Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 12, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Entity Registrant Name | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | ||
Entity Central Index Key | 0001335105 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | No | ||
Entity a Voluntary Filer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 13,193,000 | ||
Entity Common Stock, Shares Outstanding | 13,538,259 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2020 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 5,069,266 | $ 2,598,864 |
Advances on research and development contract services | 76,898 | |
Accrued interest receivable | 14,367 | |
Prepaid insurance | 67,311 | 34,508 |
Other prepaid expenses and current assets | 15,000 | 24,294 |
Total current assets | 5,228,475 | 2,672,033 |
Total assets | 5,228,475 | 2,672,033 |
Current liabilities: | ||
Accounts payable and accrued expenses | 190,292 | 143,549 |
Accrued offering costs | 10,467 | |
Research and development contract liabilities | 15,765 | 94,349 |
Total current liabilities | 216,524 | 237,898 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred Stock, $0.0001 par value; authorized - 10,000,000 shares; issued and outstanding - 350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, liquidation preference based on assumed conversion into common shares - 729,167 shares | 3,500,000 | 3,500,000 |
Common stock, $0.0001 par value; authorized - 100,000,000 shares; issued, issuable and outstanding - 12,402,157 shares and 11,174,737 shares at December 31, 2020 and 2019, respectively | 1,240 | 1,117 |
Additional paid-in capital | 31,864,479 | 26,021,904 |
Accumulated deficit | (30,353,768) | (27,088,886) |
Total stockholders' equity | 5,011,951 | 2,434,135 |
Total liabilities and stockholders' equity | $ 5,228,475 | $ 2,672,033 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 12,402,157 | 11,174,737 |
Common stock, shares issuable | 12,402,157 | 11,174,737 |
Common stock, shares outstanding | 12,402,157 | 11,174,737 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, shares issued | 350,000 | 350,000 |
Preferred stock, shares outstanding | 350,000 | 350,000 |
Preferred stock, stated value | $ 10 | $ 10 |
Preferred stock, issuable upon conversion | 729,167 | 729,167 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Revenues | ||
Costs and expenses: | ||
General and administrative costs, including $765,085 and $422,631 to related parties for the years ended December 31, 2020 and 2019, respectively | 2,042,764 | 1,669,160 |
Research and development costs | 1,223,676 | 820,906 |
Total costs and expenses | 3,266,440 | 2,490,066 |
Loss from operations | (3,266,440) | (2,490,066) |
Interest income | 5,232 | 49,723 |
Interest expense | (3,674) | |
Net loss | $ (3,264,882) | $ (2,440,343) |
Net loss per common share - basic and diluted | $ (0.29) | $ (0.22) |
Weighted average common shares outstanding - basic and diluted | 11,277,126 | 11,174,737 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
General and administrative costs, to related parties | $ 765,085 | $ 422,631 |
Consolidated Statements of Stoc
Consolidated Statements 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, 2018 | $ 3,500,000 | $ 1,117 | $ 25,273,249 | $ (24,648,543) | $ 4,125,823 |
Balance, shares at Dec. 31, 2018 | 350,000 | 11,174,737 | |||
Stock-based compensation expense | 748,655 | 748,655 | |||
Net loss | (2,440,343) | (2,440,343) | |||
Balance at Dec. 31, 2019 | $ 3,500,000 | $ 1,117 | 26,021,904 | (27,088,886) | 2,434,135 |
Balance, shares at Dec. 31, 2019 | 350,000 | 11,174,737 | |||
Stock-based compensation expense | 1,151,349 | 1,151,349 | |||
Proceeds from sale of common stock units in public offering, net of offering costs | $ 120 | 4,591,229 | 4,591,349 | ||
Proceeds from sale of common stock units in public offering, net of offering costs, shares | 1,200,000 | ||||
Common stock issued for services | $ 3 | 99,997 | 100,000 | ||
Common stock issued for services, shares | 27,420 | ||||
Net loss | (3,264,882) | (3,264,882) | |||
Balance at Dec. 31, 2020 | $ 3,500,000 | $ 1,240 | $ 31,864,479 | $ (30,353,768) | $ 5,011,951 |
Balance, shares at Dec. 31, 2020 | 350,000 | 12,402,157 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Extension of stock options | $ 670,715 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (3,264,882) | $ (2,440,343) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense included in - General and administrative costs | 580,634 | 314,631 |
Stock-based compensation expense included in - Research and development costs | 670,715 | 434,024 |
(Increase) decrease in - | ||
Advances on research and development contract services | (76,898) | |
Accrued interest receivable | 14,367 | (14,367) |
Prepaid insurance | (32,803) | (4,250) |
Other prepaid expenses and current assets | 9,294 | 9,174 |
Increase (decrease) in - | ||
Accounts payable and accrued expenses | 46,743 | (51,662) |
Research and development contract liabilities | (78,584) | 78,645 |
Net cash used in operating activities | (2,131,414) | (1,674,148) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock units in public offering, net of offering costs | 4,601,816 | |
Net cash provided by financing activities | 4,601,816 | |
Cash: | ||
Net increase (decrease) | 2,470,402 | (1,674,148) |
Balance at beginning of period | 2,598,864 | 4,273,012 |
Balance at end of period | 5,069,266 | 2,598,864 |
Supplemental disclosures of cash flow information: | ||
Interest | 3,674 | |
Income taxes | ||
Non-cash investing and financing activities: | ||
Accrued offering costs (paid subsequent to December 31, 2020) | $ 10,467 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
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 is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital, as described below. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, and is dependent on periodic infusions of equity capital to fund its operating requirements. The Company’s common stock and warrants issued in the public offering (see Note 3) are traded on The Nasdaq Capital Market under the symbols “LIXT” and. “LIXTW”, respectively. Going Concern At December 31, 2020, the Company had cash of $5,069,266 available to fund its operations. Because the Company is currently engaged in Phase 2 clinical trials, it is expected that it will take a significant amount of time and resources 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. Even if the Company is able to generate revenues through licensing its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and operating cash flows. The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements primarily through the recurring sale of its equity securities. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the accompanying consolidated financial statements have been issued. The Company’s independent registered public accounting firm, in its report on the Company’s consolidated financial statements for the year ended December 31, 2020, has also expressed substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace and design of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities. Effective November 30, 2020, the Company listed on The Nasdaq Capital Market in conjunction with the completion of its public offering of units of common stock and warrants that generated net cash proceeds of $4,591,349. Subsequently, on January 18, 2021, the Company entered into a clinical trial agreement to carry out a Phase 1b clinical trial of LB-100, combined with a standard regimen for untreated, extensive stage-disease small cell lung cancer. This new clinical trial is being conducted through City of Hope, and is estimated to cost from $2,500,000 to $2,900,000 and take approximately 18 to 24 months to conduct from its expected commencement during the quarter ending June 30, 2021. Combined with the Company’s existing clinical trial commitments, this new clinical trial commitment represents an additional demand on the Company’s working capital resources. Although the Company completed a sale of common stock under a registered direct equity offering on March 2, 2021 that generated net proceeds of approximately $3,690,000, the Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments, by mid-2022. In addition, the Company’s operating plan may change as a result of many factors which are currently unknown to the Company, including possible additional clinical trials, and the Company may need additional funds sooner than currently planned. As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, as and when necessary to continue to conduct operations. There is also significant uncertainty as to the effect that the coronavirus may have on the Company’s clinical trial schedule and the amount and type of financing available to the Company in the future. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely. Reverse Stock Split On November 18, 2020, the Company effected a 1-for-6 reverse split of its outstanding shares of common stock. No fractional shares were issued in connection with the reverse split, with any fractional shares resulting from the reverse split were rounded up to the nearest whole share. All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
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. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash Cash, including accrued interest, is primarily held in a cash bank deposit program maintained by a major financial institution. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company may periodically have cash balances in financial institutions in excess of FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. The financial institution that currently holds the Company’s cash balances also maintains supplemental insurance coverage for its customers’ cash balances. The Company has not experienced any losses to date resulting from this practice. Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition, design, development and clinical trials with respect to the Company’s compounds and product candidates. Research and development costs also include the costs to produce the compounds used in research and clinical trials. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the agreement. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations to date. Such amortization is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy periods. As the policy premiums incurred are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and amortized to the Company’s consolidated statement of operations for each reporting period. As of December 31, 2020, total insurance policy premiums, in excess of premiums paid to date, amounted to $175,658, and are payable in six monthly installments of $29,767 through June 2021, with interest at 5.27% per annum. As of December 31, 2019, there was no unpaid insurance premium obligation. Patent and Licensing Related Legal and Filing Costs Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent-related legal and filing fees and licensing-related legal fees are charged to operations as incurred. Patent and licensing-related legal and filing costs were $553,173 and $742,918 for the years ended December 31, 2020 and 2019, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs in the Company’s consolidated statements of operations. Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2020 and 2019 are described as follows. General and administrative costs for the years ended December 31, 2020 and 2019 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.3% and 44.5%, respectively, of total general and administrative costs. General and administrative costs for the years ended December 31, 2020 and 2019 also include charges for the amortized value of stock options granted to directors and officers representing 23.7% and 18.8%, respectively, of total general and administrative costs. Research and development costs for the year ended December 31, 2020 include charges from a consultant, and the value associated with extending stock options previously granted to that consultant, representing 65.6% of total research and development costs, and charges from a vendor representing 13.7% of total research and development costs. Research and development costs for the year ended December 31, 2019 include charges for the value associated with fully-vested stock options granted to a consultant representing 52.9% of total research and development costs, and charges from a consultant and from a vendor representing 12.2% and 10.7%, respectively, of total research and development costs. Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of December 31, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to December 31, 2020. The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of December 31, 2020 or December 31, 2019. Subsequent to December 31, 2020, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members contractors and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At December 30, 2020 and 2019, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. December 31, 2020 2019 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,000,000 1,500,000 Common stock options, including options issued in the form of warrants 1,475,000 1,308,333 Total 5,204,167 3,537,500 Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. The carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards board (the “FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 will be effective January 1, 2021. The adoption of ASU 2019-12 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption. In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. ASU 2020-06 will be effective January 1, 2024, and a cumulative-effect adjustment to the opening balance of retained earnings is required upon adoption. Early adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year. The adoption of ASU 2020-06 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption, with any effect being largely dependent on the composition and terms of outstanding financial instruments at the time of adoption. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 3. Stockholders’ Equity Preferred Stock The Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share. On March 17, 2015, the Company filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock with the Delaware Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written consent of a majority of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the, Preferences, Rights and Limitations. The holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividend equal to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. As of December 31, 2020 and 2019, 9,650,000 shares of preferred stock were undesignated and may be issued with such rights and powers as the Board of Directors may designate. Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 2.0833 shares of common stock (subject to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. 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 729,167 shares of common stock at December 31, 2020 and 2019. The Company had the right to redeem the Series A Convertible Preferred Stock up to the fifth anniversary of their respective closing dates (March 17, 2015 and January 21, 2016) at a price per share equal to $50.00. Accordingly, as of December 31, 2020, the Company had the right to redeem the 175,000 shares of Series A Convertible Preferred Stock that were issued on January 21, 2016, however, that right expired on January 21, 2021. The Series A Convertible Preferred Stock has no right to cash, except with respect to the payment of the aforementioned dividend based on the generation of revenues by the Company. The shares of Series A Convertible Preferred Stock do not have any registration rights. Based on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible Preferred Stock as a permanent component of stockholders’ equity. Common Stock The Company is authorized to issue a total of 100,000,000 shares of common stock, par value $0.0001 per share. As of December 31, 2020 and 2019, the Company had 12,402,157 shares and 11,174,737 shares, respectively, of common stock issued, issuable and outstanding. On November 30, 2020, the Company raised gross proceeds $5,700,000 through a public offering of 1,200,000 units at a sale price of $4.75 per unit. Each unit consists of one share of common stock and one warrant to purchase one share of common stock exercisable for five years at an exercise price of $5.70 per share. Additionally, on December 7, 2020, the Company received an additional $1,800 from the sale of 180,000 warrants as part of the overallotment option granted to the underwriters in the public offering. The warrants sold on December 7, 2020 are exercisable for five years and represent the right to purchase one share of common stock at an exercise price of $5.70 per share. The total cash costs of the public offering were $1,110,451, resulting in net cash proceeds of $4,591,349. Pursuant to the underwriting agreement, the Company also granted to the underwriters warrants to purchase up to 120,000 shares of common stock commencing on May 24, 2021 and expiring on November 24, 2025, at an exercise price of $5.70 per share. On December 21, 2020, the Company entered into a services agreement with IRTH Communications, LLC and agreed to issue 27,420 shares of common stock, fully vested upon issuance, with a grant date fair value of $100,000 ($3.65 per share), which was charged to general and administrative costs in the consolidated statement of operations at December 31, 2020 (see Notes 5 and 7). 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 public offering, during the years ended December 31, 2020 and 2019 is presented below. Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2018 1,500,000 $ 6.000 Issued — — Exercised — — Expired — — Warrants outstanding at December 31, 2019 1,500,000 $ 6.000 Issued 1,500,000 5.700 Exercised — — Expired — — Warrants outstanding at December 31, 2020 3,000,000 $ 5.850 3.42 Warrants exercisable at December 31, 2019 1,500,000 $ 6.000 Warrants exercisable at December 31, 2020 2,880,000 $ 5.850 3.42 Based on a fair market value of $3.17 per share on December 31, 2020, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at December 31, 2020. 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, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 4. Related Party Transactions The Company’s principal office facilities are being provided without charge by Dr. John S. Kovach, the President and Chief Executive Officer. Such costs were not material to the consolidated financial statements and accordingly, have not been reflected therein. In September 2007, the Company entered into a consulting agreement with Gil Schwartzberg for Mr. Schwartzberg to provide financial advisory and consulting services to the Company with respect to financing matters, capital structure and strategic development, and to assist management in communications with investors and stockholders. In January 2014 and August 2018, the Company entered into respective amendments to this consulting agreement, which have extended the consulting agreement through January 28, 2024. Consideration under this consulting agreement, including amendments, has been paid exclusively in the form of stock options. Mr. Schwartzberg is currently a significant stockholder of the Company and continues to be a consultant to the Company. Legal and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $38,000 and $48,000 for the years ended December 31, 2020 and 2019, respectively, excluding amounts paid to Mr. Forman pursuant to an employment agreement during 2020 (see Note 7). Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the Company, and is the son of Dr. Stephen Forman, a member of the Company’s Board of Directors. Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, where the Company’s cash is deposited and the Company maintains a continuing banking relationship. Robert N. Weingarten was appointed as the Company’s Vice President and Chief Financial Officer on August 12, 2020. During the year ended December 31, 2020 (prior to his appointment as Vice President and Chief Financial Officer), the Company paid Mr. Weingarten a total of $79,995 for accounting and financial consulting services rendered with respect to the preparation of the Company’s consolidated financial statements and certain other financial and compliance matters. During the year ended December 31, 2019, the Company paid Mr. Weingarten a total of $80,380 for similar accounting and financial consulting services rendered. These amounts are excluded from the summary of related party costs presented below. A summary of related party costs for the years ended December 31, 2020 and 2019 is as follows: Years Ended December 31, 2020 2019 Related party costs: Cash-based $ 284,451 $ 108,000 Stock-based 480,634 314,631 Total $ 765,085 $ 422,631 Stock-based compensation arrangements involving members of the Company’s Board of Directors. officers and affiliates are described at Note 5. Additional information with respect to cash compensation paid to the Company’s officers during the year ended December 31, 2020 pursuant to employment agreements are provided at Note 7. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [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 employees, contractors and consultants of the Company. On June 20, 2007, the Board of Directors of the Company approved the 2007 Stock Compensation Plan (the “2007 Plan”), which provided for the granting of awards, consisting of stock options, stock appreciation rights, performance shares, and restricted shares of common stock, to employees and consultants, for up to 416,667 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, 2020, unexpired stock options for 208,333 shares were issued and outstanding under the 2007 Plan. On July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates for up to 2,333,333 shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors. The fair value of each stock option awarded is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts and is assumed to be zero. The expected volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of the common stock is determined by reference to the quoted market price of the common stock on the grant date. For stock options requiring an assessment of value during the year ended December 31, 2020, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 0.23% to 0.31 % Expected dividend yield 0 % Expected volatility 207.67 % Expected life 4 to 5 years For stock options requiring an assessment of value during the year ended December 31, 2019, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 1.47% to 1.85 % Expected dividend yield 0 % Expected volatility 133.01% to 171.87 % Expected life 5 years Effective August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted stock options to each of Dr. Winson Sze Chun Ho and Dr. Yun Yen to purchase an aggregate of 33,333 shares of the Company’s common stock, exercisable for a period of five years from the grant date at $1.68 per share, which was the approximate fair market value of the Company’s common stock on such date, with one-half of such stock options (16,667 shares for each director) vesting on August 4, 2018 and the remaining one-half of such stock options (16,667 shares for each director) vesting on August 4, 2019. The aggregate fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $104,920 ($1.5738 per share), of which $101,475 was attributable to the stock options fully-vested on August 4, 2018 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from August 4, 2018 through August 4, 2019. During the year ended December 31, 2019, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $31,046 with respect to these stock options. Effective May 22, 2019, in recognition with their service as directors of the Company over the past year, the Company granted to each of Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman, and Dr. Philip Palmedo, fully-vested stock options to purchase an aggregate of 33,333 shares (8,333 shares to each director) of the Company’s common stock, exercisable for a period of five years from the grant date at $6.60 per share, which was the approximate fair market value of the Company’s common stock on such date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $189,060 ($5.6718 per share) and was recorded as a charge to general and administrative costs in the consolidated statement of operations on the grant date. Effective May 22, 2019, in recognition of his continuing service as consultant to the Company, the Company granted to Eric Forman fully-vested stock options to purchase 16,667 shares of the Company’s common stock, exercisable for a period of five years from the grant date at $6.60 per share, which was the approximate fair market value of the Company’s common stock on such date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $94,525 ($5.6718 per share) and was recorded as a charge to general and administrative costs in the consolidated statement of operations on the grant date. Effective July 23, 2019, the Company granted Francis Johnson, a consultant to the Company, fully-vested stock options to purchase 83,333 shares of the Company’s common stock in recognition of Mr. Johnson’s continuing contributions to the development of the Company’s proprietary compounds. The stock options are exercisable for a period of five years from the date of grant at $6.00 per share, which was the fair market value of the Company’s common stock on the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $434,024 ($5.2083 per share) and was recorded as a charge to research and development costs in the consolidated statement of operations on the grant date. Effective September 14, 2015, in connection with the Collaboration Agreement with BioPharmaWorks as described at Note 7, the Company issued to BioPharmaWorks two stock options, in the form of warrants, to purchase 166,666 shares (83,333 shares per warrant) of the Company’s common stock. The first warrant vested on September 14, 2016 and was exercisable for a period of five years from the date of grant at $6.00 per share. The second warrant vested on September 14, 2017 and was exercisable for a period of five years from the date of grant at $12.00 per share. On July 3, 2020, the Company’s Board of Directors approved an extension of the term of the outstanding warrants to acquire an aggregate of 166,666 shares of the Company’s common stock from September 14, 2020 to September 14, 2025. The Company’s closing stock price on July 2, 2020 was $5.40 per share. The fair value of the extension of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured for accounting purposes as the difference in the fair value of the stock options immediately before and immediately after the extension date and was determined to be $670,715 ($4.0242 per share), which was recorded as a charge to research and development costs in the consolidated statement of operations on that date. On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric Forman, Mr. Forman was granted options for 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $138,926 with respect to these stock options. On August 1, 2020, in connection with an employment agreement entered into with Dr. James Miser, M.D., Dr. Miser was granted options for 83,334 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common stock on the effective date of the employment agreement. The options vested as to 25% on the effective date, and will vest 25% on each of the first, second and third anniversaries of the effective date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($6.8718 per share), of which $143,163 was attributable to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023. During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $202,782 with respect to these stock options. On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 58,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $138,926 with respect to these stock options. On December 21, 2020, the Company entered into a services agreement with IRTH Communications, LLC and agreed to issue 27,420 shares of common stock, fully vested upon issuance, with a grant date fair value of $100,000 ($3.65 per share), which was charged to general and administrative costs in the consolidated statement of operations at December 31, 2020 (see Note 7). A summary of stock-based compensation costs for the years ended December 31, 2020 and 2019 is as follows: Years Ended December 31, 2020 2019 Related parties $ 480,634 $ 314,631 Non-related parties 770,715 434,024 Total stock-based compensation costs $ 1,251,349 $ 748,655 A summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2020 and 2019 is presented below. Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2018 1,291,667 $ 3.498 Granted 133,333 6.228 Exercised — — Expired (116,667 ) 1.926 Stock options outstanding at December 31, 2019 1,308,333 3.648 Granted 200,000 7.140 Exercised — — Expired (33,333 ) 3.000 Stock options outstanding at December 31, 2020 1,475,000 $ 4.136 3.09 Stock options exercisable at December 31, 2019 1,308,333 $ 3.648 Stock options exercisable at December 31, 2020 1,325,000 $ 3.796 2.92 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $894,000 at December 31, 2020, which will be recognized subsequent to December 31, 2020 over a weighted-average period of approximately thirty-one months. The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31, 2020 are as follows: Exercise Prices Options Outstanding (Shares) Options Exercisable (Shares) $ 0.720 75,000 75,000 $ 0.900 50,000 50,000 $ 0.960 33,333 33,333 $ 1.200 83,333 83,333 $ 1.680 66,667 66,667 $ 3.000 666,667 666,667 $ 6.000 166,667 166,667 $ 6.600 50,000 50,000 $ 7.140 200,000 50,000 $ 12.000 83,333 83,333 1,475,000 1,325,000 The intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2020 was approximately $747,750, based on a fair market value of $3.17 per share on December 31, 2020. Outstanding stock options to acquire 150,000 shares of the Company’s common stock had not vested at December 31, 2020. The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2020 and 2019 are summarized below. December 31, 2020 2019 Start-up and organization costs $ 5,000 $ 10,000 Research credits 390,000 359,000 Stock-based compensation 1,107,000 799,000 Net operating loss carryforwards 5,477,000 4,879,000 Total deferred tax assets 6,979,000 6,047,000 Valuation allowance (6,979,000 ) (6,047,000 ) 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, 2020 and 2019, 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, 2020 and 2019 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, 2020 and 2019. Years Ended December 31, 2020 2019 U. S. federal statutory tax rate (21.0 )% (21.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 0.5 % 1.2 % Adjustment to deferred tax asset (0.8 )% (0.3 )% Change in valuation allowance 27.3 % 26.1 % Effective tax rate 0.0 % 0.0 % At December 31, 2020, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately $19,188,000 and $20,087,000, respectively. Federal net operating losses, if not utilized earlier, expire through 2040. The state net operating loss carryovers were incurred solely in the state of 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 $928,313, each year. Unutilized PNOLC amounts carry forward to succeeding years until they expire in 2035. In addition, the full New York net operating losses incurred in post-2015 tax years may be utilized in future tax years. Post-2015 New York net operating losses expire through 2040. As the Company’s net operating losses have yet to be utilized, all previous tax years since 2006 remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Legal Claims The Company may be subject to legal claims and actions from time to time as part of its business activities. As of December 31, 2020, the Company was not subject to any pending or threatened legal claims or actions. Clinical Trial Agreements Moffitt. In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application (“IND”) to conduct a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilizes LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy. The bone marrow cells of patients with del5qMDS are deficient in PP2A by virtue of an acquired mutation and are especially vulnerable to further inhibition of PP2A by LB-100. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. A total enrollment of 41 patients is planned. An interim analysis will be done after the first 21 patients are entered. If there are 3 or more responders but fewer than 7, an additional 20 patients will be entered. If at any point there are 7 or more responders, this will be sufficient evidence to support continued development of LB-100 for the treatment of low and intermediate-1 risk MDS. Recruitment has been slow and the Covid-19 pandemic has further reduced recruitment of patients into the protocol. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. However, with additional funds, the Company’s objective would be to add two additional MDS centers to the Phase 2 portion of the study to accelerate patient accrual, with the goal of an earlier reporting date. During the years ended December 31, 2020 and 2019, the Company paid Moffitt $41,142 and $45,093, respectively, pursuant to this agreement. As of December 31, 2020, total costs of $102,944 have been incurred pursuant to this agreement. GEIS. GEIS has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as well as to provide funding for the clinical trial. The goal was to enter the first patient during the quarter ending December 31, 2020, with approximately 150 patients to be enrolled over two years. Advanced sarcoma is a very aggressive disease. The design of the study assumes a median progression free survival (PFS, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of the primary endpoint when about half of the 102 events required for final analysis is reached. The Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July 2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol, it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These regulations were adopted subsequent to the production of the Company’s existing LB-100 inventory. The Company is in the process of obtaining approval from the European Union regulatory authorities for new inventory of LB-100. Accordingly, the clinical trial is now estimated to begin during the quarter ending September 30, 2021 and to be completed by the quarter ending September 30, 2024. The interim analysis is expected in June 2023 and could indicate either inferiority or superiority of LB-100 plus doxorubicin as compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone. The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. On February 18, 2020, the Company advanced $43,411 to GEIS towards a second milestone payment obligation of $87,471, which was expected to become due and payable during the quarter ended June 30, 2020 based on the anticipated achievement of the second milestone, and which was therefore recorded as an advance on the Company’s balance sheet at March 31, 2020. However, as a result of the substantial delay in commencing the clinical trial as described above, the achievement of the second milestone had been delayed until mid-2021 and the Company therefore determined to charge such advance to research and development costs in the Company’s statement of operations at June 30, 2020. Subsequently, on March 9, 2021, the Company paid an additional $23,802 to GEIS for current work being done under this agreement. Accordingly, during the years ended December 31, 2020 and 2019, the Company incurred costs of $43,411 and $87,471, respectively, pursuant to this agreement. As of December 31, 2020, total costs of $130,882 have been incurred pursuant to this agreement. The Company’s aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to date under these agreements, totaled approximately $5,230,000 as of December 31, 2020, consisting of approximately $4,614,000 relating to the GEIS clinical trial and approximately $616,000 relating to the Moffit clinical trial, which are expected to be incurred over the next five years through December 31, 2025. In order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company has engaged a number of vendors to carry out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks include the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the steps involved by an independent auditor. The API is then transferred to a vendor that prepares the clinical drug product (DP), also under GMP conditions documented by an independent auditor. The DP is then sent to a vendor to test for purity and sterility, provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal application documenting all steps taken to prepare the DP for clinical use must be submitted to the appropriate regulatory authorities for review and approval before being used in a clinical trial. The Company estimates that this program to provide new inventory of the DP for the Spanish sarcoma study, and potentially for subsequent multiple trials within the European Union, will cost from $600,000 and $700,000. The Company’s remaining aggregate commitments under this program, less amounts previously paid to date, totaled approximately $300,000 as of December 31, 2020, which are expected to be incurred through June 30, 2021. City of Hope. The Company estimates that from 24 to 30 patients will be needed to complete this clinical trial, at an estimated cost of $2,500,000 to $2,900,000, respectively. If a significant number of patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of $800,000. The clinical trial is planned to commence during the quarter ending June 30, 2021, with patient accrual expected to take approximately 18 to 24 months to conduct. If LB-100 does potentiate the benefit of the standard regimen, some evidence could be noted at 12 months into the clinical trial, but an assessment of potential increased activity is likely to require at least 24 months. Clinical Trial Monitoring Agreements On September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc. (“Theradex”), an international contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs. The costs of the Phase 1b/2 clinical trial being paid to or through Theradex are being recorded and charged to operations based on the periodic documentation provided by the CRO. During the years ended December 31, 2020 and 2019, the Company incurred costs of $18,663 and $51,586, respectively, pursuant to this work order. As of December 31, 2020, total costs of $75,788 have been incurred pursuant to this work order agreement. The Company’s aggregate commitments pursuant to this clinical trial monitoring agreement, less amounts previously paid to date under this agreement, totaled approximately $874,000 as of December 31, 2020, which are expected to be incurred over the next five years through June 30, 2025. Patent and License Agreements On March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement with INSERM TRANSFERT SA, acting as delegatee of the French National Institute of Health and Medical Research, for the assignment to the Company of INSERM’S interest in United States Patent No. 9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders”, which was filed with the United States Patent and Trademark Office in the name of INSERM and the Company as co-owners on February 19, 2015 and granted on May 12, 2017, and related patent applications and filings. INSERM is a French public institution dedicated to research in the field of health and medicine that had previously entered into a Material Transfer Agreement with the Company to allow INSERM to conduct research on the Company’s proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress disorders in humans. Pursuant to the Agreement, the Company has agreed to make certain milestone payments to INSERM aggregating up to $1,750,000 upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones. The Company also agreed to pay INSERM certain commercial royalties on net sales of products attributed to the Agreement. The Company’s current plan is to complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans within three years; however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will require substantial additional capital and/or a joint venture or other type of business arrangement with a pharmaceutical company with substantially greater capital and business resources than those available to the Company. As there can be no assurances that the Company will be able to obtain the capital or business resources necessary to focus on the exploitation of this patent, it is uncertain as to when, if at all, the Company may reach any of the development or commercialization milestones under the Agreement. As of December 31, 2020 and 2019, no amounts were due under this agreement. Effective April 2, 2018, the Company entered into a consulting agreement for a term of two years with Liberi Life Sciences Consultancy BV, located in The Netherlands, for consulting and advisory services with respect to sales and licensing, as well as the procurement of investors in China, Japan and South Korea. The Consulting Agreement provided for the payment of a fixed, one-time retainer of EURO 15,000 (US $18,348), which was paid on April 5, 2018, and 2.5% of the net payments received by the Company from sales of products or licensing activities arising directly and exclusively from leads generated by the advisor during the term of the Consulting Agreement, and any investors introduced to the Company by the advisor that results in an investment in the Company during the term of the Consulting Agreement. The Company recorded the payment of the retainer as a prepaid expense in the Company’s consolidated balance sheet and amortized the retainer payment over the two-year life of the Consulting Agreement, as a result of which the Company recorded charges to operations of $2,294 and $9,174 during the years ended December 31, 2020 and 2019, respectively. As of December 31, 2020, the prepaid consulting fee had been fully amortized. At December 31, 2019, the unamortized balance of the retainer payment was $9,174, all of which was classified as a current asset in the Company’s consolidated balance sheet at such date. On March 1, 2020, the Consulting Agreement was extended to April 2, 2021 without any additional consideration. Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient is entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. The Company is also obligated to pay Moffitt an annual license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences payment of minimum royalty payments. The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. During the years ended December 31, 2020 and 2019, the Company recorded charges to operations of $25,001 and $80,669, respectively, in connection with its obligations under the License Agreement. As of December 31, 2020, no milestones had yet been attained. The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first sale of a royalty-bearing product, and shall automatically expire on a country-by-country basis on the date on which the last valid claim of the Licensed Patents expires, lapses or is declared invalid, and the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last valid claim of the Licensed Patents expires, lapses, or is declared to be invalid in all countries. Employment Agreements Dr. John Kovach Prior to the employment agreement described above, Dr. Kovach was paid a salary of $45,000 and $60,000 for the years ended December 31, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s consolidated statements of operations. Eric Forman. Prior to the employment agreement described above, Mr. Forman was paid consulting fees of $38,000 and $48,000 for the years ended December 31, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s consolidated statements of operations (see Note 4). Dr. James Miser Robert N. Weingarten Prior to the employment agreement described above, Mr. Weingarten was paid consulting fees of $79,995 and $80,380 for the years ended December 31, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s consolidated statements of operations (see Note 4). Other Significant Agreements and Contracts On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement were $16,000 and $16,000 for the years ended December 31, 2020 and 2019, respectively, which were included in research and development costs in the consolidated statements of operations. Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company. Those services included, among other things: (a) assisting the Company to (i) commercialize its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products; (b) at the request of the Board of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader be temporarily unable to carry out his duties; (c) being available for consultation in drug discovery and development; and (d) identifying providers and overseeing tasks relating to clinical use and commercialization of new compounds. BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation. In April 2018, it was mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the period from February 1, 2018 through the September 13, 2019 anniversary date. In February 2019, the Company and BioPharmaWorks subsequently agreed to resume the Collaboration Agreement effective March 1, 2019, and the Collaboration Agreement is currently in effect. The Company recorded charges to operations pursuant to this Collaboration Agreement of $131,650, including reimbursed expenses of $11,650, and $100,000 for the years ended December 31, 2020 and 2019, respectively, which were included in research and development costs in the consolidated statements of operations. Effective August 12, 2020, the Company entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST) to collaborate in supporting preclinical studies of the potential benefit of LB-100 in a mouse model of Angelman Syndrome (AS) as reported in The Proceedings of The National Academy of Science (Wang et al, June 3, 2019). The preclinical studies will take place at The University of California - Davis under the direction of Dr. David Segal, an internationally recognized leader in AS research. If the preclinical studies confirm that LB-100 reduces AS signs in rodent models, the Company has agreed to enter into discussions with FAST with respect to possible collaborations to most efficiently assess the benefit of LB-100 in patients with AS, which is a rare disease affecting an estimated one out of 12,000 to one out of 20,000 persons in the United States. The genetic cause of AS, reduced function of a specific maternal gene called Ube3, has been understood for some time, but the molecular abnormality resulting from the genetic lesion has now been shown to be increased concentrations of protein phosphatase 2A (PP2A), a molecular target of the Company’s investigational compound, LB-100. The Company has agreed to provide FAST with a supply of LB-100 to be utilized in the conduct of this study, which is initially expected to be completed within three years. Conditioned on FAST’s completion of this study, the Company has agreed to pay FAST five percent (5%) of all proceeds, as defined in the Master Service Agreement, received by the Company, up to a maximum of $250,000 from the exploitation of the study results. Effective December 21, 2020, the Company entered into a services agreement with IRTH Communications, LLC for investor/public relations, financial communications and strategic consulting services, effective for an initial term of twelve months and renewable annually thereafter. The Company agreed to pay a monthly fee of $7,500, including any renewal term, and also agreed to issue restricted shares of common stock, fully vested upon issuance, with a grant date fair value of $100,000 (see Note 5). Upon the commencement of any renewal term, the Company will be obligated to issue additional restricted shares of common stock, fully vested upon issuance, with a grant date fair value of $100,000. Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations The global outbreak of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials are conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indications from the clinical research organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several months as a result of the coronavirus pandemic. There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
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. Other than those matters described below, there were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements. Issuance of Stock Options Effective January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted to each of Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman, and Dr. Philip Palmedo, fully-vested stock options to purchase an aggregate of 200,000 shares (50,000 shares to each director) of the Company’s common stock, exercisable for a period of five years from the grant date at $3.21 per share, which was the approximate fair market value of the Company’s common stock on such date. Clinical Trial Agreement Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”), to carry out a Phase 1b clinical trial of LB-100. Information with respect to this clinical trial agreement is provided at Note 7. Clinical Trial Monitoring Agreement On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party (see Note 7). The Company estimates that it will incur approximately $335,000 of costs under this work order agreement through September 30, 2023. Sale of Common Stock Effective March 2, 2021, the Company completed the sale of 1,133,102 shares of common stock at a price of $3.70 per share in a registered direct equity offering, generating gross proceeds of $4,192,477. The total cash costs of this offering were approximately $502,447, resulting in net proceeds of approximately $3,690,030. Pursuant to the placement agents’ agreement, the Company granted to the placement agents warrants to purchase up to 113,310 shares of common stock commencing on March 2, 2021 and expiring on March 2, 2026, at an exercise price of $3.70 per share. Exercise of Warrants During February and March 2021, the Company issued 3,000 shares of common stock upon the exercise of 3,000 warrants at $5.70 per share and received cash proceeds of $17,100. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash and Cash Equivalents | Cash Cash, including accrued interest, is primarily held in a cash bank deposit program maintained by a major financial institution. The Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company may periodically have cash balances in financial institutions in excess of FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. The financial institution that currently holds the Company’s cash balances also maintains supplemental insurance coverage for its customers’ cash balances. The Company has not experienced any losses to date resulting from this practice. |
Research and Development | Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition, design, development and clinical trials with respect to the Company’s compounds and product candidates. Research and development costs also include the costs to produce the compounds used in research and clinical trials. Research and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Obligations incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges to research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified in the agreement. Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis. |
Prepaid Insurance | Prepaid Insurance Prepaid insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in excess of the amortization of the total policy premium charged to operations to date. Such amortization is determined by amortizing the total policy premium charged on a straight-line basis over the respective policy periods. As the policy premiums incurred are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance sheet at each reporting date and amortized to the Company’s consolidated statement of operations for each reporting period. As of December 31, 2020, total insurance policy premiums, in excess of premiums paid to date, amounted to $175,658, and are payable in six monthly installments of $29,767 through June 2021, with interest at 5.27% per annum. As of December 31, 2019, there was no unpaid insurance premium obligation. |
Patent and Licensing Related Legal and Filing Costs | Patent and Licensing Related Legal and Filing Costs Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent-related legal and filing fees and licensing-related legal fees are charged to operations as incurred. Patent and licensing-related legal and filing costs were $553,173 and $742,918 for the years ended December 31, 2020 and 2019, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs in the Company’s consolidated statements of operations. |
Concentration of Risk | Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10% or more of general and administrative costs or research and development costs for the years ended December 31, 2020 and 2019 are described as follows. General and administrative costs for the years ended December 31, 2020 and 2019 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 27.3% and 44.5%, respectively, of total general and administrative costs. General and administrative costs for the years ended December 31, 2020 and 2019 also include charges for the amortized value of stock options granted to directors and officers representing 23.7% and 18.8%, respectively, of total general and administrative costs. Research and development costs for the year ended December 31, 2020 include charges from a consultant, and the value associated with extending stock options previously granted to that consultant, representing 65.6% of total research and development costs, and charges from a vendor representing 13.7% of total research and development costs. Research and development costs for the year ended December 31, 2019 include charges for the value associated with fully-vested stock options granted to a consultant representing 52.9% of total research and development costs, and charges from a consultant and from a vendor representing 12.2% and 10.7%, respectively, of total research and development costs. |
Income Taxes | Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of December 31, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to December 31, 2020. The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of December 31, 2020 or December 31, 2019. Subsequent to December 31, 2020, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period. The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members contractors and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. The fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date. The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to satisfy stock option exercises. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share The Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options outstanding were anti-dilutive. At December 30, 2020 and 2019, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. December 31, 2020 2019 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,000,000 1,500,000 Common stock options, including options issued in the form of warrants 1,475,000 1,308,333 Total 5,204,167 3,537,500 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. The carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards board (the “FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting guidance in ASC 740. ASU 2019-12 will be effective January 1, 2021. The adoption of ASU 2019-12 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption. In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. ASU 2020-06 will be effective January 1, 2024, and a cumulative-effect adjustment to the opening balance of retained earnings is required upon adoption. Early adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year. The adoption of ASU 2020-06 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption, with any effect being largely dependent on the composition and terms of outstanding financial instruments at the time of adoption. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At December 30, 2020 and 2019, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. December 31, 2020 2019 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,000,000 1,500,000 Common stock options, including options issued in the form of warrants 1,475,000 1,308,333 Total 5,204,167 3,537,500 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 public offering, during the years ended December 31, 2020 and 2019 is presented below. Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2018 1,500,000 $ 6.000 Issued — — Exercised — — Expired — — Warrants outstanding at December 31, 2019 1,500,000 $ 6.000 Issued 1,500,000 5.700 Exercised — — Expired — — Warrants outstanding at December 31, 2020 3,000,000 $ 5.850 3.42 Warrants exercisable at December 31, 2019 1,500,000 $ 6.000 Warrants exercisable at December 31, 2020 2,880,000 $ 5.850 3.42 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Summary of Related Party Costs | A summary of related party costs for the years ended December 31, 2020 and 2019 is as follows: Years Ended December 31, 2020 2019 Related party costs: Cash-based $ 284,451 $ 108,000 Stock-based 480,634 314,631 Total $ 765,085 $ 422,631 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Fair Value of Each Option Award Estimated Assumption | For stock options requiring an assessment of value during the year ended December 31, 2020, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 0.23% to 0.31 % Expected dividend yield 0 % Expected volatility 207.67 % Expected life 4 to 5 years For stock options requiring an assessment of value during the year ended December 31, 2019, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Risk-free interest rate 1.47% to 1.85 % Expected dividend yield 0 % Expected volatility 133.01% to 171.87 % Expected life 5 years |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the years ended December 31, 2020 and 2019 is as follows: Years Ended December 31, 2020 2019 Related parties $ 480,634 $ 314,631 Non-related parties 770,715 434,024 Total stock-based compensation costs $ 1,251,349 $ 748,655 |
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, 2020 and 2019 is presented below. Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2018 1,291,667 $ 3.498 Granted 133,333 6.228 Exercised — — Expired (116,667 ) 1.926 Stock options outstanding at December 31, 2019 1,308,333 3.648 Granted 200,000 7.140 Exercised — — Expired (33,333 ) 3.000 Stock options outstanding at December 31, 2020 1,475,000 $ 4.136 3.09 Stock options exercisable at December 31, 2019 1,308,333 $ 3.648 Stock options exercisable at December 31, 2020 1,325,000 $ 3.796 2.92 |
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants | The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31, 2020 are as follows: Exercise Prices Options Outstanding (Shares) Options Exercisable (Shares) $ 0.720 75,000 75,000 $ 0.900 50,000 50,000 $ 0.960 33,333 33,333 $ 1.200 83,333 83,333 $ 1.680 66,667 66,667 $ 3.000 666,667 666,667 $ 6.000 166,667 166,667 $ 6.600 50,000 50,000 $ 7.140 200,000 50,000 $ 12.000 83,333 83,333 1,475,000 1,325,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets as of December 31, 2020 and 2019 are summarized below. December 31, 2020 2019 Start-up and organization costs $ 5,000 $ 10,000 Research credits 390,000 359,000 Stock-based compensation 1,107,000 799,000 Net operating loss carryforwards 5,477,000 4,879,000 Total deferred tax assets 6,979,000 6,047,000 Valuation allowance (6,979,000 ) (6,047,000 ) 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, 2020 and 2019. Years Ended December 31, 2020 2019 U. S. federal statutory tax rate (21.0 )% (21.0 )% State income taxes, net of federal tax benefit (6.0 )% (6.0 )% Expirations related to stock-based compensation 0.5 % 1.2 % Adjustment to deferred tax asset (0.8 )% (0.3 )% Change in valuation allowance 27.3 % 26.1 % Effective tax rate 0.0 % 0.0 % |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Details Narrative) - USD ($) | Mar. 02, 2021 | Nov. 30, 2020 | Nov. 18, 2020 | Jan. 18, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Cash and cash equivalents | $ 5,069,266 | $ 2,598,864 | ||||
Proceeds from issuance of common stock and warrants | $ 4,591,349 | |||||
Common Stock [Member] | ||||||
Reverse stock split | 1-for-6 reverse split | |||||
Subsequent Event [Member] | Common Stock [Member] | ||||||
Estimated gross proceeds from offering of shares | $ 3,690,000 | |||||
Subsequent Event [Member] | Phase 1b Clinical Trial [Member] | Minimum [Member] | ||||||
Estimated cost of clinical trial | $ 2,500,000 | |||||
Subsequent Event [Member] | Phase 1b Clinical Trial [Member] | Maximum [Member] | ||||||
Estimated cost of clinical trial | $ 2,900,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2021 | |
Cash FDIC insurance | $ 250,000 | ||
Cash SIPC insurance | 500,000 | ||
Insurance premium obligation | $ 175,658 | ||
Interest rate of insurance premium payable | 5.27% | ||
Patent and licensing costs | $ 553,173 | 742,918 | |
Unrecognized tax benefits | |||
Consultant [Member] | |||
Concentration of risk, percentage | 65.60% | ||
General and Administrative Expense [Member] | |||
Concentration of risk, percentage | 10.00% | ||
General and Administrative Expense [Member] | Intellectual Properties [Member] | |||
Concentration of risk, percentage | 27.30% | 44.50% | |
Research and Development Expense [Member] | Directors and Officers [Member] | |||
Concentration of risk, percentage | 23.70% | 18.80% | |
Research and Development Expense [Member] | Consultant [Member] | |||
Concentration of risk, percentage | 13.70% | 52.90% | |
Research and Development Expense [Member] | Consultant and Vendor [Member] | |||
Concentration of risk, percentage | 12.20% | 10.70% | |
Eric Forman [Member] | General and Administrative Expense [Member] | |||
Concentration of risk, percentage | 10.00% | ||
Forecast [Member] | |||
Insurance premium obligation | $ 29,767 |
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, 2020 | Dec. 31, 2019 | |
Anti-dilutive securities excluded from computation of earnings per share | 5,204,167 | 3,537,500 |
Series A Convertible Preferred Stock [Member] | ||
Anti-dilutive securities excluded from computation of earnings per share | 729,167 | 729,167 |
Common Stock Warrants [Member] | ||
Anti-dilutive securities excluded from computation of earnings per share | 3,000,000 | 1,500,000 |
Common Stock Options, Including Options Issued in the form of Warrants [Member] | ||
Anti-dilutive securities excluded from computation of earnings per share | 1,475,000 | 1,308,333 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Dec. 21, 2020 | Dec. 07, 2020 | Nov. 30, 2020 | Mar. 17, 2015 | Dec. 31, 2020 | Dec. 31, 2019 | May 22, 2019 |
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 | 12,402,157 | 11,174,737 | |||||
Common stock, shares issuable | 12,402,157 | 11,174,737 | |||||
Common stock, shares outstanding | 12,402,157 | 11,174,737 | |||||
Sale of stock during period, amount | $ 5,700,000 | ||||||
Sale of stock during period, shares | 1,200,000 | ||||||
Equity issuance price per share | $ 4.75 | ||||||
Common stock units, description | Each unit consists of one share of common stock and one warrant to purchase one share of common stock exercisable for five years at an exercise price of $5.70 per share. | ||||||
Fair market value of stock | $ 3.65 | $ 5.6718 | |||||
IRTH Communications, LLC [Member] | |||||||
Fair market value of stock | $ 3.17 | ||||||
Warrant [Member] | |||||||
Sale of stock during period, amount | $ 1,800 | ||||||
Sale of stock during period, shares | 180,000 | ||||||
Warrants exercise price | $ 5.70 | $ 5.70 | |||||
Costs of public offering | $ 1,110,451 | ||||||
Proceeds from sale of common stock units in public offering | $ 4,591,349 | ||||||
Preferred Stock Undesignated [Member] | |||||||
Preferred stock, shares authorized | 9,650,000 | 9,650,000 | |||||
Underwriting Agreement [Member] | Warrant [Member] | |||||||
Warrants exercise price | $ 5.70 | ||||||
Warrants to purchase of common stock, shares | 120,000 | ||||||
Warrant expire date | Nov. 24, 2025 | ||||||
Service Agreement [Member] | IRTH Communications, LLC [Member] | |||||||
Number of shares fully vested | 27,420 | ||||||
Fair value of shares vested | $ 100,000 | ||||||
Stock price per share | $ 3.65 | ||||||
Series A Convertible Preferred Stock [Member] | |||||||
Preferred stock, shares authorized | 350,000 | ||||||
Number of share tranche of convertible preferred stock receive a per share dividend | 175,000 | 729,167 | 729,167 | ||||
Percentage of dividend from annual revenue | 1.00% | ||||||
Annual net revenue divided by converted or redeemed shares | 175,000 | ||||||
Preferred stock convertible into common stock | 729,167 | 729,167 | |||||
Preferred stock, shares outstanding | 350,000 | 350,000 | |||||
Preferred stock, per share redemption price | $ 50 | ||||||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | |||||||
Preferred stock convertible into common stock | 2.0833 | ||||||
Gross proceeds from sale of transaction | $ 21,875,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares, Warrants Outstanding, Beginning Balance | 1,500,000 | 1,500,000 |
Number of Shares, Issued | 1,500,000 | |
Number of Shares, Exercised | ||
Number of Shares, Expired | ||
Number of Shares, Warrants Outstanding, Ending Balance | 3,000,000 | 1,500,000 |
Number of Shares, Warrants exercisable, Ending Balance | 2,880,000 | 1,500,000 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ 6 | $ 6 |
Weighted Average Exercise Price, Issued | 5.700 | |
Weighted Average Exercise Price, Exercised | ||
Weighted Average Exercise Price, Expired | ||
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ 5.850 | $ 6 |
Weighted Average Exercise Price, Warrants exercisable, Ending Balance | 5.850 | 6 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 3 years 5 months 1 day | |
Weighted Average Remaining Contractual Life (in Years), Exercisable | 3 years 5 months 1 day |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Eric Forman [Member] | ||
Legal and consulting fees charged to operations for services rendered | $ 38,000 | $ 48,000 |
Mr. Weingarten [Member] | ||
Legal and consulting fees charged to operations for services rendered | $ 79,995 | $ 80,380 |
Related Party Transactions - Su
Related Party Transactions - Summary of Related Party Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Total | $ 765,085 | $ 422,631 |
Cash-based [Member] | ||
Total | 284,451 | 108,000 |
Stock-based [Member] | ||
Total | $ 480,634 | $ 314,631 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | Aug. 12, 2020 | Aug. 01, 2020 | Jul. 15, 2020 | Jul. 14, 2020 | Jul. 03, 2020 | Aug. 04, 2019 | Jul. 23, 2019 | May 22, 2019 | Aug. 04, 2018 | Sep. 14, 2015 | Jun. 20, 2007 | Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 02, 2020 | Dec. 31, 2018 | Sep. 14, 2017 | Sep. 14, 2016 |
Stock options granted to purchase common stock, issued | 33,333 | |||||||||||||||||
Stock options granted to purchase common stock, outstanding | 1,475,000 | 1,475,000 | 1,308,333 | 1,291,667 | ||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 6.60 | |||||||||||||||||
Number of fully vested option issued | 27,420 | |||||||||||||||||
Stock price per share | $ 5.6718 | $ 3.65 | $ 3.65 | |||||||||||||||
Stock options fully vested amount, fair value | $ 189,060 | $ 100,000 | ||||||||||||||||
Stock based compensation | 1,251,349 | $ 748,655 | ||||||||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | 894,000 | |||||||||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 747,750 | $ 747,750 | ||||||||||||||||
Fair market value, per share | $ 3.17 | |||||||||||||||||
Outstanding stock options to acquire shares of common stock not vested | 150,000 | 150,000 | ||||||||||||||||
Board of Directors [Member] | ||||||||||||||||||
Number of warrants outstanding acquire common stock | 166,666 | |||||||||||||||||
Warrants term, description | September 14, 2020 to September 14, 2025 | |||||||||||||||||
Closing stock price of warrants | $ 5.40 | |||||||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks [Member] | ||||||||||||||||||
Stock price per share | $ 4.0242 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 670,715 | |||||||||||||||||
Number of warrants to purchase common stock | 166,666 | |||||||||||||||||
Number of warrants to purchase common stock per warrant | 83,333 | |||||||||||||||||
Warrant exercisable term | 5 years | 5 years | ||||||||||||||||
Warrants exercise price | $ 12 | $ 6 | ||||||||||||||||
General and Administrative Expense [Member] | ||||||||||||||||||
Stock based compensation | $ 31,046 | |||||||||||||||||
Winson Sze Chun Ho [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 33,333 | |||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 1.68 | |||||||||||||||||
Number of fully vested option issued | 16,667 | 16,667 | ||||||||||||||||
Fair value of stock options | $ 104,920 | |||||||||||||||||
Stock price per share | $ 1.5738 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 101,475 | |||||||||||||||||
Dr. Yun Yen [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 8,333 | 33,333 | ||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 1.68 | |||||||||||||||||
Number of fully vested option issued | 16,667 | 16,667 | ||||||||||||||||
Fair value of stock options | $ 104,920 | |||||||||||||||||
Stock price per share | $ 1.5738 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 101,475 | |||||||||||||||||
Dr. Winson Sze Chun Ho [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 8,333 | |||||||||||||||||
Dr. Stephen Forman [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 8,333 | |||||||||||||||||
Dr. Philip Palmedo [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 8,333 | |||||||||||||||||
Eric Forman [Member] | ||||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 6.60 | |||||||||||||||||
Number of fully vested option issued | 16,667 | |||||||||||||||||
Stock price per share | $ 5.6718 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 94,525 | |||||||||||||||||
Eric Forman [Member] | Employment Agreement [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 58,333 | |||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 7.14 | |||||||||||||||||
Fair value of stock options | $ 400,855 | |||||||||||||||||
Stock price per share | $ 6.8718 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | |||||||||||||||||
Stock options description | On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric Forman, Mr. Forman was granted options for 58,333 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company's common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $138,926 with respect to these stock options. | |||||||||||||||||
Eric Forman [Member] | General and Administrative Expense [Member] | ||||||||||||||||||
Stock based compensation | $ 138,926 | |||||||||||||||||
Mr. Johnson's [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 83,333 | |||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 6 | |||||||||||||||||
Stock price per share | $ 5.2083 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 434,024 | |||||||||||||||||
Dr. James Miser [Member] | Employment Agreement [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 83,334 | |||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 7.14 | |||||||||||||||||
Fair value of stock options | $ 572,650 | |||||||||||||||||
Stock price per share | $ 6.8718 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 143,163 | |||||||||||||||||
Stock options description | Dr. Miser was granted options for 83,334 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company's common stock on the effective date of the employment agreement. The options vested as to 25% on the effective date, and will vest 25% on each of the first, second and third anniversaries of the effective date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $572,650 ($6.8718 per share), of which $143,163 was attributable to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023. During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $202,782 with respect to these stock options. | |||||||||||||||||
Dr. James Miser [Member] | General and Administrative Expense [Member] | ||||||||||||||||||
Stock based compensation | $ 202,782 | |||||||||||||||||
Robert N. Weingarten [Member] | Employment Agreement [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 58,333 | |||||||||||||||||
Stock option vested exercisable term | 5 years | |||||||||||||||||
Stock options are exercisable price per share | $ 7.14 | |||||||||||||||||
Fair value of stock options | $ 400,855 | |||||||||||||||||
Stock price per share | $ 6.8718 | |||||||||||||||||
Stock options fully vested amount, fair value | $ 100,214 | |||||||||||||||||
Stock options description | On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 58,333 shares of the Company's common stock. The options can be exercised on a cashless basis. The options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company's common stock on the grant date. The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third anniversaries of the grant date. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023. During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $138,926 with respect to these stock options. | |||||||||||||||||
Robert N. Weingarten [Member] | General and Administrative Expense [Member] | ||||||||||||||||||
Stock based compensation | $ 138,926 | |||||||||||||||||
2007 Stock Compensation Plan [Member] | ||||||||||||||||||
Stock options granted to purchase common stock, issued | 208,333 | |||||||||||||||||
Stock options granted to purchase common stock, outstanding | 208,333 | 208,333 | ||||||||||||||||
2007 Stock Compensation Plan [Member] | Maximum [Member] | ||||||||||||||||||
Number of restricted stock issued | 416,667 | |||||||||||||||||
2020 Stock Incentive Plan [Member] | Maximum [Member] | ||||||||||||||||||
Number of restricted stock issued | 2,333,333 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Risk-free interest rate, minimum | 0.23% | 1.47% |
Risk-free interest rate, maximum | 0.31% | 1.85% |
Expected dividend yield | 0.00% | 0.00% |
Expected volatility, minimum | 133.01% | |
Expected volatility, maximum | 171.87% | |
Expected volatility | 207.67% | |
Expected life | 5 years | |
Minimum [Member] | ||
Expected life | 4 years | |
Maximum [Member] | ||
Expected life | 5 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-based Compensation Costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Total stock-based compensation costs | $ 1,251,349 | $ 748,655 |
Related Parties [Member] | ||
Total stock-based compensation costs | 480,634 | 314,631 |
Non-related Parties [Member] | ||
Total stock-based compensation costs | $ 770,715 | $ 434,024 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity Including Options Form of Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Number of shares, stock options outstanding, at the beginning | 1,308,333 | 1,291,667 |
Number of shares, Granted | 200,000 | 133,333 |
Number of shares, Exercised | ||
Number of shares, Expired | (33,333) | (116,667) |
Number of shares, stock options outstanding, at the end | 1,475,000 | 1,308,333 |
Number of shares, stock options exercisable, at the end | 1,325,000 | 1,308,333 |
Weighted average exercise price, stock options outstanding, at the beginning | $ 3.648 | $ 3.498 |
Weighted average exercise price, granted | 7.140 | 6.228 |
Weighted average exercise price, exercised | ||
Weighted average exercise price, expired | 3 | 1.926 |
Weighted average exercise price, stock options outstanding, at the end | 4.136 | 3.648 |
Weighted average exercise price, stock options exercisable, at the end | $ 3.796 | $ 3.648 |
Weighted average remaining contractual life (in years), stock options outstanding | 3 years 1 month 2 days | |
Weighted average remaining contractual life (in years), stock options exercisable | 2 years 11 months 1 day |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Options Outstanding (Shares) | 1,475,000 |
Options Exercisable (Shares) | 1,325,000 |
Exercise Price One [Member] | |
Exercise Prices | $ / shares | $ 0.720 |
Options Outstanding (Shares) | 75,000 |
Options Exercisable (Shares) | 75,000 |
Exercise Price Two [Member] | |
Exercise Prices | $ / shares | $ 0.900 |
Options Outstanding (Shares) | 50,000 |
Options Exercisable (Shares) | 50,000 |
Exercise Price Three [Member] | |
Exercise Prices | $ / shares | $ .960 |
Options Outstanding (Shares) | 33,333 |
Options Exercisable (Shares) | 33,333 |
Exercise Price Four [Member] | |
Exercise Prices | $ / shares | $ 1.200 |
Options Outstanding (Shares) | 83,333 |
Options Exercisable (Shares) | 83,333 |
Exercise Price Five [Member] | |
Exercise Prices | $ / shares | $ 1.680 |
Options Outstanding (Shares) | 66,667 |
Options Exercisable (Shares) | 66,667 |
Exercise Price Six [Member] | |
Exercise Prices | $ / shares | $ 3 |
Options Outstanding (Shares) | 666,667 |
Options Exercisable (Shares) | 666,667 |
Exercise Price Seven [Member] | |
Exercise Prices | $ / shares | $ 6 |
Options Outstanding (Shares) | 166,667 |
Options Exercisable (Shares) | 166,667 |
Exercise Price Eight [Member] | |
Exercise Prices | $ / shares | $ 6.600 |
Options Outstanding (Shares) | 50,000 |
Options Exercisable (Shares) | 50,000 |
Exercise Price Nine [Member] | |
Exercise Prices | $ / shares | $ 7.140 |
Options Outstanding (Shares) | 200,000 |
Options Exercisable (Shares) | 50,000 |
Exercise Price Ten [Member] | |
Exercise Prices | $ / shares | $ 12 |
Options Outstanding (Shares) | 83,333 |
Options Exercisable (Shares) | 83,333 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Income Tax Disclosure [Abstract] | |
Operating loss carryforwards amount federal | $ 19,188,000 |
Operating loss carryforwards amount state | $ 20,087,000 |
Operating loss carryforwards, expiration date | expire through 2040 |
Prior net operating loss conversion | $ 928,313 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Start-up and organization costs | $ 5,000 | $ 10,000 |
Research credits | 390,000 | 359,000 |
Stock-based compensation | 1,107,000 | 799,000 |
Net operating loss carryforwards | 5,477,000 | 4,879,000 |
Total deferred tax assets | 6,979,000 | 6,047,000 |
Valuation allowance | (6,979,000) | (6,047,000) |
Net deferred tax assets |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
U. S. federal statutory tax rate | (21.00%) | (21.00%) |
State income taxes, net of federal tax benefit | (6.00%) | (6.00%) |
Expirations related to stock-based compensation | 0.50% | 1.20% |
Adjustment to deferred tax asset | (0.80%) | (0.30%) |
Change in valuation allowance | 27.30% | 26.10% |
Effective tax rate | 0.00% | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) | Mar. 20, 2021USD ($) | Jan. 18, 2021USD ($) | Dec. 21, 2020USD ($) | Aug. 12, 2020USD ($)shares | Aug. 01, 2020USD ($)shares | Jul. 15, 2020USD ($)shares | Feb. 18, 2020USD ($) | May 22, 2019USD ($) | Sep. 12, 2018USD ($) | Aug. 20, 2018USD ($) | Apr. 05, 2018USD ($) | Apr. 05, 2018EUR (€) | Apr. 02, 2018 | Mar. 22, 2018USD ($) | Sep. 14, 2015USD ($) | Dec. 24, 2013USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares |
Research and development costs | $ 1,223,676 | $ 820,906 | |||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 200,000 | 133,333 | |||||||||||||||||
Stock options grant date fair value | $ 189,060 | $ 100,000 | |||||||||||||||||
NDA Consulting Corp [Member] | |||||||||||||||||||
Agreement term | 1 year | ||||||||||||||||||
Consulting and advisory fee | $ 4,000 | 16,000 | $ 16,000 | ||||||||||||||||
Clinical Trial Research Agreement [Member] | |||||||||||||||||||
Research and development costs | 102,944 | ||||||||||||||||||
Clinical Trial Research Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||||
Payments for clinical trial | 41,142 | 45,093 | |||||||||||||||||
Aggregate commitments expected | 616,000 | ||||||||||||||||||
Collaboration Agreement [Member] | |||||||||||||||||||
Research and development costs | 130,882 | ||||||||||||||||||
Advance amount related to milestone payment | $ 87,471 | 43,411 | 87,471 | ||||||||||||||||
Collaboration Agreement [Member] | Subsequent Event [Member] | |||||||||||||||||||
Advance amount related to milestone payment | $ 23,802 | ||||||||||||||||||
Collaboration Agreement [Member] | Grupo Espanol de Investigacion en Sarcomas [Member] | |||||||||||||||||||
Advance amount related to milestone payment | $ 43,411 | ||||||||||||||||||
Aggregate commitments expected | 4,614,000 | ||||||||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks LLC [Member] | |||||||||||||||||||
Amount charges to operations | 131,650 | ||||||||||||||||||
Consulting and advisory fee | $ 10,000 | ||||||||||||||||||
Reimbursed expense | 11,650 | 100,000 | |||||||||||||||||
Clinical Trial Agreement [Member] | |||||||||||||||||||
Aggregate commitments expected | $ 5,230,000 | ||||||||||||||||||
Aggregate commitments expected, description | The Company's aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to date under these agreements, totaled approximately $5,230,000 as of December 31, 2020, consisting of approximately $4,614,000 relating to the GEIS clinical trial and approximately $616,000 relating to the Moffit clinical trial, which are expected to be incurred over the next five years through December 31, 2025. | ||||||||||||||||||
Clinical Trial Agreement [Member] | City of Hope [Member] | Subsequent Event [Member] | |||||||||||||||||||
Aggregate commitments expected, description | The Company estimates that from 24 to 30 patients will be needed to complete this clinical trial, at an estimated cost of $2,500,000 to $2,900,000, respectively. If a significant number of patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of $800,000. | ||||||||||||||||||
Additional estimated commitments cost | $ 800,000 | ||||||||||||||||||
Clinical Trial Agreement [Member] | City of Hope [Member] | Subsequent Event [Member] | Minimum [Member] | |||||||||||||||||||
Aggregate commitments expected | 2,500,000 | ||||||||||||||||||
Clinical Trial Agreement [Member] | City of Hope [Member] | Subsequent Event [Member] | Maximum [Member] | |||||||||||||||||||
Aggregate commitments expected | $ 2,900,000 | ||||||||||||||||||
Other Clinical Agreements [Member] | |||||||||||||||||||
Aggregate commitments expected | $ 300,000 | ||||||||||||||||||
Other Clinical Agreements [Member] | Minimum [Member] | |||||||||||||||||||
Research and development costs | 600,000 | ||||||||||||||||||
Other Clinical Agreements [Member] | Maximum [Member] | |||||||||||||||||||
Research and development costs | 700,000 | ||||||||||||||||||
Work Order Agreement [Member] | |||||||||||||||||||
Research and development costs | 75,788 | ||||||||||||||||||
Aggregate commitments expected | 874,000 | ||||||||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc [Member] | |||||||||||||||||||
Research and development costs | $ 954,000 | 18,663 | 51,586 | ||||||||||||||||
Payment expected dividend for pass-through costs, description | The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023. Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs. | ||||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Maximum [Member] | Development Milestones [Member] | |||||||||||||||||||
Milestone payments | $ 1,750,000 | ||||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Maximum [Member] | Commercial Milestones [Member] | |||||||||||||||||||
Milestone payments | $ 6,500,000 | ||||||||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | |||||||||||||||||||
Agreement term | 2 years | ||||||||||||||||||
Payment of a fixed, one-time retainer | $ 18,348 | ||||||||||||||||||
Net payments of sales of products or licensing activities, percentage | 2.50% | 2.50% | |||||||||||||||||
Consulting Agreement with Liberi Life Consultancy BV [Member] | EURO [Member] | |||||||||||||||||||
Payment of a fixed, one-time retainer | € | € 15,000 | ||||||||||||||||||
Consulting Agreement [Member] | |||||||||||||||||||
Amount charges to operations | 2,294 | 9,174 | |||||||||||||||||
Unamortized balance of the retainer payment | 9,174 | ||||||||||||||||||
Exclusive License Agreement [Member] | |||||||||||||||||||
Amount charges to operations | $ 25,001 | 80,669 | |||||||||||||||||
Royalties description | The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement. | ||||||||||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | |||||||||||||||||||
Minimum payments for royalties | $ 50,000 | ||||||||||||||||||
Exclusive License Agreement [Member] | Five Years and Thereafter [Member] | |||||||||||||||||||
Minimum payments for royalties | 100,000 | ||||||||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||||
Non-refundable license issue fee | $ 25,000 | ||||||||||||||||||
Annual license maintenance fee | 25,000 | ||||||||||||||||||
Payments on non-refundable milestone | $ 1,897,000 | ||||||||||||||||||
Percentage of milestone | 40.00% | ||||||||||||||||||
Employment Agreement [Member] | General and Administrative Expense [Member] | |||||||||||||||||||
Charges for salary | 62,500 | ||||||||||||||||||
Employment Agreement [Member] | Dr. John Kovach [Member] | |||||||||||||||||||
Annual salary | $ 250,000 | 45,000 | 60,000 | ||||||||||||||||
Employment Agreement [Member] | Eric Forman [Member] | |||||||||||||||||||
Annual salary | $ 120,000 | ||||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 350,000 | ||||||||||||||||||
Employment Agreement [Member] | Eric Forman [Member] | General and Administrative Expense [Member] | |||||||||||||||||||
Charges for salary | 30,000 | ||||||||||||||||||
Consulting fee | 38,000 | 48,000 | |||||||||||||||||
Employment Agreement [Member] | Dr. James Miser [Member] | General and Administrative Expense [Member] | |||||||||||||||||||
Charges for salary | 62,500 | ||||||||||||||||||
Employment Agreement [Member] | Dr. James Miser [Member] | |||||||||||||||||||
Annual salary | $ 150,000 | ||||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 500,000 | ||||||||||||||||||
Stock options grant date fair value | $ 143,163 | ||||||||||||||||||
Employment Agreement [Member] | Robert N. Weingarten [Member] | |||||||||||||||||||
Annual salary | $ 120,000 | ||||||||||||||||||
Stock options granted to purchase common stock, issued | shares | 350,000 | ||||||||||||||||||
Stock options grant date fair value | $ 100,214 | ||||||||||||||||||
Employment Agreement [Member] | Robert N. Weingarten [Member] | General and Administrative Expense [Member] | |||||||||||||||||||
Charges for salary | 46,451 | ||||||||||||||||||
Consulting fee | $ 79,995 | $ 80,380 | |||||||||||||||||
Master Service Agreement [Member] | Foundation for Angelman Syndrome Therapy [Member] | |||||||||||||||||||
Percentage of proceeds agree to pay under agreement | 5.00% | ||||||||||||||||||
Maximum amount received under agreement | $ 250,000 | ||||||||||||||||||
Service Agreement [Member] | IRTH Communications, LLC [Member] | |||||||||||||||||||
Consulting and advisory fee | $ 7,500 | ||||||||||||||||||
Stock options grant date fair value | $ 100,000 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Mar. 02, 2021 | Feb. 05, 2021 | Jan. 06, 2021 | Nov. 30, 2020 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Stock option exercisable period | 2 years 11 months 1 day | ||||||
Stock option grant price per share | $ 3.17 | ||||||
Number of sale of common stock, shares | 1,200,000 | ||||||
Sale of stock price per share | $ 4.75 | ||||||
Proceed from issuance of common stock | $ 4,601,816 | ||||||
Subsequent Event [Member] | |||||||
Number of stock options to purchase of shares | 200,000 | ||||||
Stock option exercisable period | 5 years | ||||||
Stock option grant price per share | $ 3.21 | ||||||
Number of sale of common stock, shares | 1,133,102 | ||||||
Sale of stock price per share | $ 3.70 | ||||||
Proceed from issuance of common stock gross | $ 4,192,477 | ||||||
Offering cost | 502,447 | ||||||
Proceed from issuance of common stock | $ 3,690,030 | ||||||
Warrants exercise price per share | $ 5.70 | ||||||
Number of common stock issued during the period | 3,000 | ||||||
Number of common stock upon exercise of warrants | 3,000 | ||||||
Proceeds from warrants exercise | $ 17,100 | ||||||
Subsequent Event [Member] | New Work Order Agreement [Member] | Theradex [Member] | |||||||
Clinical trial monitoring cost | $ 335,000 | ||||||
Subsequent Event [Member] | Placement Agents' Agreement [Member] | Placement Agents [Member] | |||||||
Warrants expiration date | Mar. 2, 2026 | ||||||
Warrants exercise price per share | $ 3.70 | ||||||
Subsequent Event [Member] | Placement Agents' Agreement [Member] | Placement Agents [Member] | Maximum [Member] | |||||||
Number of warrants to purchase of common stock, shares | 113,310 | ||||||
Subsequent Event [Member] | Dr. Winson Sze Chun Ho [Member] | |||||||
Number of stock options to purchase of shares | 50,000 | ||||||
Subsequent Event [Member] | Dr. Yun Yen [Member] | |||||||
Number of stock options to purchase of shares | 50,000 | ||||||
Subsequent Event [Member] | Dr. Stephen Forman [Member] | |||||||
Number of stock options to purchase of shares | 50,000 | ||||||
Subsequent Event [Member] | Dr. Philip Palmedo [Member] | |||||||
Number of stock options to purchase of shares | 50,000 |