Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 01, 2021 | |
Entity Addresses [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-39717 | |
Entity Registrant Name | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | |
Entity Central Index Key | 0001335105 | |
Entity Tax Identification Number | 20-2903526 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 680 East Colorado Boulevard | |
Entity Address, Address Line Two | Suite 180 | |
Entity Address, City or Town | Pasadena | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 91101 | |
City Area Code | (631) | |
Local Phone Number | 830-7092 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 13,746,593 | |
Common Stock, par value $0.0001 per share [Member] | ||
Entity Addresses [Line Items] | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | LIXT | |
Security Exchange Name | NASDAQ | |
Warrants to Purchase Common Stock, par value $0.0001 per share [Member] | ||
Entity Addresses [Line Items] | ||
Title of 12(b) Security | Warrants to Purchase Common Stock, par value $0.0001 per share | |
Trading Symbol | LIXTW | |
Security Exchange Name | NASDAQ | |
Former Address [Member] | ||
Entity Addresses [Line Items] | ||
Entity Address, Address Line One | 248 Route 25A | |
Entity Address, Address Line Two | No. 2 | |
Entity Address, City or Town | East Setauket | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 11733 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 6,798,477 | $ 5,069,266 |
Advances on research and development contract services | 323,333 | 76,898 |
Prepaid insurance | 75,983 | 67,311 |
Other prepaid expenses and current assets | 44,871 | 15,000 |
Total current assets | 7,242,664 | 5,228,475 |
Total assets | 7,242,664 | 5,228,475 |
Current liabilities: | ||
Accounts payable and accrued expenses, including $27,833 and $0 to related parties at June 30, 2021 and December 31, 2020, respectively | 162,447 | 190,292 |
Accrued offering costs | 10,467 | |
Research and development contract liabilities | 213,879 | 15,765 |
Total current liabilities | 376,326 | 216,524 |
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 and outstanding – 13,663,260 shares and 12,402,157 shares at June 30, 2021 and December 31, 2020, respectively | 1,366 | 1,240 |
Additional paid-in capital | 37,179,050 | 31,864,479 |
Accumulated deficit | (33,814,078) | (30,353,768) |
Total stockholders’ equity | 6,866,338 | 5,011,951 |
Total liabilities and stockholders’ equity | $ 7,242,664 | $ 5,228,475 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Accounts payable and accrued expenses | $ 27,833 | $ 0 |
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 | 13,663,260 | 12,402,157 |
Common stock, shares outstanding | 13,663,260 | 12,402,157 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenues | ||||
Costs and expenses: | ||||
General and administrative costs, including compensation to officers, directors and affiliates of $1,033,304 and $27,000 for the three months ended June 30, 2021 and 2020, respectively, and $1,849,336 and $54,000 to related parties for the six months ended June 30, 2021 and 2020, respectively | 1,470,180 | 255,443 | 2,751,834 | 547,928 |
Research and development costs | 262,415 | 117,946 | 705,941 | 212,618 |
Total costs and expenses | 1,732,595 | 373,389 | 3,457,775 | 760,546 |
Loss from operations | (1,732,595) | (373,389) | (3,457,775) | (760,546) |
Interest income | 180 | 264 | 326 | 4,246 |
Interest expense | (751) | (2,861) | ||
Net loss | $ (1,733,166) | $ (373,125) | $ (3,460,310) | $ (756,300) |
Net loss per common share – basic and diluted | $ (0.13) | $ (0.03) | $ (0.26) | $ (0.07) |
Weighted average common shares outstanding – basic and diluted | 13,633,040 | 11,174,302 | 13,203,010 | 11,174,302 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
General and administrative costs, to related parties | $ 1,033,304 | $ 27,000 | $ 1,849,336 | $ 54,000 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Series A Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value 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 | 11,174,302 | |||
Net loss for the period | (756,300) | (756,300) | |||
Ending balance, value at Jun. 30, 2020 | $ 3,500,000 | $ 1,117 | 26,021,904 | (27,845,186) | 1,677,835 |
Balance, shares at Jun. 30, 2020 | 350,000 | 11,174,302 | |||
Beginning balance, value at Mar. 31, 2020 | $ 3,500,000 | $ 1,117 | 26,021,904 | (27,472,061) | 2,050,960 |
Balance, shares at Mar. 31, 2020 | 350,000 | 11,174,302 | |||
Net loss for the period | (373,125) | (373,125) | |||
Ending balance, value at Jun. 30, 2020 | $ 3,500,000 | $ 1,117 | 26,021,904 | (27,845,186) | 1,677,835 |
Balance, shares at Jun. 30, 2020 | 350,000 | 11,174,302 | |||
Beginning balance, value 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 | |||
Exercise of options | $ 12 | 100,988 | $ 101,000 | ||
Exercise of options, shares | 125,001 | 125,001 | |||
Proceeds from sale of common stock in direct equity offering, net of offering costs | $ 113 | 3,689,648 | $ 3,689,761 | ||
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares | 1,133,102 | ||||
Exercise of warrants | $ 1 | 17,099 | 17,100 | ||
Exercise of warrants, shares | 3,000 | ||||
Stock-based compensation expense | 1,506,836 | 1,506,836 | |||
Net loss for the period | (3,460,310) | (3,460,310) | |||
Ending balance, value at Jun. 30, 2021 | $ 3,500,000 | $ 1,366 | 37,179,050 | (33,814,078) | 6,866,338 |
Balance, shares at Jun. 30, 2021 | 350,000 | 13,663,260 | |||
Beginning balance, value at Mar. 31, 2021 | $ 3,500,000 | $ 1,354 | 36,227,258 | (32,080,912) | 7,647,700 |
Balance, shares at Mar. 31, 2021 | 350,000 | 13,538,259 | |||
Exercise of options | $ 12 | 100,988 | 101,000 | ||
Exercise of options, shares | 125,001 | ||||
Stock-based compensation expense | 850,804 | 850,804 | |||
Net loss for the period | (1,733,166) | (1,733,166) | |||
Ending balance, value at Jun. 30, 2021 | $ 3,500,000 | $ 1,366 | $ 37,179,050 | $ (33,814,078) | $ 6,866,338 |
Balance, shares at Jun. 30, 2021 | 350,000 | 13,663,260 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (3,460,310) | $ (756,300) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
General and administrative costs | 1,506,836 | |
(Increase) decrease in - | ||
Advances on research and development contract services | (246,435) | |
Accrued interest receivable | 14,367 | |
Prepaid insurance | (8,672) | 19,889 |
Other prepaid expenses and current assets | (29,871) | 8,295 |
Increase (decrease) in - | ||
Accounts payable and accrued expenses | (27,845) | 15,319 |
Research and development contract liabilities | 198,114 | (70,252) |
Net cash used in operating activities | (2,068,183) | (768,682) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock in direct equity offering, net of offering costs | 3,689,761 | |
Payment of deferred offering costs | (55,850) | |
Exercise of common stock warrants | 17,100 | |
Exercise of common stock options | 101,000 | |
Payment of public offering costs | (10,467) | |
Net cash provided by (used in) financing activities | 3,797,394 | (55,850) |
Cash: | ||
Net increase (decrease) | 1,729,211 | (824,532) |
Balance at beginning of period | 5,069,266 | 2,598,864 |
Balance at end of period | 6,798,477 | 1,774,332 |
Supplemental disclosures of cash flow information: | ||
Interest | 2,944 | |
Income taxes |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (“Lixte”) (collectively, the “Company”), at June 30, 2021, and for the three months and six months ended June 30, 2021 and 2020, are unaudited. In the opinion of management of the Company, all adjustments, including normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of June 30, 2021, and the results of its operations for the three months and six months ended June 30, 2021 and 2020, and its cash flows for the six months ended June 30, 2021 and 2020. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The consolidated balance sheet at December 31, 2020 has been derived from the Company’s audited consolidated financial statements at such date. The condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC. |
Business
Business | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business | 2. Business The Company is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, and is dependent on periodic infusions of equity capital to fund its operating requirements. Going Concern At June 30, 2021, the Company had cash of $ 6,798,477 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. 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 2,500,000 2,900,000 3,689,761 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 pandemic 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 All share and per share amounts and information presented herein has been retroactively adjusted to reflect the reverse stock split for all periods presented. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Principles of Consolidation The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. Cash 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 $ 250,000 500,000 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, which are charged to operations as incurred. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred. Obligations incurred with respect to mandatory scheduled payments under 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 accounted for when due, 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. 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 $ 108,193 143,444 228,352 276,912 Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10 General and administrative costs for the three months ended June 30, 2021 and 2020 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 7.5 56.3 General and administrative costs for the six months ended June 30, 2021 and 2020 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 8.4 50.7 Research and development costs for the three months ended June 30, 2021 include charges from three vendors and consultants representing 26.3 26.0 11.4 36.8 25.6 10.5 Research and development costs for the six months ended June 30, 2021 include charges from two vendors and consultants representing 43.8 19.7 28.3 20.4 15.1 11.9 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 12 The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of June 30, 2021 or December 31, 2020. Subsequent to June 30, 2021, 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 June 30, 2021 and 2020, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share June 30, 2021 2020 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,110,310 1,500,000 Common stock options, including options issued in the form of warrants 2,550,000 1,308,333 Total 6,389,477 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 was effective January 1, 2021. The adoption of ASU 2019-12 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. 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. For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06 are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider whether collateral is required to be posted, and (iii) assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if adopted as of the beginning of such fiscal year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted for all entities, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | 4. Stockholders’ Equity Preferred Stock The Company is authorized to issue a total of 10,000,000 0.0001 350,000 175,000 1 175,000 9,650,000 Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 2.0833 21,875,000 If fully converted, the 350,000 729,167 50.00 175,000 Based on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible Preferred Stock as a permanent component of stockholders’ equity. Common Stock The Company is authorized to issue a total of 100,000,000 0.0001 13,663,260 12,402,157 On November 30, 2020, the Company raised gross proceeds $ 5,700,000 1,200,000 4.75 5.70 1,800 180,000 5.70 1,110,451 4,591,349 120,000 May 24, 2021 5.70 During February and March 2021, the Company issued 3,000 3,000 17,100 Effective March 2, 2021, the Company completed the sale of 1,133,102 3.70 4,192,478 502,717 3,689,761 113,310 March 2, 2026 3.70 On April 22, 2021, the Company issued 125,001 75,000 0.72 16,66 0.90 33,334 0.96 101,100 Common Stock Warrants A summary of common stock warrant activity during the six months ended June 30, 2021 is presented below. Schedule of Warrants Outstanding Number of Shares Weighted Average Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2020 3,000,000 $ 5.850 Issued 113,310 3.700 Exercised (3,000 ) 5.700 Expired — — Warrants outstanding at June 30, 2021 3,110,310 $ 5.772 2.98 At June 30, 2021, all outstanding warrants are exercisable at the following prices per common share: Schedule of Warrants Outstanding and Exercisable Exercise Prices Warrants Outstanding (Shares) $ 3.700 113,310 $ 5.700 1,497,000 $ 6.000 1,500,000 3,110,310 Based on a fair market value of $ 3.03 Information with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 6. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions Gil N Schwartzberg In September 2007, the Company entered into a consulting agreement with Gil N 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. Effective April 9, 2021, Mr. Schwartzberg was appointed to the Company’s Board of Directors. Mr. Schwartzberg is currently a significant stockholder of the Company and continues to be a consultant to the Company. Employment Agreements with Officers The Company entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, for Dr. Kovach to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer with an annual salary of $ 250,000 15,000 30,000 The Company entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020 to act as the Company’s Chief Medical Officer with an annual salary of $ 150,000 175,000 The Company entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as the Company’s Chief Administrative Officer with an annual salary of $ 120,000 175,000 12,000 $24,000 The Company entered into an employment agreement with Robert N. Weingarten effective August 12, 2020 to act as the Company’s Vice President and Chief Financial Officer with an annual salary of $ 120,000 175,000 14,980 47,375 On April 9, 2021, the Board of Directors increased the annual compensation of Eric J. Forman, the Company’s Chief Administrative Officer, Dr. James S. Miser, the Company’s Chief Medical Officer, and Robert N. Weingarten, the Company’s Chief Financial Officer, under the employment agreements such that the total aggregate annual compensation of all officers increased to $ 775,000 Compensatory Arrangements for Board of Directors On April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation package for the members of the Board of Directors and committee members, effective immediately. The Board of Directors approved the following cash compensation for non-officer directors, payable quarterly: Base director compensation - $ 20,000 Chairman of audit committee - additional $ 10,000 Chairman of any other committees - additional $ 5,000 Member of audit committee - additional $ 5,000 Member of any other committees - additional $ 2,500 Stock-based compensation arrangements involving members of the Company’s Board of Directors. officers and affiliates are described at Note 6. A summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors for their service on the Board of Directors, for the three months and six months ended June 30, 2021 and 2020 is presented below. This summary includes the above-described payments to Mr. Forman in 2020 prior to his appointment as Chief Administrative Officer, but excludes the payments to Mr. Weingarten in 2020 prior to his appointment as Vice President and Chief Financial Officer. Summary of Related Party Costs Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2019 Related party costs: Cash-based $ 182,500 $ 27,000 $ 342,500 $ 54,000 Stock-based 850,804 — 1,506,836 — Total $ 1,033,304 $ 27,000 $ 1,849,336 $ 54,000 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation The Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees, contractors and consultants of the Company. On June 20, 2007, the Board of Directors of the Company approved the 2007 Stock Compensation Plan (the “2007 Plan”), which provided for the granting of awards, consisting of stock options, stock appreciation rights, performance shares, and restricted shares of common stock, to employees and consultants, for up to 416,667 83,333 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 2,333,333 400,000 On April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation package for the members of the Board of Directors and committee members, effective immediately. Stock-based features of the compensation package consisted of the annual granting of stock options to each non-officer director to purchase 100,000 250,000 Cash-based features of the compensation package are described at Note 8. The fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts and is assumed to be zero. The 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 six months ended June 30, 2021, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Schedule of Fair Value of Each Option Award Estimated Assumption Risk-free interest rate 0.89 % Expected dividend yield 0 % Expected volatility 198.79 % Expected life 3.5 3.6 There were no stock options requiring an assessment of value during the six months ended June 30, 2020. On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted options for 58,333 five years 7.14 400,855 6.8718 100,214 24,985 49,695 On August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted options for 83,334 five years 7.14 572,650 6.8718 143,163 35,693 70,993 On August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted options for 58,333 five years 7.14 400,855 6.8718 100,214 24,985 49,695 Effective January 6, 2021, in recognition with their service as directors of the Company over the past year, the Company granted to each of Dr. Winson Sze Chun Ho, Dr. Yun Yen, Dr. Stephen Forman, and Dr. Philip Palmedo, fully-vested stock options to purchase an aggregate of 200,000 50,000 five years 3.21 571,312 2.8566 On April 9, 2021, Winson Sze Chun Ho resigned from the Company’s Board of Directors to focus on clinical and pre-clinical cancer research in academic medicine. Concurrent with his resignation, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by Dr. Ho’s resignation. In connection with his appointment to the Board of Directors, and in accordance with the recently adopted cash and equity compensation package for the members of the Board of Directors, Mr. Schwartzberg was granted options exercisable for a period of five years 250,000 3.20 753,611 3.0144 376,800 414,851 On May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board of Directors, and in accordance with the recently adopted cash and equity compensation package for the members of the Board of Directors, Ms. Brown was granted options exercisable for a period of five years 250,000 2.80 658,363 2.6335 329,188 350,290 On June 30, 2021, the Board of Directors, in accordance with the recently adopted cash and equity compensation package for the members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options exercisable for a period of five years 100,000 3.03 500,000 1,421,095 2.84225 A summary of stock-based compensation costs for the three months and six months ended June 30, 2021 and 2020 is as follows: Summary of Stock-based Compensation Costs Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Related parties $ 850,804 $ — $ 1,506,836 $ — Non-related parties — — — — Total stock-based compensation costs $ 850,804 $ — $ 1,506,836 $ — A summary of stock option activity, including options issued in the form of warrants, during the six months ended June 30, 2021 is presented below. Summary of Stock Option Activity Including Options Form of Warrants Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2020 1,475,000 $ 4.136 Granted 1,200,000 3.048 Exercised (125,001 ) 0.808 Expired — — Adjustment attributable to reverse stock split 1 — Stock options outstanding at June 30, 2021 2,550,000 $ 3.787 3.79 Stock options exercisable at June 30, 2021 1,650,000 $ 3.831 3.24 Total deferred compensation expense for the outstanding value of unvested stock options was approximately $ 2,791,000 24 The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at June 30, 2021 are as follows: Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants Exercise Prices Options Outstanding Options Exercisable $ 0.900 33,333 33,333 $ 1.200 83,333 83,333 $ 1.680 66,667 66,667 $ 2.800 250,000 125,000 $ 3.000 666,667 666,667 $ 3.030 500,000 — $ 3.200 250,000 125,000 $ 3.210 200,000 200,000 $ 6.000 166,667 166,667 $ 6.600 50,000 50,000 $ 7.140 200,000 50,000 $ 12.000 83,333 83,333 2,550,000 1,650,000 The intrinsic value of exercisable but unexercised in-the-money stock options at June 30, 2021 was approximately $ 362,251 3.03 Outstanding stock options to acquire 900,000 The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes During the three months and six months ended June 30, 2021 and 2020, there was no provision for income taxes as the Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company recorded a full valuation allowance against its deferred tax assets as the Company believes it is more likely than not the deferred tax assets will not be realized. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Legal Claims The Company may be subject to legal claims and actions from time to time as part of its business activities. As of June 30, 2021, 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 clinical trial is expected to be completed over a period of approximately four years from its initiation. 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. During the three months ended June 30, 2021 and 2020, the Company incurred costs of $ 10,309 11,698 17,693 25,364 103,927 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 ended December 31, 2020, with approximately 150 patients to be enrolled over two years. As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival (PFS, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of the primary endpoint when 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. A new batch of LB 100 has been prepared and is now undergoing the multitude of analytical studies of the formulated product necessary to gain approval for use in the European Union. Regulatory reviews by the European Union have been delayed until October 2021 as a result of which the final review of the clinical product by Spanish regulatory authorities will also be delayed. Accordingly, the clinical trial is now estimated to begin during the quarter ending June 30, 2022 and take approximately three years to conduct. The interim analysis of this clinical trial 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 87,471 24,171 Accordingly, during the three months ended June 30, 2021 and 2020, the Company incurred costs of $ 0 43,411 24,171 43,411 155,053 The Company’s aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to date under these agreements, totaled approximately $ 5,798,000 5,193,000 605,000 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. As of June 30, 2021, 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 approximately $ 737,000 371,000 City of Hope. The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately 18 to 24 months to complete. 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. The Company is seeking two additional centers to increase the rate of accrual. As described below, a recent publication may heighten the interest of institutions with large populations of small cell lung cancer (SCLC) patients. LB-100 was reported to enhance the effectiveness of elements of standard therapy in models of SCLC (Mirzapoiazova el al., Molecular Cancer Therapeutics, online July 12, 2021). Dr. Ravi Salgia, MD, PhD, Professor and Chair of the Department of Medical Oncology and Therapeutics Research at the City of Hope National Medical Center, is the corresponding author of the paper and also the principal investigator for the Company’s SCLC clinical trial. Dr. Salgia and collaborators found multiple metabolic changes associated with cell death in SCLC cells when exposed to LB-100 alone and when combined with the drugs in a standard clinical regimen for this notoriously aggressive disease. LB-100 has been reported to increase the effectiveness of a number of anti-cancer drugs against several different types of human cancers without increasing toxicity in animal models. The recent pre-clinical study of SCLC cells observed that (1) LB-100 increases the amount of carboplatin that enters the tumor cells without increasing toxicity, and (2) LB-100 potentiates the action of the immune-blocker, atezolizumab. These observations are important because, taken together, they not only constitute a strong rationale for the clinical trial of LB-100 plus chemo-immunotherapy in SCLC, but they also complement earlier pre-clinical observations that LB-100 can (1) reverse resistance of cancer cells (ovarian) to cisplatin, another widely used chemotherapy drug (Chang et al., Molecular Cancer Therapeutics, November 5, 2014), (2) increase the entry of another important anti-cancer agent, doxorubicin, into liver cancer cells associated with increased anti-tumor activity (Bai et al, Molecular Cancer Therapeutics, August 14, 2014), and (3) enhance the effectiveness of immune-blockers against several types of cancers (Ho et al. Nature Comm., May 29, 2018). These observations raise the possibility that the addition of LB-100 may be a general way to enhance standard therapies for cancers for which better treatments are urgently needed. The present clinical trial in SCLC is an initial step in testing that hypothesis, as is the planned clinical trial in advanced soft tissue sarcoma in which LB-100 is combined with doxorubicin. During the three months and six months ended June 30, 2021, the Company incurred costs of $ 69,001 309,509 309,509 The Company’s aggregate commitments pursuant to this clinical trial agreement, less amounts previously paid to date under this agreement, totaled approximately $ 2,433,000 800,000 Clinical Trial Monitoring Agreements Moffitt. Costs under this work order agreement are estimated to be approximately $ 954,000 7,540 5,790 8,481 11,476 90,636 The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date under this agreement, totaled approximately $ 873,000 City of Hope. 10,773 14,313 14,313 The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date under this agreement, totaled approximately $ 324,000 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 6,500,000 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 25,000 1,897,000 40 6,233 6,233 12,397 12,398 The Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $ 50,000 100,000 Employment Agreements with Officers During July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual compensation of $ 640,000 one-year periods 775,000 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 4,000 4,000 8,000 8,000 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 30,000 30,000 60,000 60,000 Effective August 12, 2020, the Company entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST) to collaborate in supporting pre-clinical 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 pre-clinical studies will be conducted at The University of California - Davis under the direction of Dr. David Segal, an internationally recognized leader in AS research. If the pre-clinical 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 ( 5 250,000 The research team at the University of California, Davis recently completed their pre-clinical study of the potential benefit of LB-100 in a mouse model of AS, and the results are currently under review by FAST. The preliminary analysis indicates that the positive results previously reported by Chinese investigators were not confirmed in the US model. The Company is awaiting input from FAST as to whether it intends to continue to pursue pre-clinical studies of LB 100. 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 $ 7,500 100,000 100,000 22,500 45,000 Impact of the Novel Coronavirus (Covid-19) on the Company’s Business Activities The global outbreak of the novel coronavirus (Covid-19) has led to disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. In light of the uncertain and continually evolving situation relating to the spread of Covid-19, this pandemic could pose a risk to the Company. The extent to which the coronavirus may impact the Company’s business activities will depend on future developments, which are highly uncertain and cannot be predicted at this time. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available. 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. The most problematic issue directly related to Covid-19 for the Company is the delay in completing the glioblastoma (GBM) pharmacology clinical trial at NCI. This clinical trial is being conducted by the NCI without charge to the Company. The neurosurgical unit at the NCI is closed due to the Covid-19 epidemic. Patient entry remains at two, with the goal to enter eight patients before analyzing results. There is an urgent need to improve therapy for this type of aggressive brain tumor. If the NCI study shows that LB-100 does penetrate the brain, a clinical study of LB-100 in combination with standard therapy for GBM, the drug temozolomide and radiation, both of which have been well documented in pre-clinical studies to be significantly enhanced by LB-100, would be of significant interest to neuro-oncologists frustrated by decades of limited advances in therapy for this common brain tumor in adults. 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. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. 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. Exercise of Stock Options Effective July 14, 2021, stock options for 83,333 1.20 100,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets. |
Cash | 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 $ 250,000 500,000 |
Research and Development | Research and Development Research and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the 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, which are charged to operations as incurred. Research and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are charged to operations as incurred. Obligations incurred with respect to mandatory scheduled payments under 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 accounted for when due, 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. |
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 $ 108,193 143,444 228,352 276,912 |
Concentration of Risk | Concentration of Risk The Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred that represented 10 General and administrative costs for the three months ended June 30, 2021 and 2020 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 7.5 56.3 General and administrative costs for the six months ended June 30, 2021 and 2020 include charges from a legal firm for general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 8.4 50.7 Research and development costs for the three months ended June 30, 2021 include charges from three vendors and consultants representing 26.3 26.0 11.4 36.8 25.6 10.5 Research and development costs for the six months ended June 30, 2021 include charges from two vendors and consultants representing 43.8 19.7 28.3 20.4 15.1 11.9 |
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 12 The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. The Company had not recorded any liability for uncertain tax positions as of June 30, 2021 or December 31, 2020. Subsequent to June 30, 2021, 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 June 30, 2021 and 2020, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share June 30, 2021 2020 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,110,310 1,500,000 Common stock options, including options issued in the form of warrants 2,550,000 1,308,333 Total 6,389,477 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 was effective January 1, 2021. The adoption of ASU 2019-12 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. 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. For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06 are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider whether collateral is required to be posted, and (iii) assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if adopted as of the beginning of such fiscal year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted for all entities, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | At June 30, 2021 and 2020, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share June 30, 2021 2020 Series A Convertible Preferred Stock 729,167 729,167 Common stock warrants 3,110,310 1,500,000 Common stock options, including options issued in the form of warrants 2,550,000 1,308,333 Total 6,389,477 3,537,500 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding | A summary of common stock warrant activity during the six months ended June 30, 2021 is presented below. Schedule of Warrants Outstanding Number of Shares Weighted Average Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2020 3,000,000 $ 5.850 Issued 113,310 3.700 Exercised (3,000 ) 5.700 Expired — — Warrants outstanding at June 30, 2021 3,110,310 $ 5.772 2.98 |
Schedule of Warrants Outstanding and Exercisable | At June 30, 2021, all outstanding warrants are exercisable at the following prices per common share: Schedule of Warrants Outstanding and Exercisable Exercise Prices Warrants Outstanding (Shares) $ 3.700 113,310 $ 5.700 1,497,000 $ 6.000 1,500,000 3,110,310 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
Summary of Related Party Costs | A summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors for their service on the Board of Directors, for the three months and six months ended June 30, 2021 and 2020 is presented below. This summary includes the above-described payments to Mr. Forman in 2020 prior to his appointment as Chief Administrative Officer, but excludes the payments to Mr. Weingarten in 2020 prior to his appointment as Vice President and Chief Financial Officer. Summary of Related Party Costs Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2019 Related party costs: Cash-based $ 182,500 $ 27,000 $ 342,500 $ 54,000 Stock-based 850,804 — 1,506,836 — Total $ 1,033,304 $ 27,000 $ 1,849,336 $ 54,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Fair Value of Each Option Award Estimated Assumption | For stock options requiring an assessment of value during the six months ended June 30, 2021, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model with the following assumptions: Schedule of Fair Value of Each Option Award Estimated Assumption Risk-free interest rate 0.89 % Expected dividend yield 0 % Expected volatility 198.79 % Expected life 3.5 3.6 |
Summary of Stock-based Compensation Costs | A summary of stock-based compensation costs for the three months and six months ended June 30, 2021 and 2020 is as follows: Summary of Stock-based Compensation Costs Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Related parties $ 850,804 $ — $ 1,506,836 $ — Non-related parties — — — — Total stock-based compensation costs $ 850,804 $ — $ 1,506,836 $ — |
Summary of Stock Option Activity Including Options Form of Warrants | A summary of stock option activity, including options issued in the form of warrants, during the six months ended June 30, 2021 is presented below. Summary of Stock Option Activity Including Options Form of Warrants Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Stock options outstanding at December 31, 2020 1,475,000 $ 4.136 Granted 1,200,000 3.048 Exercised (125,001 ) 0.808 Expired — — Adjustment attributable to reverse stock split 1 — Stock options outstanding at June 30, 2021 2,550,000 $ 3.787 3.79 Stock options exercisable at June 30, 2021 1,650,000 $ 3.831 3.24 |
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants | The exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at June 30, 2021 are as follows: Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants Exercise Prices Options Outstanding Options Exercisable $ 0.900 33,333 33,333 $ 1.200 83,333 83,333 $ 1.680 66,667 66,667 $ 2.800 250,000 125,000 $ 3.000 666,667 666,667 $ 3.030 500,000 — $ 3.200 250,000 125,000 $ 3.210 200,000 200,000 $ 6.000 166,667 166,667 $ 6.600 50,000 50,000 $ 7.140 200,000 50,000 $ 12.000 83,333 83,333 2,550,000 1,650,000 |
Business (Details Narrative)
Business (Details Narrative) - USD ($) | Mar. 02, 2021 | Nov. 30, 2020 | Nov. 18, 2020 | Jan. 18, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Entity Listings [Line Items] | ||||||
Cash and cash equivalents | $ 6,798,477 | $ 5,069,266 | ||||
Proceeds from issuance of common stock and warrants | $ 4,591,349 | |||||
Estimated gross proceeds from offering of shares | $ 502,717 | |||||
Common Stock [Member] | ||||||
Entity Listings [Line Items] | ||||||
Estimated gross proceeds from offering of shares | $ 3,689,761 | |||||
Reverse stock split | 1-for-6 reverse split | |||||
Phase 1b Clinical Trial [Member] | Minimum [Member] | ||||||
Entity Listings [Line Items] | ||||||
Estimated cost of clinical trial | $ 2,500,000 | |||||
Phase 1b Clinical Trial [Member] | Maximum [Member] | ||||||
Entity Listings [Line Items] | ||||||
Estimated cost of clinical trial | $ 2,900,000 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 6,389,477 | 3,537,500 |
Series A Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 729,167 | 729,167 |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,110,310 | 1,500,000 |
Common Stock Options Including Options Issued in the Form of Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,550,000 | 1,308,333 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Product Information [Line Items] | |||||
Cash FDIC insurance | $ 250,000 | $ 250,000 | |||
Cash SIPC insurance | 500,000 | 500,000 | |||
Patent and licensing costs | 108,193 | $ 143,444 | 228,352 | $ 276,912 | |
Unrecognized tax benefits | $ 0 | $ 0 | $ 0 | ||
Deferred setup and organization costs, amortization period | 12 months | ||||
Cost of Sales [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 10.00% | 10.00% | |||
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 7.50% | 56.30% | 8.40% | 50.70% | |
Research and Development Expense [Member] | Revenue Benchmark [Member] | One Vendors and Consultants [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 26.30% | 36.80% | 43.80% | 28.30% | |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Two Vendors and Consultants [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 26.00% | 25.60% | 19.70% | 20.40% | |
Research and Development Expense [Member] | Revenue Benchmark [Member] | Three Vendors and Consultants [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 11.40% | 10.50% | 15.10% | ||
Research and Development Expense [Member] | Revenue Benchmark [Member] | Four Vendors And Consultants [Member] | |||||
Product Information [Line Items] | |||||
Concentration of risk, percentage | 11.90% |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Number of Shares, Warrants Outstanding, Beginning Balance | shares | 3,000,000 |
Weighted Average Exercise Price, Warrants Outstanding, Beginning | $ / shares | $ 5.850 |
Number of Shares, Issued | shares | 113,310 |
Weighted Average Exercise Price, Issued | $ / shares | $ 3.700 |
Number of Shares, Exercised | shares | (3,000) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 5.700 |
Number of Shares, Expired | shares | |
Weighted Average Exercise Price, Expired | $ / shares | |
Number of Shares, Warrants Outstanding, Ending Balance | shares | 3,110,310 |
Weighted Average Exercise Price, Warrants Outstanding, Ending | $ / shares | $ 5.772 |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 2 years 11 months 23 days |
Schedule of Warrants Outstand_2
Schedule of Warrants Outstanding and Exercisable (Details) - $ / shares | Jun. 30, 2021 | Mar. 02, 2021 |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.70 | |
Warrants Outstanding Shares | 3,110,310 | |
Exercise Price One [Member] | ||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 3.700 | |
Warrants Outstanding Shares | 113,310 | |
Exercise Price Two [Member] | ||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 5.700 | |
Warrants Outstanding Shares | 1,497,000 | |
Exercise Price Three [Member] | ||
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | ||
Exercise Prices | $ 6 | |
Warrants Outstanding Shares | 1,500,000 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | Apr. 22, 2021 | Mar. 02, 2021 | Dec. 07, 2020 | Nov. 30, 2020 | Mar. 17, 2015 | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jan. 21, 2016 | Dec. 31, 2020 | Jan. 06, 2021 |
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | ||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Common stock, shares issued | 13,663,260 | 13,663,260 | 12,402,157 | ||||||||
Common stock, shares outstanding | 13,663,260 | 13,663,260 | 12,402,157 | ||||||||
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 | ||||||||||
Warrants exercise price | $ 3.70 | ||||||||||
Costs of public offering | $ 10,467 | ||||||||||
Costs of public offering | $ 502,717 | ||||||||||
Warrants to purchase of common stock, shares | 113,310 | ||||||||||
Warrant expire date | Mar. 2, 2026 | ||||||||||
Stock issued new issue shares | 1,133,102 | ||||||||||
Proceeds from issuance of common stock gross | $ 4,192,478 | ||||||||||
Proceeds from issuance of common stock | 3,689,761 | $ 3,689,761 | |||||||||
Total cash proceeds | $ 101,100 | ||||||||||
Fair market value of stock | $ 2.8566 | ||||||||||
Officer And Directors [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock upon the exercise of options | 125,001 | ||||||||||
Director [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock upon the exercise of options | 75,000 | ||||||||||
Exercise price | $ 0.72 | ||||||||||
Director One [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock upon the exercise of options | 16.66 | ||||||||||
Directors One [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price | $ 0.90 | ||||||||||
Director Two [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock upon the exercise of options | 33,334 | ||||||||||
Directors Two [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price | $ 0.96 | ||||||||||
Common Stock [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Costs of public offering | $ 3,689,761 | ||||||||||
Stock issued new issue shares | 3,000 | 1,133,102 | |||||||||
Share issued per share | $ 3.70 | ||||||||||
Warrant [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Sale of stock during period, amount | $ 1,800 | ||||||||||
Sale of stock during period, shares | 180,000 | ||||||||||
Warrants exercise price | $ 5.70 | $ 5.70 | $ 5.70 | ||||||||
Costs of public offering | $ 1,110,451 | ||||||||||
Costs of public offering | $ 4,591,349 | ||||||||||
Stock issued new issue shares | 3,000 | ||||||||||
Proceeds from warrant exercises | $ 17,100 | ||||||||||
Warrant [Member] | Underwriting Agreement [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants to purchase of common stock, shares | 120,000 | ||||||||||
Warrant expire date | May 24, 2021 | ||||||||||
Common stock warrant [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Fair market value of stock | $ 3.03 | $ 3.03 | |||||||||
Series A Convertible Preferred Stock [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 350,000 | ||||||||||
Number of share tranche of the series A convertible preferred stock receive a per share dividend | 175,000 | ||||||||||
Percentage of dividend from annual revenue | 1.00% | ||||||||||
Annual net revenue divided by converted or redeemed shares | 175,000 | ||||||||||
Preferred stock convertible into common stock | 729,167 | 175,000 | 729,167 | ||||||||
Gross proceeds from sale of transaction | $ 21,875,000 | ||||||||||
Preferred stock, shares outstanding | 350,000 | 350,000 | 350,000 | ||||||||
Preferred stock, per share redemption price | $ 50 | ||||||||||
Series A Convertible Preferred Stock [Member] | Common Stock [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, conversion description | Each share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 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 $21,875,000. | ||||||||||
Preferred stock convertible into common stock | 2.0833 | ||||||||||
Undesignated Preferred Stock [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 9,650,000 | 9,650,000 | 9,650,000 |
Summary of Related Party Costs
Summary of Related Party Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Related Party Transaction [Line Items] | ||||
Total | $ 1,033,304 | $ 27,000 | $ 1,849,336 | $ 54,000 |
Cash Based [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total | 182,500 | 27,000 | 342,500 | 54,000 |
Stock Based [Member] | ||||
Related Party Transaction [Line Items] | ||||
Total | $ 850,804 | $ 1,506,836 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Apr. 09, 2021 | Aug. 12, 2020 | Aug. 02, 2020 | Jul. 15, 2020 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Aggregate annual compensation | $ 775,000 | ||||||
Eric Forman [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Professional fees | $ 12,000 | $ 24,000 | |||||
Director [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | 20,000 | ||||||
Chairman Of Audit Committee [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | 10,000 | ||||||
Chairman Of Other Committees [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | 5,000 | ||||||
Member Of Audit Committee [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | 5,000 | ||||||
Member Of Other Committees [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | $ 2,500 | ||||||
Employment Agreement [Member] | Dr. Kovach [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | $ 250,000 | 15,000 | 30,000 | ||||
Employment Agreement [Member] | Dr. James S. Miser, M.D [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | $ 150,000 | ||||||
Increase in annual salary | $ 175,000 | ||||||
Employment Agreement [Member] | Eric J. Forman [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | $ 120,000 | ||||||
Increase in annual salary | 175,000 | ||||||
Employment Agreement [Member] | Robert N. Weingarten [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | $ 120,000 | ||||||
Increase in annual salary | $ 175,000 | ||||||
Employment Agreement [Member] | Mr. Weingarten [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Compensatipon for non officer directors | $ 14,980 | $ 47,375 |
Schedule of Fair Value of Each
Schedule of Fair Value of Each Option Award Estimated Assumption (Details) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Risk-free interest rate | 0.89% |
Expected dividend yield | 0.00% |
Expected volatility | 198.79% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected life | 3 years 6 months |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected life | 3 years 7 months 6 days |
Summary of Stock-based Compensa
Summary of Stock-based Compensation Costs (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Discounted Future Net Cash Flows Relating to Proved Oil and Gas Reserves [Line Items] | ||||
Total stock-based compensation costs | $ 850,804 | $ 1,506,836 | ||
Related Parties [Member] | ||||
Discounted Future Net Cash Flows Relating to Proved Oil and Gas Reserves [Line Items] | ||||
Total stock-based compensation costs | 850,804 | 1,506,836 | ||
Non Related Parties [Member] | ||||
Discounted Future Net Cash Flows Relating to Proved Oil and Gas Reserves [Line Items] | ||||
Total stock-based compensation costs |
Summary of Stock Option Activit
Summary of Stock Option Activity Including Options Form of Warrants (Details) | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Number of shares, stock options outstanding, at the beginning | shares | 1,475,000 |
Weighted average exercise price, stock options outstanding, at the beginning | $ / shares | $ 4.136 |
Number of shares, Granted | shares | 1,200,000 |
Weighted average exercise price, granted | $ / shares | $ 3.048 |
Number of shares, Exercised | shares | (125,001) |
Weighted average exercise price, exercised | $ / shares | $ 0.808 |
Number of shares, Expired | shares | |
Weighted average exercise price, expired | $ / shares | |
Adjustment attributable to reverse stock split | shares | 1 |
Weighted average exercise price, reverse stock split | $ / shares | |
Number of shares, stock options outstanding, at the end | shares | 2,550,000 |
Weighted average exercise price, stock options outstanding, at the end | $ / shares | $ 3.787 |
Weighted average remaining contractual life (in years), stock options outstanding | 3 years 9 months 14 days |
Number of shares, stock options exercisable, at the end | shares | 1,650,000 |
Weighted average exercise price, stock options exercisable, at the end | $ / shares | $ 3.831 |
Weighted average remaining contractual life (in years), stock options exercisable | 3 years 2 months 26 days |
Schedule of Exercise Prices of
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details) | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options Outstanding (Shares) | 2,550,000 |
Options Exercisable (Shares) | 1,650,000 |
Exercise Price One [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 0.900 |
Options Outstanding (Shares) | 33,333 |
Options Exercisable (Shares) | 33,333 |
Exercise Price Two [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 1.200 |
Options Outstanding (Shares) | 83,333 |
Options Exercisable (Shares) | 83,333 |
Exercise Price Three [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 1.680 |
Options Outstanding (Shares) | 66,667 |
Options Exercisable (Shares) | 66,667 |
Exercise Price Four [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 2.800 |
Options Outstanding (Shares) | 250,000 |
Options Exercisable (Shares) | 125,000 |
Exercise Price Five [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3 |
Options Outstanding (Shares) | 666,667 |
Options Exercisable (Shares) | 666,667 |
Exercise Price Six [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3.030 |
Options Outstanding (Shares) | 500,000 |
Options Exercisable (Shares) | |
Exercise Price Seven [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3.200 |
Options Outstanding (Shares) | 250,000 |
Options Exercisable (Shares) | 125,000 |
Exercise Price Eight [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 3.210 |
Options Outstanding (Shares) | 200,000 |
Options Exercisable (Shares) | 200,000 |
Exercise Price Nine [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 6 |
Options Outstanding (Shares) | 166,667 |
Options Exercisable (Shares) | 166,667 |
Exercise Price Ten [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 6.600 |
Options Outstanding (Shares) | 50,000 |
Options Exercisable (Shares) | 50,000 |
Exercise Price Eleven [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 7.140 |
Options Outstanding (Shares) | 200,000 |
Options Exercisable (Shares) | 50,000 |
Exercise Price Twelve [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Prices | $ / shares | $ 12 |
Options Outstanding (Shares) | 83,333 |
Options Exercisable (Shares) | 83,333 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | May 11, 2021 | Apr. 09, 2021 | Jan. 06, 2021 | Aug. 12, 2020 | Aug. 01, 2020 | Jul. 15, 2020 | Jul. 14, 2020 | Jun. 20, 2007 | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option exercisable | 1,650,000 | 1,650,000 | 1,650,000 | ||||||||||
Stock option vested exercisable term | 5 years | 24 months | |||||||||||
Stock options are exercisable price per share | $ 3.21 | ||||||||||||
Fair value of stock options | $ 571,312 | ||||||||||||
Stock price per share | $ 2.8566 | ||||||||||||
Stock based compensation | $ 850,804 | $ 1,506,836 | |||||||||||
Total deferred compensation expense for outstanding value of unvested stock options | 2,791,000 | ||||||||||||
Intrinsic value of exercisable but unexercised in-the-money stock options | $ 362,251 | $ 362,251 | $ 362,251 | ||||||||||
Fair market value, per share | $ 3.03 | ||||||||||||
Outstanding stock options to acquire shares of common stock not vested | 900,000 | 900,000 | 900,000 | ||||||||||
DrWinson Sze Chun Ho [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||
Dr. Yun Yen [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||
DrStephen Forman [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||
Philip Palmedo [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option issued | 50,000 | ||||||||||||
MsRegina Brown [Member] | General and Administrative Expense [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock based compensation | $ 350,290 | $ 350,290 | |||||||||||
Eric Forman [Member] | General and Administrative Expense [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock based compensation | 24,985 | 49,695 | |||||||||||
Eric Forman [Member] | Employment Agreement [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock options granted to purchase common stock, issued | 58,333 | ||||||||||||
Stock options description | On July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman was granted 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 three months and six months ended June 30, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $24,985 and $49,695, respectively, with respect to these stock options. | ||||||||||||
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 | ||||||||||||
Dr. James Miser [Member] | General and Administrative Expense [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock based compensation | 35,693 | 70,993 | |||||||||||
Dr. James Miser [Member] | Employment Agreement [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock options granted to purchase common stock, issued | 83,334 | ||||||||||||
Stock options description | Dr. James S. 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 three months and six months ended June 30, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $35,693 and $70,993, respectively, with respect to these stock options. | ||||||||||||
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 | ||||||||||||
Robert N. Weingarten [Member] | General and Administrative Expense [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock based compensation | 24,985 | 49,695 | |||||||||||
Robert N. Weingarten [Member] | Employment Agreement [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock options granted to purchase common stock, issued | 58,333 | ||||||||||||
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 three months and six months ended June 30, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $24,985 and $49,695, respectively, with respect to these stock options. | ||||||||||||
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 | ||||||||||||
DrWinson Sze Chun Ho [Member] | General and Administrative Expense [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock based compensation | $ 414,851 | $ 414,851 | |||||||||||
DrWinson Sze Chun Ho [Member] | Employment Agreement [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Fair value of stock options | $ 753,611 | ||||||||||||
Stock price per share | $ 3.0144 | ||||||||||||
Stock options fully vested amount, fair value | $ 376,800 | ||||||||||||
Non Officer Directors [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option exercisable | 100,000 | 100,000 | 100,000 | 100,000 | |||||||||
Stock option vested exercisable term | 5 years | ||||||||||||
Stock options are exercisable price per share | $ 3.03 | $ 3.03 | $ 3.03 | ||||||||||
Fair value of stock options | $ 1,421,095 | ||||||||||||
Stock price per share | $ 2.84225 | ||||||||||||
Fair value of stock options | 500,000 | ||||||||||||
Director [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option issued | 200,000 | ||||||||||||
Director [Member] | MsRegina Brown [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option exercisable | 250,000 | 250,000 | |||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||
Stock options are exercisable price per share | $ 2.80 | ||||||||||||
Fair value of stock options | $ 658,363 | ||||||||||||
Stock price per share | $ 2.6335 | ||||||||||||
Stock options fully vested amount, fair value | $ 329,188 | ||||||||||||
Director [Member] | DrWinson Sze Chun Ho [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option exercisable | 250,000 | ||||||||||||
Stock option vested exercisable term | 5 years | ||||||||||||
Stock options are exercisable price per share | $ 3.20 | ||||||||||||
2007 Stock Compensation Plan [Member]. | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock options granted to purchase common stock, issued | 83,333 | ||||||||||||
2007 Stock Compensation Plan [Member]. | Maximum [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of restricted stock issued | 416,667 | ||||||||||||
2020 Stock Incentive Plan [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of fully vested option exercisable | 400,000 | 400,000 | 400,000 | ||||||||||
2020 Stock Incentive Plan [Member] | Maximum [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Number of restricted stock issued | 2,333,333 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | May 02, 2021 | Feb. 26, 2021 | Dec. 21, 2020 | Aug. 12, 2020 | Feb. 18, 2020 | Sep. 12, 2018 | Aug. 20, 2018 | Mar. 22, 2018 | Sep. 14, 2015 | Dec. 24, 2013 | Dec. 24, 2013 | Apr. 30, 2020 | Aug. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Loss Contingencies [Line Items] | |||||||||||||||||
Research and development costs | $ 262,415 | $ 117,946 | $ 705,941 | $ 212,618 | |||||||||||||
General and administrative costs | 1,470,180 | 255,443 | 2,751,834 | 547,928 | |||||||||||||
NDA Consulting Corp [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Agreement term | one-year periods | ||||||||||||||||
Consulting and advisory fee | $ 4,000 | 4,000 | 4,000 | 8,000 | 8,000 | ||||||||||||
City of Hope [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Aggregate commitments expected | 324,000 | 324,000 | |||||||||||||||
City of Hope [Member] | Health Care, Patient Service [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Aggregate commitments expected | 800,000 | 800,000 | |||||||||||||||
Collaboration Agreement [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Advance amount related to milestone payment | $ 24,171 | $ 87,471 | 0 | 43,411 | 24,171 | 43,411 | |||||||||||
Research and development costs | 155,053 | ||||||||||||||||
Collaboration Agreement [Member] | GEIS [Member]. | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Advance amount related to milestone payment | $ 43,411 | ||||||||||||||||
Aggregate commitments expected | 5,193,000 | 5,193,000 | |||||||||||||||
Collaboration Agreement [Member] | BioPharmaWorks LLC [Member]. | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Consulting and advisory fee | $ 10,000 | ||||||||||||||||
Reimbursed expense | 30,000 | 30,000 | 60,000 | 60,000 | |||||||||||||
Collaboration Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Advance amount related to milestone payment | 10,309 | 11,698 | 17,693 | 25,364 | |||||||||||||
Research and development costs | $ 103,927 | ||||||||||||||||
Clinical Trial Agreement [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
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 $5,798,000 as of June 30, 2021, consisting of approximately $5,193,000 relating to the GEIS clinical trial and approximately $605,000 relating to the Moffit clinical trial, which are expected to be incurred over approximately the next five years through December 31, 2025. | ||||||||||||||||
Aggregate commitments expected | 5,798,000 | $ 5,798,000 | |||||||||||||||
Clinical Trial Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Aggregate commitments expected | 605,000 | 605,000 | |||||||||||||||
Clinical Trial Agreement [Member] | City of Hope [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Advance amount related to milestone payment | 69,001 | 309,509 | |||||||||||||||
Research and development costs | 309,509 | ||||||||||||||||
Aggregate commitments expected | 2,433,000 | 2,433,000 | |||||||||||||||
Other Clinical Agreements [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Aggregate commitments expected | 371,000 | 371,000 | |||||||||||||||
Other Clinical Agreements [Member] | Minimum [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Research and development costs | 737,000 | ||||||||||||||||
Work Order Agreement [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Research and development costs | 90,636 | ||||||||||||||||
Aggregate commitments expected | 873,000 | 873,000 | |||||||||||||||
Work Order Agreement [Member] | City of Hope [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Advance amount related to milestone payment | 10,773 | 14,313 | |||||||||||||||
Aggregate commitments expected | 14,313 | 14,313 | |||||||||||||||
Work Order Agreement [Member] | Theradex Systems, Inc. [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Research and development costs | $ 954,000 | 7,540 | $ 5,790 | 8,481 | 11,476 | ||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Maximum [Member] | Development Milestones [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Milestone payments | $ 1,750,000 | ||||||||||||||||
Material Transfer Agreement [Member] | INSERM [Member] | Maximum [Member] | Commercial Milestones [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Milestone payments | $ 6,500,000 | ||||||||||||||||
Exclusive License Agreement [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Amount charges to operations | $ 6,233 | 6,233 | 12,397 | $ 12,398 | |||||||||||||
Exclusive License Agreement [Member] | First Four Years [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Minimum payments for royalties | 50,000 | ||||||||||||||||
Exclusive License Agreement [Member] | Five Years And Thereafter [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Minimum payments for royalties | 100,000 | ||||||||||||||||
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
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] | Dr. John Kovach [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Annual salary | $ 640,000 | ||||||||||||||||
Employment Agreement [Member] | Dr.James [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Annual compensation | $ 775,000 | ||||||||||||||||
Master Service Agreement [Member] | Foundation for Angelman Syndrome Therapy [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Percentage of proceeds agree to pay under agreement | 5.00% | ||||||||||||||||
Maximum amount received under agreement | $ 250,000 | ||||||||||||||||
Service Agreement [Member] | IRTH Communications, LLC [Member] | |||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||
Consulting and advisory fee | $ 7,500 | ||||||||||||||||
Stock options grant date fair value | $ 100,000 | ||||||||||||||||
General and administrative costs | $ 22,500 | $ 45,000 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Jul. 14, 2021 | Mar. 02, 2021 | Jan. 06, 2021 |
Subsequent Event [Line Items] | |||
Stock issued new issue share | 1,133,102 | ||
Share price | $ 2.8566 | ||
Subsequent Event [Member] | Officer And Directors [Member] | |||
Subsequent Event [Line Items] | |||
Stock issued new issue share | 83,333 | ||
Share price | $ 1.20 | ||
Proceeds from stock options exercised | $ 100,000 |