Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 01, 2019 | Jun. 30, 2018 | |
Document And Entity Information | |||
Entity Registrant Name | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | ||
Entity Central Index Key | 0001335105 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 3,376,000 | ||
Entity Common Stock, Shares Outstanding | 67,045,814 | ||
Trading Symbol | LIXT | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash | $ 4,273,012 | $ 1,305,748 |
Prepaid expenses and other current assets | 61,433 | 62,317 |
Total current assets | 4,334,445 | 1,368,065 |
Prepaid expense, less current portion | 2,293 | |
Total assets | 4,336,738 | 1,368,065 |
Current liabilities: | ||
Accounts payable and accrued expenses | 195,211 | 312,034 |
Research and development contract liabilities | 15,704 | 60,990 |
Total current liabilities | 210,915 | 373,024 |
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, $50.00 per share cash redemption value; aggregate cash redemption value - $17,500,000; liquidation preference based on assumed conversion into common shares - 4,375,000 shares | 3,500,000 | 3,500,000 |
Common stock, $0.0001 par value; authorized - 100,000,000 shares; issued and outstanding - 67,045,814 shares and 58,025,814 shares at December 31, 2018 and 2017, respectively | 6,704 | 5,802 |
Additional paid-in capital | 25,267,662 | 20,004,654 |
Accumulated deficit | (24,648,543) | (22,515,415) |
Total stockholders' equity | 4,125,823 | 995,041 |
Total liabilities and stockholders' equity | $ 4,336,738 | $ 1,368,065 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 58,025,814 |
Common stock, shares outstanding | 67,045,814 | 58,025,814 |
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, per share redemption price | $ 50 | $ 50 |
Preferred stock, aggregate cash redemption value | $ 17,500,000 | $ 17,500,000 |
Preferred stock, issuable upon conversion | 4,375,000 | 4,375,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Revenues | ||
Costs and expenses: | ||
General and administrative costs, including $759,738 and $83,686 to related parties for the years ended December 31, 2018 and 2017, respectively | 2,097,348 | 1,342,531 |
Research and development costs, including $22,198 and $105,698 to Theradex for the years ended December 31, 2018 and 2017, respectively | 40,703 | 467,258 |
Total costs and expenses | 2,138,051 | 1,809,789 |
Loss from operations | (2,138,051) | (1,809,789) |
Interest income | 4,923 | 1,375 |
Net loss | $ (2,133,128) | $ (1,808,414) |
Net loss per common share - basic and diluted | $ (0.04) | $ (0.03) |
Weighted average common shares outstanding - basic and diluted | 58,796,115 | 55,817,458 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
General and administrative costs, to related parties | $ 759,738 | $ 83,686 |
Research and development costs, to Theradex | $ 22,198 | $ 105,698 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity - USD ($) | Series A Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 3,500,000 | $ 4,787 | $ 17,416,974 | $ (20,707,001) | $ 214,760 |
Balance, shares at Dec. 31, 2016 | 350,000 | 47,875,814 | |||
Sale of common stock units | $ 1,000 | 2,499,000 | 2,500,000 | ||
Sale of common stock units, shares | 10,000,000 | ||||
Exercise of common stock options | $ 15 | 17,985 | 18,000 | ||
Exercise of common stock options, shares | 150,000 | ||||
Stock-based compensation expense, including $711,738 for extension of stock options to related party | 70,695 | 70,695 | |||
Net loss | (1,808,414) | (1,808,414) | |||
Balance at Dec. 31, 2017 | $ 3,500,000 | $ 5,802 | 20,004,654 | (22,515,415) | 995,041 |
Balance, shares at Dec. 31, 2017 | 350,000 | 58,025,814 | |||
Sale of common stock units | $ 900 | 4,499,100 | 4,500,000 | ||
Sale of common stock units, shares | 9,000,000 | ||||
Costs incurred in connection with the sale of common stock units | (24,702) | (24,702) | |||
Exercise of common stock options | $ 2 | 2,998 | 3,000 | ||
Exercise of common stock options, shares | 20,000 | ||||
Stock-based compensation expense, including $711,738 for extension of stock options to related party | 785,612 | 785,612 | |||
Stock-based compensation expense, including $711,738 for extension of stock options to related party, shares | |||||
Net loss | (2,133,128) | (2,133,128) | |||
Balance at Dec. 31, 2018 | $ 3,500,000 | $ 6,704 | $ 25,267,662 | $ (24,648,543) | $ 4,125,823 |
Balance, shares at Dec. 31, 2018 | 350,000 | 67,045,814 |
Consolidated Statement of Sto_2
Consolidated Statement of Stockholders' Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Extension of stock options to related party | $ 711,738 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (2,133,128) | $ (1,808,414) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense included in - General and administrative costs | 785,612 | 38,675 |
Stock-based compensation expense included in - Research and development costs | 32,020 | |
(Increase) decrease in - | ||
Advances on research and development contract services | 183,490 | |
Prepaid expenses and other current assets | (1,409) | (12,325) |
Increase (decrease) in - | ||
Accounts payable and accrued expenses | (116,823) | 152,439 |
Research and development contract liabilities | (45,286) | 1,934 |
Net cash used in operating activities | (1,511,034) | (1,412,181) |
Cash flows from financing activities: | ||
Exercise of common stock options | 3,000 | 18,000 |
Proceeds from sale of common stock and common stock units | 4,500,000 | 2,500,000 |
Costs incurred in connection with the sale of common stock units | (24,702) | |
Net cash provided by financing activities | 4,478,298 | 2,518,000 |
Cash: | ||
Net increase (decrease) | 2,967,264 | 1,105,819 |
Balance at beginning of period | 1,305,748 | 199,929 |
Balance at end of period | 4,273,012 | 1,305,748 |
Supplemental disclosures of cash flow information: | ||
Interest | ||
Income taxes |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Lixte Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (“Lixte”) (collectively, the “Company”), is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s product pipeline encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital, as described below. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, and is dependent on periodic infusions of equity capital to fund its operating requirements. The Company’s common stock is traded on the OTCQB operated by the OTC Markets under the symbol “LIXT”. Going Concern The Company’s consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future. Furthermore, the Company has experienced recurring operating losses and negative operating cash flows since inception and has financed its working capital requirements during this period primarily through the recurring sale of its equity securities and the exercise of outstanding common stock options and purchase warrants. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the consolidated financial statements are being issued. In addition, the Company’s independent registered public accounting firm, in their report on the Company’s consolidated financial statements for the year ended December 31, 2018, 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. Because the Company is currently engaged in clinical research at a relatively early stage, it will likely 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. At December 31, 2018, the Company had cash of $4,273,012 available to fund its operations. The next step in the development of the Company’s lead anti-cancer clinical compound LB-100 is to evaluate its safety and therapeutic benefit in a Phase 1b/2 clinical trial. This clinical trial is currently expected to begin during the quarter ending June 30, 2019, to complete patient accrual over a period of two years, and to take approximately three years to complete. The Company’s longer-term objective is to secure one or more strategic partnerships with pharmaceutical companies with major programs in cancer. The amount and timing of future cash requirements will depend on the pace and design of the Company’s clinical trial program. As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, or at all, as and when necessary to continue to conduct operations. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or any clinical trials, 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 | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly-owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash Concentrations The Company maintains its cash balances with financial institutions in federally-insured accounts. The Company may periodically have cash balances in banks in excess of FDIC insurance limits. The Company maintains its accounts with financial institutions with high credit ratings. The Company has not experienced any losses to date resulting from this practice. Beginning in 2019, the Company intends to invest the majority of its cash resources in short-term federally insured certificates of deposit. Research and Development Research and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the acquisition, design, development and testing of the Company’s compounds and product candidates. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. On January 10, 2010, the Company retained Theradex Systems, Inc. (“Theradex”) under a Master Agreement to provide technical and advisory services to the Company with respect to clinical trial matters involving the U.S. Food and Drug Administration (“FDA”). Theradex is an international contract research organization (“CRO”) that provides technical and advisory services with respect to clinical research and development of pharmaceutical compounds under the rules and regulations of the FDA. On September 21, 2012, the Company entered into a work order agreement with Theradex to manage and administer the Company’s Phase 1 clinical trial of LB-100. This Phase 1 clinical trial had been substantially completed at December 31, 2017. The costs of the Phase 1 clinical trial of LB-100 paid to or through Theradex were recorded and charged to operations based upon the periodic documentation provided by the CRO. During the year ended December 31, 2018, the Company has paid Theradex $10,292 to update FDA documents relative to the completed Phase 1 clinical trial of LB-100. On September 12, 2018, the Company finalized a work order agreement with Theradex to monitor a Phase 1b/2 clinical trial that was approved by the FDA in early November 2018. This clinical trial is currently expected to begin during the quarter ending June 30, 2019, to complete patient accrual over a period of two years, and to take approximately three years to complete. The clinical trial will be managed and conducted by the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida, to evaluate the safety and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS). This work order agreement became operational in August 2018 and is estimated to be completed by December 2021. 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 5% for payments for pass-through costs. The costs of the upcoming Phase 1b/2 clinical trial to be paid to or through Theradex will be recorded and charged to operations based on the periodic documentation provided by the CRO. As of December 31, 2018, costs of $11,906 have been incurred pursuant to this work order agreement. In addition to the costs associated with the previously described work order agreements with Theradex with respect to the Company’s clinical trials, the Company has also from time to time engaged Theradex to provide other technical and advisory services. 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 then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. Patent and Licensing 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 costs were $842,325 and $846,169 for the years ended December 31, 2018 and 2017, respectively. Patent and licensing costs are included in general and administrative costs in the Company’s consolidated statements of operations. Accounting for Preferred Stock The Company accounts for preferred stock as either equity or debt, depending on the specific characteristics of the security issued. The Series A Convertible Preferred Stock issued by the Company in January 2016 and March 2015 has been classified as a component of stockholders’ equity (see Note 3). Concentration of Risk The Company periodically contracts with directors, including companies controlled by or associated with directors, to provide consulting services related to the Company’s research and development and clinical trial activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task and can include both cash and non-cash compensation. The only such contracts that represent 10% or more of general and administrative or research and development costs are described below. As discussed above at “Research and Development”, the Company has retained Theradex to provide technical and advisory services to the Company with respect to clinical trial matters involving the FDA. Total costs charged to operations from 2013 through December 31, 2017 for services paid to or through Theradex for the Phase 1 clinical trial of LB-100 aggregated $2,233,248, with approximately 60% of such costs allocated for services provided by Theradex and approximately 40% for pass-through costs for clinical center laboratory costs and investigator costs over the life of the clinical trial. During the year ended December 31, 2018, the Company did not incur any such clinical trial costs with Theradex. During the year ended December 31, 2017, the Company incurred $105,698 of such clinical trial costs with Theradex, representing approximately 24% of research and development costs for the year ended December 31, 2017. Costs incurred pursuant to this agreement are included in research and development costs in the Company’s consolidated statements of operations. Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company has elected to deduct research and development costs on a current basis for federal income tax purposes. For federal tax purposes, start-up and organization costs were deferred until January 1, 2008 at which time the Company began to amortize such costs over a 180-month period. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of December 31, 2018 and 2017 and does not anticipate any material amount of unrecognized tax benefits within the next 12 months. The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. As of December 31, 2018, the Company had not recorded any liability for uncertain tax positions. In subsequent periods, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. On December 22, 2017, the Tax Reform Act was signed into law. The Tax Reform Act is effective for tax years beginning on or after January 1, 2018, except for certain provisions, and resulted in significant changes to existing United States tax law, including various provisions that are expected to impact the Company. Among other provisions, the Tax Reform Act reduced the federal corporate tax rate from 35% to 21% effective January 1, 2018. Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, Scientific Advisory Committee members and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. The Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The Company accounts for stock-based payments to Scientific Advisory Committee members and consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment is reached or (b) at the date at which the necessary performance to earn the equity instruments is complete. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. Stock options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are revalued each reporting period to determine the amount to be recorded as an expense in the respective period. As the stock options vest, they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the value on the date of vesting. The fair value of common stock issued as stock-based compensation is determined by reference to the closing price of the Company’s common stock on the date of issuance. 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 over the term of the equity award. Estimated volatility is based on the historical volatility of the Company’s common stock. 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 common stock is determined by reference to the quoted market price of the Company’s common stock. 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 is the same for all periods presented because all preferred shares, warrants and stock options outstanding are anti-dilutive. At December 31, 2018 and 2017, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. December 31, 2018 2017 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 — Common stock options, including options issued in the form of warrants 7,750,000 7,470,000 Total 21,125,000 11,845,000 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 accounts payable and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. Recent Accounting Pronouncements Recently Adopted Accounting Standards In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 eliminates transaction- and industry-specific revenue recognition guidance under current GAAP and replaces it with a principles-based approach for determining revenue recognition. ASU 2014-09 requires that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The FASB has recently issued ASU 2016-08, ASU 2016-10, ASU 2016-11, ASU 2016-12, and ASU 2016-20, all of which clarify certain implementation guidance within ASU 2014-09. ASU 2014-09 is effective for reporting periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2014-09 in the quarter beginning January 1, 2018. The adoption of ASU 2014-09 did not have any impact on the Company’s financial statement presentation or disclosures. In July 2017, the FASB issued Accounting Standards Update No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features; (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). ASU 2017-11 allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity’s own stock. As a result, financial instruments (or embedded conversion features) with down round features are no longer required to be accounted for as derivative liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, an entity will treat the value of the effect of the down round as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. For convertible instruments with embedded conversion features containing down round provisions, entities will recognize the value of the down round as a beneficial conversion discount to be amortized to earnings. ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The Company early adopted the provisions of ASU 2017-11 in the quarter beginning January 1, 2018. The adoption of ASU 2017-11 did not have any impact on the Company’s financial statement presentation or disclosures. Recently Issued Accounting Standards In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 requires a lessee to record a right-of-use asset and a corresponding lease liability, initially measured at the present value of the lease payments, on the balance sheet for all leases with terms longer than 12 months, as well as the disclosure of key information about leasing arrangements. ASU 2016-02 requires recognition in the statement of operations of a single lease cost, calculated so that the cost of the lease is allocated over the lease term, generally on a straight-line basis. ASU 2016-02 requires classification of all cash payments within operating activities in the statement of cash flows. Disclosures are required to provide the amount, timing and uncertainty of cash flows arising from leases. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. ASU 2016-02 has subsequently been amended and modified by ASU 2018-10, 2018-11 and 2018-20. ASU 2016-02 (including the subsequent amendments and modifications) is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company will adopt the provisions of ASU 2016-02 in the quarter beginning January 1, 2019. The adoption of ASU 2016-02 is not expected to have any impact on the Company’s financial statement presentation or disclosures. In June 2018, the FASB issued Accounting Standards Update 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Revenue from Contracts with Customers (Topic 606). ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company will adopt the provisions of ASU 2018-07 in the quarter beginning January 1, 2019. The adoption of ASU 2018-07 is not expected to have any impact on the Company’s financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | 3. Stockholders’ Equity Preferred Stock The Company has authorized 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 designated 175,000 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. Effective January 28, 2016, the Series A Convertible Preferred Stock Certificate of Designations was amended to increase the authorized shares of Series A Convertible Preferred Stock from 175,000 shares to 350,000 shares. Accordingly, as of December 31, 2017, 9,650,000 shares of preferred stock were undesignated and may be issued with such rights and powers as the Board of Directors may designate. Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 12.5 shares of common stock (subject to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. The Series A Convertible Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred Stock does not have a cash liquidation preference. If fully converted, the 350,000 outstanding shares of Series A Convertible Preferred Stock would convert into 4,375,000 shares of common stock at December 31, 2018. The Company has the right to redeem the Series A Convertible Preferred Stock up to the fifth anniversary of the respective closing dates at a price per share equal to $50.00. The Series A Convertible Preferred Stock has no right to cash, except for the payment of the aforementioned dividend based on the generation of revenues by the Company and does not have any registration rights. Based on the attributes of the Series A Convertible Preferred Stock described above, the Company 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 up to 100,000,000 shares of common stock (par value $0.0001). As of December 31, 2018 and 2017, the Company had 67,045,814 shares and 58,025,814 shares of common stock issued and outstanding, respectively. Effective February 24, 2017, the Company entered into a Securities Purchase Agreement with an accredited investor pursuant to which the purchaser purchased 4,000,000 shares of the Company’s common stock at a price of $0.25 per share for an aggregate purchase price of $1,000,000. Effective April 3, 2017, the Company entered into a Securities Purchase Agreement with an accredited investor pursuant to which the purchaser purchased 6,000,000 shares of the Company’s common stock at a price of $0.25 per share for an aggregate purchase price of $1,500,000. Effective November 30, 2018, the Company raised $4,500,000 through the sale to sixteen accredited investors of 9,000,000 units at a purchase price of $0.50 per unit. Each unit consisted of one share of common stock and one four-year warrant to purchase one share of common stock at an exercise price of $1.00 per share. Accordingly, a total of 9,000,000 shares of common stock and warrants to purchase 9,000,000 shares of common stock were issued by the Company. The warrants do not have any reset provisions. Legal costs of the private placement were $24,702. There were no commissions paid with respect to the private placement. The units sold were not registered under the Securities Act of 1933, as amended (the “Act”), in reliance upon the exemption from registration contained in Section 4(2) of the Act and Regulation D promulgated thereunder. The Company accounted for the issuance of the units as a capital transaction. Common Stock Warrants A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, is presented below. Weighted Average Weighted Remaining Number Average Contractual of Exercise Life Shares Price (in Years) Warrants outstanding at December 31, 2017 — $ — Issued 9,000,000 1.000 Exercised — — Expired — — Warrants outstanding at December 31, 2018 9,000,000 $ 1.000 3.92 At December 31, 2018, all outstanding warrants are exercisable at $1.000 per common share. Based on a fair market value of $0.93 per share on December 31, 2018, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at December 31, 2018. Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 5. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 4. Related Party Transactions The Company’s Chairman and major stockholder, Dr. John Kovach, was paid a salary of $60,000 for the years ended December 31, 2018 and 2017, which amounts are included in general and administrative costs in the Company’s consolidated statements of operations. Beginning in late February 2017, Dr. Kovach began devoting 100% of his time to the Company’s business activities. The Company’s principal office facilities are being provided without charge by Dr. Kovach. Such costs were not material to the Company’s consolidated financial statements and, accordingly, have not been reflected therein. On September 12, 2007, the Company entered into a consulting agreement with Gil Schwartzberg for Mr. Schwartzberg to provide financial advisory and consulting services to the Company with respect to financing matters, capital structure and strategic development, and to assist management in communications with investors and shareholders. Mr. Schwartzberg is currently a significant stockholder of the Company and continues to be a consultant to the Company. Consideration under this consulting agreement, including subsequent extensions, has been paid exclusively in the form of stock options. On January 28, 2014, the Company entered into a second amendment to its consulting agreement with Mr. Schwartzberg to extend it to January 28, 2019. In conjunction with such amendment, the Company granted Mr. Schwartzberg stock options to purchase an additional 4,000,000 shares of common stock, exercisable at $0.50 per share for a period of the earlier of five years from the grant date or the termination of the consulting agreement, with one-half of the stock options (2,000,000 shares) vested immediately and one-half of the stock options (2,000,000 shares) vested on January 28, 2015. Stock-based compensation expense with respect to the grant of the stock options to purchase the 4,000,000 shares of common stock was previously charged to general and administrative costs in the consolidated statement of operations over the vesting period. On August 2, 2018, with the approval of the Board of Directors, the Company entered into a third amendment to its consulting agreement with Mr. Schwartzberg to extend it to January 28, 2024. In conjunction with such amendment, the Company extended the expiration date of the fully-vested stock options for 4,000,000 shares of common stock previously granted to Mr. Schwartzberg, from January 28, 2019 to January 28, 2024. The fair value of the extension of these vested stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured for accounting purposes as the difference in the fair value of the stock options immediately before and immediately after the extension date, and was determined to be $711,738 ($0.1779 per share), which was charged to general and administrative costs in the consolidated statement of operations on the extension date. Legal and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $48,000 for the years ended December 31, 2018 and 2017, respectively. In addition, effective October 16, 2017, in connection with his continuing role as a consultant to the Company, Eric Forman was granted fully-vested stock options to purchase 100,000 shares of the Company’s common stock. The stock options are exercisable for a period of five years from the date of grant at $0.15 per share, which was the 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 $14,997 ($0.1500 per share), which was charged to operations on the date of grant. Eric J. 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 J. 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 banking relationship. Stock-based compensation arrangements involving members of the Company’s Board of Directors and affiliates are described at Note 5. Total stock-based compensation expense relating to directors, officers, affiliates and related parties was $785,612 and $35,676 for the years ended December 31, 2018 and 2017, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 5. Stock-Based Compensation The Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of independent contractors and consultants of the Company. On June 20, 2007, the Board of Directors of the Company approved the 2007 Stock Compensation Plan (the “2007 Plan”), which provides for the granting of awards, consisting of stock options, stock appreciation rights, performance shares, or restricted shares of common stock, to employees and independent contractors, for up to 2,500,000 shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors. The 2007 Plan terminated on June 19, 2017. As of December 31, 2018, 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 date of grant and subsequent measurement dates using the Black-Scholes option-pricing model. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts. The expected volatilities are based on historical volatility of the Company’s stock. The risk-free interest rate is based on the U.S. treasury yield curve in effect as of the grant date. The expected life of the stock options is the average of the vesting term and the full contractual term of the stock options. For stock options requiring an assessment of value during the year ended December 31, 2018, the fair value of each stock option award was calculated using the Black-Scholes option-pricing model utilizing the following assumptions: Risk-free interest rate 2.44% to 3.01% Expected dividend yield 0% Expected volatility 170.32% Expected life 0.5 to 5.5 years For stock options requiring an assessment of value during the year ended December 31, 2017, the fair value of each stock option award was calculated using the Black-Scholes option-pricing model utilizing the following assumptions: Risk-free interest rate 1.18% to 2.47% Expected dividend yield 0% Expected volatility 308.51% to 332.63% Expected life 1.5 to 5.0 years 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. In connection with this agreement, NDA was granted stock options to purchase 100,000 shares of the Company’s common stock, vesting 25,000 shares on June 24, 2014, and thereafter 25,000 shares annually on June 24, 2015, 2016 and 2017, exercisable for a period of five years from the date of grant at $0.13 per share, which was the fair market value of the Company’s common stock on the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $12,960 ($0.13 per share). The Company re-measured the non-vested options to fair value at the end of each reporting period. The unvested portion of the fair value of the stock options was charged to operations ratably from December 24, 2013 through June 24, 2017. During the year ended December 31, 2017, the Company recorded a charge to operations of $2,492 with respect to these stock options. Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks LLC (“BioPharmaWorks”), pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company as described at Note 7. In connection with the Collaboration Agreement, the Company agreed to issue to BioPharmaWorks 1,000,000 fully-vested shares of the Company’s common stock, valued at $260,000, based upon the closing price of the Company’s common stock of $0.26 per share, on September 14, 2015. Additionally, the Company issued to BioPharmaWorks two 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 is 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 is exercisable for a period of five years from the date of grant at $2.00 per share. The fair value of the first and second warrants, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $128,400 ($0.2568 per share) and $127,850 ($0.2557 per share), respectively. The Company re-measured the non-vested stock options to fair value at the end of each reporting period through September 30, 2017. During the year ended December 31, 2017, the Company recorded a charge to operations of $29,528 with respect to these warrants. Effective May 13, 2016, in conjunction with his appointment as a director of the Company, the Company granted to Dr. Stephen J. Forman stock options to purchase an aggregate of 200,000 shares of the Company’s common stock under the 2007 Plan, exercisable for a period of five years from vesting date at $0.16 per share, which was the fair market value of the Company’s common stock on such date. One-half of such stock options (100,000 shares) vested on May 13, 2016 and the remaining one-half of such stock options (100,000 shares) vested on May 13, 2017. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $31,180 ($0.1559 per share), of which $15,590 was attributable to the stock options fully-vested on May 13, 2016 and was therefore was charged to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from May 13, 2016 through May 13, 2017. During the year ended December 31, 2017, the Company recorded a charge to operations of $5,681 with respect to these stock options. Effective October 16, 2017, in connection with his continuing role as a member of the Company’s Board of Directors, Dr. Philip F. Palmedo was granted fully-vested stock options to purchase 50,000 shares of the Company’s common stock. The stock options are exercisable for a period of five years from the date of grant at $0.15 per share, which was the 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 $7,499 ($0.1500 per share), which was charged to operations on the date of grant. Effective October 16, 2017, in connection with his continuing role as a member of the Company’s Board of Directors, Dr. Stephen J. Forman was granted fully-vested stock options to purchase 50,000 shares of the Company’s common stock. The stock options are exercisable for a period of five years from the date of grant at $0.15 per share, which was the 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 $7,499 ($0.1500 per share), which was charged to operations on the date of grant. Effective August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted to Dr. Winson Sze Chun Ho and Dr. Yun Yen stock options for each person 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. One-half of such stock options (100,000 shares each) vested on August 4, 2018 and the remaining one-half of such stock options (100,000 shares each) will vest on August 4, 2019. The 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 was charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 4, 2018 through August 4, 2019. During the year ended December 31, 2018, the Company recorded a charge to operations of $73,874 with respect to these stock options. Total stock-based compensation expense was $785,612 and $70,695 for the years ended December 31, 2018 and 2017, respectively. The total stock-based compensation expense for the year ended December 31, 2018 of $785,612 includes $711,738 of costs associated with the extension of stock options previously granted to Gil Schwartzberg, as described at Note 4. A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2018 and 2017 is presented below. Weighted Average Weighted Remaining Number Average Contractual of Exercise Life Shares Price (in Years) Stock options outstanding at December 31, 2016 8,600,000 $ 0.583 Granted 220,000 0.150 Exercised (150,000 ) 0.120 Expired (1,200,000 ) 0.796 Stock options outstanding at December 31, 2017 7,470,000 0.545 Granted 400,000 0.280 Exercised (20,000 ) 0.150 Expired (100,000 ) 0.130 Stock options outstanding at December 31, 2018 7,750,000 $ 0.538 3.68 Stock options exercisable at December 31, 2017 7,470,000 $ 0.545 Stock options exercisable at December 31, 2018 7,550,000 $ 0.545 3.65 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $31,000 at December 31, 2018, which will be recognized subsequent to December 31, 2018 over a weighted-average period of approximately seven months. The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, are as follows at December 31, 2018: Options Options Exercise Outstanding Exercisable Prices (Shares) (Shares) $ 0.120 450,000 450,000 $ 0.150 300,000 300,000 $ 0.160 200,000 200,000 $ 0.200 500,000 500,000 $ 0.250 500,000 500,000 $ 0.280 400,000 200,000 $ 0.500 4,400,000 4,400,000 $ 1.000 500,000 500,000 $ 2.000 500,000 500,000 7,750,000 7,550,000 The intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2018 was approximately $3,482,800, based on a fair market value of $0.93 per share on December 31, 2018. Outstanding options to acquire 200,000 shares of the Company’s common stock had not vested at December 31, 2018. The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2018 and 2017 are summarized below. The calculations presented below at December 31, 2018 and 2017 reflect the new U.S. federal statutory corporate tax rate of 21% effective January 1, 2018 (see Note 2). December 31, 2018 2017 Start-up and organization costs $ 14,000 $ 19,000 Research credits 351,000 316,000 Stock-based compensation 626,000 407,000 Net operating loss carryforwards 4,395,000 4,020,000 Total deferred tax assets 5,386,000 4,762,000 Valuation allowance (5,386,000 ) (4,762,000 ) Net deferred tax assets $ — $ — In assessing the potential realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during the periods in which those temporary differences become deductible. As of December 31, 2018 and 2017, management was unable to determine if it is more likely than not that the Company’s deferred tax assets will be realized and has therefore recorded an appropriate valuation allowance against deferred tax assets at such dates. No federal tax provision has been provided for the years ended December 31, 2018 and 2017 due to the losses incurred during such periods. The reconciliation below presents the difference between the income tax rate computed by applying the U.S. federal statutory rate and the effective tax rate for the years ended December 31, 2018 and 2017. Years Ended December 31, 2018 2017 U. S. federal statutory tax rate (21.0 )% (35.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 0.2 % 13.4 % Adjustment to deferred tax asset (1.3 )% (1.0 )% Change in valuation allowance 28.1 % 28.6 % Effective tax rate 0.0 % 0.0 % At December 31, 2018, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately $15,389,000 and $16,288,000, respectively. Federal net operating losses, if not utilized earlier, expire through 2038. The state net operating loss carryovers were incurred solely in New York. New York tax law requires New York net operating loss carryovers from years prior to 2015 to be converted, by applying a formula, into a Prior Net Operating Loss Conversion (PNOLC) subtraction pool. The Company may utilize up to 1/10 of the PNOLC subtraction pool, or $928,367 each year. Unutilized PNOLC amounts carry forward to succeeding years until they expire in 2035. In addition, the full New York net operating loss incurred in post-2015 tax years may be utilized in future tax years. Post-2015 New York net operating losses expire through 2038. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
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 December 31, 2018, the Company was not subject to any pending or threatened legal claims or actions. Significant agreements and contracts Effective October 18, 2013, the Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) for a term of four years. The Surgical Neurology Branch of NINDS is conducting research characterizing a variety of compounds proprietary to the Company and is examining the potential of the compounds for anti-cancer activity, reducing neurological deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases. Under an M-CRADA, a party provides research material, in this case proprietary compounds from the Company’s pipeline, for study by scientists at NIH. The exchange of material is for research only and does not imply any endorsement of the material on the part of either party. Under the M-CRADA, the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license. On June 14, 2017, the Company executed Amendment No. 1 to the M-CRADA, pursuant to which the Company agreed to provide funding in the amount of $100,000 to the National Cancer Institute for use in acquiring technical, statistical and administrative support for research activities. The $100,000 amount was scheduled to be paid in two equal installments of $50,000, the first installment of which was paid, as scheduled, on July 9, 2017, and was charged to research and development costs in the consolidated statement of operations on such date. The second installment of $50,000 was scheduled to be paid on the June 14, 2018 anniversary date of the amendment and was accreted ratably through such date and included in research and development contract liabilities in the Company’s consolidated balance sheet. Pursuant to revised and updated collaboration plans, on November 3, 2018, the NINDS and the Company agreed to a cancellation of the second installment payment of $50,000. Accordingly, the previously accreted charge of $50,000, of which $25,000 was recorded during the six months ended June 30, 2018, was reversed during the fourth quarter of the year ended December 31, 2018. During the years ended December 31, 2018 and 2017, $0 and $75,000, respectively, was included in research and development costs in the consolidated statement of operations. 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. In 2014, 2015, 2016, 2017 and 2018, the agreement was automatically renewed on its anniversary date for an additional one-year term. Consulting and advisory fees charged to operations pursuant to this agreement were $16,000 during the years ended December 31, 2018 and 2017. 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 include, 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 as described at Note 5. In November 2016, it was mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from November 1, 2016 through March 31, 2017. The Collaboration Agreement resumed as scheduled on April 1, 2017 and was automatically renewed for additional one-year periods on September 13, 2017 and 2018, respectively. In April 2018, it was again mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from February 1, 2018 through the September 13, 2019 anniversary date. In February 2019, the Company and BioPharmaWorks subsequently agreed to resume the Collaboration Agreement effective March 1, 2019. The Company recorded charges to operations pursuant to this Collaboration Agreement of $10,000 and $60,000, which were included in research and development costs in the consolidated statement of operations, during the years ended December 31, 2018 and 2017, respectively. 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 when the Company may reach any of the development or commercialization milestones under the Agreement, if at all. 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. The Company is amortizing the retainer payment over the two-year life of the Consulting Agreement, as a result of which the Company recorded a charge to operations of $6,881 during the year ended December 31, 2018. At December 31, 2018, the unamortized balance of the retainer payment was $11,468, of which $9,175 was classified as a current asset and $2,293 was classified as a non-current asset in the Company’s consolidated balance sheet at such date. Effective August 20, 2018 (the “Effective Date”), the Company and the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”) entered into an Exclusive License Agreement (the “License Agreement”). Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents. The Company is obligated to pay Moffitt a non-refundable license issue fee of $25,000 on the date on which the first patient is entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt that is scheduled to begin during the quarter ending June 30, 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. 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. Effective August 20, 2018, the Company and Moffitt also entered into a Clinical Trial Research Agreement (the “Clinical Trial Research Agreement”) effective for a term of five years, unless terminated earlier by the Company pursuant to 30 days written notice. Pursuant to the Clinical Trial Research Agreement, Moffitt will conduct and manage a Phase 1b/2 clinical trial to evaluate the safety and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk MDS. In early November 2018, the Company received approval from the FDA for its Investigational New Drug (IND) Application to conduct a Phase 1b/2 clinical trial to evaluate the safety and therapeutic benefit of the Company’s lead clinical compound LB-100 in patients with low and intermediate-1 risk myelodysplastic syndrome (MDS) who have failed or are intolerant of standard treatment. This clinical trial is currently expected to begin during the quarter ending June 30, 2019, to complete patient accrual over a period of two years, and to take approximately three years to complete. On September 12, 2018, the Company finalized a work order agreement with Theradex to monitor the Phase 1b/2 clinical trial that is scheduled to begin during the quarter ending June 30, 2019. The clinical trial will be managed and conducted by Moffitt to evaluate the safety and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 administered intravenously in patients with low or intermediate-1 risk MDS. This work order agreement became operational in August 2018 and is estimated to be completed by December 2021. Costs under this work order agreement are estimated to be approximately $954,000. As of December 31, 2018, costs of $11,906 have been incurred pursuant to this work order agreement. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 8. Subsequent Events The Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC. There were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of 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. 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 Concentrations | Cash Concentrations The Company maintains its cash balances with financial institutions in federally-insured accounts. The Company may periodically have cash balances in banks in excess of FDIC insurance limits. The Company maintains its accounts with financial institutions with high credit ratings. The Company has not experienced any losses to date resulting from this practice. Beginning in 2019, the Company intends to invest the majority of its cash resources in short-term federally insured certificates of deposit. |
Research and Development | Research and Development Research and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the acquisition, design, development and testing of the Company’s compounds and product candidates. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. On January 10, 2010, the Company retained Theradex Systems, Inc. (“Theradex”) under a Master Agreement to provide technical and advisory services to the Company with respect to clinical trial matters involving the U.S. Food and Drug Administration (“FDA”). Theradex is an international contract research organization (“CRO”) that provides technical and advisory services with respect to clinical research and development of pharmaceutical compounds under the rules and regulations of the FDA. On September 21, 2012, the Company entered into a work order agreement with Theradex to manage and administer the Company’s Phase 1 clinical trial of LB-100. This Phase 1 clinical trial had been substantially completed at December 31, 2017. The costs of the Phase 1 clinical trial of LB-100 paid to or through Theradex were recorded and charged to operations based upon the periodic documentation provided by the CRO. During the year ended December 31, 2018, the Company has paid Theradex $10,292 to update FDA documents relative to the completed Phase 1 clinical trial of LB-100. On September 12, 2018, the Company finalized a work order agreement with Theradex to monitor a Phase 1b/2 clinical trial that was approved by the FDA in early November 2018. This clinical trial is currently expected to begin during the quarter ending June 30, 2019, to complete patient accrual over a period of two years, and to take approximately three years to complete. The clinical trial will be managed and conducted by the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida, to evaluate the safety and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS). This work order agreement became operational in August 2018 and is estimated to be completed by December 2021. 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 5% for payments for pass-through costs. The costs of the upcoming Phase 1b/2 clinical trial to be paid to or through Theradex will be recorded and charged to operations based on the periodic documentation provided by the CRO. As of December 31, 2018, costs of $11,906 have been incurred pursuant to this work order agreement. In addition to the costs associated with the previously described work order agreements with Theradex with respect to the Company’s clinical trials, the Company has also from time to time engaged Theradex to provide other technical and advisory services. 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 then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. |
Patent and Licensing Costs | Patent and Licensing 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 costs were $842,325 and $846,169 for the years ended December 31, 2018 and 2017, respectively. Patent and licensing costs are included in general and administrative costs in the Company’s consolidated statements of operations. |
Accounting for Preferred Stock | Accounting for Preferred Stock The Company accounts for preferred stock as either equity or debt, depending on the specific characteristics of the security issued. The Series A Convertible Preferred Stock issued by the Company in January 2016 and March 2015 has been classified as a component of stockholders’ equity (see Note 3). |
Concentration of Risk | Concentration of Risk The Company periodically contracts with directors, including companies controlled by or associated with directors, to provide consulting services related to the Company’s research and development and clinical trial activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task and can include both cash and non-cash compensation. The only such contracts that represent 10% or more of general and administrative or research and development costs are described below. As discussed above at “Research and Development”, the Company has retained Theradex to provide technical and advisory services to the Company with respect to clinical trial matters involving the FDA. Total costs charged to operations from 2013 through December 31, 2017 for services paid to or through Theradex for the Phase 1 clinical trial of LB-100 aggregated $2,233,248, with approximately 60% of such costs allocated for services provided by Theradex and approximately 40% for pass-through costs for clinical center laboratory costs and investigator costs over the life of the clinical trial. During the year ended December 31, 2018, the Company did not incur any such clinical trial costs with Theradex. During the year ended December 31, 2017, the Company incurred $105,698 of such clinical trial costs with Theradex, representing approximately 24% of research and development costs for the year ended December 31, 2017. Costs incurred pursuant to this agreement are included in research and development costs in the Company’s consolidated statements of operations. |
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 December 31, 2018 and 2017 and does not anticipate any material amount of unrecognized tax benefits within the next 12 months. The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. As of December 31, 2018, the Company had not recorded any liability for uncertain tax positions. In subsequent periods, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. On December 22, 2017, the Tax Reform Act was signed into law. The Tax Reform Act is effective for tax years beginning on or after January 1, 2018, except for certain provisions, and resulted in significant changes to existing United States tax law, including various provisions that are expected to impact the Company. Among other provisions, the Tax Reform Act reduced the federal corporate tax rate from 35% to 21% effective January 1, 2018. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, Scientific Advisory Committee members and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. The Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The Company accounts for stock-based payments to Scientific Advisory Committee members and consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment is reached or (b) at the date at which the necessary performance to earn the equity instruments is complete. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. Stock options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are revalued each reporting period to determine the amount to be recorded as an expense in the respective period. As the stock options vest, they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the value on the date of vesting. The fair value of common stock issued as stock-based compensation is determined by reference to the closing price of the Company’s common stock on the date of issuance. 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 over the term of the equity award. Estimated volatility is based on the historical volatility of the Company’s common stock. 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 common stock is determined by reference to the quoted market price of the Company’s common stock. 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 is the same for all periods presented because all preferred shares, warrants and stock options outstanding are anti-dilutive. At December 31, 2018 and 2017, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. December 31, 2018 2017 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 — Common stock options, including options issued in the form of warrants 7,750,000 7,470,000 Total 21,125,000 11,845,000 |
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 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 Recently Adopted Accounting Standards In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 eliminates transaction- and industry-specific revenue recognition guidance under current GAAP and replaces it with a principles-based approach for determining revenue recognition. ASU 2014-09 requires that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The FASB has recently issued ASU 2016-08, ASU 2016-10, ASU 2016-11, ASU 2016-12, and ASU 2016-20, all of which clarify certain implementation guidance within ASU 2014-09. ASU 2014-09 is effective for reporting periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2014-09 in the quarter beginning January 1, 2018. The adoption of ASU 2014-09 did not have any impact on the Company’s financial statement presentation or disclosures. In July 2017, the FASB issued Accounting Standards Update No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features; (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). ASU 2017-11 allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity’s own stock. As a result, financial instruments (or embedded conversion features) with down round features are no longer required to be accounted for as derivative liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, an entity will treat the value of the effect of the down round as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. For convertible instruments with embedded conversion features containing down round provisions, entities will recognize the value of the down round as a beneficial conversion discount to be amortized to earnings. ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The Company early adopted the provisions of ASU 2017-11 in the quarter beginning January 1, 2018. The adoption of ASU 2017-11 did not have any impact on the Company’s financial statement presentation or disclosures. Recently Issued Accounting Standards In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 requires a lessee to record a right-of-use asset and a corresponding lease liability, initially measured at the present value of the lease payments, on the balance sheet for all leases with terms longer than 12 months, as well as the disclosure of key information about leasing arrangements. ASU 2016-02 requires recognition in the statement of operations of a single lease cost, calculated so that the cost of the lease is allocated over the lease term, generally on a straight-line basis. ASU 2016-02 requires classification of all cash payments within operating activities in the statement of cash flows. Disclosures are required to provide the amount, timing and uncertainty of cash flows arising from leases. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. ASU 2016-02 has subsequently been amended and modified by ASU 2018-10, 2018-11 and 2018-20. ASU 2016-02 (including the subsequent amendments and modifications) is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company will adopt the provisions of ASU 2016-02 in the quarter beginning January 1, 2019. The adoption of ASU 2016-02 is not expected to have any impact on the Company’s financial statement presentation or disclosures. In June 2018, the FASB issued Accounting Standards Update 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Revenue from Contracts with Customers (Topic 606). ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company will adopt the provisions of ASU 2018-07 in the quarter beginning January 1, 2019. The adoption of ASU 2018-07 is not expected to have any impact on the Company’s financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At December 31, 2018 and 2017, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. December 31, 2018 2017 Series A Convertible Preferred Stock 4,375,000 4,375,000 Common stock warrants 9,000,000 — Common stock options, including options issued in the form of warrants 7,750,000 7,470,000 Total 21,125,000 11,845,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding | A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, is presented below. Weighted Average Weighted Remaining Number Average Contractual of Exercise Life Shares Price (in Years) Warrants outstanding at December 31, 2017 — $ — Issued 9,000,000 1.000 Exercised — — Expired — — Warrants outstanding at December 31, 2018 9,000,000 $ 1.000 3.92 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Fair Value of Each Option Award Estimated Assumption | For stock options requiring an assessment of value during the year ended December 31, 2018, the fair value of each stock option award was calculated using the Black-Scholes option-pricing model utilizing the following assumptions: Risk-free interest rate 2.44% to 3.01% Expected dividend yield 0% Expected volatility 170.32% Expected life 0.5 to 5.5 years For stock options requiring an assessment of value during the year ended December 31, 2017, the fair value of each stock option award was calculated using the Black-Scholes option-pricing model utilizing the following assumptions: Risk-free interest rate 1.18% to 2.47% Expected dividend yield 0% Expected volatility 308.51% to 332.63% Expected life 1.5 to 5.0 years |
Summary of Stock Option Activity Including Options Form of Warrants | A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2018 and 2017 is presented below. Weighted Average Weighted Remaining Number Average Contractual of Exercise Life Shares Price (in Years) Stock options outstanding at December 31, 2016 8,600,000 $ 0.583 Granted 220,000 0.150 Exercised (150,000 ) 0.120 Expired (1,200,000 ) 0.796 Stock options outstanding at December 31, 2017 7,470,000 0.545 Granted 400,000 0.280 Exercised (20,000 ) 0.150 Expired (100,000 ) 0.130 Stock options outstanding at December 31, 2018 7,750,000 $ 0.538 3.68 Stock options exercisable at December 31, 2017 7,470,000 $ 0.545 Stock options exercisable at December 31, 2018 7,550,000 $ 0.545 3.65 |
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, are as follows at December 31, 2018: Options Options Exercise Outstanding Exercisable Prices (Shares) (Shares) $ 0.120 450,000 450,000 $ 0.150 300,000 300,000 $ 0.160 200,000 200,000 $ 0.200 500,000 500,000 $ 0.250 500,000 500,000 $ 0.280 400,000 200,000 $ 0.500 4,400,000 4,400,000 $ 1.000 500,000 500,000 $ 2.000 500,000 500,000 7,750,000 7,550,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets | December 31, 2018 2017 Start-up and organization costs $ 14,000 $ 19,000 Research credits 351,000 316,000 Stock-based compensation 626,000 407,000 Net operating loss carryforwards 4,395,000 4,020,000 Total deferred tax assets 5,386,000 4,762,000 Valuation allowance (5,386,000 ) (4,762,000 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate | The reconciliation below presents the difference between the income tax rate computed by applying the U.S. federal statutory rate and the effective tax rate for the years ended December 31, 2018 and 2017. Years Ended December 31, 2018 2017 U. S. federal statutory tax rate (21.0 )% (35.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 0.2 % 13.4 % Adjustment to deferred tax asset (1.3 )% (1.0 )% Change in valuation allowance 28.1 % 28.6 % Effective tax rate 0.0 % 0.0 % |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details Narrative) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash | $ 4,273,012 | $ 1,305,748 | $ 199,929 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | Sep. 12, 2018 | Dec. 22, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2017 |
Payments for research and development | $ 40,703 | $ 467,258 | |||
Costs under work | 11,906 | ||||
Patent and licensing costs | $ 842,325 | 846,169 | |||
Deferred setup and organization costs, amortization period | 180 months | ||||
Unrecognized tax benefits | |||||
Federal corporate tax rate | 21.00% | 35.00% | |||
Tax Reform Law [Member] | |||||
Income tax reconciliation description | The Tax Reform Act reduced the federal corporate tax rate from 35% to 21% effective January 1, 2018 | ||||
Theradex Systems, Inc [Member] | |||||
Total estimated clinical costs to be charged to operations | $ 2,233,248 | ||||
Percentage of clinical trial service | 60.00% | ||||
Percentage of clinical center laboratory cost | 40.00% | ||||
Clinical costs charged to operations | $ 105,698 | ||||
Percentage of research and development costs | 24.00% | ||||
Theradex Systems, Inc [Member] | |||||
Payments for research and development | $ 10,292 | ||||
Research and development, description | 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 5% for payments for pass-through costs. | ||||
Costs under work | $ 11,906 | ||||
Theradex Systems, Inc [Member] | Work Order Agreement [Member] | |||||
Costs under work | $ 954,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Anti-dilutive securities excluded from computation of earnings per share | 21,125,000 | 11,845,000 |
Common Stock Options, Including Options Issued in the Form of Warrants [Member] | ||
Anti-dilutive securities excluded from computation of earnings per share | 7,750,000 | 7,470,000 |
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 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Nov. 30, 2018 | Apr. 03, 2017 | Feb. 24, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 28, 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 | 58,025,814 | ||||
Common stock, shares outstanding | 67,045,814 | 58,025,814 | ||||
Sale of stock during period, amount | $ 4,500,000 | $ 2,500,000 | ||||
Sixteen Accredited Investors [Member] | ||||||
Sale of stock during period, amount | $ 4,500,000 | |||||
Sale of stock during period, shares | 9,000,000 | |||||
Equity issuance price per share | $ 0.50 | |||||
Common stock units, description | Each unit consisted of one share of common stock and one four-year warrant to purchase one share of common stock at an exercise price of $1.00 per share. | |||||
Warrants exercise price | $ 1 | |||||
Number of common stock issued | 9,000,000 | |||||
Warrants to purchase common stock | 9,000,000 | |||||
Legal costs for shares issuance | $ 24,702 | |||||
Securities Purchase Agreement [Member] | ||||||
Number of common stock purchase | 6,000,000 | 4,000,000 | ||||
Common stock price per share | $ 0.25 | $ 0.25 | ||||
Value of common stock purchase price | $ 1,500,000 | $ 1,000,000 | ||||
Preferred Stock [Member] | ||||||
Undesignated preferred stock, shares | 9,650,000 | |||||
Series A Convertible Preferred Stock [Member] | ||||||
Number of designated preferred stock, shares | 175,000 | |||||
Number of share tranche of the series A convertible preferred stock receive a per share dividend | 175,000 | |||||
Annual net revenue divided by converted or redeemed shares | 175,000 | |||||
Percentage of dividend from annual revenue | 1.00% | |||||
Preferred shares converted to common stock conversion rate | 12.5 | |||||
Gross proceeds need to trigger mandatory conversion of series a preferred | $ 21,875,000 | |||||
Preferred stock, shares outstanding | 350,000 | |||||
Preferred stock convertible into common stock | 4,375,000 | |||||
Preferred stock, per share redemption price | $ 50 | |||||
Sale of stock during period, amount | ||||||
Sale of stock during period, shares | ||||||
Series A Convertible Preferred Stock [Member] | Minimum [Member] | ||||||
Preferred stock, shares authorized | 175,000 | |||||
Series A Convertible Preferred Stock [Member] | Maximum [Member] | ||||||
Preferred stock, shares authorized | 350,000 | |||||
Common Stock Warrants [Member] | ||||||
Common stock price per share | $ 0.93 | |||||
Outstanding warrants exercisable price per share | $ 1 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Shares, Warrants Outstanding, Beginning Balance | shares | |
Number of Shares, Issued | shares | 9,000,000 |
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, Outstanding, Beginning | $ / shares | |
Weighted Average Exercise Price, Issued | $ / shares | 1 |
Weighted Average Exercise Price, Exercised | $ / shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Weighted Average Exercise Price, Outstanding, Ending | $ / shares | $ 1 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 3 years 11 months 1 day |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Aug. 02, 2018 | Oct. 16, 2017 | Jan. 28, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 28, 2015 |
Eric Forman [Member] | ||||||
Stock options granted to purchase common stock | 100,000 | |||||
Options, exercisable price per share | $ 0.15 | |||||
Options exercisable period | 5 years | |||||
Fair value of stock options | $ 14,997 | |||||
Fair value stock options price per share | $ 0.1500 | |||||
Legal and consulting fees charged to operations for services rendered | $ 48,000 | $ 48,000 | ||||
Dr. John Kovach [Member] | ||||||
Salaries paid | $ 60,000 | 60,000 | ||||
Percentage of devoting business activities | 100.00% | |||||
Mr. Schwartzberg [Member] | Consulting Agreement [Member] | ||||||
Stock options granted to purchase common stock | 4,000,000 | |||||
Options, exercisable price per share | $ 0.50 | |||||
Options exercisable period | 5 years | |||||
Number of stock options vested | 2,000,000 | 2,000,000 | ||||
Option extended period | Jan. 28, 2024 | |||||
Mr. Schwartzberg [Member] | Consulting Agreement [Member] | General and Administrative Expense [Member] | ||||||
Fair value of stock options | $ 711,738 | |||||
Fair value stock options price per share | $ 0.1779 | |||||
Directors and Officers Affiliates and Related Parties[Member] | ||||||
Stock-based compensation expense | $ 785,612 | $ 35,676 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | Aug. 04, 2018 | Oct. 16, 2017 | Sep. 14, 2017 | May 13, 2017 | Sep. 14, 2016 | May 13, 2016 | Sep. 14, 2015 | Dec. 24, 2013 | Jun. 20, 2007 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 24, 2017 | Jun. 24, 2016 | Jun. 24, 2015 | Jun. 24, 2014 |
Fair market value, per share | $ 0.93 | ||||||||||||||
Stock based compensation | $ 785,612 | $ 70,695 | |||||||||||||
Stock options granted value | 785,612 | 70,695 | |||||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | 31,000 | ||||||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 3,482,800 | ||||||||||||||
Stock option outstanding acquired common stock | 200,000 | ||||||||||||||
Director [Member] | Dr. Stephen J. Forman [Member] | |||||||||||||||
Stock options granted to purchase common stock | 50,000 | 200,000 | |||||||||||||
Options exercisable period | 5 years | ||||||||||||||
Options, exercisable price per share | $ 0.15 | ||||||||||||||
Stock options fully vested amount, fair value | $ 15,590 | ||||||||||||||
Stock price per share | $ 0.1559 | ||||||||||||||
Charges to operations | 5,681 | ||||||||||||||
Number of fully vested option issued | 100,000 | 100,000 | |||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||
Stock options are exercisable price per share | $ 0.16 | ||||||||||||||
Fair value of stock options | $ 7,499 | $ 31,180 | |||||||||||||
Fair value stock options price per share | $ 0.1500 | ||||||||||||||
Director [Member] | Dr. Philip F. Palmedo [Member] | |||||||||||||||
Stock options granted to purchase common stock | 50,000 | ||||||||||||||
Options exercisable period | 5 years | ||||||||||||||
Options, exercisable price per share | $ 0.15 | ||||||||||||||
Fair value of stock options | $ 7,499 | ||||||||||||||
Fair value stock options price per share | $ 0.1500 | ||||||||||||||
Director [Member] | Winson Sze Chun Ho [Member] | |||||||||||||||
Stock options granted to purchase common stock | 200,000 | ||||||||||||||
Stock options fully vested amount, fair value | $ 52,460 | ||||||||||||||
Stock price per share | $ 0.2623 | ||||||||||||||
Charges to operations | $ 73,874 | ||||||||||||||
Number of fully vested option issued | 100,000 | ||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||
Stock options are exercisable price per share | $ 0.28 | ||||||||||||||
Fair value of stock options | $ 104,920 | ||||||||||||||
Director [Member] | Winson Sze Chun Ho [Member] | August 4, 2019 [Member] | |||||||||||||||
Number of fully vested option issued | 100,000 | ||||||||||||||
Director [Member] | Dr. Yun Yen [Member] | |||||||||||||||
Stock options granted to purchase common stock | 200,000 | ||||||||||||||
Stock options fully vested amount, fair value | $ 52,460 | ||||||||||||||
Stock price per share | $ 0.2623 | ||||||||||||||
Charges to operations | $ 73,874 | ||||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||||
Stock options are exercisable price per share | $ 0.28 | ||||||||||||||
Fair value of stock options | $ 104,920 | ||||||||||||||
Director [Member] | Dr. Yun Yen [Member] | August 4, 2019 [Member] | |||||||||||||||
Number of fully vested option issued | 100,000 | ||||||||||||||
Mr. Schwartzberg [Member] | |||||||||||||||
Stock based compensation | $ 785,612 | ||||||||||||||
Stock options granted value | $ 711,738 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | Warrant [Member] | |||||||||||||||
Charges to operations | 29,528 | ||||||||||||||
NDA Agreement [Member] | |||||||||||||||
Stock options granted to purchase common stock | 100,000 | ||||||||||||||
Number of stock options vested | 25,000 | 25,000 | 25,000 | 25,000 | |||||||||||
Options exercisable period | 5 years | ||||||||||||||
Options, exercisable price per share | $ 0.13 | ||||||||||||||
Stock options fully vested amount, fair value | $ 12,960 | ||||||||||||||
Stock price per share | $ 0.13 | ||||||||||||||
Charges to operations | $ 2,492 | ||||||||||||||
2007 Stock Compensation Plan [Member] | |||||||||||||||
Number of restricted stock issued | 2,500,000 | ||||||||||||||
Stock options granted to purchase common stock | 1,250,000 | ||||||||||||||
Stock options granted to purchase common stock, outstanding | 1,250,000 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | |||||||||||||||
Options, exercisable price per share | $ 0.26 | ||||||||||||||
Stock options fully vested amount, fair value | $ 260,000 | ||||||||||||||
Number of fully vested option issued | 1,000,000 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | First Warrant [Member] | |||||||||||||||
Options exercisable period | 5 years | ||||||||||||||
Stock price per share | $ 0.2568 | ||||||||||||||
Fair market value, per share | $ 1 | ||||||||||||||
Fair value of warrants | $ 128,400 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | Second Warrant [Member] | |||||||||||||||
Options exercisable period | 5 years | ||||||||||||||
Stock price per share | $ 0.2557 | ||||||||||||||
Fair market value, per share | $ 2 | ||||||||||||||
Fair value of warrants | $ 127,850 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | Two Options [Member] | |||||||||||||||
Issuance of warrants to purchase of common stock | 1,000,000 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | Option 1 [Member] | |||||||||||||||
Issuance of warrants to purchase of common stock | 500,000 | ||||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | Option 2 [Member] | |||||||||||||||
Issuance of warrants to purchase of common stock | 500,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Expected dividend yield | 0.00% | 0.00% |
Expected volatility | 170.32% | |
Minimum [Member] | ||
Risk-free interest rate | 2.44% | 1.18% |
Expected volatility | 308.51% | |
Expected life | 6 months | 1 year 6 months |
Maximum [Member] | ||
Risk-free interest rate | 3.01% | 2.47% |
Expected volatility | 332.63% | |
Expected life | 5 years 6 months | 5 years |
Stock-Based Compensation -Summa
Stock-Based Compensation -Summary of Stock Option Activity Including Options Form of Warrants (Details) - Employee Stock Option [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of shares, stock options outstanding, at the beginning | 7,470,000 | 8,600,000 |
Number of shares, Granted | 400,000 | 220,000 |
Number of shares, Exercised | (20,000) | (150,000) |
Number of shares, Expired | (100,000) | (1,200,000) |
Number of shares, stock options outstanding, at the end | 7,750,000 | 7,470,000 |
Number of shares, stock options exercisable, at the beginning | 7,470,000 | |
Number of shares, stock options exercisable, at the end | 7,550,000 | 7,470,000 |
Weighted Average Exercise Price, stock options outstanding, at the beginning | $ 0.545 | $ 0.583 |
Weighted Average Exercise Price, Granted | 0.280 | 0.150 |
Weighted Average Exercise Price, Exercised | 0.150 | 0.120 |
Weighted Average Exercise Price, Expired | 0.130 | 0.796 |
Weighted Average Exercise Price, stock options outstanding, at the end | 0.538 | 0.545 |
Weighted Average Exercise Price, stock options exercisable, at the beginning | 0.545 | |
Weighted Average Exercise Price, stock options exercisable, at the end | $ 0.545 | $ 0.545 |
Weighted Average Remaining Contractual Life (in Years), stock options outstanding | 3 years 8 months 5 days | |
Weighted Average Remaining Contractual Life (in Years), stock options exercisable | 3 years 7 months 24 days |
Schedule of Exercise Prices of
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Options Outstanding (Shares) | 7,750,000 |
Options Exercisable (Shares) | 7,550,000 |
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 | $ 0.250 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | 500,000 |
Exercise Price Six [Member] | |
Exercise Prices | $ / shares | $ 0.280 |
Options Outstanding (Shares) | 400,000 |
Options Exercisable (Shares) | 200,000 |
Exercise Price Seven [Member] | |
Exercise Prices | $ / shares | $ 0.500 |
Options Outstanding (Shares) | 4,400,000 |
Options Exercisable (Shares) | 4,400,000 |
Exercise Price Eight [Member] | |
Exercise Prices | $ / shares | $ 1 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | 500,000 |
Exercise Price Nine [Member] | |
Exercise Prices | $ / shares | $ 2 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | 500,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory corporate tax rate | 21.00% | 35.00% |
Operating loss carryforwards amount federal | $ 15,389,000 | |
Operating loss carryforwards amount state | $ 16,288,000 | |
Operating loss carryforwards, expiration date | expire through 2038 | |
Prior net operating loss conversion | $ 928,367 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Start-up and organization costs | $ 14,000 | $ 19,000 |
Research credits | 351,000 | 316,000 |
Stock-based compensation | 626,000 | 407,000 |
Net operating loss carryforwards | 4,395,000 | 4,020,000 |
Total deferred tax assets | 5,386,000 | 4,762,000 |
Valuation allowance | (5,386,000) | (4,762,000) |
Net deferred tax assets |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
U. S. federal statutory tax rate | (21.00%) | (35.00%) |
State income taxes, net of federal tax benefit | (6.00%) | (6.00%) |
Expirations related to stock-based compensation | 0.20% | 13.40% |
Adjustment to deferred tax asset | (1.30%) | (1.00%) |
Change in valuation allowance | 28.10% | 28.60% |
Effective tax rate | 0.00% | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) | Nov. 03, 2018USD ($) | Sep. 12, 2018USD ($) | Jun. 14, 2018USD ($) | Apr. 05, 2018USD ($) | Apr. 05, 2018EUR (€) | Apr. 02, 2018 | Mar. 22, 2018USD ($) | Jul. 09, 2017USD ($) | Jun. 14, 2017USD ($) | Sep. 14, 2015USD ($) | Dec. 24, 2013USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Accreted charges | $ 25,000 | $ 50,000 | ||||||||||||
Research and development costs | 40,703 | $ 467,258 | ||||||||||||
Amortizing the retainer payment | 6,881 | |||||||||||||
Unamortized balance of the retainer payment | 11,468 | |||||||||||||
Unamortized balance of the retainer payment classified as a current asset | 9,175 | |||||||||||||
Unamortized balance of the retainer payment classified as a non-current asset | 2,293 | |||||||||||||
Annual license maintenance fee | 25,000 | |||||||||||||
Payments on non-refundable milestone | $ 1,897,000 | |||||||||||||
Percentage of milestone | 40.00% | |||||||||||||
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. | |||||||||||||
Costs under work | $ 11,906 | |||||||||||||
First Four Years [Member] | ||||||||||||||
Minimum payments for royalties | 50,000 | |||||||||||||
Five Years and Thereafter [Member] | ||||||||||||||
Minimum payments for royalties | 100,000 | |||||||||||||
First Quarter of Two Thousand Nineteen [Member] | ||||||||||||||
Non-refundable license issue fee | 25,000 | |||||||||||||
Collaboration Agreement BioPharmaWorks LLC [Member] | ||||||||||||||
Consulting and advisory fee | $ 10,000 | |||||||||||||
Collaboration agreement value | 10,000 | 60,000 | ||||||||||||
NDA Consulting Corp [Member] | ||||||||||||||
Consulting and advisory fee | $ 4,000 | 16,000 | 16,000 | |||||||||||
Theradex Systems, Inc [Member] | ||||||||||||||
Research and development costs | 10,292 | |||||||||||||
Costs under work | 11,906 | |||||||||||||
Materials Cooperative Research and Development Agreement [Member] | ||||||||||||||
Funds provide for use in acquiring technical, statistical and administrative support for research activities | $ 100,000 | |||||||||||||
Research and development costs | $ 0 | $ 75,000 | ||||||||||||
Materials Cooperative Research and Development Agreement [Member] | First Installment [Member] | ||||||||||||||
Paid two equal installments | $ 50,000 | |||||||||||||
Materials Cooperative Research and Development Agreement [Member] | Second Installment [Member] | ||||||||||||||
Paid two equal installments | $ 50,000 | |||||||||||||
Cancellation of installment, amount | $ 50,000 | |||||||||||||
Material Transfer Agreement [Member] | Development Milestones [Member] | INSERM [Member] | Maximum [Member] | ||||||||||||||
Milestone payments | $ 1,750,000 | |||||||||||||
Material Transfer Agreement [Member] | Commercial Milestones [Member] | INSERM [Member] | Maximum [Member] | ||||||||||||||
Milestone payments | $ 6,500,000 | |||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | ||||||||||||||
Agreement term | 2 years | |||||||||||||
Payment of a fixed, one-time retainer one time retainer | $ 18,348 | |||||||||||||
Net payments of sales of products or licensing activities, percentage | 2.50% | 2.50% | ||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | EURO [Member] | ||||||||||||||
Payment of a fixed, one-time retainer one time retainer | € | € 15,000 | |||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc [Member] | ||||||||||||||
Costs under work | $ 954,000 |