Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 01, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | |
Entity Central Index Key | 0001335105 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2020 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 67,045,814 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2020 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 1,774,332 | $ 2,598,864 |
Accrued interest receivable | 14,367 | |
Prepaid expenses and other current assets | 30,618 | 58,802 |
Total current assets | 1,804,950 | 2,672,033 |
Deferred offering costs | 86,850 | |
Total assets | 1,891,800 | 2,672,033 |
Current liabilities: | ||
Accounts payable and accrued expenses | 189,868 | 143,549 |
Research and development contract liabilities | 24,097 | 94,349 |
Total current liabilities | 213,965 | 237,898 |
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 | 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 |
Additional paid-in capital | 26,016,317 | 26,016,317 |
Accumulated deficit | (27,845,186) | (27,088,886) |
Total stockholders' equity | 1,677,835 | 2,434,135 |
Total liabilities and stockholders' equity | $ 1,891,800 | $ 2,672,033 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 67,045,814 | 67,045,814 |
Common stock, shares outstanding | 67,045,814 | 67,045,814 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, shares issued | 350,000 | 350,000 |
Preferred stock, shares outstanding | 350,000 | 350,000 |
Preferred stock, stated value | $ 10 | $ 10 |
Preferred stock, issuable upon conversion | 4,375,000 | 4,375,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenues | ||||
Costs and expenses: | ||||
General and administrative costs, including $27,000 and $323,665 to related parties for the three months ended June 30, 2020 and 2019, respectively, and $54,000 and $363,601 to related parties for the six months ended June 30, 2020 and 2019, respectively | 255,443 | 547,763 | 547,928 | 938,191 |
Research and development costs | 117,946 | 80,123 | 212,618 | 128,437 |
Total costs and expenses | 373,389 | 627,886 | 760,546 | 1,066,628 |
Loss from operations | (373,389) | (627,886) | (760,546) | (1,066,628) |
Interest income | 264 | 17,422 | 4,246 | 27,428 |
Net loss | $ (373,125) | $ (610,464) | $ (756,300) | $ (1,039,200) |
Net loss per common share - basic and diluted | $ (0.01) | $ (0.01) | $ (0.01) | $ (0.02) |
Weighted average common shares outstanding - basic and diluted | 67,045,814 | 67,045,814 | 67,045,814 | 67,045,814 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
General and administrative costs, to related parties | $ 27,000 | $ 323,665 | $ 54,000 | $ 363,601 |
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, 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 | (1,039,200) | ||||
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 | |||
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 | |||
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 | |||
Net loss | (756,300) | ||||
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 | |||
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 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (756,300) | $ (1,039,200) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense included in - General and administrative costs | 309,601 | |
(Increase) decrease in - | ||
Accrued interest receivable | 14,367 | (17,071) |
Prepaid expenses and other current assets | 28,184 | 25,495 |
Increase (decrease) in - | ||
Accounts payable and accrued expenses | 15,319 | (11,329) |
Research and development contract liabilities | (70,252) | 23,448 |
Net cash used in operating activities | (768,682) | (709,056) |
Cash flows from financing activities: | ||
Payment of deferred offering costs | (55,850) | |
Net cash used in financing activities | (55,850) | |
Cash: | ||
Net decrease | (824,532) | (709,056) |
Balance at beginning of period | 2,598,864 | 4,273,012 |
Balance at end of period | 1,774,332 | 3,563,956 |
Supplemental disclosures of cash flow information: | ||
Interest | ||
Income taxes | ||
Noncash investing and financing activities: | ||
Accrual of deferred offering costs | $ 31,000 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020, and for the three months and six months ended June 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 June 30, 2020, and the results of its operations for the three months and six months ended June 30, 2020 and 2019, and its cash flows for the six months ended June 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. |
Business
Business | 6 Months Ended |
Jun. 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 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. The Company expects that it will need to begin to raise additional capital by no later than early 2021. At June 30, 2020, the Company had cash and cash equivalents of $1,774,332 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 amount and timing of future cash requirements will depend on the pace and design of the Company’s clinical trial program. Current indications from the clinical research organizations conducting the clinical trials for the Company indicate that such clinical trials are being delayed or extended for at least three to six months as a result of the coronavirus pandemic. 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 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 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
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 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. 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 and are 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 $143,444 and $119,133 for the three months ended June 30, 2020 and 2019, and $276,911 and $309,906 for the six months ended June 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 six months ended June 30, 2020 and 2019 is described as follows. General and administrative costs for the three months ended June 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 56.2% and 21.7%, respectively, of total general and administrative costs for those periods. General and administrative costs for the six months ended June 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 50.5% and 33.0%, respectively, of total general and administrative costs for those periods. Research and development costs for the three months ended June 30, 2020 include charges from three vendors and consultants representing 36.8%, 25.6% and 10.5%, respectively, of total research and development costs for that period. Research and development costs for the three months ended June 30, 2019 include charges from four vendors and consultants representing 37.4%, 21.7%, 21.1% and 16.5%, respectively, of total research and development costs for that period. Research and development costs for the six months ended June 30, 2020 include charges from four vendors and consultants representing 28.3%, 20.4%, 15.1%, and 11.9%, respectively, of total research and development costs for that period. Research and development costs for the six months ended June 30, 2019 include charges from four vendors and consultants representing 39.9%, 31.1%, 14.1% and 10.3%, respectively, of total research and development costs 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 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 June 30, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to June 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 June 30, 2020 or December 31, 2019. Subsequent to June 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 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 June 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. June 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 7,850,000 7,550,000 Total 21,225,000 20,925,000 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 December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The adoption of ASU 2019-12 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 | 6 Months Ended |
Jun. 30, 2020 | |
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 (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 June 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 June 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 June 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 June 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 six months ended June 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 June 30, 2020 9,000,000 $ 1.000 2.42 At June 30, 2020, all outstanding warrants are exercisable at $1.000 per common share. Based on a fair market value of $0.90 per share on June 30, 2020, 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 June 30, 2020. Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 6. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions The Company’s Chairman and major stockholder, Dr. John Kovach, was paid a salary of $15,000 for the three months ended June 30, 2020 and 2019, and $30,000 for the six months ended June 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 $12,000 and $12,000 for the three months ended June 30, 2020 and 2019, respectively, and $24,000 and $24,000 for the six months ended June 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 six months ended June 30, 2020 and 2019 is as follows: Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Related party costs: Cash-based $ 27,000 $ 27,000 $ 54,000 $ 54,000 Stock-based — 296,665 — 309,601 Total $ 27,000 $ 323,665 $ 54,000 $ 363,601 Stock-based compensation arrangements involving members of the Company’s Board of Directors and affiliates are described at Note 6. Additional information with respect to cash-based compensation arrangements are described at Note 6. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020, 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. There were no stock options requiring an assessment of value during the six months ended June 30, 2020 and 2019. 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 three months and six months ended June 30, 2019, the Company recorded a charge to operations of $13,080 and $26,016, 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. A summary of stock-based compensation costs for the three months and six months ended June 30, 2020 and 2019 is as follows: Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Related parties $ — $ 296,665 $ — $ 309,601 Non-related parties — — — — Total stock-based compensation costs $ — $ 296,665 $ — $ 309,601 A summary of stock option activity, including options issued in the form of warrants, during the six months ended June 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 — — Exercised — — Expired — — Stock options outstanding at June 30, 2020 7,850,000 $ 0.608 2.64 Stock options exercisable at June 30, 2020 7,850,000 $ 0.608 2.64 There was no deferred compensation expense for the outstanding value of unvested stock options at June 30, 2020. The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at June 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 $ 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 June 30, 2020 was approximately $3,002,000, based on a fair market value of $0.90 per share on June 30, 2020. All outstanding stock options to acquire shares of the Company’s common stock were vested at June 30, 2020. The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
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 June 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 (“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. 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 June 30, 2020 and 2019, the Company paid Moffitt $11,698 and $13,253, respectively, pursuant to this agreement. During the six months ended June 30, 2020 and 2019, the Company paid Moffitt $25,365 and $13,253, respectively, pursuant to this agreement. As of June 30, 2020, total costs of $70,458 have been incurred pursuant to this agreement. GEIS. GEIS has a network of referral centers in Span 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 was 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 and six months ended June 30, 2020, the Company incurred costs of $43,411 pursuant to this agreement. As of June 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 $4,795,000 as of June 30, 2020, consisting of approximately $4,162,000 relating to the GEIS clinical trial and approximately $633,000 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. (Theradex”), 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 June 30, 2020 and 2019, the Company incurred costs of $5,790 and $15,529, respectively, pursuant to this work order. During the six months ended June 30, 2020 and 2019, the Company incurred costs of $11,476 and $48,493, respectively, pursuant to this work order. As of June 30, 2020, total costs of $74,968 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 $876,000 as of June 30, 2020, which are expected to be incurred over the next five years through June 30, 2025. 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, if at all, the Company may reach any of the development or commercialization milestones under the Agreement. As of June 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”). 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 June 30, 2020 and 2019, and $2,294 and $4,588 during the six months ended June 30, 2020 and 2019, respectively. As of June 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 “Effective Date”), the Company entered into an Exclusive License Agreement (the “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 June 30, 2020 and 2019, the Company recorded charges to operations of $6,233 and $27,793, respectively, in connection with its obligations under the License Agreement. During the six months ended June 30, 2020 and 2019, the Company recorded charges to operations of $12,398 and $43,067, respectively, in connection with its obligations under the License Agreement. As of June 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. Other Significant Agreements and Contracts 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 were $4,000 and $4,000 for the three months ended June 30, 2020 and 2019, respectively, and $8,000 and $8,000 for the six months ended June 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 June 30, 2020 and 2019, respectively, and $60,000 and $40,000 for the six months ended June 30, 2020 and 2019, respectively, which were included in research and development costs in the consolidated statements of operations. 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 at least three to six months as a result of the coronavirus pandemic. There is also significant uncertainty as to the affect that the coronavirus may have on the amount and type of financing available to the Company in the future. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 8. Subsequent Events 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, providing appropriate legal notice to stockholders, and approval for the Company’s common stock to be listed on the Nasdaq Capital Market. 2020 Stock Incentive 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. Extension of Warrants 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. Employment Agreements Dr. John Kovach Eric Forman. Dr. James Miser 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 other than those discussed above. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash 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. |
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 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. |
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 and are 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 $143,444 and $119,133 for the three months ended June 30, 2020 and 2019, and $276,911 and $309,906 for the six months ended June 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 | 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 six months ended June 30, 2020 and 2019 is described as follows. General and administrative costs for the three months ended June 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 56.2% and 21.7%, respectively, of total general and administrative costs for those periods. General and administrative costs for the six months ended June 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 50.5% and 33.0%, respectively, of total general and administrative costs for those periods. Research and development costs for the three months ended June 30, 2020 include charges from three vendors and consultants representing 36.8%, 25.6% and 10.5%, respectively, of total research and development costs for that period. Research and development costs for the three months ended June 30, 2019 include charges from four vendors and consultants representing 37.4%, 21.7%, 21.1% and 16.5%, respectively, of total research and development costs for that period. Research and development costs for the six months ended June 30, 2020 include charges from four vendors and consultants representing 28.3%, 20.4%, 15.1%, and 11.9%, respectively, of total research and development costs for that period. Research and development costs for the six months ended June 30, 2019 include charges from four vendors and consultants representing 39.9%, 31.1%, 14.1% and 10.3%, respectively, of total research and development costs for that 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 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 June 30, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to June 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 June 30, 2020 or December 31, 2019. Subsequent to June 30, 2020, 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 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 June 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. June 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 7,850,000 7,550,000 Total 21,225,000 20,925,000 |
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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The adoption of ASU 2019-12 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) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At June 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. June 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 7,850,000 7,550,000 Total 21,225,000 20,925,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding | A summary of common stock warrant activity during the six months ended June 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 June 30, 2020 9,000,000 $ 1.000 2.42 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Related Party Transactions [Abstract] | |
Summary of Related Party Costs | A summary of related party costs for the three months and six months ended June 30, 2020 and 2019 is as follows: Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Related party costs: Cash-based $ 27,000 $ 27,000 $ 54,000 $ 54,000 Stock-based — 296,665 — 309,601 Total $ 27,000 $ 323,665 $ 54,000 $ 363,601 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the three months and six months ended June 30, 2020 and 2019 is as follows: Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Related parties $ — $ 296,665 $ — $ 309,601 Non-related parties — — — — Total stock-based compensation costs $ — $ 296,665 $ — $ 309,601 |
Summary of Stock Option Activity Including Options Form of Warrants | A summary of stock option activity, including options issued in the form of warrants, during the six months ended June 30, 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 — — Exercised — — Expired — — Stock options outstanding at June 30, 2020 7,850,000 $ 0.608 2.64 Stock options exercisable at June 30, 2020 7,850,000 $ 0.608 2.64 |
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants | The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at June 30, 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 $ 2.000 500,000 500,000 7,850,000 7,850,000 |
Business (Details Narrative)
Business (Details Narrative) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 1,774,332 | $ 2,598,864 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Patent and licensing costs | $ 143,444 | $ 119,133 | $ 276,911 | $ 309,906 | |
Concentration of risk, percentage | 10.00% | 10.00% | 10.00% | 10.00% | |
Deferred setup and organization costs, amortization period | 180 months | ||||
Unrecognized tax benefits | |||||
General and Administrative Expense [Member] | |||||
Concentration of risk, percentage | 56.20% | 21.70% | 50.50% | 33.00% | |
Research and Development Expense [Member] | One Vendor and Consultants [Member] | |||||
Concentration of risk, percentage | 36.80% | 37.40% | 28.30% | 39.90% | |
Research and Development Expense [Member] | Two Vendors and Consultants [Member] | |||||
Concentration of risk, percentage | 25.60% | 21.70% | 20.40% | 31.10% | |
Research and Development Expense [Member] | Three Vendors and Consultants [Member] | |||||
Concentration of risk, percentage | 10.50% | 21.10% | 15.10% | 14.10% | |
Research and Development Expense [Member] | Four Vendors and Consultants [Member] | |||||
Concentration of risk, percentage | 16.50% | 11.90% | 10.30% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Anti-dilutive securities excluded from computation of earnings per share | 21,225,000 | 20,925,000 |
Series A Convertible Preferred Stock [Member] | ||
Anti-dilutive securities excluded from computation of earnings per share | 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 |
Common Stock Options, Including Options Issued in the Form of Warrants [Member] | ||
Anti-dilutive securities excluded from computation of earnings per share | 7,850,000 | 7,550,000 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Mar. 17, 2015 | Jun. 30, 2020 | Dec. 31, 2019 | Jan. 21, 2016 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||
Common stock, shares issued | 67,045,814 | 67,045,814 | ||
Common stock, shares outstanding | 67,045,814 | 67,045,814 | ||
Common Stock Warrant [Member] | ||||
Warrants exercise price | $ 1 | |||
Warrant exercisable price per shares | $ 0.90 | |||
Intrinsic value of exercisable warrants | ||||
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 | ||
Gross proceeds from sale of transaction | $ 21,875,000 | |||
Preferred stock, shares outstanding | 350,000 | 350,000 | ||
Preferred stock, per share redemption price | $ 50 | $ 50 | ||
Preferred stock, shares right to redeem | 175,000 | |||
Preferred stock, aggregate cash redemption value | $ 8,750,000 | |||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | ||||
Preferred stock convertible into common stock | 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 $21,875,000. | |||
Undesignated Preferred Stock [Member] | ||||
Preferred stock, shares authorized | 9,650,000 | 9,650,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Number of Shares, Warrants Outstanding, Beginning Balance | shares | 9,000,000 |
Number of Shares, Issued | shares | |
Number of Shares, Exercised | shares | |
Number of Shares, Expired | shares | |
Number of Shares, Warrants Outstanding, Ending Balance | shares | 9,000,000 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ / shares | $ 1 |
Weighted Average Exercise Price, Issued | $ / shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ / shares | $ 1 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 2 years 5 months 1 day |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Eric Forman [Member] | ||||
Legal and consulting fees charged to operations for services rendered | $ 12,000 | $ 12,000 | $ 24,000 | $ 24,000 |
Dr. John Kovach [Member] | ||||
Salaries paid | $ 15,000 | $ 15,000 | $ 30,000 | $ 30,000 |
Related Party Transactions - Su
Related Party Transactions - Summary of Related Party Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Total | $ 27,000 | $ 323,665 | $ 54,000 | $ 363,601 |
Cash-based [Member] | ||||
Total | 27,000 | 27,000 | 54,000 | 54,000 |
Stock-based [Member] | ||||
Total | $ 296,665 | $ 309,601 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | Aug. 04, 2019 | May 22, 2019 | Aug. 04, 2018 | Jun. 20, 2007 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 |
Stock options granted to purchase common stock, outstanding | 7,850,000 | 7,850,000 | ||||||
Charges to operations | $ 13,080 | $ 26,016 | ||||||
Total deferred compensation expense for outstanding value of unvested stock options | ||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 3,002,000 | |||||||
Fair market value, per share | $ 0.90 | |||||||
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 | $ 52,460 | |||||||
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 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 | |||||||
2007 Stock Compensation Plan [Member] | ||||||||
Stock options granted to purchase common stock, issued | 1,250,000 | |||||||
Stock options granted to purchase common stock, outstanding | 1,250,000 | |||||||
2007 Stock Compensation Plan [Member] | Maximum [Member] | ||||||||
Number of restricted stock issued | 2,500,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-based Compensation Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Total stock-based compensation costs | $ 296,665 | $ 309,601 | ||
Related Parties [Member] | ||||
Total stock-based compensation costs | 296,665 | 309,601 | ||
Non-related Parties [Member] | ||||
Total stock-based compensation costs |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity Including Options Form of Warrants (Details) | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Number of shares, stock options outstanding, at the beginning | shares | 7,850,000 |
Number of shares, Granted | shares | |
Number of shares, Exercised | shares | |
Number of shares, Expired | shares | |
Number of shares, stock options outstanding, at the end | shares | 7,850,000 |
Number of shares, stock options exercisable, at the end | shares | 7,850,000 |
Weighted average exercise price, stock options outstanding, at the beginning | $ / shares | $ 0.608 |
Weighted average exercise price, granted | $ / shares | |
Weighted average exercise price, exercised | $ / shares | |
Weighted average exercise price, expired | $ / shares | |
Weighted average exercise price, stock options outstanding, at the end | $ / shares | 0.608 |
Weighted average exercise price, stock options exercisable, at the end | $ / shares | $ 0.608 |
Weighted average remaining contractual life (in years), stock options outstanding | 2 years 7 months 21 days |
Weighted average remaining contractual life (in years), stock options exercisable | 2 years 7 months 21 days |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Options Outstanding (Shares) | 7,850,000 |
Options Exercisable (Shares) | 7,850,000 |
Exercise Price One [Member] | |
Exercise Prices | $ / shares | $ 0.120 |
Options Outstanding (Shares) | 450,000 |
Options Exercisable (Shares) | 450,000 |
Exercise Price Two [Member] | |
Exercise Prices | $ / shares | $ 0.150 |
Options Outstanding (Shares) | 300,000 |
Options Exercisable (Shares) | 300,000 |
Exercise Price Three [Member] | |
Exercise Prices | $ / shares | $ 0.160 |
Options Outstanding (Shares) | 200,000 |
Options Exercisable (Shares) | 200,000 |
Exercise Price Four [Member] | |
Exercise Prices | $ / shares | $ 0.200 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | 500,000 |
Exercise Price Five [Member] | |
Exercise Prices | $ / shares | $ 0.280 |
Options Outstanding (Shares) | 400,000 |
Options Exercisable (Shares) | 400,000 |
Exercise Price Six [Member] | |
Exercise Prices | $ / shares | $ 0.500 |
Options Outstanding (Shares) | 4,200,000 |
Options Exercisable (Shares) | 4,200,000 |
Exercise Price Seven [Member] | |
Exercise Prices | $ / shares | $ 1 |
Options Outstanding (Shares) | 1,000,000 |
Options Exercisable (Shares) | 1,000,000 |
Exercise Price Eight [Member] | |
Exercise Prices | $ / shares | $ 1.100 |
Options Outstanding (Shares) | 300,000 |
Options Exercisable (Shares) | 300,000 |
Exercise Price Nine [Member] | |
Exercise Prices | $ / shares | $ 2 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | 500,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) | 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 ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) |
Research and development costs | $ 117,946 | $ 80,123 | $ 212,618 | $ 128,437 | ||||||||||
NDA Consulting Corp [Member] | ||||||||||||||
Agreement term | 1 year | |||||||||||||
Consulting and advisory fee | $ 4,000 | 4,000 | 4,000 | 8,000 | 8,000 | |||||||||
Clinical Trial Research Agreement [Member] | ||||||||||||||
Research and development costs | 70,458 | |||||||||||||
Clinical Trial Research Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||
Payments for clinical trial | 11,698 | 13,253 | 25,365 | 13,253 | ||||||||||
Aggregate commitments expected | 633,000 | 633,000 | ||||||||||||
Collaboration Agreement [Member] | ||||||||||||||
Research and development costs | 87,471 | 130,882 | ||||||||||||
Advance amount related to milestone payment | 43,411 | 43,411 | ||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks LLC [Member] | ||||||||||||||
Research and development costs | 30,000 | 30,000 | 60,000 | 40,000 | ||||||||||
Consulting and advisory fee | $ 10,000 | |||||||||||||
Collaboration Agreement [Member] | Grupo Espanol de Investigacion en Sarcomas [Member] | ||||||||||||||
Advance amount related to milestone payment | $ 43,411 | |||||||||||||
Aggregate commitments expected | 4,162,000 | 4,162,000 | ||||||||||||
Clinical Trial Agreement [Member] | ||||||||||||||
Aggregate commitments expected | 4,795,000 | $ 4,795,000 | ||||||||||||
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 $4,795,000 as of June 30, 2020, consisting of approximately $4,162,000 relating to the GEIS clinical trial and approximately $633,000 relating to the Moffit clinical trial, which are expected to be incurred over the next five years through June 30, 2025. | |||||||||||||
Work Order Agreement [Member] | ||||||||||||||
Research and development costs | $ 74,968 | |||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc [Member] | ||||||||||||||
Research and development costs | $ 954,000 | 5,790 | 15,529 | 11,476 | 48,493 | |||||||||
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. | |||||||||||||
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 | 4,588 | ||||||||||
Unamortized balance of the retainer payment | $ 9,174 | |||||||||||||
Exclusive License Agreement [Member] | ||||||||||||||
Amount charges to operations | $ 6,233 | $ 27,793 | $ 12,398 | $ 43,067 | ||||||||||
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 | |||||||||||||
Exclusive License Agreement [Member] | Five Years and Thereafter [Member] | ||||||||||||||
Minimum payments for royalties | $ 100,000 | |||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | ||||||||||||||
Non-refundable license issue fee | $ 25,000 | |||||||||||||
Annual license maintenance fee | 25,000 | |||||||||||||
Payments on non-refundable milestone | $ 1,897,000 | |||||||||||||
Percentage of milestone | 40.00% |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Aug. 01, 2020 | Jul. 15, 2020 | Jul. 14, 2020 | Jul. 03, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jul. 02, 2020 | Sep. 14, 2017 | Sep. 14, 2016 | Sep. 14, 2015 |
Dr. John Kovach [Member] | ||||||||||||
Annual salary | $ 15,000 | $ 15,000 | $ 30,000 | $ 30,000 | ||||||||
Collaboration Agreement [Member] | BioPharmaWorks [Member] | ||||||||||||
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 | ||||||||||
Subsequent Event [Member] | Common Stock [Member] | ||||||||||||
Reverse stock split | 1-for-6 reverse split | |||||||||||
Subsequent Event [Member] | 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 | |||||||||||
Subsequent Event [Member] | Employment Agreement [Member] | Dr. John Kovach [Member] | ||||||||||||
Annual salary | $ 250,000 | |||||||||||
Subsequent Event [Member] | Employment Agreement [Member] | Eric Forman [Member] | ||||||||||||
Annual salary | $ 100,000 | |||||||||||
Subsequent Event [Member] | Employment Agreement [Member] | Dr. James Miser [Member] | ||||||||||||
Stock options description | Dr. Miser will be required to devote at least 50% of his business time to Company activities. Dr. Miser will receive a monthly salary of $12,500. He will also receive options to purchase up to 500,000 shares of the Company's common stock (the "Options"). The Options will 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. The Options shall vest as to 25% on the effective date, and 25% on each of the first, second and third anniversaries of the effective date. The effective date of the agreement is August 1, 2020, and shall remain in effect until the earlier of (i) one year from the effective date, automatically renewable for additional one year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one year period, (ii) his death, or (iii) termination for cause. | |||||||||||
Monthly salary | $ 12,500 | |||||||||||
Stock option vested exercisable term | 5 years | |||||||||||
Subsequent Event [Member] | Maximum [Member] | Employment Agreement [Member] | Dr. James Miser [Member] | ||||||||||||
Stock options granted to purchase common stock, issued | 500,000 | |||||||||||
Stock option excercise price | $ 1.19 | |||||||||||
Subsequent Event [Member] | 2020 Stock Incentive Plan [Member] | Maximum [Member] | ||||||||||||
Number of restricted stock issued | 14,000,000 |