fund its clinical trial program through alternative financing sources. As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, as and when necessary to continue to conduct operations. There is also significant uncertainty as to the effect that the coronavirus may have on the Company’s clinical trial schedule and the amount and type of financing available to the Company in the future. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its 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. Proposed Public Offering and Listing on The Nasdaq Capital Market On November 2, 2020, the Company filed Amendment No. 2 to its Registration Statement on Form S-1 with the SEC to register and sell newly-issued shares of common stock in an underwritten public offering, currently estimated to generate gross proceeds of approximately $9,375,000, to fund the Company’s operating capital requirements for at least the next two years. However, there can be no assurances that such public offering will be completed, or that if completed, that such public offering will generate gross proceeds of approximately $9,375,000. On October 21, 2020, the Company’s application to have its shares of common stock listed for trading on The Nasdaq Capital Market under the symbol “LIXT” was approved, subject to notice of issuance of the shares in the public offering. Reverse Stock Split On July 14, 2020, the Board of Directors of the Company approved a 1-for-6 reverse split of the Company’s outstanding shares of common stock. Holders of a majority of shares of the Company’s common stock have provided their consent for such reverse stock split. The Company intends to implement such reverse stock split upon receiving regulatory approval for such action, and concurrently with the completion of the public offering. All common share and per share amounts presented herein are on a pre-split basis. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Principles of Consolidation The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash and Cash Equivalents Cash and cash equivalents include cash and short-term certificates of deposit. The Company maintains its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”). The Company may periodically have cash balances in banks in excess of FDIC insurance limits. The Company has not experienced any losses to date resulting from this practice. Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition, design, development and testing of the Company’s compounds and product candidates. Research and development costs also include costs to produce the compounds used in research and clinical trials. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the agreement. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations to date. Such amortization is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy periods. As the policy premiums incurred are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and amortized to the Company’s consolidated statement of operations for each reporting period. As of September 30, 2020, total insurance policy premiums, in excess of premiums paid to date, amounted to $261,625, and will be payable with interest at 5.27% per annum, in nine monthly installments of $29,767 through June 2021. As of December 31, 2019, there was no unpaid insurance premium obligation. Deferred Offering Costs Deferred offering costs consist of payments with respect to pending equity financing transactions, including legal fees. Such costs are deferred and charged to additional paid-in capital upon the successful completion of such financings, or will be charged to operations if such financings are abandoned or terminated. Patent and Licensing Related Legal and Filing 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-related legal and filing fees and licensing-related legal fees are charged to operations as incurred. Patent and licensing-related legal and filing costs were $163,987 and $362,755 for the three months ended September 30, 2020 and 2019, and $440,899 and $672,661 for the nine months ended September 30, 2020 and 2019, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs in the Company’s consolidated statements of operations. Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10% or more of general and administrative costs or research and development costs for the three months and nine months ended September 30, 2020 and 2019 is described as follows. General and administrative costs for the three months ended September 30, 2020 and 2019 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 20.4% and 69.4%, respectively, of total general and administrative costs for those periods. General and administrative costs for the three months ended September 30, 2020 also includes charges for the amortized value of stock options granted to three corporate officers representing 49.1% of total general and administrative costs for that period. General and administrative costs for the nine months ended September 30, 2020 and 2019 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 32.7% and 46.1%, respectively, of total general and administrative costs for those periods. General and administrative costs for the nine months ended September 30, 2020 also includes charges for the amortized value of stock options granted to three corporate officers representing 29.2% of total general and administrative costs for that period. Research and development costs for the three months ended September 30, 2020 include charges from a consultant, and the value associated with extending stock options previously granted to that consultant, representing 87.7% of total research and development costs for that period. Research and development costs for the three months ended September 30, 2019 include charges for the value associated with fully vested stock options granted to a consultant representing 76.1% of total research and development costs, and charges from a vendor representing 15.3% of total research and development costs, respectively, for that period. Research and development costs for the nine months ended September 30, 2020 include charges from a consultant, and the value extending stock options previously granted to that consultant, representing 75.2% of total research and development costs for that period. Research and development costs for the nine months ended September 30, 2019 include charges for the value of fully vested stock options granted to a consultant representing 62.1% of total research and development costs, and charges from a consultant and from a vendor representing 12.5% and 10.0% of total research and development costs, respectively, for that period. 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. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of September 30, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to September 30, 2020. The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of September 30, 2020 or December 31, 2019. Subsequent to September 30, 2020, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members contractors and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the estimated 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 Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At September 30, 2020 and 2019, 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. September 30, 2020 2019 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 9,000,000 Common stock options, including options issued in the form of warrants 9,050,000 8,050,000 Total 22,425,000 21,425,000 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 cash and cash equivalents, and 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 June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 significantly changes how entities measure credit losses for most financial assets, including accounts and notes receivables. ASU 2016-13 will replace the current “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the provisions of ASU 2016-13 as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which ASU 2016-13 is effective. ASU 2016-13 will be effective for the Company for interim and annual reporting periods beginning after December 15, 2022. Management is currently in the process of assessing the impact of the adoption of ASU-2016-13 on the Company’s consolidated financial statement presentation and disclosures subsequent to its adoption. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 is effective for interim and annual reporting periods beginning after December 15, 2020. The adoption of ASU 2019-12 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption. In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 will simplify the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract as compared with current GAAP. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 will be effective for public companies for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Management has not yet evaluated the effect that the adoption of ASU 2020-06 will have on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption. 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. | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash and Cash Equivalents Cash and cash equivalents include cash and short-term certificates of deposit. The Company maintains its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”). The Company may periodically have cash balances in banks in excess of FDIC insurance limits. The Company has not experienced any losses to date resulting from this practice. Research and Development Research and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the acquisition, design, development and testing of the Company’s compounds and product candidates. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. Patent and Licensing Related Legal and Filing 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-related legal and filing fees and licensing-related legal fees are charged to operations as incurred. Patent and licensing-related legal and filing costs were $742,918 and $842,325 for the years ended December 31, 2019 and 2018, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs in the Company’s consolidated statements of operations. Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s research and development activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task. The only such contract that represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2019 and 2018 is described below. As discussed at Note 7, effective as of July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with GEIS to carry out a clinical trial entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma”. The Company estimates that this clinical trial will be completed and results will be published by June 2023. Costs incurred pursuant to the agreement with GEIS are included in research and development costs in the Company’s consolidated statements of operations. During the year ended December 31, 2019, the Company incurred costs of $87,471 pursuant to this agreement, reflecting 10.7% of total research and development costs for such period. 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 has elected to deduct research and development costs on a current basis for federal income tax purposes. For federal tax purposes, start-up and organization costs were deferred until January 1, 2008, at which time the Company began to amortize such costs over a 180-month period. 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. Likewise, 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 December 31, 2019 and 2018 and does not anticipate any material amount of unrecognized tax benefits within the next 12 months. 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. As of December 31, 2019, the Company had not recorded any liability for uncertain tax positions. In subsequent periods, 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, Scientific Advisory Committee members 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. Through December 31, 2018, the Company accounted for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The Company accounted for stock-based payments to Scientific Advisory Committee members and consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment was reached or (b) at the date at which the necessary performance to earn the equity instruments was complete. In accordance with the Company’s adoption of Accounting Standards Update 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (see “Recent Accounting Pronouncements” below), effective January 1, 2019, stock options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are now accounted for consistent with the accounting for stock-based payments to officers and directors, as described above, by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the life of the equity award, 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. Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a one-year look-back period, as the Company believes that such measurement period provides a more accurate and meaningful volatility factor given the changes in the Company’s research and development program and capital requirements over the past several years. 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 Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At December 31, 2019 and 2018, 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. December 31, 2019 2018 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 9,000,000 Common stock options, including options issued in the form of warrants 7,850,000 7,750,000 Total 21,225,000 21,125,000 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 cash and cash equivalents, and 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 Recently Adopted Accounting Standards In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Revenue from Contracts with Customers (Topic 606). ASU 2018-07 was effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted the provisions of ASU 2018-07 effective January 1, 2019 (see “Stock-Based Compensation” above). The adoption of ASU 2018-07 did not have any impact on the Company’s financial statement presentation or disclosures subsequent to its adoption. Recently Issued Accounting Standards In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The adoption of ASU 2018-07 is not expected to have any impact on the Company’s financial statement presentation or disclosures subsequent to its adoption. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Equity [Abstract] | ||
Stockholders' Equity | 4. Stockholders’ Equity Preferred Stock The Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share. On March 17, 2015, the Company filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock with the Delaware Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written consent of a majority of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the, Preferences, Rights and Limitations. The holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividend equal to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. As of September 30, 2020 and December 31, 2019, 9,650,000 shares of preferred stock were undesignated and may be issued with such rights and powers as the Board of Directors may designate. Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 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. The Series A Convertible Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred Stock does not have a cash liquidation preference. If fully converted, the 350,000 outstanding shares of Series A Convertible Preferred Stock would convert into 4,375,000 shares of common stock at September 30, 2020 and December 31, 2019. The Company has the right to redeem the Series A Convertible Preferred Stock up to the fifth anniversary of their respective closing dates (March 17, 2015 and January 21, 2016) at a price per share equal to $50.00. Accordingly, as of September 30, 2020, the Company has the right to redeem the 175,000 shares of Series A Convertible Preferred Stock that were issued on January 21, 2016 at an aggregate cash redemption value of $8,750,000. The Series A Convertible Preferred Stock has no right to cash, except with respect to the payment of the aforementioned dividend based on the generation of revenues by the Company. The shares of Series A Convertible Preferred Stock do not have any registration rights. Based on the attributes of the Series A Convertible Preferred Stock as previously described, the Company determined to account 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 shares of common stock, par value $0.0001 per share. As of September 30, 2020 and December 31, 2019, the Company had 67,045,814 shares of common stock issued and outstanding. Common Stock Warrants A summary of common stock warrant activity during the nine months ended September 30, 2020 is presented below. Number of Shares Weighted Average Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2019 9,000,000 $ 1.000 Issued — — Exercised — — Expired — — Warrants outstanding at September 30, 2020 9,000,000 $ 1.000 2.42 At September 30, 2020, all outstanding warrants are exercisable at $1.000 per common share. Based on a fair market value of $1.17 per share on September 30, 2020, the intrinsic value attributable to exercisable but unexercised in-the-money common stock warrants on that date was $1,530,000. Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 6. | 3. Stockholders’ Equity Preferred Stock The Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share. On March 17, 2015, the Company filed a Certificate of Designations, Preferences, Rights and Limitations (the “Certificate of Designations”) of its Series A Convertible Preferred Stock with the Delaware Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written consent of a majority of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the Certificate of Designations. The holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividend equal to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. As of December 31, 2019, 9,650,000 shares of preferred stock were undesignated and may be issued with such rights and powers as the Board of Directors may designate. Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 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. The Series A Convertible Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred Stock does not have a cash liquidation preference. If fully converted, the 350,000 outstanding shares of Series A Convertible Preferred Stock would convert into 4,375,000 shares of common stock at December 31, 2019. The Company has the right to redeem the Series A Convertible Preferred Stock up to the fifth anniversary of their respective closing dates (March 17, 2015 and January 21, 2016) at a price per share equal to $50.00. The Series A Convertible Preferred Stock has no right to cash, except with respect to the payment of the aforementioned dividend based on the generation of revenues by the Company, and does not have any registration rights. Based on the attributes of the Series A Convertible Preferred Stock described above, the Company has determined to account 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 shares of common stock (par value $0.0001). As of December 31, 2019 and 2018, the Company had 67,045,814 shares of common stock issued and outstanding. Effective November 30, 2018, the Company raised $4,500,000 through the sale to sixteen accredited investors of 9,000,000 units at a purchase price of $0.50 per unit. Each unit consisted of one share of common stock and one four-year warrant to purchase one share of common stock at an exercise price of $1.00 per share. Accordingly, a total of 9,000,000 shares of common stock and warrants to purchase 9,000,000 shares of common stock were issued by the Company. The warrants do not have any reset provisions. Common Stock Warrants A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, during the years ended December 31, 2019 and 2018 is presented below. Number of Shares Weighted Average Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2017 — $ — Issued 9,000,000 1.000 Exercised — — Expired — — Warrants outstanding at December 31, 2018 9,000,000 $ 1.000 Issued — — Exercised — — Expired — — Warrants outstanding at December 31, 2019 9,000,000 $ 1.000 2.92 At December 31, 2019, all outstanding warrants are exercisable at $1.000 per common share. Based on a fair market value of $0.68 per share on December 31, 2019, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at December 31, 2019. Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 5. |
Related Party Transactions
Related Party Transactions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Related Party Transactions [Abstract] | ||
Related Party Transactions | 5. Related Party Transactions The Company’s principal office facilities are being provided without charge by Dr. John S. Kovach, the President and Chief Executive Officer. Such costs were not material to the consolidated financial statements and accordingly, have not been reflected therein. The Company’s Chairman and major stockholder, Dr. John Kovach, was paid a salary of $15,000 for the three months ended September 30, 2020 and 2019, and $45,000 for the nine months ended September 30, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s consolidated statements of operations. In September 2007, the Company entered into a consulting agreement with Gil Schwartzberg for Mr. Schwartzberg to provide financial advisory and consulting services to the Company with respect to financing matters, capital structure and strategic development, and to assist management in communications with investors and stockholders. In January 2014 and August 2018, the Company entered into respective amendments to this consulting agreement, which have extended the consulting agreement through January 28, 2024. Consideration under this consulting agreement, including amendments, has been paid exclusively in the form of stock options. Mr. Schwartzberg is currently a significant stockholder of the Company and continues to be a consultant to the Company. Legal and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $14,000 and $12,000 for the three months ended September 30, 2020 and 2019, respectively, and $38,000 and $36,000 for the nine months ended September 30, 2020 and 2019, respectively. Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the Company, and is the son of Dr. Stephen Forman, who was elected to the Company’s Board of Directors on May 13, 2016. Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, where the Company maintains a continuing banking relationship.. A summary of related party costs for the three months and nine months ended September 30, 2020 and 2019 is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Related party costs: Cash-based $ 70,452 $ 27,000 $ 124,452 $ 81,000 Stock-based 394,031 5,030 394,031 314,631 Total $ 464,483 $ 32,030 $ 518,483 $ 395,631 Stock-based compensation arrangements involving members of the Company’s Board of Directors. officers and affiliates are described at Note 6. Additional information with respect to cash-based compensation arrangements are described at Note 7. | 4. Related Party Transactions The Company’s Chairman and major stockholder, Dr. John Kovach, was paid a salary of $60,000 for the years ended December 31, 2019 and 2018, respectively, which amounts are included in general and administrative costs in the Company’s consolidated statements of operations. On September 12, 2007, the Company entered into a consulting agreement with Gil Schwartzberg for Mr. Schwartzberg to provide financial advisory and consulting services to the Company with respect to financing matters, capital structure and strategic development, and to assist management in communications with investors and shareholders. Mr. Schwartzberg is currently a significant stockholder of the Company and continues to be a consultant to the Company. Consideration under this consulting agreement, including subsequent extensions, has been paid exclusively in the form of stock options. On January 28, 2014, the Company entered into a second amendment to its consulting agreement with Mr. Schwartzberg to extend such agreement to January 28, 2019. In conjunction with such amendment, the Company granted Mr. Schwartzberg stock options to purchase an additional 4,000,000 shares of common stock, exercisable at $0.50 per share for a period of the earlier of five years from the grant date or the termination of the consulting agreement, with one-half of the stock options (2,000,000 shares) vesting immediately and one-half of the stock options (2,000,000 shares) vesting on January 28, 2015. Stock-based compensation expense with respect to the grant of the stock options to purchase the 4,000,000 shares of common stock was previously charged to general and administrative costs in the consolidated statement of operations over the vesting period. On August 2, 2018, the Company entered into a third amendment to its consulting agreement with Mr. Schwartzberg to extend it to January 28, 2024, which was approved by the Company’s Board of Directors. In conjunction with such amendment, the Company extended the expiration date of the fully vested stock options for 4,000,000 shares of common stock previously granted to Mr. Schwartzberg, from January 28, 2019 to January 28, 2024. The fair value of the extension of these vested stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured for accounting purposes as the difference in the fair value of the stock options immediately before and immediately after the extension date, and was determined to be $711,738 ($0.1779 per share), which was reflected as a charge to general and administrative costs in the consolidated statement of operations for the year ended December 31, 2018. Legal and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $48,000 for the years ended December 31, 2019 and 2018, respectively. Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the Company, and is the son of Dr. Stephen Forman, who was elected to the Company’s Board of Directors on May 13, 2016. Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, where the Company maintains a continuing banking relationship. A summary of related party costs for the years ended December 31, 2019 and 2018 is as follows: Years Ended December 31, 2019 2018 Related party costs: Cash-based $ 48,000 $ 48,000 Stock-based 314,631 785,612 Total $ 362,631 $ 833,612 Stock-based compensation arrangements involving members of the Company’s Board of Directors and affiliates are described at Note 5. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Stock-Based Compensation | 6. Stock-Based Compensation The Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees, contractors and consultants of the Company. On June 20, 2007, the Board of Directors of the Company approved the 2007 Stock Compensation Plan (the “2007 Plan”), which provided for the granting of awards, consisting of stock options, stock appreciation rights, performance shares, and restricted shares of common stock, to employees and consultants, for up to 2,500,000 shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors. The 2007 Plan terminated on June 19, 2017. As of September 30, 2020, unexpired stock options for 1,250,000 shares were issued and outstanding under the 2007 Plan. On July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates for up to 14,000,000 shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors. The fair value of each stock option awarded 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 expected volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the estimated life of the stock option being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of the common stock is determined by reference to the quoted market price of the common stock on the grant date. For stock options requiring an assessment of value during the nine months ended September 30, 2020, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 0.23% to 0.31 % Expected dividend yield 0 % Expected volatility 207.67 % Expected life 4 to 5 years For stock options requiring an assessment of value during the nine months ended September 30, 2019, 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 1.47% to 1.85 % Expected dividend yield 0 % Expected volatility 133.01% to 171.87 % Expected life 4 years Effective August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted stock options to each of Dr. Winson Sze Chun Ho and Dr. Yun Yen to purchase an aggregate of 200,000 shares of the Company’s common stock, exercisable for a period of five years from the vesting date at $0.28 per share, which was the approximate fair market value of the Company’s common stock on such date, with one-half of such stock options (100,000 shares for each director) vesting on August 4, 2018 and the remaining one-half of such stock options (100,000 shares for each director) vesting on August 4, 2019. The aggregate fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $104,920 ($0.2623 per share), of which $101,475 was attributable to the stock options fully-vested on August 4, 2018 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 August 4, 2018 through August 4, 2019. During the three months and nine months ended September 30, 2019, the Company recorded a charge to operations of $5,030 and $31,046, respectively, with respect to these stock options. Effective May 22, 2019, in recognition with their service as directors of the Company over the past year, the Company granted to each of Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman, and Dr. Philip Palmedo, fully-vested stock options to purchase an aggregate of 200,000 shares (50,000 shares for each director) of the Company’s common stock, exercisable for a period of five years from the vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $189,060 ($0.9453 per share), which was charged to operations on the grant date. Effective May 22, 2019, in recognition of his continuing service as consultant to the Company, the Company granted to Eric Forman fully-vested stock options to purchase 100,000 shares of the Company’s common stock, exercisable for a period of five years from the vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $94,525 ($0.9453 per share), which was charged to operations on the grant date. Effective July 23, 2019, the Company granted Francis Johnson, a consultant to the Company, fully vested stock options to purchase 500,000 shares of the Company’s common stock in recognition of Mr. Johnson’s continuing contributions to the development of the Company’s proprietary compounds. The stock options are exercisable for a period of five years from the date of grant at $1.00 per share, which was the fair market value of the Company’s common stock on the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $434,024 ($0.8680 per share), which was attributable to the stock options fully vested on July 23, 2019 and was therefore charged to operations on that date. Effective September 14, 2015, in connection with the Collaboration Agreement with BioPharmaWorks as described at Note 7, the Company issued to BioPharmaWorks two stock options, in the form of warrants, to purchase 1,000,000 shares (500,000 shares per warrant) of the Company’s common stock. The first warrant vested on September 14, 2016 and was exercisable for a period of five years from the date of grant at $1.00 per share. The second warrant vested on September 14, 2017 and was exercisable for a period of five years from the date of grant at $2.00 per share. On July 3, 2020, the Company’s Board of Directors approved an extension of the term of the outstanding warrants to acquire an aggregate of 1,000,000 shares of the Company’s common stock from September 14, 2020 to September 14, 2025. The Company’s closing stock price on July 2, 2020 was $0.90 per share. The fair value of the extension of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured for accounting purposes as the difference in the fair value of the stock options immediately before and immediately after the extension date, and was determined to be $670,715 ($0.6707 per share), which was reflected as a charge to general and administrative costs in the consolidated statement of operations on that date. On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric Forman, Mr. Forman was granted options for 350,000 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of 5 years and an exercise price of $1.19 per share, which was equal to the closing price of the Company’s common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($1.1453 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $113,667 with respect to these stock options. On August 1, 2020, in connection with an employment agreement entered into with Dr. James Miser, M.D., Dr. Miser was granted options for 500,000 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $1.19 per share, which was equal to the closing price of the Company’s common stock on the effective date of the employment agreement. The options vested as to 25% on the effective date, and will vest 25% on each of the first, second and third anniversaries of the effective date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($1.1453 per share), of which $143,163 was attributable to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $166,697 with respect to these stock options. On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 350,000 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of 5 years and an exercise price of $1.19 per share, which was equal to the closing price of our common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($1.1453 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $113,667, with respect to these stock options. A summary of stock-based compensation costs for the three months and nine months ended September 30, 2020 and 2019 is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Related parties $ 394,031 $ 5,030 $ 394,031 $ 314,631 Non-related parties 670,715 434,024 670,715 434,024 Total stock-based compensation costs $ 1,064,746 $ 439,054 $ 1,064,746 $ 748,655 A summary of stock option activity, including options issued in the form of warrants, during the nine months ended September 30, 2020 is presented below. Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2019 7,850,000 $ 0.608 Granted 1,200,000 1.190 Exercised — — Expired — — Stock options outstanding at September 30, 2020 9,050,000 $ 0.685 3.27 Stock options exercisable at September 30, 2020 8,150,000 $ 0.629 3.10 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $980,000 at September 30, 2020, which will be recognized subsequent to September 30, 2020 over a weighted-average period of approximately thirty-four months. The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at September 30, 2020 are as follows: Exercise Options Options $ 0.120 450,000 450,000 $ 0.150 300,000 300,000 $ 0.160 200,000 200,000 $ 0.200 500,000 500,000 $ 0.280 400,000 400,000 $ 0.500 4,200,000 4,200,000 $ 1.000 1,000,000 1,000,000 $ 1.100 300,000 300,000 $ 1.190 1,200,000 300,000 $ 2.000 500,000 500,000 9,050,000 8,150,000 The intrinsic value of exercisable but unexercised in-the-money stock options at September 30, 2020 was approximately $5,496,500, based on a fair market value of $1.17 per share on September 30, 2020. Outstanding options to acquire 900,000 shares of the Company’s common stock had not vested at September 30, 2020. The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. | 5. Stock-Based Compensation The Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of independent contractors and consultants of the Company. On June 20, 2007, the Board of Directors of the Company approved the 2007 Stock Compensation Plan (the “2007 Plan”), which provided for the granting of awards, consisting of stock options, stock appreciation rights, performance shares, and restricted shares of common stock, to employees and independent contractors, for up to 2,500,000 shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors. The 2007 Plan terminated on June 19, 2017. As of December 31, 2019, unexpired stock options for 1,250,000 shares were issued and outstanding under the 2007 Plan. The fair value of each stock option awarded 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 expected volatility is based on the historical volatility of the Company’s common stock. The expected life of the stock option is considered its full contractual term. The fair market value of the common stock is determined by reference to the quoted market price of the common stock on the grant date. For stock options requiring an assessment of value during the year ended December 31, 2019, 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 1.47% to 1.85 % Expected dividend yield 0 % Expected volatility 133.01% to 171.87 % Expected life 5 years For stock options requiring an assessment of value during the year ended December 31, 2018, 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 2.44% to 3.01 % Expected dividend yield 0 % Expected volatility 170.32 % Expected life 0.5 to 5.5 years Effective August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted stock options to each of Dr. Winson Sze Chun Ho and Dr. Yun Yen to purchase an aggregate of 200,000 shares of the Company’s common stock, exercisable for a period of five years from the vesting date at $0.28 per share, which was the approximate fair market value of the Company’s common stock on such date, with one-half of such stock options (100,000 shares for each director) vesting on August 4, 2018 and the remaining one-half of such stock options (100,000 shares for each director) vesting on August 4, 2019. The aggregate fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $104,920 ($0.2623 per share), of which $52,460 was attributable to the stock options fully-vested on August 4, 2018 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 August 4, 2018 through August 4, 2019. During the years ended December 31, 2019 and 2018, the Company recorded charges to operations of $31,046 and $73,874, respectively, with respect to these stock options. Effective May 22, 2019, in recognition with their service as directors of the Company over the past year, the Company granted to each of Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman, and Dr. Philip Palmedo, fully-vested stock options to purchase an aggregate of 200,000 shares (50,000 shares for each director) of the Company’s common stock, exercisable for a period of five years from the vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $189,060 ($0.9453 per share), which was charged to operations on the grant date. Effective May 22, 2019, in recognition of his continuing service as consultant to the Company, the Company granted to Eric Forman fully-vested stock options to purchase 100,000 shares of the Company’s common stock, exercisable for a period of five years from the vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $94,525 ($0.9453 per share), which was charged to operations on the grant date. Effective July 23, 2019, the Company granted Francis Johnson, a consultant to the Company, fully vested stock options to purchase 500,000 shares of the Company’s common stock in recognition of Mr. Johnson’s continuing contributions to the development of the Company’s proprietary compounds. The stock options are exercisable for a period of five years from the date of grant at $1.00 per share, which was the fair market value of the Company’s common stock on the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $434,024 ($0.8680 per share), which was attributable to the stock options fully vested on July 23, 2019 and was therefore charged to operations on that date. A summary of stock-based compensation costs for the years ended December 31, 2019 and 2018 is as follows: Years Ended December 31, 2019 2018 Related parties $ 314,631 $ 785,612 Non-related parties 434,024 — Total stock-based compensation costs $ 748,655 $ 785,612 A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2019 and 2018 is presented below. Weighted Weighted Number of Average Contractual Shares Exercise Price Life (in Years) Stock options outstanding at December 31, 2017 7,470,000 $ 0.545 Granted 400,000 0.280 Exercised (20,000 ) 0.150 Expired (100,000 ) 0.130 Stock options outstanding at December 31, 2018 7,750,000 0.583 Granted 800,000 1.038 Exercised — — Expired (700,000 ) 0.321 Stock options outstanding at December 31, 2019 7,850,000 $ 0.608 3.14 Stock options exercisable at December 31, 2018 7,550,000 $ 0.545 Stock options exercisable at December 31, 2019 7,850,000 $ 0.608 3.14 There was no deferred compensation expense for the outstanding value of unvested stock options at December 31, 2019. The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31, 2019 are as follows: Exercise Options Options $ 0.120 450,000 450,000 $ 0.150 300,000 300,000 $ 0.160 200,000 200,000 $ 0.200 500,000 500,000 $ 0.280 400,000 400,000 $ 0.500 4,200,000 4,200,000 $ 1.000 1,000,000 1,000,000 $ 1.100 300,000 300,000 $ 2.000 500,000 500,000 7,850,000 7,850,000 The intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2019 was approximately $1,664,950, based on a fair market value of $0.68 per share on December 31, 2019. All outstanding options to acquire shares of the Company’s common stock were vested at December 31, 2019. The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are summarized below. December 31, 2019 2018 Start-up and organization costs $ 10,000 $ 14,000 Research credits 359,000 351,000 Stock-based compensation 799,000 626,000 Net operating loss carryforwards 4,879,000 4,395,000 Total deferred tax assets 6,047,000 5,386,000 Valuation allowance (6,047,000 ) (5,386,000 ) Net deferred tax assets $ — $ — In assessing the potential realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during the periods in which those temporary differences become deductible. As of December 31, 2019 and 2018, management was unable to determine if it is more likely than not that the Company’s deferred tax assets will be realized and has therefore recorded an appropriate valuation allowance against deferred tax assets at such dates. No federal tax provision has been provided for the years ended December 31, 2019 and 2018 due to the losses incurred during such periods. The reconciliation below presents the difference between the income tax rate computed by applying the U.S. federal statutory rate and the effective tax rate for the years ended December 31, 2019 and 2018. Years Ended December 31, 2019 2018 U. S. federal statutory tax rate (21.0 )% (21.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 1.2 % 0.2 % Adjustment to deferred tax asset (0.3 )% (1.3 )% Change in valuation allowance 26.1 % 28.1 % Effective tax rate 0.0 % 0.0 % At December 31, 2019, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately $17,088,000 and $17,987,000, respectively. Federal net operating losses, if not utilized earlier, expire through 2039. The state net operating loss carryovers were incurred solely in New York. New York tax law requires New York net operating loss carryovers from years prior to 2015 to be converted, by applying a formula, into a Prior Net Operating Loss Conversion (PNOLC) subtraction pool. The Company may utilize up to 1/10 of the PNOLC subtraction pool, or $928,367 each year. Unutilized PNOLC amounts carry forward to succeeding years until they expire in 2035. In addition, the full New York net operating losses incurred in post-2015 tax years may be utilized in future tax years. Post-2015 New York net operating losses expire through 2039. As the Company’s net operating losses have yet to be utilized, all previous tax years since 2006 remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Commitments and Contingencies | 7. Commitments and Contingencies Legal Claims The Company may be subject to legal claims and actions from time to time as part of its business activities. As of September 30, 2020, the Company was not subject to any pending or threatened legal claims or actions. Clinical Trial Agreements Moffitt. In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application (“IND”) to conduct a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilizes LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy. The bone marrow cells of patients with del5qMDS are deficient in PP2A by virtue of an acquired mutation and are especially vulnerable to further inhibition of PP2A by LB-100. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. A total enrollment of 41 patients is planned. An interim analysis will be done after the first 21 patients are entered. If there are 3 or more responders but fewer than 7, an additional 20 patients will be entered. If at any point there are 7 or more responders, this will be sufficient evidence to support continued development of LB-100 for the treatment of low and intermediate-1 risk MDS. Recruitment has been slow and the Covid-19 pandemic has further reduced recruitment of patients into the protocol. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. However, with additional funds, the Company’s objective would be to add two additional MDS centers to the Phase 2 portion of the study to accelerate patient accrual, with the goal of an earlier reporting date. During the three months ended September 30, 2020 and 2019, the Company paid Moffitt $10,643 and $9,996, respectively, pursuant to this agreement. During the nine months ended September 30, 2020 and 2019, the Company paid Moffitt $36,008 and $23,249, respectively, pursuant to this agreement. As of September 30, 2020, total costs of $81,101 have been incurred pursuant to this agreement. GEIS. GEIS has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as well as to provide funding for the clinical trial. The goal was to enter the first patient during the quarter ending December 31, 2020, with approximately 150 patients to be enrolled over two years. 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 about half 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 body known as the Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or “AEMPS”) advised the Company that although it had approved the scientific and ethical basis of the protocol, it required that the Company manufacture a new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These regulations were adopted subsequent to the production of the Company’s existing LB-100 inventory. The Company is in the process of determining how soon new inventory of LB-100 meeting Spanish specifications can be produced. Accordingly, the clinical trial is now estimated to begin during the quarter ending September 30, 2021 and to be completed by the quarter ending September 30, 2024. The interim analysis expected in June 2023 could indicate either inferiority or superiority of the LB-100 plus doxorubicin arm 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. On February 18, 2020, the Company advanced $43,411 to GEIS towards a second milestone payment obligation of $87,471, which was expected to become due and payable during the quarter ended June 30, 2020 based on the anticipated achievement of the second milestone, and which was therefore recorded as an advance on the Company’s balance sheet at March 31, 2020. However, as a result of the substantial delay in commencing the clinical trial as described above, the achievement of the second milestone has been delayed until mid-2021 and the Company therefore determined to charge such advance to research and development costs in the Company’s statement of operations at June 30, 2020. Accordingly, during the three months ended September 30, 2020 and 2019, the Company incurred costs of $0 and $87,471, respectively, and during the nine months ended September 30, 2020 and 2019, the Company incurred costs of $43,411 and $87,471, respectively, pursuant to this agreement. As of September 30, 2020, total costs of $130,882 have been incurred pursuant to this agreement. The Company’s aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to date under these agreements, totaled approximately $5,049,000 as of September 30, 2020, consisting of approximately $4,428,000 relating to the GEIS clinical trial and approximately $621,000 relating to the Moffit clinical trial, which are expected to be incurred over the next five years through June 30, 2025. Clinical Trial Monitoring Agreements On September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc., an international contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs. The costs of the Phase 1b/2 clinical trial being paid to or through Theradex are being recorded and charged to operations based on the periodic documentation provided by the CRO. During the three months ended September 30, 2020 and 2019, the Company incurred costs of $917 and $3,190, respectively, pursuant to this work order. During the nine months ended September 30, 2020 and 2019, the Company incurred costs of $12,393 and $51,683, respectively, pursuant to this work order. As of September 30, 2020, total costs of $75,885 have been incurred pursuant to this work order agreement. The Company’s aggregate commitments pursuant to this clinical trial monitoring agreement, less amounts previously paid to date under this agreement, totaled approximately $875,000 as of September 30, 2020, which are expected to be incurred over the next five years through June 30, 2025. Other Clinical Agreements As of September 30, 2020, the Company was committed to two other partially completed short-term clinical study agreements. The Company’s aggregate commitments pursuant to these clinical study agreements, less amounts previously paid to date under these agreements, totaled approximately $258,000 as of September 30, 2020, which is expected to be incurred over the next five months. During the three months and nine months ended September 30, 2020, the Company incurred costs of $41,625, pursuant to these agreements. Patent and License Agreements On March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement with INSERM TRANSFERT SA, acting as delegatee of the French National Institute of Health and Medical Research, for the assignment to the Company of INSERM’S interest in United States Patent No. 9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders”, which was filed with the United States Patent and Trademark Office in the name of INSERM and the Company as co-owners on February 19, 2015 and granted on May 12, 2017, and related patent applications and filings. INSERM is a French public institution dedicated to research in the field of health and medicine that had previously entered into a Material Transfer Agreement with the Company to allow INSERM to conduct research on the Company’s proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress disorders in humans. Pursuant to the Agreement, the Company has agreed to make certain milestone payments to INSERM aggregating up to $1,750,000 upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones. The Company also agreed to pay INSERM certain commercial royalties on net sales of products attributed to the Agreement. The Company’s current plan is to complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans within three years; however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will require substantial additional capital and/or a joint venture or other type of business arrangement with a pharmaceutical company with substantially greater capital and business resources than those available to the Company. As there can be no assurances that the Company will be able to obtain the capital or business resources necessary to focus on the exploitation of this patent, it is uncertain as to when, if at all, the Company may reach any of the development or commercialization milestones under the Agreement. As of September 30, 2020 and December 31, 2019, no amounts were due under this agreement. Effective April 2, 2018, the Company entered into a consulting agreement for a term of two years with Liberi Life Sciences Consultancy BV, located in The Netherlands, for consulting and advisory services with respect to sales and licensing, as well as the procurement of investors in China, Japan and South Korea. The Consulting Agreement provided for the payment of a fixed, one-time retainer of EURO 15,000 (US $18,348), which was paid on April 5, 2018, and 2.5% of the net payments received by the Company from sales of products or licensing activities arising directly and exclusively from leads generated by the advisor during the term of the Consulting Agreement, and any investors introduced to the Company by the advisor that results in an investment in the Company during the term of the Consulting Agreement. The Company recorded the payment of the retainer as a prepaid expense in the Company’s consolidated balance sheet, and is amortizing the retainer payment over the two-year life of the Consulting Agreement, as a result of which the Company recorded charges to operations of $0 and $2,294 during the three months ended September 30, 2020 and 2019, and $2,294 and $6,882 during the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, the prepaid consulting fee had been fully amortized. At December 31, 2019, the unamortized balance of the retainer payment was $9,174, all of which was classified as a current asset in the Company’s consolidated balance sheet at such date. On March 1, 2020, the Consulting Agreement was extended to April 2, 2021 without any additional consideration. Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient is entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. The Company is also obligated to pay Moffitt an annual license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences payment of minimum royalty payments. The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. During the three months ended September 30, 2020 and 2019, the Company recorded charges to operations of $6,301 and $31,301, respectively, in connection with its obligations under the License Agreement. During the nine months ended September 30, 2020 and 2019, the Company recorded charges to operations of $18,699 and $74,368, respectively, in connection with its obligations under the License Agreement. As of September 30, 2020, no milestones had yet been attained. The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first sale of a royalty-bearing product, and shall automatically expire on a country-by-country basis on the date on which the last valid claim of the Licensed Patents expires, lapses or is declared invalid, and the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last valid claim of the Licensed Patents expires, lapses, or is declared to be invalid in all countries. Employment Agreements Dr. John Kovach Eric Forman. Dr. James Miser Robert Weingarten Other Significant Agreements and Contracts On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $4,000 for the three months ended September 30, 2020 and 2019, respectively, and $12,000 and $12,000 for the nine months ended September 30, 2020 and 2019, respectively, which were included in research and development costs in the consolidated statements of operations. Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company. Those services included, among other things: (a) assisting the Company to (i) commercialize its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products; (b) at the request of the Board of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader be temporarily unable to carry out his duties; (c) being available for consultation in drug discovery and development; and (d) identifying providers and overseeing tasks relating to clinical use and commercialization of new compounds. BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation. In April 2018, it was mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from February 1, 2018 through the September 13, 2019 anniversary date. In February 2019, the Company and BioPharmaWorks subsequently agreed to resume the Collaboration Agreement effective March 1, 2019, and the Collaboration Agreement is currently in effect. The Company recorded charges to operations pursuant to this Collaboration Agreement of $30,000 and $30,000 for the three months ended September 30, 2020 and 2019, respectively, and $90,000 and $70,000 for the nine months ended September 30, 2020 and 2019, respectively, which were included in research and development costs in the consolidated statements of operations. Effective August 12, 2020, the Company entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST) to collaborate in supporting preclinical studies of the potential benefit of LB-100 in a mouse model of Angelman Syndrome (AS) as reported in The Proceedings of The National Academy of Science (Wang et al, June 3, 2019). The preclinical studies will take place at The University of California - Davis under the direction of Dr. David Segal, an internationally recognized leader in AS research. If the preclinical studies confirm that LB-100 reduces AS signs in rodent models, the Company has agreed to enter into discussions with FAST with respect to possible collaborations to most efficiently assess the benefit of LB-100 in patients with AS, which is a rare disease affecting an estimated one out of 12,000 to one out of 20,000 persons in the United States. The genetic cause of AS, reduced function of a specific maternal gene called Ube3, has been understood for some time, but the molecular abnormality resulting from the genetic lesion has now been shown to be increased concentrations of protein phosphatase 2A (PP2A), a molecular target of the Company’s investigational compound, LB-100. The Company has agreed to provide FAST with a supply of LB-100 to be utilized in the conduct of this study, which is initially expected to be completed within three years. Conditioned on FAST’s completion of this study, the Company has agreed to pay FAST five percent (5%) of all proceeds, as defined in the Master Service Agreement, received by the Company, up to a maximum of $250,000 from the exploitation of the study results. Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations The global outbreak of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials are conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indications from the clinical research organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several months as a result of the coronavirus pandemic. There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future. | 7. Commitments and Contingencies Legal Claims The Company may be subject to legal claims and actions from time to time as part of its business activities. As of December 31, 2019, the Company was not subject to any pending or threatened legal claims or actions. Clinical Trial Agreements Effective August 20, 2018, the Company and the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”) entered into a Clinical Trial Research Agreement (the “Clinical Trial Research Agreement”) effective for a term of five years, unless terminated earlier by the Company pursuant to 30 days written notice. Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS). In November 2018, the Company received approval from the FDA for its Investigational New Drug (IND) Application to conduct a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who have failed or are intolerant of standard treatment. This clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. The clinical trial is expected to be completed over a period of two years, with final analysis and reporting expected within three years. This Phase 1b/2 clinical trial utilizes LB-100 as a single agent in the treatment of patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy. The bone marrow cells of these patients are deficient in PP2A and are especially vulnerable to further inhibition of PP2A by LB-100. During the years ended December 31, 2019 and 2018, the Company paid Moffitt $45,093 and $0, respectively, pursuant to this agreement. As of December 31, 2019, total costs of $45,093 have been incurred pursuant to this agreement. Effective as of July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the Spanish Sarcoma Group (Grupo Espanol de Investigacion en Sarcomas or “GEIS”), Madrid, Spain, to carry out a clinical trial entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma”. The purpose of this clinical trial is to obtain information about the efficacy and safety of the Company’s lead anti-cancer clinical compound LB-100 combined with doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (ASTA). Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 consistently enhances the antitumor activity of doxorubicin without apparent increases in toxicity. 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 has 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 the first patient into this clinical trial during the quarter ending June 30, 2020, with approximately 170 patients to be subsequently enrolled over a period of two years. The Company estimates that this clinical trial will be completed and results will be published by June 30, 2023. The original start date for patient entry was delayed due to longer than expected processing of formal approval of importation of LB-100 into the European Union. This approval was originally expected to be received in the quarter ended September 30, 2019, but was delayed and is now expected to be received during the quarter ending June 30, 2020. The Company’s aggregate commitments pursuant to these clinical trial agreements, less amounts previously incurred to date under these agreements, totaled approximately $5,000,000 as of December 31, 2019, which are expected to be incurred over the next five years through 2024. Clinical Trial Monitoring Agreements On September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc. (Theradex”), an international contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt. The clinical trial is expected to be completed over a period of two years, with final analysis and reporting expected within three years. Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs. The costs of the Phase 1b/2 clinical trial being paid to or through Theradex are being recorded and charged to operations based on the periodic documentation provided by the CRO. During the years ended December 31, 2019 and 2018, the Company incurred costs of $51,586 and $11,906, respectively, pursuant to this work order. As of December 31, 2019, total costs of $63,492 have been incurred pursuant to this work order agreement. The Company expects to enter into a separate work order agreement with Theradex to monitor the GEIS clinical trial as described above. Patent and License Agreements On March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement (the “Agreement”) with INSERM TRANSFERT SA, acting as delegatee of the French National Institute of Health and Medical Research (“INSERM”), for the assignment to the Company of INSERM’S interest in United States Patent No. 9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders,” which was filed with the United States Patent and Trademark Office in the name of INSERM and the Company as co-owners on February 19, 2015 and granted on May 12, 2017, and related patent applications and filings. INSERM is a French public institution dedicated to research in the field of health and medicine that had previously entered into a Material Transfer Agreement (“MTA”) with the Company to allow INSERM to conduct research on the Company’s proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress disorders in humans. Pursuant to the Agreement, the Company has agreed to make certain milestone payments to INSERM aggregating up to $1,750,000 upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones. The Company also agreed to pay INSERM certain commercial royalties on net sales of products attributed to the Agreement. The Company’s current plan is to complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans within three years; however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will require substantial additional capital and/or a joint venture or other type of business arrangement with a pharmaceutical company with substantially greater capital and business resources than those available to the Company. As there can be no assurances that the Company will be able to obtain the capital or business resources necessary to focus on the exploitation of this patent, it is uncertain as to when the Company may reach any of the development or commercialization milestones under the Agreement, if at all. As of December 31, 2019 and 2018, no amounts were due under this agreement. Effective April 2, 2018, the Company entered into a consulting agreement for a term of two years with Liberi Life Sciences Consultancy BV, located in The Netherlands, for consulting and advisory services with respect to sales and licensing, as well as the procurement of investors in China, Japan and South Korea (the “Consulting Agreement”). The Consulting Agreement provided for the payment of a fixed, one-time retainer of EURO 15,000 (US $18,348), which was paid on April 5, 2018, and 2.5% of the net payments received by the Company from sales of products or licensing activities arising directly and exclusively from leads generated by the advisor during the term of the Consulting Agreement, and any investors introduced to the Company by the advisor that results in an investment in the Company during the term of the Consulting Agreement. The Company recorded the payment of the retainer as a prepaid expense in the Company’s consolidated balance sheet, and is amortizing the retainer payment over the two-year life of the Consulting Agreement, as a result of which the Company recorded charges to operations of $9,174 and $6,881 during the years ended December 31, 2019 and 2018, respectively. At December 31, 2019, the unamortized balance of the retainer payment was $2,294, all of which was classified as a current asset in the Company’s consolidated balance sheet at such date. At December 31, 2018, the unamortized balance of the retainer payment was $11,468, of which $9,175 was classified as a current asset and $2,293 was classified as a non-current asset in the Company’s consolidated balance sheet at such date. Effective August 20, 2018 (the “Effective Date”), the Company and Moffitt entered into an Exclusive License Agreement (the “License Agreement”). Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents. The Company is obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient is entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. The clinical trial is expected to be completed over a period of two years, with final analysis and reporting expected within three years. The Company is also obligated to pay Moffitt an annual license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences payment of minimum royalty payments. The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. During the years ended December 31, 2019 and 2018, the Company recorded charges to operations of $80,669 and $0, respectively, in connection with its obligations under the License Agreement. As of December 31, 2019, no milestones had yet been attained. The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first sale of a royalty-bearing product, and shall automatically expire on a country-by-country basis on the date on which the last valid claim of the Licensed Patents expires, lapses or is declared invalid, and the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last valid claim of the Licensed Patents expires, lapses, or is declared to be invalid in all countries. Other Significant Agreements and Contracts Effective October 18, 2013, the Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) for a term of four years. The Surgical Neurology Branch of NINDS is conducting research characterizing a variety of compounds proprietary to the Company and is examining the potential of the compounds for anti-cancer activity, reducing neurological deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases. Under an M-CRADA, a party provides research material, in this case proprietary compounds from the Company’s pipeline, for study by scientists at NIH. The exchange of material was for research only and did not imply any endorsement of the material on the part of either party. Under the M-CRADA, the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license. On June 14, 2017, the Company executed Amendment No. 1 to the M-CRADA, pursuant to which the Company agreed to provide funding in the amount of $100,000 to the National Cancer Institute for use in acquiring technical, statistical and administrative support for research activities. The $100,000 amount was scheduled to be paid in two equal installments of $50,000, the first installment of which was paid, as scheduled, on July 9, 2017, and which was charged to research and development costs in the consolidated statement of operations on such date. The second installment of $50,000 was scheduled to be paid on the June 14, 2018 anniversary date of the amendment and was accreted ratably through such date and included in research and development contract liabilities in the Company’s consolidated balance sheet. Pursuant to revised and updated collaboration plans, on November 3, 2018, the NINDS and the Company agreed to a cancellation of the second installment payment of $50,000. Accordingly, the previously accreted charge of $50,000, of which $25,000 was recorded during the year ended December 31, 2018, was reversed during the year ended December 31, 2018. On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement for the years ended December 31, 2019 and 2018 were $16,000 and $16,000, respectively, which were included in research and development costs in the consolidated statements of operations. Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company. Those services included, among other things: (a) assisting the Company to (i) commercialize its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products; (b) at the request of the Board of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader be temporarily unable to carry out his duties; (c) being available for consultation in drug discovery and development; and (d) identifying providers and overseeing tasks relating to clinical use and commercialization of new compounds. BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation. In November 2016, it was mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from November 1, 2016 through March 31, 2017. The Collaboration Agreement resumed as scheduled on April 1, 2017. In April 2018, it was again mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from February 1, 2018 through the September 13, 2019 anniversary date. In February 2019, the Company and BioPharmaWorks subsequently agreed to resume the Collaboration Agreement effective March 1, 2019, and the Collaboration Agreement is currently in effect. The Company recorded charges to operations pursuant to this Collaboration Agreement for the years ended December 31, 2019 and 2018 of $100,000 and $10,000, respectively, which were included in research and development costs in the consolidated statements of operations. |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Subsequent Events [Abstract] | ||
Subsequent Events | 8. Subsequent Events The Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC. There were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements. | 8. Subsequent Events The Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC. There were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. | Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. | 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. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include cash and short-term certificates of deposit. The Company maintains its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”). The Company may periodically have cash balances in banks in excess of FDIC insurance limits. The Company has not experienced any losses to date resulting from this practice. | Cash and Cash Equivalents Cash and cash equivalents include cash and short-term certificates of deposit. The Company maintains its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”). The Company may periodically have cash balances in banks in excess of FDIC insurance limits. The Company has not experienced any losses to date resulting from this practice. |
Research and Development | Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition, design, development and testing of the Company’s compounds and product candidates. Research and development costs also include costs to produce the compounds used in research and clinical trials. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the agreement. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. | Research and Development Research and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the acquisition, design, development and testing of the Company’s compounds and product candidates. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. |
Prepaid Insurance | Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations to date. Such amortization is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy periods. As the policy premiums incurred are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and amortized to the Company’s consolidated statement of operations for each reporting period. As of September 30, 2020, total insurance policy premiums, in excess of premiums paid to date, amounted to $261,625, and will be payable with interest at 5.27% per annum, in nine monthly installments of $29,767 through June 2021. As of December 31, 2019, there was no unpaid insurance premium obligation. | |
Deferred Offering Costs | Deferred Offering Costs Deferred offering costs consist of payments with respect to pending equity financing transactions, including legal fees. Such costs are deferred and charged to additional paid-in capital upon the successful completion of such financings, or will be charged to operations if such financings are abandoned or terminated. | |
Patent and Licensing Related Legal and Filing Costs | Patent and Licensing Related Legal and Filing 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-related legal and filing fees and licensing-related legal fees are charged to operations as incurred. Patent and licensing-related legal and filing costs were $163,987 and $362,755 for the three months ended September 30, 2020 and 2019, and $440,899 and $672,661 for the nine months ended September 30, 2020 and 2019, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs in the Company’s consolidated statements of operations. | Patent and Licensing Related Legal and Filing 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-related legal and filing fees and licensing-related legal fees are charged to operations as incurred. Patent and licensing-related legal and filing costs were $742,918 and $842,325 for the years ended December 31, 2019 and 2018, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs in the Company’s consolidated statements of operations. |
Concentration of Risk | Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10% or more of general and administrative costs or research and development costs for the three months and nine months ended September 30, 2020 and 2019 is described as follows. General and administrative costs for the three months ended September 30, 2020 and 2019 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 20.4% and 69.4%, respectively, of total general and administrative costs for those periods. General and administrative costs for the three months ended September 30, 2020 also includes charges for the amortized value of stock options granted to three corporate officers representing 49.1% of total general and administrative costs for that period. General and administrative costs for the nine months ended September 30, 2020 and 2019 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 32.7% and 46.1%, respectively, of total general and administrative costs for those periods. General and administrative costs for the nine months ended September 30, 2020 also includes charges for the amortized value of stock options granted to three corporate officers representing 29.2% of total general and administrative costs for that period. Research and development costs for the three months ended September 30, 2020 include charges from a consultant, and the value associated with extending stock options previously granted to that consultant, representing 87.7% of total research and development costs for that period. Research and development costs for the three months ended September 30, 2019 include charges for the value associated with fully vested stock options granted to a consultant representing 76.1% of total research and development costs, and charges from a vendor representing 15.3% of total research and development costs, respectively, for that period. Research and development costs for the nine months ended September 30, 2020 include charges from a consultant, and the value extending stock options previously granted to that consultant, representing 75.2% of total research and development costs for that period. Research and development costs for the nine months ended September 30, 2019 include charges for the value of fully vested stock options granted to a consultant representing 62.1% of total research and development costs, and charges from a consultant and from a vendor representing 12.5% and 10.0% of total research and development costs, respectively, for that period. | Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s research and development activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task. The only such contract that represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2019 and 2018 is described below. As discussed at Note 7, effective as of July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with GEIS to carry out a clinical trial entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma”. The Company estimates that this clinical trial will be completed and results will be published by June 2023. Costs incurred pursuant to the agreement with GEIS are included in research and development costs in the Company’s consolidated statements of operations. During the year ended December 31, 2019, the Company incurred costs of $87,471 pursuant to this agreement, reflecting 10.7% of total research and development costs for such period. |
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. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of September 30, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to September 30, 2020. The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of September 30, 2020 or December 31, 2019. Subsequent to September 30, 2020, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. | 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 has elected to deduct research and development costs on a current basis for federal income tax purposes. For federal tax purposes, start-up and organization costs were deferred until January 1, 2008, at which time the Company began to amortize such costs over a 180-month period. 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. Likewise, 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 December 31, 2019 and 2018 and does not anticipate any material amount of unrecognized tax benefits within the next 12 months. 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. As of December 31, 2019, the Company had not recorded any liability for uncertain tax positions. In subsequent periods, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members contractors and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the estimated 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 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. | Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, Scientific Advisory Committee members 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. Through December 31, 2018, the Company accounted for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The Company accounted for stock-based payments to Scientific Advisory Committee members and consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment was reached or (b) at the date at which the necessary performance to earn the equity instruments was complete. In accordance with the Company’s adoption of Accounting Standards Update 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (see “Recent Accounting Pronouncements” below), effective January 1, 2019, stock options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are now accounted for consistent with the accounting for stock-based payments to officers and directors, as described above, by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the life of the equity award, 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. Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a one-year look-back period, as the Company believes that such measurement period provides a more accurate and meaningful volatility factor given the changes in the Company’s research and development program and capital requirements over the past several years. 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 Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At September 30, 2020 and 2019, 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. September 30, 2020 2019 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 9,000,000 Common stock options, including options issued in the form of warrants 9,050,000 8,050,000 Total 22,425,000 21,425,000 | Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At December 31, 2019 and 2018, 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. December 31, 2019 2018 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 9,000,000 Common stock options, including options issued in the form of warrants 7,850,000 7,750,000 Total 21,225,000 21,125,000 |
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 cash and cash equivalents, and accounts payable and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those 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 cash and cash equivalents, and 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 June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 significantly changes how entities measure credit losses for most financial assets, including accounts and notes receivables. ASU 2016-13 will replace the current “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the provisions of ASU 2016-13 as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which ASU 2016-13 is effective. ASU 2016-13 will be effective for the Company for interim and annual reporting periods beginning after December 15, 2022. Management is currently in the process of assessing the impact of the adoption of ASU-2016-13 on the Company’s consolidated financial statement presentation and disclosures subsequent to its adoption. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 is effective for interim and annual reporting periods beginning after December 15, 2020. The adoption of ASU 2019-12 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption. In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 will simplify the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract as compared with current GAAP. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 will be effective for public companies for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Management has not yet evaluated the effect that the adoption of ASU 2020-06 will have on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption. 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. | Recent Accounting Pronouncements Recently Adopted Accounting Standards In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Revenue from Contracts with Customers (Topic 606). ASU 2018-07 was effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted the provisions of ASU 2018-07 effective January 1, 2019 (see “Stock-Based Compensation” above). The adoption of ASU 2018-07 did not have any impact on the Company’s financial statement presentation or disclosures subsequent to its adoption. Recently Issued Accounting Standards In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The adoption of ASU 2018-07 is not expected to have any impact on the Company’s financial statement presentation or disclosures subsequent to its adoption. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At September 30, 2020 and 2019, 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. September 30, 2020 2019 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 9,000,000 Common stock options, including options issued in the form of warrants 9,050,000 8,050,000 Total 22,425,000 21,425,000 | At December 31, 2019 and 2018, 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. December 31, 2019 2018 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 9,000,000 Common stock options, including options issued in the form of warrants 7,850,000 7,750,000 Total 21,225,000 21,125,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Equity [Abstract] | ||
Schedule of Warrants Outstanding | A summary of common stock warrant activity during the nine months ended September 30, 2020 is presented below. Number of Shares Weighted Average Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2019 9,000,000 $ 1.000 Issued — — Exercised — — Expired — — Warrants outstanding at September 30, 2020 9,000,000 $ 1.000 2.42 | A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, during the years ended December 31, 2019 and 2018 is presented below. Number of Shares Weighted Average Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2017 — $ — Issued 9,000,000 1.000 Exercised — — Expired — — Warrants outstanding at December 31, 2018 9,000,000 $ 1.000 Issued — — Exercised — — Expired — — Warrants outstanding at December 31, 2019 9,000,000 $ 1.000 2.92 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Related Party Transactions [Abstract] | ||
Summary of Related Party Costs | A summary of related party costs for the three months and nine months ended September 30, 2020 and 2019 is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Related party costs: Cash-based $ 70,452 $ 27,000 $ 124,452 $ 81,000 Stock-based 394,031 5,030 394,031 314,631 Total $ 464,483 $ 32,030 $ 518,483 $ 395,631 | A summary of related party costs for the years ended December 31, 2019 and 2018 is as follows: Years Ended December 31, 2019 2018 Related party costs: Cash-based $ 48,000 $ 48,000 Stock-based 314,631 785,612 Total $ 362,631 $ 833,612 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Schedule of Fair Value of Each Option Award Estimated Assumption | For stock options requiring an assessment of value during the nine months ended September 30, 2020, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 0.23% to 0.31 % Expected dividend yield 0 % Expected volatility 207.67 % Expected life 4 to 5 years For stock options requiring an assessment of value during the nine months ended September 30, 2019, 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 1.47% to 1.85 % Expected dividend yield 0 % Expected volatility 133.01% to 171.87 % Expected life 4 years | For stock options requiring an assessment of value during the year ended December 31, 2019, 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 1.47% to 1.85 % Expected dividend yield 0 % Expected volatility 133.01% to 171.87 % Expected life 5 years For stock options requiring an assessment of value during the year ended December 31, 2018, 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 2.44% to 3.01 % Expected dividend yield 0 % Expected volatility 170.32 % Expected life 0.5 to 5.5 years |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the three months and nine months ended September 30, 2020 and 2019 is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Related parties $ 394,031 $ 5,030 $ 394,031 $ 314,631 Non-related parties 670,715 434,024 670,715 434,024 Total stock-based compensation costs $ 1,064,746 $ 439,054 $ 1,064,746 $ 748,655 | A summary of stock-based compensation costs for the years ended December 31, 2019 and 2018 is as follows: Years Ended December 31, 2019 2018 Related parties $ 314,631 $ 785,612 Non-related parties 434,024 — Total stock-based compensation costs $ 748,655 $ 785,612 |
Summary of Stock Option Activity Including Options Form of Warrants | A summary of stock option activity, including options issued in the form of warrants, during the nine months ended September 30, 2020 is presented below. Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2019 7,850,000 $ 0.608 Granted 1,200,000 1.190 Exercised — — Expired — — Stock options outstanding at September 30, 2020 9,050,000 $ 0.685 3.27 Stock options exercisable at September 30, 2020 8,150,000 $ 0.629 3.10 | A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2019 and 2018 is presented below. Weighted Weighted Number of Average Contractual Shares Exercise Price Life (in Years) Stock options outstanding at December 31, 2017 7,470,000 $ 0.545 Granted 400,000 0.280 Exercised (20,000 ) 0.150 Expired (100,000 ) 0.130 Stock options outstanding at December 31, 2018 7,750,000 0.583 Granted 800,000 1.038 Exercised — — Expired (700,000 ) 0.321 Stock options outstanding at December 31, 2019 7,850,000 $ 0.608 3.14 Stock options exercisable at December 31, 2018 7,550,000 $ 0.545 Stock options exercisable at December 31, 2019 7,850,000 $ 0.608 3.14 |
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants | The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at September 30, 2020 are as follows: Exercise Options Options $ 0.120 450,000 450,000 $ 0.150 300,000 300,000 $ 0.160 200,000 200,000 $ 0.200 500,000 500,000 $ 0.280 400,000 400,000 $ 0.500 4,200,000 4,200,000 $ 1.000 1,000,000 1,000,000 $ 1.100 300,000 300,000 $ 1.190 1,200,000 300,000 $ 2.000 500,000 500,000 9,050,000 8,150,000 | The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31, 2019 are as follows: Exercise Options Options $ 0.120 450,000 450,000 $ 0.150 300,000 300,000 $ 0.160 200,000 200,000 $ 0.200 500,000 500,000 $ 0.280 400,000 400,000 $ 0.500 4,200,000 4,200,000 $ 1.000 1,000,000 1,000,000 $ 1.100 300,000 300,000 $ 2.000 500,000 500,000 7,850,000 7,850,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are summarized below. December 31, 2019 2018 Start-up and organization costs $ 10,000 $ 14,000 Research credits 359,000 351,000 Stock-based compensation 799,000 626,000 Net operating loss carryforwards 4,879,000 4,395,000 Total deferred tax assets 6,047,000 5,386,000 Valuation allowance (6,047,000 ) (5,386,000 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate | The reconciliation below presents the difference between the income tax rate computed by applying the U.S. federal statutory rate and the effective tax rate for the years ended December 31, 2019 and 2018. Years Ended December 31, 2019 2018 U. S. federal statutory tax rate (21.0 )% (21.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 1.2 % 0.2 % Adjustment to deferred tax asset (0.3 )% (1.3 )% Change in valuation allowance 26.1 % 28.1 % Effective tax rate 0.0 % 0.0 % |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details Narrative) (10-K) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash and cash equivalents | $ 1,076,248 | $ 2,598,864 | $ 4,273,012 |
Business (Details Narrative)
Business (Details Narrative) - USD ($) | Nov. 02, 2020 | Jul. 14, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Cash and cash equivalents | $ 1,076,248 | $ 2,598,864 | $ 4,273,012 | ||
Common Stock [Member] | |||||
Reverse stock split | 1-for-6 reverse split | ||||
Common Stock [Member] | Underwritting Public Offering [Member] | Subsequent Event [Member] | |||||
Estimated gross proceeds from offering of shares | $ 9,375,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2019 | Jun. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Insurance premium obligation | $ 261,625 | $ 261,625 | |||||
Interest rate of insurance premium payable | 5.27% | 5.27% | |||||
Patent and licensing costs | $ 163,987 | $ 362,755 | $ 440,899 | $ 672,661 | $ 742,918 | $ 842,325 | |
Concentration of risk, percentage | 10.00% | 10.00% | 10.00% | 10.00% | 10.00% | 10.00% | |
Unrecognized tax benefits | |||||||
General and Administrative Expense [Member] | |||||||
Concentration of risk, percentage | 20.40% | 69.40% | 32.70% | 46.10% | |||
General and Administrative Expense [Member] | Stock Options granted to Three Corporate Officers [Member] | |||||||
Concentration of risk, percentage | 49.10% | 29.20% | |||||
Research and Development Expense [Member] | Consultant [Member] | |||||||
Concentration of risk, percentage | 87.70% | 76.10% | 75.20% | 62.10% | |||
Research and Development Expense [Member] | Vendor [Member] | |||||||
Concentration of risk, percentage | 15.30% | 15.30% | |||||
Research and Development Expense [Member] | Consultant and Vendor [Member] | |||||||
Concentration of risk, percentage | 12.50% | 10.00% | |||||
Forecast [Member] | |||||||
Insurance premium to be paid | $ 29,767 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details Narrative) (10-K) - USD ($) | Jul. 31, 2019 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Patent and licensing costs | $ 163,987 | $ 362,755 | $ 440,899 | $ 672,661 | $ 742,918 | $ 842,325 | ||
Research and development costs | $ 799,420 | $ 570,601 | $ 1,012,038 | $ 699,038 | $ 820,906 | $ 40,703 | ||
Concentration of risk, percentage | 10.00% | 10.00% | 10.00% | 10.00% | 10.00% | 10.00% | ||
Deferred setup and organization costs, amortization period | 180 months | |||||||
Unrecognized tax benefits | ||||||||
Collaboration Agreement [Member] | ||||||||
Research and development costs | $ 87,471 | $ 130,882 | 87,471 | |||||
Collaboration Agreement [Member] | Grupo Espanol de Investigacion en Sarcomas [Member] | ||||||||
Collaboration agreement description | Effective as of July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with GEIS to carry out a clinical trial entitled "Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma". The Company estimates that this clinical trial will be completed and results will be published by June 2023. | |||||||
Research and development costs | $ 87,471 | |||||||
Concentration of risk, percentage | 10.70% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Anti-dilutive securities excluded from computation of earnings per share | 22,425,000 | 21,425,000 | 21,225,000 | 21,125,000 |
Series A Convertible Preferred Stock [Member] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 4,375,000 | 4,375,000 | 4,375,000 | 4,375,000 |
Common Stock Warrants [Member] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 9,000,000 | 9,000,000 | 9,000,000 | 9,000,000 |
Common Stock Options, Including Options Issued in the Form of Warrants [Member] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 9,050,000 | 8,050,000 | 7,850,000 | 7,750,000 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) (10-K) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Anti-dilutive securities excluded from computation of earnings per share | 22,425,000 | 21,425,000 | 21,225,000 | 21,125,000 |
Series A Convertible Preferred Stock [Member] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 4,375,000 | 4,375,000 | 4,375,000 | 4,375,000 |
Common Stock Warrants [Member] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 9,000,000 | 9,000,000 | 9,000,000 | 9,000,000 |
Common Stock Options, Including Options Issued in the Form of Warrants [Member] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 9,050,000 | 8,050,000 | 7,850,000 | 7,750,000 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Mar. 17, 2015 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 21, 2016 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Common stock, shares issued | 67,045,814 | 67,045,814 | 67,045,814 | ||
Common stock, shares outstanding | 67,045,814 | 67,045,814 | 67,045,814 | ||
Common Stock Warrant [Member] | |||||
Warrants exercise price | $ 1 | $ 1 | |||
Warrant exercisable price per shares | $ 1.17 | $ 0.68 | |||
Intrinsic value of exercisable warrants | $ 1,530,000 | ||||
Series A Convertible Preferred Stock [Member] | |||||
Preferred stock, shares authorized | 350,000 | ||||
Number of share tranche of convertible preferred stock receive a per share dividend | 175,000 | ||||
Percentage of dividend from annual revenue | 1.00% | ||||
Annual net revenue divided by converted or redeemed shares | 175,000 | ||||
Preferred stock convertible into common stock | 4,375,000 | 4,375,000 | |||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 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. | ||||
Gross proceeds from sale of transaction | $ 21,875,000 | $ 21,875,000 | |||
Preferred stock, shares outstanding | 350,000 | 350,000 | 350,000 | ||
Preferred stock, per share redemption price | $ 50 | $ 50 | $ 50 | $ 50 | |
Preferred stock, shares right to redeem | 175,000 | ||||
Preferred stock, aggregate cash redemption value | $ 8,750,000 | $ 17,500,000 | $ 17,500,000 | ||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | |||||
Preferred stock convertible into common stock | 12.5 | 12.5 | |||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 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 $21,875,000. | ||||
Undesignated Preferred Stock [Member] | |||||
Preferred stock, shares authorized | 9,650,000 | 9,650,000 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details Narrative) (10-K) - USD ($) | Nov. 30, 2018 | Mar. 17, 2015 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 21, 2016 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | |||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common stock, shares issued | 67,045,814 | 67,045,814 | 67,045,814 | |||
Common stock, shares outstanding | 67,045,814 | 67,045,814 | 67,045,814 | |||
Sixteen Accredited Investors [Member] | ||||||
Sale of stock during period, amount | $ 4,500,000 | |||||
Sale of stock during period, shares | 9,000,000 | |||||
Equity issuance price per share | $ 0.50 | |||||
Common stock units, description | Each unit consisted of one share of common stock and one four-year warrant to purchase one share of common stock at an exercise price of $1.00 per share. | |||||
Warrants term | 4 years | |||||
Warrants exercise price | $ 1 | |||||
Warrants to purchase common stock | 9,000,000 | |||||
Common Stock Warrant [Member] | ||||||
Warrants exercise price | $ 1 | $ 1 | ||||
Warrant exercisable price per shares | $ 1.17 | $ 0.68 | ||||
Intrinsic value of exercisable warrants | $ 1,530,000 | |||||
Series A Convertible Preferred Stock [Member] | ||||||
Preferred stock, shares authorized | 350,000 | |||||
Number of share tranche of the series A convertible preferred stock receive a per share dividend | 175,000 | |||||
Percentage of dividend from annual revenue | 1.00% | |||||
Annual net revenue divided by converted or redeemed shares | 175,000 | |||||
Preferred stock convertible into common stock | 4,375,000 | 4,375,000 | ||||
Gross proceeds from sale of transaction | $ 21,875,000 | $ 21,875,000 | ||||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 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, shares outstanding | 350,000 | 350,000 | 350,000 | |||
Preferred stock, per share redemption price | $ 50 | $ 50 | $ 50 | $ 50 | ||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | ||||||
Preferred stock convertible into common stock | 12.5 | 12.5 | ||||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 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. | |||||
Undesignated Preferred Stock [Member] | ||||||
Preferred stock, shares authorized | 9,650,000 | 9,650,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares, Warrants Outstanding, Beginning Balance | 9,000,000 | 9,000,000 | |
Number of Shares, Issued | 9,000,000 | ||
Number of Shares, Exercised | |||
Number of Shares, Expired | |||
Number of Shares, Warrants Outstanding, Ending Balance | 9,000,000 | 9,000,000 | 9,000,000 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ 1 | $ 1 | |
Weighted Average Exercise Price, Issued | 1 | ||
Weighted Average Exercise Price, Exercised | |||
Weighted Average Exercise Price, Expired | |||
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ 1 | $ 1 | $ 1 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 2 years 5 months 1 day | 2 years 11 months 1 day | 0 years |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Warrants Outstanding (Details) (10-K) - Common Stock Warrants [Member] - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares, Warrants Outstanding, Beginning Balance | 9,000,000 | 9,000,000 | |
Number of Shares, Issued | 9,000,000 | ||
Number of Shares, Exercised | |||
Number of Shares, Expired | |||
Number of Shares, Warrants Outstanding, Ending Balance | 9,000,000 | 9,000,000 | 9,000,000 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ 1 | $ 1 | |
Weighted Average Exercise Price, Issued | 1 | ||
Weighted Average Exercise Price, Exercised | |||
Weighted Average Exercise Price, Expired | |||
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ 1 | $ 1 | $ 1 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 2 years 5 months 1 day | 2 years 11 months 1 day | 0 years |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Eric Forman [Member] | ||||||
Legal and consulting fees charged to operations for services rendered | $ 14,000 | $ 12,000 | $ 38,000 | $ 36,000 | $ 48,000 | $ 48,000 |
Dr. John Kovach [Member] | ||||||
Salaries paid | $ 15,000 | $ 15,000 | $ 45,000 | $ 45,000 | $ 60,000 | $ 60,000 |
Related Party Transactions (D_2
Related Party Transactions (Details Narrative) (10-K) - USD ($) | Aug. 02, 2018 | Jan. 28, 2014 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 28, 2015 |
Stock options granted to purchase common stock | 900,000 | ||||||||
Options, exercisable price per share | $ 0.629 | $ 0.629 | $ 0.608 | $ 0.545 | |||||
Options exercisable period | 3 years 1 month 6 days | 3 years 1 month 20 days | |||||||
Eric Forman [Member] | |||||||||
Legal and consulting fees charged to operations for services rendered | $ 14,000 | $ 12,000 | $ 38,000 | $ 36,000 | $ 48,000 | $ 48,000 | |||
General and Administrative Expense [Member] | |||||||||
Fair value of vesting option | $ 711,738 | ||||||||
Fair value stock options price per share | $ 0.1779 | ||||||||
Dr. John Kovach [Member] | |||||||||
Salaries | $ 15,000 | $ 15,000 | $ 45,000 | $ 45,000 | $ 60,000 | $ 60,000 | |||
Consulting Agreement [Member] | Mr. Gil Schwartzberg [Member] | |||||||||
Stock options granted to purchase common stock | 4,000,000 | ||||||||
Options, exercisable price per share | $ 0.50 | ||||||||
Options exercisable period | 5 years | ||||||||
Number of stock options vested | 2,000,000 | 2,000,000 | |||||||
Option extended period | Jan. 28, 2024 |
Related Party Transactions - Su
Related Party Transactions - Summary of Related Party Costs (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total | $ 464,483 | $ 32,030 | $ 518,483 | $ 395,631 | $ 362,631 | $ 833,612 |
Cash-based [Member] | ||||||
Total | 70,452 | 27,000 | 124,452 | 81,000 | 48,000 | 48,000 |
Stock-based [Member] | ||||||
Total | $ 394,031 | $ 5,030 | $ 394,031 | $ 314,631 | $ 314,631 | $ 785,612 |
Related Party Transactions - _2
Related Party Transactions - Summary of Related Party Costs (Details) (10-K) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total | $ 464,483 | $ 32,030 | $ 518,483 | $ 395,631 | $ 362,631 | $ 833,612 |
Cash-based [Member] | ||||||
Total | 70,452 | 27,000 | 124,452 | 81,000 | 48,000 | 48,000 |
Stock-based [Member] | ||||||
Total | $ 394,031 | $ 5,030 | $ 394,031 | $ 314,631 | $ 314,631 | $ 785,612 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | Aug. 12, 2020 | Aug. 01, 2020 | Jul. 15, 2020 | Jul. 14, 2020 | Jul. 03, 2020 | Aug. 04, 2019 | Jul. 23, 2019 | May 22, 2019 | Aug. 04, 2018 | Sep. 14, 2015 | Jun. 20, 2007 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jul. 02, 2020 | Dec. 31, 2017 | Sep. 14, 2017 | Sep. 14, 2016 |
Stock options granted to purchase common stock, issued | 900,000 | ||||||||||||||||||||
Stock options granted to purchase common stock, outstanding | 9,050,000 | 9,050,000 | 7,850,000 | 7,750,000 | 7,470,000 | ||||||||||||||||
Charges to operations | $ 5,030 | $ 31,046 | $ 31,046 | $ 73,874 | |||||||||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | $ 980,000 | ||||||||||||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 5,496,500 | $ 5,496,500 | $ 1,664,950 | ||||||||||||||||||
Fair market value, per share | $ 1.17 | $ 0.68 | |||||||||||||||||||
Board of Directors [Member] | |||||||||||||||||||||
Number of warrants outstanding acquire common stock | 1,000,000 | ||||||||||||||||||||
Warrants term, description | September 14, 2020 to September 14, 2025 | ||||||||||||||||||||
Closing stock price of warrants | $ 0.90 | ||||||||||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks [Member] | |||||||||||||||||||||
Stock price per share | $ 0.6707 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 670,715 | ||||||||||||||||||||
Number of warrants to purchase common stock | 1,000,000 | ||||||||||||||||||||
Number of warrants to purchase common stock per warrant | 500,000 | ||||||||||||||||||||
Warrant exercisable term | 5 years | 5 years | |||||||||||||||||||
Warrants exercise price | $ 2 | $ 1 | |||||||||||||||||||
Employment Agreement [Member] | Dr. James Miser [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 500,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Fair value of stock options | $ 572,650 | ||||||||||||||||||||
Stock price per share | $ 1.1453 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 143,163 | ||||||||||||||||||||
Stock options description | Dr. Miser was granted options for 500,000 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $1.19 per share, which was equal to the closing price of the Company's common stock on the effective date of the employment agreement. The options vested as to 25% on the effective date, and will vest 25% on each of the first, second and third anniversaries of the effective date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($1.1453 per share), of which $143,163 was attributable to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $166,697 with respect to these stock options. | ||||||||||||||||||||
Charges to operations | 166,697 | $ 166,697 | |||||||||||||||||||
Stock option excercise price | $ 1.19 | ||||||||||||||||||||
Employment Agreement [Member] | Mr. Weingarten [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 350,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 1.19 | ||||||||||||||||||||
Fair value of stock options | $ 400,855 | ||||||||||||||||||||
Stock price per share | $ 1.1453 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | ||||||||||||||||||||
Stock options description | On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 350,000 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of 5 years and an exercise price of $1.19 per share, which was equal to the closing price of our common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($1.1453 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $113,667, with respect to these stock options. | ||||||||||||||||||||
Charges to operations | 113,667 | 113,667 | |||||||||||||||||||
Winson Sze Chun Ho [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 200,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 0.28 | ||||||||||||||||||||
Number of fully vested option issued | 100,000 | 100,000 | |||||||||||||||||||
Fair value of stock options | $ 104,920 | ||||||||||||||||||||
Stock price per share | $ 0.2623 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 101,475 | ||||||||||||||||||||
Dr. Yun Yen [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 50,000 | 200,000 | |||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 0.28 | ||||||||||||||||||||
Number of fully vested option issued | 100,000 | 100,000 | |||||||||||||||||||
Fair value of stock options | $ 104,920 | ||||||||||||||||||||
Stock price per share | $ 0.2623 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 52,460 | ||||||||||||||||||||
Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman and Dr. Philip Palmedo [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 200,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 1.10 | ||||||||||||||||||||
Stock price per share | $ 0.9453 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 189,060 | ||||||||||||||||||||
Dr. Winson Sze Chun Ho [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 50,000 | ||||||||||||||||||||
Dr. Stephen Forman [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 50,000 | ||||||||||||||||||||
Dr. Philip Palmedo [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 50,000 | ||||||||||||||||||||
Eric Forman [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 100,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 1.10 | ||||||||||||||||||||
Number of fully vested option issued | 100,000 | ||||||||||||||||||||
Stock price per share | $ 0.9453 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 94,525 | ||||||||||||||||||||
Eric Forman [Member] | Employment Agreement [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 350,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 1.19 | ||||||||||||||||||||
Number of fully vested option issued | 100,214 | ||||||||||||||||||||
Fair value of stock options | $ 400,855 | ||||||||||||||||||||
Stock price per share | $ 1.1453 | ||||||||||||||||||||
Stock options description | On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric Forman, Mr. Forman was granted options for 350,000 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of 5 years and an exercise price of $1.19 per share, which was equal to the closing price of the Company's common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($1.1453 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $113,667 with respect to these stock options. | ||||||||||||||||||||
Charges to operations | $ 113,667 | $ 113,667 | |||||||||||||||||||
Mr. Johnson's [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 500,000 | ||||||||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||||||||
Stock options are exercisable price per share | $ 1.10 | ||||||||||||||||||||
Stock price per share | $ 0.8680 | ||||||||||||||||||||
Stock options fully vested amount, fair value | $ 434,024 | ||||||||||||||||||||
2007 Stock Compensation Plan [Member] | |||||||||||||||||||||
Stock options granted to purchase common stock, issued | 1,250,000 | 1,250,000 | |||||||||||||||||||
Stock options granted to purchase common stock, outstanding | 1,250,000 | 1,250,000 | 1,250,000 | ||||||||||||||||||
2007 Stock Compensation Plan [Member] | Maximum [Member] | |||||||||||||||||||||
Number of restricted stock issued | 2,500,000 | ||||||||||||||||||||
2020 Stock Incentive Plan [Member] | Maximum [Member] | |||||||||||||||||||||
Number of restricted stock issued | 14,000,000 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details Narrative) (10-K) - USD ($) | Aug. 04, 2019 | Jul. 23, 2019 | May 22, 2019 | Aug. 04, 2018 | Jun. 20, 2007 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Stock options granted to purchase common stock, issued | 900,000 | ||||||||||
Stock options granted to purchase common stock, outstanding | 9,050,000 | 7,850,000 | 7,750,000 | 7,470,000 | |||||||
Charges to operations | $ 5,030 | $ 31,046 | $ 31,046 | $ 73,874 | |||||||
Total deferred compensation expense for outstanding value of unvested stock options | $ 980,000 | ||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 5,496,500 | $ 1,664,950 | |||||||||
Fair market value, per share | $ 1.17 | $ 0.68 | |||||||||
Winson Sze Chun Ho [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 200,000 | ||||||||||
Stock option vested exercisable term | 5 years | ||||||||||
Stock options are exercisable price per share | $ 0.28 | ||||||||||
Number of fully vested option issued | 100,000 | 100,000 | |||||||||
Fair value of stock options | $ 104,920 | ||||||||||
Stock price per share | $ 0.2623 | ||||||||||
Stock options fully vested amount, fair value | $ 101,475 | ||||||||||
Dr. Yun Yen [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 50,000 | 200,000 | |||||||||
Stock option vested exercisable term | 5 years | ||||||||||
Stock options are exercisable price per share | $ 0.28 | ||||||||||
Number of fully vested option issued | 100,000 | 100,000 | |||||||||
Fair value of stock options | $ 104,920 | ||||||||||
Stock price per share | $ 0.2623 | ||||||||||
Stock options fully vested amount, fair value | $ 52,460 | ||||||||||
Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman and Dr. Philip Palmedo [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 200,000 | ||||||||||
Stock option vested exercisable term | 5 years | ||||||||||
Stock options are exercisable price per share | $ 1.10 | ||||||||||
Stock price per share | $ 0.9453 | ||||||||||
Stock options fully vested amount, fair value | $ 189,060 | ||||||||||
Dr. Winson Sze Chun Ho [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 50,000 | ||||||||||
Dr. Stephen Forman [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 50,000 | ||||||||||
Dr. Philip Palmedo [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 50,000 | ||||||||||
Eric Forman [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 100,000 | ||||||||||
Stock option vested exercisable term | 5 years | ||||||||||
Stock options are exercisable price per share | $ 1.10 | ||||||||||
Number of fully vested option issued | 100,000 | ||||||||||
Stock price per share | $ 0.9453 | ||||||||||
Stock options fully vested amount, fair value | $ 94,525 | ||||||||||
Mr. Johnson's [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 500,000 | ||||||||||
Stock option vested exercisable term | 5 years | ||||||||||
Stock options are exercisable price per share | $ 1.10 | ||||||||||
Stock price per share | $ 0.8680 | ||||||||||
Stock options fully vested amount, fair value | $ 434,024 | ||||||||||
2007 Stock Compensation Plan [Member] | |||||||||||
Stock options granted to purchase common stock, issued | 1,250,000 | 1,250,000 | |||||||||
Stock options granted to purchase common stock, outstanding | 1,250,000 | 1,250,000 | |||||||||
2007 Stock Compensation Plan [Member] | Maximum [Member] | |||||||||||
Number of restricted stock issued | 2,500,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Risk-free interest rate, minimum | 0.23% | 1.47% | 1.47% | 2.44% |
Risk-free interest rate, maximum | 0.31% | 1.85% | 1.85% | 3.01% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 133.01% | 133.01% | ||
Expected volatility, maximum | 171.87% | 171.87% | ||
Expected volatility | 207.67% | 170.32% | ||
Expected life | 4 years | 5 years | ||
Minimum [Member] | ||||
Expected life | 4 years | 6 months | ||
Maximum [Member] | ||||
Expected life | 5 years | 5 years 6 months |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Fair Value of Each Option Award Estimated Assumption (Details) (10-K) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Risk-free interest rate, minimum | 0.23% | 1.47% | 1.47% | 2.44% |
Risk-free interest rate, maximum | 0.31% | 1.85% | 1.85% | 3.01% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 133.01% | 133.01% | ||
Expected volatility, maximum | 171.87% | 171.87% | ||
Expected volatility | 207.67% | 170.32% | ||
Expected life | 4 years | 5 years | ||
Minimum [Member] | ||||
Expected life | 4 years | 6 months | ||
Maximum [Member] | ||||
Expected life | 5 years | 5 years 6 months |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-based Compensation Costs (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total stock-based compensation costs | $ 1,064,746 | $ 439,054 | $ 1,064,746 | $ 748,655 | $ 748,655 | $ 785,612 |
Related Parties [Member] | ||||||
Total stock-based compensation costs | 394,031 | 5,030 | 394,031 | 314,631 | 314,631 | 785,612 |
Non-related Parties [Member] | ||||||
Total stock-based compensation costs | $ 670,715 | $ 434,024 | $ 670,715 | $ 434,024 | $ 434,024 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock-based Compensation Costs (Details) (10-K) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total stock-based compensation costs | $ 1,064,746 | $ 439,054 | $ 1,064,746 | $ 748,655 | $ 748,655 | $ 785,612 |
Related Parties [Member] | ||||||
Total stock-based compensation costs | 394,031 | 5,030 | 394,031 | 314,631 | 314,631 | 785,612 |
Non-related Parties [Member] | ||||||
Total stock-based compensation costs | $ 670,715 | $ 434,024 | $ 670,715 | $ 434,024 | $ 434,024 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity Including Options Form of Warrants (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | |||
Number of shares, stock options outstanding, at the beginning | 7,850,000 | 7,750,000 | 7,470,000 |
Number of shares, Granted | 1,200,000 | 800,000 | 400,000 |
Number of shares, Exercised | (20,000) | ||
Number of shares, Expired | (700,000) | (100,000) | |
Number of shares, stock options outstanding, at the end | 9,050,000 | 7,850,000 | 7,750,000 |
Number of shares, stock options exercisable, at the end | 8,150,000 | 7,850,000 | 7,550,000 |
Weighted average exercise price, stock options outstanding, at the beginning | $ 0.608 | $ 0.583 | $ 0.545 |
Weighted average exercise price, granted | 1.190 | 1.038 | 0.280 |
Weighted average exercise price, exercised | 0.150 | ||
Weighted average exercise price, expired | 0.321 | 0.130 | |
Weighted average exercise price, stock options outstanding, at the end | 0.685 | 0.608 | 0.583 |
Weighted average exercise price, stock options exercisable, at the end | $ 0.629 | $ 0.608 | $ 0.545 |
Weighted average remaining contractual life (in years), stock options outstanding | 3 years 3 months 8 days | 3 years 1 month 20 days | |
Weighted average remaining contractual life (in years), stock options exercisable | 3 years 1 month 6 days | 3 years 1 month 20 days |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock Option Activity Including Options Form of Warrants (Details) (10-K) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | |||
Number of shares, stock options outstanding, at the beginning | 7,850,000 | 7,750,000 | 7,470,000 |
Number of shares, Granted | 1,200,000 | 800,000 | 400,000 |
Number of shares, Exercised | (20,000) | ||
Number of shares, Expired | (700,000) | (100,000) | |
Number of shares, stock options outstanding, at the end | 9,050,000 | 7,850,000 | 7,750,000 |
Number of shares, stock options exercisable, at the end | 8,150,000 | 7,850,000 | 7,550,000 |
Weighted average exercise price, stock options outstanding, at the beginning | $ 0.608 | $ 0.583 | $ 0.545 |
Weighted average exercise price, granted | 1.190 | 1.038 | 0.280 |
Weighted average exercise price, exercised | 0.150 | ||
Weighted average exercise price, expired | 0.321 | 0.130 | |
Weighted average exercise price, stock options outstanding, at the end | 0.685 | 0.608 | 0.583 |
Weighted average exercise price, stock options exercisable, at the end | $ 0.629 | $ 0.608 | $ 0.545 |
Weighted average remaining contractual life (in years), stock options outstanding | 3 years 3 months 8 days | 3 years 1 month 20 days | |
Weighted average remaining contractual life (in years), stock options exercisable | 3 years 1 month 6 days | 3 years 1 month 20 days |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Options Outstanding (Shares) | 9,050,000 | 7,850,000 |
Options Exercisable (Shares) | 8,150,000 | 7,850,000 |
Exercise Price One [Member] | ||
Exercise Prices | $ 0.120 | $ 0.120 |
Options Outstanding (Shares) | 450,000 | 450,000 |
Options Exercisable (Shares) | 450,000 | 450,000 |
Exercise Price Two [Member] | ||
Exercise Prices | $ 0.150 | $ 0.150 |
Options Outstanding (Shares) | 300,000 | 300,000 |
Options Exercisable (Shares) | 300,000 | 300,000 |
Exercise Price Three [Member] | ||
Exercise Prices | $ 0.160 | $ 0.160 |
Options Outstanding (Shares) | 200,000 | 200,000 |
Options Exercisable (Shares) | 200,000 | 200,000 |
Exercise Price Four [Member] | ||
Exercise Prices | $ 0.200 | $ 0.200 |
Options Outstanding (Shares) | 500,000 | 500,000 |
Options Exercisable (Shares) | 500,000 | 500,000 |
Exercise Price Five [Member] | ||
Exercise Prices | $ 0.280 | $ 0.280 |
Options Outstanding (Shares) | 400,000 | 400,000 |
Options Exercisable (Shares) | 400,000 | 400,000 |
Exercise Price Six [Member] | ||
Exercise Prices | $ 0.500 | $ 0.500 |
Options Outstanding (Shares) | 4,200,000 | 4,200,000 |
Options Exercisable (Shares) | 4,200,000 | 4,200,000 |
Exercise Price Seven [Member] | ||
Exercise Prices | $ 1 | $ 1 |
Options Outstanding (Shares) | 1,000,000 | 1,000,000 |
Options Exercisable (Shares) | 1,000,000 | 1,000,000 |
Exercise Price Eight [Member] | ||
Exercise Prices | $ 1.100 | $ 1.100 |
Options Outstanding (Shares) | 300,000 | 300,000 |
Options Exercisable (Shares) | 300,000 | 300,000 |
Exercise Price Nine [Member] | ||
Exercise Prices | $ 1.190 | $ 2 |
Options Outstanding (Shares) | 1,200,000 | 500,000 |
Options Exercisable (Shares) | 300,000 | 500,000 |
Exercise Price Ten [Member] | ||
Exercise Prices | $ 2 | |
Options Outstanding (Shares) | 500,000 | |
Options Exercisable (Shares) | 500,000 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) (10-K) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Options Outstanding (Shares) | 9,050,000 | 7,850,000 |
Options Exercisable (Shares) | 8,150,000 | 7,850,000 |
Exercise Price One [Member] | ||
Exercise Prices | $ 0.120 | $ 0.120 |
Options Outstanding (Shares) | 450,000 | 450,000 |
Options Exercisable (Shares) | 450,000 | 450,000 |
Exercise Price Two [Member] | ||
Exercise Prices | $ 0.150 | $ 0.150 |
Options Outstanding (Shares) | 300,000 | 300,000 |
Options Exercisable (Shares) | 300,000 | 300,000 |
Exercise Price Three [Member] | ||
Exercise Prices | $ 0.160 | $ 0.160 |
Options Outstanding (Shares) | 200,000 | 200,000 |
Options Exercisable (Shares) | 200,000 | 200,000 |
Exercise Price Four [Member] | ||
Exercise Prices | $ 0.200 | $ 0.200 |
Options Outstanding (Shares) | 500,000 | 500,000 |
Options Exercisable (Shares) | 500,000 | 500,000 |
Exercise Price Five [Member] | ||
Exercise Prices | $ 0.280 | $ 0.280 |
Options Outstanding (Shares) | 400,000 | 400,000 |
Options Exercisable (Shares) | 400,000 | 400,000 |
Exercise Price Six [Member] | ||
Exercise Prices | $ 0.500 | $ 0.500 |
Options Outstanding (Shares) | 4,200,000 | 4,200,000 |
Options Exercisable (Shares) | 4,200,000 | 4,200,000 |
Exercise Price Seven [Member] | ||
Exercise Prices | $ 1 | $ 1 |
Options Outstanding (Shares) | 1,000,000 | 1,000,000 |
Options Exercisable (Shares) | 1,000,000 | 1,000,000 |
Exercise Price Eight [Member] | ||
Exercise Prices | $ 1.100 | $ 1.100 |
Options Outstanding (Shares) | 300,000 | 300,000 |
Options Exercisable (Shares) | 300,000 | 300,000 |
Exercise Price Nine [Member] | ||
Exercise Prices | $ 1.190 | $ 2 |
Options Outstanding (Shares) | 1,200,000 | 500,000 |
Options Exercisable (Shares) | 300,000 | 500,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) (10-K) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Income Tax Disclosure [Abstract] | |
Operating loss carryforwards amount federal | $ 17,088,000 |
Operating loss carryforwards amount state | $ 17,987,000 |
Operating loss carryforwards, expiration date | expire through 2039 |
Prior net operating loss conversion | $ 928,367 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets (Details) (10-K) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Start-up and organization costs | $ 10,000 | $ 14,000 |
Research credits | 359,000 | 351,000 |
Stock-based compensation | 799,000 | 626,000 |
Net operating loss carryforwards | 4,879,000 | 4,395,000 |
Total deferred tax assets | 6,047,000 | 5,386,000 |
Valuation allowance | (6,047,000) | (5,386,000) |
Net deferred tax assets |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate (Details) (10-K) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
U. S. federal statutory tax rate | (21.00%) | (21.00%) |
State income taxes, net of federal tax benefit | (6.00%) | (6.00%) |
Expirations related to stock-based compensation | 1.20% | 0.20% |
Adjustment to deferred tax asset | (0.30%) | (1.30%) |
Change in valuation allowance | 26.10% | 28.10% |
Effective tax rate | 0.00% | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) | Aug. 12, 2020USD ($)shares | Aug. 01, 2020USD ($)shares | Jul. 15, 2020USD ($)shares | Feb. 18, 2020USD ($) | Sep. 12, 2018USD ($) | Aug. 20, 2018USD ($) | Apr. 05, 2018USD ($) | Apr. 05, 2018EUR (€) | Apr. 02, 2018 | Mar. 22, 2018USD ($) | Sep. 14, 2015USD ($) | Dec. 24, 2013USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)shares | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Research and development costs | $ 799,420 | $ 570,601 | $ 1,012,038 | $ 699,038 | $ 820,906 | $ 40,703 | |||||||||||||
Stock options granted to purchase common stock, issued | shares | 900,000 | ||||||||||||||||||
Dr. John Kovach [Member] | |||||||||||||||||||
Annual salary | 15,000 | 15,000 | $ 45,000 | 45,000 | 60,000 | 60,000 | |||||||||||||
NDA Consulting Corp [Member] | |||||||||||||||||||
Agreement term | 1 year | ||||||||||||||||||
Consulting and advisory fee | $ 4,000 | 4,000 | 4,000 | 12,000 | 12,000 | 16,000 | 16,000 | ||||||||||||
Clinical Trial Research Agreement [Member] | |||||||||||||||||||
Research and development costs | 81,101 | 45,093 | |||||||||||||||||
Clinical Trial Research Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||||
Payments for clinical trial | 10,643 | 9,996 | 36,008 | 23,249 | |||||||||||||||
Research and development costs | 45,093 | 0 | |||||||||||||||||
Aggregate commitments expected | 621,000 | 621,000 | |||||||||||||||||
Collaboration Agreement [Member] | |||||||||||||||||||
Research and development costs | $ 87,471 | 130,882 | 87,471 | ||||||||||||||||
Advance amount related to milestone payment | 0 | 87,471 | 43,411 | 87,471 | |||||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks LLC [Member] | |||||||||||||||||||
Research and development costs | 30,000 | 30,000 | 90,000 | 70,000 | 100,000 | 10,000 | |||||||||||||
Consulting and advisory fee | $ 10,000 | ||||||||||||||||||
Collaboration Agreement [Member] | Grupo Espanol de Investigacion en Sarcomas [Member] | |||||||||||||||||||
Research and development costs | 87,471 | ||||||||||||||||||
Advance amount related to milestone payment | $ 43,411 | ||||||||||||||||||
Aggregate commitments expected | 4,428,000 | 4,428,000 | |||||||||||||||||
Clinical Trial Agreement [Member] | |||||||||||||||||||
Aggregate commitments expected | 5,049,000 | $ 5,049,000 | $ 5,000,000 | ||||||||||||||||
Aggregate commitments expected, description | The Company's aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to date under these agreements, totaled approximately $5,049,000 as of September 30, 2020, consisting of approximately $4,428,000 relating to the GEIS clinical trial and approximately $621,000 relating to the Moffit clinical trial, which are expected to be incurred over the next five years through June 30, 2025. | The Company's aggregate commitments pursuant to these clinical trial agreements, less amounts previously incurred to date under these agreements, totaled approximately $5,000,000 as of December 31, 2019, which are expected to be incurred over the next five years through 2024. | |||||||||||||||||
Work Order Agreement [Member] | |||||||||||||||||||
Research and development costs | $ 75,885 | $ 63,492 | |||||||||||||||||
Aggregate commitments expected | 875,000 | 875,000 | |||||||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc [Member] | |||||||||||||||||||
Research and development costs | $ 954,000 | 917 | 3,190 | 12,393 | 51,683 | 51,586 | 11,906 | ||||||||||||
Payment expected dividend for pass-through costs, description | The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs. | ||||||||||||||||||
Other Clinical Agreements [Member] | |||||||||||||||||||
Research and development costs | 41,625 | 41,625 | |||||||||||||||||
Aggregate commitments expected | 258,000 | 258,000 | |||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Development Milestones [Member] | Maximum [Member] | |||||||||||||||||||
Milestone payments | $ 1,750,000 | ||||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Commercial Milestones [Member] | Maximum [Member] | |||||||||||||||||||
Milestone payments | $ 6,500,000 | ||||||||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | |||||||||||||||||||
Agreement term | 2 years | ||||||||||||||||||
Payment of a fixed, one-time retainer | $ 18,348 | ||||||||||||||||||
Net payments of sales of products or licensing activities, percentage | 2.50% | 2.50% | |||||||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | EURO [Member] | |||||||||||||||||||
Payment of a fixed, one-time retainer | € | € 15,000 | ||||||||||||||||||
Consulting Agreement [Member] | |||||||||||||||||||
Amortizing the retainer payment | 0 | 2,294 | 2,294 | 6,882 | 9,174 | 6,881 | |||||||||||||
Unamortized balance of the retainer payment | $ 9,174 | 11,468 | |||||||||||||||||
Royalties description | 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 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. | ||||||||||||||||||
Exclusive License Agreement [Member] | |||||||||||||||||||
Amount charges to operations | 6,301 | $ 31,301 | $ 18,699 | $ 74,368 | $ 80,669 | $ 0 | |||||||||||||
Royalties description | 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 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. | ||||||||||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | |||||||||||||||||||
Minimum payments for royalties | $ 50,000 | 50,000 | |||||||||||||||||
Exclusive License Agreement [Member] | Five Years and Thereafter [Member] | |||||||||||||||||||
Minimum payments for royalties | 100,000 | $ 100,000 | |||||||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||||
Non-refundable license issue fee | $ 25,000 | ||||||||||||||||||
Clinical trial analysis expected term | 2 years | ||||||||||||||||||
Clinical trial final analysis expected term | 3 years | ||||||||||||||||||
Annual license maintenance fee | $ 25,000 | ||||||||||||||||||
Payments on non-refundable milestone | $ 1,897,000 | ||||||||||||||||||
Percentage of milestone | 40.00% | ||||||||||||||||||
Employment Agreement [Member] | Dr. John Kovach [Member] | |||||||||||||||||||
Annual salary | $ 250,000 | ||||||||||||||||||
Employment Agreement [Member] | Eric Forman [Member] | |||||||||||||||||||
Annual salary | $ 120,000 | ||||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 350,000 | ||||||||||||||||||
Employment Agreement [Member] | Dr. James Miser [Member] | |||||||||||||||||||
Annual salary | $ 150,000 | ||||||||||||||||||
Stock options description | Dr. Miser was granted options for 500,000 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $1.19 per share, which was equal to the closing price of the Company's common stock on the effective date of the employment agreement. The options vested as to 25% on the effective date, and will vest 25% on each of the first, second and third anniversaries of the effective date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($1.1453 per share), of which $143,163 was attributable to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $166,697 with respect to these stock options. | ||||||||||||||||||
Charges for salary | 25,000 | 25,000 | |||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 500,000 | ||||||||||||||||||
Employment Agreement [Member] | Mr. Weingarten [Member] | |||||||||||||||||||
Annual salary | $ 120,000 | ||||||||||||||||||
Stock options description | On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 350,000 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of 5 years and an exercise price of $1.19 per share, which was equal to the closing price of our common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($1.1453 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the three months and nine months ended September 30, 2020, the Company recorded a charge to operations of $113,667, with respect to these stock options. | ||||||||||||||||||
Charges for salary | $ 16,452 | $ 16,452 | |||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 350,000 | ||||||||||||||||||
Master Service Agreement [Member] | Foundation for Angelman Syndrome Therapy [Member] | |||||||||||||||||||
Percentage of proceeds agree to pay under agreement | 5.00% | ||||||||||||||||||
Maximum amount received under agreement | $ 250,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) (10-K) - USD ($) | Nov. 03, 2018 | Sep. 12, 2018 | Aug. 20, 2018 | Jun. 14, 2018 | Apr. 05, 2018 | Apr. 02, 2018 | Mar. 22, 2018 | Jul. 09, 2017 | Jun. 14, 2017 | Sep. 14, 2015 | Dec. 24, 2013 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Research and development costs | $ 799,420 | $ 570,601 | $ 1,012,038 | $ 699,038 | $ 820,906 | $ 40,703 | ||||||||||||
Unamortized balance of the retainer payment classified as a non-current asset | 2,293 | |||||||||||||||||
Accreted charges | 25,000 | |||||||||||||||||
Reversal of accreted charges | 25,000 | |||||||||||||||||
NDA Consulting Corp [Member] | ||||||||||||||||||
Agreement term | 1 year | |||||||||||||||||
Consulting and advisory fee | $ 4,000 | 4,000 | 4,000 | 12,000 | 12,000 | 16,000 | 16,000 | |||||||||||
Clinical Trial Research Agreement [Member] | ||||||||||||||||||
Research and development costs | 81,101 | 45,093 | ||||||||||||||||
Clinical Trial Research Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||||||
Research and development costs | 45,093 | 0 | ||||||||||||||||
Aggregate commitments expected | 621,000 | 621,000 | ||||||||||||||||
Collaboration Agreement [Member] | ||||||||||||||||||
Research and development costs | $ 87,471 | 130,882 | 87,471 | |||||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks LLC [Member] | ||||||||||||||||||
Research and development costs | 30,000 | 30,000 | 90,000 | 70,000 | 100,000 | 10,000 | ||||||||||||
Consulting and advisory fee | $ 10,000 | |||||||||||||||||
Collaboration Agreement [Member] | Grupo Espanol de Investigacion en Sarcomas [Member] | ||||||||||||||||||
Research and development costs | 87,471 | |||||||||||||||||
Aggregate commitments expected | 4,428,000 | 4,428,000 | ||||||||||||||||
Clinical Trial Agreement [Member] | ||||||||||||||||||
Aggregate commitments expected | 5,049,000 | $ 5,049,000 | $ 5,000,000 | |||||||||||||||
Aggregate commitments expected, description | The Company's aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to date under these agreements, totaled approximately $5,049,000 as of September 30, 2020, consisting of approximately $4,428,000 relating to the GEIS clinical trial and approximately $621,000 relating to the Moffit clinical trial, which are expected to be incurred over the next five years through June 30, 2025. | The Company's aggregate commitments pursuant to these clinical trial agreements, less amounts previously incurred to date under these agreements, totaled approximately $5,000,000 as of December 31, 2019, which are expected to be incurred over the next five years through 2024. | ||||||||||||||||
Work Order Agreement [Member] | ||||||||||||||||||
Research and development costs | $ 75,885 | $ 63,492 | ||||||||||||||||
Aggregate commitments expected | 875,000 | 875,000 | ||||||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc [Member] | ||||||||||||||||||
Research and development costs | $ 954,000 | 917 | 3,190 | 12,393 | 51,683 | 51,586 | 11,906 | |||||||||||
Payment expected dividend for pass-through costs, description | The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs. | |||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Development Milestones [Member] | Maximum [Member] | ||||||||||||||||||
Milestone payments | $ 1,750,000 | |||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Commercial Milestones [Member] | Maximum [Member] | ||||||||||||||||||
Milestone payments | $ 6,500,000 | |||||||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | ||||||||||||||||||
Agreement term | 2 years | |||||||||||||||||
Payment of a fixed, one-time retainer one time retainer | $ 18,348 | |||||||||||||||||
Net payments of sales of products or licensing activities, percentage | 2.50% | |||||||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | EURO [Member] | ||||||||||||||||||
Payment of a fixed, one-time retainer one time retainer | $ 15,000 | |||||||||||||||||
Consulting Agreement [Member] | ||||||||||||||||||
Amortizing the retainer payment | 0 | 2,294 | 2,294 | 6,882 | 9,174 | 6,881 | ||||||||||||
Unamortized balance of the retainer payment | $ 9,174 | 11,468 | ||||||||||||||||
Unamortized balance of the retainer payment classified as a current asset | 9,175 | |||||||||||||||||
Unamortized balance of the retainer payment classified as a non-current asset | 2,293 | |||||||||||||||||
Royalties description | 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 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. | |||||||||||||||||
Exclusive License Agreement [Member] | ||||||||||||||||||
Amount charges to operations | $ 6,301 | $ 31,301 | $ 18,699 | $ 74,368 | $ 80,669 | $ 0 | ||||||||||||
Royalties description | 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 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. | |||||||||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | ||||||||||||||||||
Minimum payments for royalties | $ 50,000 | 50,000 | ||||||||||||||||
Exclusive License Agreement [Member] | Five Years and Thereafter [Member] | ||||||||||||||||||
Minimum payments for royalties | $ 100,000 | $ 100,000 | ||||||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||||||
Non-refundable license issue fee | $ 25,000 | |||||||||||||||||
Clinical trial analysis expected term | 2 years | |||||||||||||||||
Clinical trial final analysis expected term | 3 years | |||||||||||||||||
Annual license maintenance fee | $ 25,000 | |||||||||||||||||
Payments on non-refundable milestone | $ 1,897,000 | |||||||||||||||||
Percentage of milestone | 40.00% | |||||||||||||||||
Materials Cooperative Research and Development Agreement [Member] | ||||||||||||||||||
Funds provide for use in acquiring technical, statistical and administrative support for research activities | $ 100,000 | |||||||||||||||||
Materials Cooperative Research and Development Agreement [Member] | First Installment [Member] | ||||||||||||||||||
Paid two equal installments | $ 50,000 | |||||||||||||||||
Materials Cooperative Research and Development Agreement [Member] | Second Installment [Member] | ||||||||||||||||||
Paid two equal installments | $ 50,000 | |||||||||||||||||
Cancellation of installment, amount | $ 50,000 |