Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 13, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | ADIAL PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001513525 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2019 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 10,242,449 | |
Entity File Number | 001-38323 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and cash equivalents | $ 10,254,023 | $ 3,869,043 |
Prepaid research and development | 271,687 | 505,960 |
Prepaid expenses and other current assets | 155,207 | 317,547 |
Total Current Assets | 10,680,917 | 4,692,550 |
Intangible assets - net | 6,452 | 6,735 |
Total Other Assets | 6,452 | 6,735 |
Total Assets | 10,687,369 | 4,699,285 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 626,553 | 257,974 |
Total Current Liabilities | 626,553 | 257,974 |
Commitments and contingencies | ||
Shareholders’ Equity | ||
Preferred Stock, 5,000,000 shares authorized with a par value of $0.001 per share, 0 shares outstanding at June 30, 2019 and December 31, 2018 | ||
Common Stock, 50,000,000 shares authorized with a par value of $0.001 per share, 10,242,449 and 6,862,499 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 10,242 | 6,863 |
Additional paid in capital | 26,903,002 | 16,469,818 |
Accumulated deficit | (16,852,428) | (12,035,370) |
Total Shareholders’ Equity | 10,060,816 | 4,441,311 |
Total Liabilities and Shareholders’ Equity | $ 10,687,369 | $ 4,699,285 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 10,242,449 | 6,862,499 |
Common stock, shares outstanding | 10,242,449 | 6,862,499 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating Expenses: | ||||
Research and development expenses | $ 1,210,436 | $ 76,895 | $ 1,897,350 | $ 132,403 |
General and administrative expenses | 948,574 | 1,664,572 | 2,510,926 | 1,948,577 |
Total Operating Expenses | 2,159,010 | 1,741,467 | 4,408,276 | 2,080,980 |
Loss From Operations | (2,159,010) | (1,741,467) | (4,408,276) | (2,080,980) |
Other Income (Expense) | ||||
Interest income | 24,603 | 32,981 | ||
Gain on debt extinguishments | 12,241 | |||
Warrant modification expense | (441,763) | |||
Interest expense and financing charges | (50,889) | (102,567) | ||
Total other income (expense) | 24,603 | (50,889) | (408,782) | (90,326) |
Loss Before Provision For Income Taxes | (2,134,407) | (1,792,356) | (4,817,058) | (2,171,306) |
Provision for income taxes | ||||
Net Loss | $ (2,134,407) | $ (1,792,356) | $ (4,817,058) | $ (2,171,306) |
Net loss per share, basic and diluted | $ (0.21) | $ (0.50) | $ (0.52) | $ (0.64) |
Weighted average shares, basic and diluted | 10,223,704 | 3,557,102 | 9,241,828 | 3,413,352 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) | Common Stock | Additional Paid In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2017 | $ 3,268,005 | $ (596,829) | $ (403,992) | $ (997,553) |
Balance, shares at Dec. 31, 2017 | 3,268 | |||
Equity-based compensation - stock option expense | 69,161 | 69,161 | ||
Net Loss | (378,950) | (378,950) | ||
Balance at Mar. 31, 2018 | $ 3,268 | (527,668) | 782,942 | (1,307,342) |
Balance, shares at Mar. 31, 2018 | 3,268,005 | |||
Equity-based compensation - stock granted for Performance Bonus Plan cancellation | $ 292 | 1,461,253 | 1,461,545 | |
Equity-based compensation - stock granted for Performance Bonus Plan cancellation, Shares | 292,309 | |||
Equity-based compensation - stock option expense | 69,636 | 69,636 | ||
Senior Note Beneficial Conversion Feature | 52,050 | 52,050 | ||
Warrant Issue with senior note | 222,950 | 222,950 | ||
Net Loss | (1,792,356) | (1,792,356) | ||
Balance at Jun. 30, 2018 | $ 3,560 | 1,278,221 | (2,575,298) | (1,293,517) |
Balance, shares at Jun. 30, 2018 | 3,560,314 | |||
Balance at Dec. 31, 2018 | $ 6,863 | 16,469,818 | (12,035,370) | 4,441,311 |
Balance, shares at Dec. 31, 2018 | 6,862,499 | |||
Equity-based compensation - stock option expense | 129,150 | 129,150 | ||
Equity-based compensation - stock issuances to consultants | $ 94 | 154,750 | 154,854 | |
Equity-based compensation - stock issuances to consultants, Shares | 93,750 | |||
Warrant modification expense | 441,763 | 441,763 | ||
Sale of Common Stock & Warrants | $ 2,845 | 9,243,404 | 9,246,249 | |
Sale of Common Stock & Warrants, shares | 2,845,000 | |||
Offering Issuance Cost | (1,050,576) | (1,050,576) | ||
Exercise of warrants | $ 367 | 1,050,270 | 1,050,637 | |
Exercise of warrants, shares | 367,577 | |||
Net Loss | (2,682,651) | (2,682,651) | ||
Balance at Mar. 31, 2019 | $ 10,169 | 26,438,589 | (14,718,021) | 11,730,737 |
Balance, shares at Mar. 31, 2019 | 10,168,826 | |||
Equity-based compensation - stock option expense | 310,210 | 310,210 | ||
Equity-based compensation - stock issuances to consultants | $ 69 | 154,181 | 154,250 | |
Equity-based compensation - stock issuances to consultants, Shares | 68,750 | |||
Exercise of warrants | $ 4 | 22 | 26 | |
Exercise of warrants, shares | 4,873 | |||
Net Loss | (2,134,407) | (2,134,407) | ||
Balance at Jun. 30, 2019 | $ 10,242 | $ 26,903,002 | $ (16,852,428) | $ 10,060,816 |
Balance, shares at Jun. 30, 2019 | 10,242,449 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (4,817,058) | $ (2,171,306) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Equity-based compensation | 748,464 | 1,600,342 |
Non-cash warrant modification expense | 441,763 | |
Amortization of intangible assets | 283 | 281 |
Amortization of debt discounts | 60,993 | |
Loss (gain) on debt extinguishments | (12,241) | |
Changes in operating assets and liabilities: | ||
Prepaid research and development expenses | 234,273 | |
Prepaid expenses and other current assets | 162,340 | (21,044) |
Accounts payable and accrued expenses | 368,579 | 139,753 |
Net cash used in operating activities | (2,861,356) | (403,222) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from Senior Note | 275,000 | |
Net proceeds from sale of equity | 8,195,673 | |
Proceeds from Senior Secured Notes, including related party | 410,000 | |
Repayment of Senior Secured Bridge Note | (150,000) | |
Proceeds of warrant exercises | 1,050,663 | |
Net cash provided by financing activities | 9,246,336 | 535,000 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 6,384,980 | 131,778 |
CASH AND CASH EQUIVALENTS-BEGINNING OF PERIOD | 3,869,043 | 18,248 |
CASH AND CASH EQUIVALENTS-END OF PERIOD | 10,254,023 | 150,026 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||
Interest paid | ||
Income taxes paid | ||
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Issuance of warrants for financing costs classified as debt discount | 222,950 | |
Issuance of beneficial conversion discount on convertible notes payable | 52,050 | |
Exchange of Subordinated notes in the amount of $115,639 for Senior secured notes | $ 100,000 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Statement of Cash Flows [Abstract] | |
Senior secured notes | $ 115,639 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | 1 — DESCRIPTION OF BUSINESS Adial Pharmaceuticals, Inc. (the "Company" or "Adial") was converted from a limited liability company formed under the name ADial Pharmaceuticals, LLC on November 23, 2010 in the Commonwealth of Virginia to a corporation and reincorporated in Delaware on October 1, 2017. Adial is presently engaged in the development of medications for the treatment of addictions and related disorders. The Company is planning to commence its first Phase 3 clinical trial of its lead compound AD04 ("AD04") for the treatment of alcohol use disorder. Both the U.S. Food and Drug Administration ("FDA") and the European Medicines Authority ("EMA") have indicated they will accept heavy-drinking-based endpoints as a basis for approval for the treatment of alcohol use disorder rather than the previously required abstinence-based endpoints. Key patents have been issued in the United States, the European Union, and other jurisdictions for which the Company has exclusive license rights. The active ingredient in AD04 is ondansetron, a serotonin-3 antagonist. Due to its mechanism of action, AD04 has the potential to be used for the treatment of other addictive disorders, such as opioid use disorder, obesity, smoking, and other drug addictions. In July 2018, the Company raised proceeds of approximately $6.3 million in an initial public offering (the "IPO") of common stock and warrants, net of offering expenses. On July 27, 2018, the shares of common stock and offering warrants began trading on the Nasdaq Capital Market under the symbols "ADIL" and "ADILW", respectively. In February 2019, the Company raised proceeds of approximately $8.2 million in a follow-on underwritten public offering (the "Follow-on Offering") of shares of common stock and warrants, net of offering expenses. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Liquidity and Other Uncertainties The unaudited condensed financial statements have been prepared in conformity with generally accepted accounting principles ("GAAP"), which contemplate continuation of the Company as a going concern. The Company is in a development stage and has not generated any revenues. The Company had an accumulated deficit of approximately $16.8 million and $12.0 million as of June 30, 2019 and December 31, 2018, respectively, and had incurred net losses of approximately $4.8 million and $2.2 million, for the six months ended June 30, 2019 and 2018, respectively. Based on the current development plans for AD04 in both the U.S. and foreign markets and the Company's other operating requirements, management believes that the existing cash at June 30, 2019 will be sufficient to fund operations for at least the next twelve months following the issuance of these financial statements. However, while the Company's existing cash is sufficient to fund the Company's operations over the next twelve months, the Company continues to face significant uncertainly as to its longer term liquidity needs, which depend upon a number of factors, including, but not limited to, trial costs, the time required to complete planned trials, and the use of cash in pursuit of non-dilutive funding sources and the success or failure of such pursuit. The Company's longer term, continued operations will depend on its ability to raise additional capital through equity and/or debt financings, grant funding, strategic relationships, or out-licensing of its products in order to complete its current clinical trial and the subsequent research and development requirements for its lead compound, AD04. Generally, the Company's operations are subject to a number of uncertainties which can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company's product candidates; the ability to obtain regulatory approval to market the Company's products; the ability to manufacture the Company's products successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the ability to raise capital to support its operations. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2018, included in the Annual Report on Form 10-K filed on February 19, 2019. Use of Estimates The preparation of unaudited condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include the valuation of equity-based compensation, intangible assets useful life, clinical trial expense recognition, and contingent liabilities. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these condensed financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes. Basic and Diluted Earnings (Loss) per Share Basic and diluted earnings (loss) per share are computed based on the weighted-average outstanding shares of stock, which are all voting shares. Common stock equivalents consist of outstanding warrants and options. Stock equivalents of warrants to purchase approximately 6,723,240 common shares and 1,400,967 common shares to be issued upon exercise of options outstanding on June 30, 2019, and stock equivalents of warrants to purchase approximately 782,555 common shares to be issued upon exercise of 174,282 options outstanding were all excluded from the computation of diluted earnings (loss) per share for the three months ended June 30, 2018, because their effect on the loss per share is anti-dilutive. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company's cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. At June 30, 2019, the Company held a balance in a checking and a money market account that exceeded federally insured limits by approximately $10.0 million. These same accounts exceeded federally insured limits by approximately $3.6 million on December 31, 2018. The Company maintains an investment brokerage account for the purposes of investing its cash in accordance with its investment policy. At June 30, 2019, the cash balance of this account did not exceed Securities Investor Protection Corporation limits. Intangible Assets Intangible assets consist primarily of the trademarks and copyrights. The trademarks and copyrights will be amortized using the straight-line method based on an estimated useful life of 20 years. Impairment of Long-Lived Assets The Company's long-lived assets (consisting primarily of trademarks) are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the undiscounted future net cash flows expected to be generated by that asset. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Research and Development Research and development costs are charged to expense as incurred. Research and development expenses includes fees associated with direct trial expenses such as fees due to contract research organizations, consultants supporting the Company's research and development endeavors, the acquisition of certain technology rights, and compensation of clinical development personnel. Equity-Based Compensation The Company measures the cost of awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the employee was required to provide service in exchange for the entire award. The fair value of options is calculated using the Black-Scholes option pricing model, based on key assumptions such as the fair value of shares of common stock, expected volatility, and expected term. The Company's estimates of these assumptions are primarily based on historical data, peer company data and the judgment of management regarding future trends. Income Taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and tax carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. See Note 9. Fair Value of Financial Instruments and Fair Value Measurements The fair value of financial instruments held by the Company are disclosed using the three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements. The carrying amounts reported in the balance sheets for current assets and liabilities are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization. The carrying value of all other financial liabilities at cost approximates fair value. The three levels of valuation hierarchy are defined as follows: ● Level 1: Observable inputs such as quoted prices in active markets; ● Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and ● Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Recent Accounting Pronouncements Leases — Earnings per Share, Distinguishing Liabilities from Equity, and Derivatives and Hedging Fair Value Fair Value |
Intangible Assets, Net
Intangible Assets, Net | 6 Months Ended |
Jun. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS, NET | 3 — INTANGIBLE ASSETS, NET Intangible assets, net consist of the following: Useful June 30, December 31, Trademarks and Copyrights 20 years $ 11,300 $ 11,300 Less: Accumulated amortization (4,848 ) (4,565 ) Intangible Assets, net $ 6,452 $ 6,735 Amortization of trademarks and copyrights amounted to $283 and $281 for the six months ended June 30, 2019 and 2018, respectively. At June 30, 2019, the future remaining amortization periods for trademarks and copyrights are approximately 12 years. |
Senior Secured Notes
Senior Secured Notes | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
SENIOR SECURED NOTES | 4 — SENIOR SECURED NOTES Senior Secured Bridge Note Effective May 1, 2017, the Company entered into a senior secured bridge note financing with a third party investment fund (the "Senior Holder") for the original principal sum of $287,500 (the "Senior Secured Bridge Note") of which $250,000 was received as proceeds and $37,500 was recorded as original issue discount. The interest on the principal amount was at the rate of two percent per annum. The maturity date at issue was November 1, 2017, at which time the principal and accrued and unpaid interest and other fees therein, was due and payable. The Senior Secured Bridge Note was secured by all the assets held by the Company. On February 22, 2018, the Company executed a settlement agreement with the Senior Holder, paying $150,000 at time of execution of the settlement and agreement to pay an additional $100,000 and issue a number of shares of common stock and warrants to purchase shares of common at the Company's next financing. On July 31, 2018, on completion of the IPO and as required under the terms of the settlement agreement, the Company made a cash payment of $100,000 to the holder of the Senior Secured Bridge Note and issued 10,020 shares of common stock and warrants to purchase 65,130 shares of common stock at an exercise price of $4.99 per share. The net loss on extinguishment of the Senior Secured Bridge Note was $97,593. Interest expense on the Senior Secured Note during the six months ended June 30, 2018 was $23,363. Senior Secured Notes (Related Parties $470,000) On February 22, 2018 and March 1, 2018, the Company entered Security Purchase Agreements to issue Secured Notes (the "Secured Notes") to a number of Company directors and a consultant in the aggregate principal amount of $510,000. The Secured Notes ranked pari passu On July 31, 2018, upon the consummation of the IPO and as required by the terms of the Secured Notes, the principal and interest outstanding of the Secured Notes was paid in full and 408,000 units (376,000 units to related parties), each unit consisting of a share of common stock and a warrant to purchase of a share of common stock at an exercise price of $6.25 per share and 408,000 Unit Warrants (376,000 Unit Warrants to related parties) were issued, as a result of which the obligation of the Company with respect to Senior Secured Notes were fully satisfied. The loss on extinguishment of the Secured Notes was $3,399,902. For the six months ended June 30, 2018, interest expense on the Senior Secured Notes was $30,255. Senior Note On June 3, 2018, the Company entered into a Security Purchase Agreement pursuant to which it issued a note in the principal amount of $325,000 to one accredited institutional investor (the "June 2018 Senior Note"). The June 2018 Senior Note ranked pari passu On December 19, 2018, the holder of the June 2018 Senior Note elected to convert the entire outstanding principal of $325,000 into shares of common stock at the conversion price of $2.00 per share, as a result of which the Company issued to the holder 162,500 shares of common stock and the Company's obligations under the June 2018 Senior Note were fully satisfied. At the time of conversion the amortization of the remaining discounts to the June 2018 Senior Note was accelerated and recognized as interest expense of $186,397. For the six months ended June 30, 2018, amortization of discounts was $28,676. |
Subordinated Notes - Related Pa
Subordinated Notes - Related Parties | 6 Months Ended |
Jun. 30, 2019 | |
Subordinated Notes - Related Parties [Abstract] | |
SUBORDINATED NOTES - RELATED PARTIES | 5 — SUBORDINATED NOTES — RELATED PARTIES On November 20, 2017, the Company entered into subordinated notes (the "Subordinated Notes"), subordinate to the Senior Secured Bridge Note, with certain insiders, including directors and a consultant, (the "Subordinated Holders") in the aggregate principal amount of $115,000, of which $100,000 was received as proceeds and $15,000 was recorded as original issue discount. In addition, upon repayment, the Subordinated Holders were to receive a number of warrants to purchase shares of common stock. On February 22, 2018 the Subordinated Holders settled the Subordinated Notes for newly issued Secured Notes in the principal amount of $100,000, in full and complete satisfaction of the all obligations, including the principal sum of the Subordinated Notes, all accrued and unpaid interest thereon, and warrant issuance obligations. As a result of the settlement of these securities for newly issued Secured Notes, no stock or warrants were issued as a result of these provisions of the Subordinated Notes. For the six months ended June 30, 2018, interest expense on the note was $435 and amortization of debt discount was $8,287. |
Convertible Notes - Related Par
Convertible Notes - Related Parties | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE NOTES - RELATED PARTIES | 6 — CONVERTIBLE NOTES — RELATED PARTIES In September and December, 2016, the Company issued convertible notes (the "2016 Convertible Notes") with an outstanding unsecured principal amount of $235,000 to its members, including directors and officers. The principal and interest was originally due in 2029, and the 2016 Convertible Notes bore interest at a rate of 15% per annum. The 2016 Convertible Notes were to automatically convert to common stock in the event the Company issued and sold either common or preferred stock of $2,000,000 or more, excluding the value of the conversion of the 2016 Convertible Notes. On July 31, 2018, as a result of the completion of the IPO and as required under the terms of the 2016 Convertible Notes, the outstanding principal and accrued interest on the 2016 Convertible Notes was converted to 700,854 shares of common stock and 700,845 warrants to purchase shares of common stock at an exercise price of $6.25 per share, of which 395,118 share of common stock and 395,118 warrants to purchase shares of common stock at an exercise price of $6.25 per share were issued to related parties. The interest expense on the Convertible Notes was $22,525 for the six months ended June 30, 2018. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2019 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | 7 — RELATED PARTY TRANSACTIONS In January 2011, the Company entered into an exclusive, worldwide license agreement with The University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group (the "UVA LVG") for rights to make, use or sell licensed products in the United States based upon patents and patent applications made and held by UVA LVG (the "UVA LVG License"). The Company is required to pay compensation to the UVA LVG, as described Note 10. A certain percentage of these payments by the Company to the UVA LVG may then be distributed to the former Chairman of the Board who currently serves as the Company's Chief Medical Officer in his capacity as inventor of the patents by the UVA LVG in accordance with their policies at the time. On January 29, 2018, the Company entered a Medical Translations services agreement with Medico-Trans Company, LLC ("MTC"), a company under the control of the former Chairman of the Board who currently serves as the Company's Chief Medical Officer, whereby MTC agreed to perform $67,304 in medical translation services, to be paid on occurrence of a qualified financing of $2,000,000 or more; or, in the event that a qualified financing had not taken place by February 10, 2018, for installment payments of $22,000 on February 10, 2018, $22,000 on March 10, 2018, and the remaining balance on April 10, 2018, and to issue to MTC on consummation of a qualified financing a number of shares of common stock equal to $201,911 divided by the price per share of the qualified financing. The Company made $68,540 in payments to MTC, paying the entire balance and accrued interest thereon. Of these payments, $51,540 were in cash, and the remaining $17,000 payment was converted to the principal balance of a Secured Note (see Note 4). On consummation of the IPO, MTC was issued 40,463 shares of common stock, as required under the terms it the agreement. On February 22, 2018, the Company executed a Backstop Commitment Agreement ("BCA") with MVA 151 Investors, LLC ("MVA"), a company controlled by a Company director, Kevin Schuyler, pursuant to which MVA agreed to guarantee the purchase of up to $242,000 ("the Backstop Amount") in the principal amount of Secured Notes then offered for subscription and unsubscribed on March 1, 2018 (the "Backstop Commitment"). In consideration of this backstop commitment, at such time as the Company completed the Next Financing, the Company agreed to issue MVA (i) warrants to purchase a number of shares of the Company's common stock equal to 150% of the Backstop Amount divided by the price per share of the Next Financing and (ii) a number of units of Company common stock equal to 50% of the Backstop Amount divided by the price per share of the Next Financing. The warrants were to have an exercise price equal to the price per share of the Next Financing and a term of five years. On March 1, MVA invested $92,000 in Secured Notes as a result of the BCA, this amount being the $242,000 backstop amount less $150,000 in additional subscriptions received between February 22, 2018 and March 1, 2018. This investment fully satisfied the Backstop Commitment and left MVA with no further associated obligation to invest. At the time of the IPO, the Company issued MVA 151 24,200 shares of common stock, warrants to purchase 24,200 shares of common stock at an exercise price of $6.25, and warrants to purchase 72,600 units (each unit consisting of a share of common stock and a warrant to purchase a share of common stock at an exercise price of $6.25) at an exercise price of $5.00 per unit. The total cost of the issuances made as a result of the backstop agreement was $385,181, included in the net loss recognized on the Secured Notes. On April 25, 2016, the Company entered into a Consulting Agreement with a consultant, who now serves as the Company's Chief Operating Officer and Chief Financial Officer. For the period ended June 30, 2018 , total fees charged by this consultant were $25,600. Effective July 25, 2018, this consultant was employed as COO/CFO under the terms of an employment agreement that superseded the consulting agreement. On July 31, 2018, the Company completed its IPO and issued units, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock. Related parties that participated in this offering included: (i) William Stilley, the CEO, who purchased 80,000 units consisting of 80,000 shares of common stock and warrants to purchase 80,000 shares of common stock at an exercise price of $6.25 per share; (ii) Kevin Schuyler, Vice Chairman of the Board of Directors and Lead Independent Director, who purchased 90,000 units consisting of 90,000 shares of common stock and warrants to purchase 90,000 shares of common stock at an exercise price of $6.25 per; (iii) James Newman, a director, who purchased 10,000 units, consisting of 10,000 shares of common stock and warrants to purchase 10,000 shares of common stock at an exercise price of $6.25 per share, personally and 10,000 units, consisting of 10,000 shares of common stock and warrants to purchase 10,000 shares of common stock at an exercise price of $6.25 per share though a Roth IRA for his benefit; (iv) Bankole Johnson, the then Chairman of the Board who currently serves as the Company's Chief Medical Officer, who purchased 1,400 units consisting of 1,400 shares of common stock and warrants to purchase 1,400 shares of common stock at an exercise price of $6.25 per share; (v) Keller Enterprises LLC, an affiliate of Robertson Gilliland, a director, which purchased 14,000 units consisting of 14,000 shares of common stock and warrants to purchase 14,000 shares of common stock at an exercise price of $6.25 per share; (vi) Tony Goodman, a director, who purchased 7,000 units consisting of 7,000 shares of common stock and warrants to purchase 1,400 shares of common stock at an exercise price of $6.25 per share. See Notes 4, 5, and 6 for related party debt transactions. See Note 10 for related party consulting agreement. See Note 11 for a related party Master Services Agreement entered into in the period subsequent to the six months ended June 30, 2019. |
Shareholders' Deficit
Shareholders' Deficit | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
SHAREHOLDERS’ DEFICIT | 8 — SHAREHOLDERS' DEFICIT Equity Issuances/Repurchases On April 1, 2018, the Company issued 292,309 shares of common stock to Company officers and a director in compensation for termination, by mutual agreement of the Performance Bonus Plan. At the time of this issuance, the company recognized an equity-based compensation expense of $1,461,545. During the first six months of 2019, 93,100 previously-registered shares of common stock were issued as a result of the exercise of tradeable warrants to purchase 93,100 shares of common stock at an exercise price of $6.25 per share for cash payments of $581,875 and 7,039 unregistered shares of common stock were issued as a result of the exercise of warrants to purchase 7,039 shares of common stock at an exercise price of $0.005 per share for cash payments of $38. On January 22, 2019, the Company issued 250,000 unregistered shares of common stock upon the exercise of the warrant to purchase 300,000 shares of common stock at an exercise price of $3.75 per share for a cash payment of $468,750 and the cashless exercise of the remaining warrant. On January 31, 2019, the Company issued 22,311 unregistered shares of common stock upon the full cashless exercise of a warrant to purchase 65,130 shares of common stock at an exercise price of $4.99 per share. On February 22, 2019, the Company concluded the Follow-on Offering of 2,475,000 shares of common stock and warrants to purchase 1,856,250 shares of common stock at an exercise price of $4.0625 per share. The shares of common stock and accompanying warrants were sold to the public at a price of $3.25 per share and warrant. The underwriters were granted an over-allotment option to purchase up to 371,250 shares of common stock and warrant to purchase 278,437 shares of common stock at a price of $3.25 per share of common stock and warrant. The underwriters partially exercised their over-allotment option by purchasing 370,000 shares of common stock and warrants to purchase 277,500 shares common stock. Gross proceeds of the offering, totaled $9,246,249, which after offering expenses, resulted in net proceeds of $8,195,673. During the six months ended June 30, 2019, the Company issued 162,500 shares of common stock to consultants for services rendered at a total cost of $309,104 and $154,250 for the six months and three months ended June 30, 2019, respectively. Stock Options The following table provides the activity in options for the respective periods: Total Options Outstanding Weighted Average Remaining Term (Years) Weighted Average Exercise Price Weighted Average Fair Value at Issue Outstanding December 31, 2017 174,282 9.50 5.70 4.84 Issued 68,900 10.00 $ 2.80 $ 2.21 Outstanding December 31, 2018 243,182 8.93 $ 4.88 $ 4.09 Issued 1,173,000 10.00 3.31 2.56 Cancelled (15,215 ) 8.26 5.70 4.23 Outstanding June 30, 2019 1,400,967 9.62 3.55 2.81 Outstanding June 30, non-vested 1,177,732 9.63 $ 3.39 $ 2.61 All 1,173,000 options issued during the six months ended June 30, 2019 were issued under the 2017 equity incentive plan, under which 508,100 options remain issuable at June 30, 2019. At June 30, 2019, the total intrinsic value of the outstanding options was $0. The Company used the Black Scholes valuation model to determine the fair value of the options issued, using the following key assumptions for the six months ended June 30, 2019 and year ended December 31, 2018: Q2 2019 2018 Fair Value per Share $ 3.01-3.39 $ 2.80 Expected Term 6.5 years 6.5 years Expected Volatility 97.37-97.48 % 95.77 % Risk free rate 2.32-2.51 % 2.79 % Compensation expense associated with issuance of options was recognized using the straight line method over the requisite service period, which is the implied service period. During the six months ended June 30, 2019 and 2018, total equity-based compensation expense from the options issued was $439,360 and $138,797, respectively, which were classified as R&D and G&A expense as presented in the table below. As of June 30, 2019, $3,007,155 in further compensation expense resulting from issued options remained to be recognized over a weighted average remaining service period of 2.49 years. The components of stock-based compensation expense included in the Company's Statements of Operations for the six months ended June 30, 2019 and 2018 are as follows: Six Months ended June 30 2019 2018 Research and development Options Expense 141,703 - Total research and development expenses 141,703 - General and administrative Options Issuance Expense 297,657 138,797 Stock issued granted for Performance Bonus Plan cancellation - 1,461,545 Stock issued to consultants 309,104 - Total general and administrative expenses 606,761 1,600,342 Total stock-based compensation expense $ 748,464 $ 1,600,342 Stock Warrants On February 22, 2019, the Company issued 2,133,750 warrants for the purchase of 2,133,750 shares common stock at an exercise price of $4.0625 per share of common stock on the conclusion of its Follow-on Offering. See Equity Issuances/Repurchases above. The following table provides the activity in warrants for the respective periods. Total Warrants Weighted Average Remaining Term (Years) Weighted Average Exercise Price Average Intrinsic Value Outstanding December 31, 2017 482,555 11.20 5.51 1.38 Issued 4,547,204 5.00 5.82 0.00 Cancelled – NA NA NA Exercised (25,000 ) 4.59 6.25 0.06 Outstanding December 31, 2018 5,054,759 5.13 $ 5.79 0.61 Issued 2,133,750 5.00 4.06 0.00 Cancelled – NA NA NA Exercised 465,269 4.39 4.54 1.29 Outstanding June 30, 2019 6,723,240 4.67 5.33 0.03 During the six months ended June 30, 2019, warrants to purchase 93,100 shares of common stock with an exercise price of $6.25 per share of common stock were exercised for $581,875, warrants to purchase 125,000 shares of common stock with an exercise price of $3.75 per share of common stock were exercised for $468,750, 7,039 warrants to purchase 7,039 shares of common stock with an exercise price of $0.005 per share of common stock were exercised for $38, and 240,130 warrants were exercised on a cashless basis for the issue of 147,311 shares of common stock. The total received in exercise fees for exercise of warrants was $1,050,663, resulting in the issue of a total of 372,450 shares of common stock on the exercise of 465,269 warrants, of which 372,169 shares of common stock were unregistered at the time of issuance. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 9 — INCOME TAXES The Company has a net operating loss carry-forward for federal and state tax purposes of approximately $11.3 million at June 30, 2019, that is potentially available to offset future taxable income. The 20-year limitation was eliminated for losses generated after January 1, 2018, giving the taxpayer the ability to carry forward losses indefinitely. However, NOL carry forward arising after January 1, 2018, will now be limited to 80 percent of taxable income. For financial reporting purposes, no deferred tax asset was recognized because management estimated, at June 30, 2019 and December 31, 2018, that it was more likely than not that substantially all of the net operating losses would remain unused through a change in control. The timing and manner in which we can utilize our net operating loss carryforward and future income tax deductions in any year may be limited by provisions of the Internal Revenue Code regarding the change in ownership of corporations. Such limitation may have an impact on the ultimate realization of our carryforwards and future tax deductions. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 10 — COMMITMENTS AND CONTINGENCIES License with University of Virginia Patent Foundation In January 2011, the Company entered into an exclusive, worldwide license agreement with (the “UVA LVG”) for rights to make, use or sell licensed products in the United States based upon the ten separate patents and patent applications made and held by UVA LVG. As consideration for the rights granted in the UVA LVG License, the Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense itself. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income. The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if the Company breaches its obligations thereunder, including failing to make any milestone, the most immediate being initiating Phase 3 clinical trials by December 31, 2019, making required payments or the failure to exercise diligence to bring licensed products to market. In the event of a termination, the Company will be obligated to pay all amounts that accrued prior to such termination. The term of the license continues until the expiration, abandonment or invalidation of all licensed patents and patent applications, and following any such expiration, abandonment or invalidation will continue in perpetuity on a royalty-free, fully-paid basis. The Company executed an amendment, dated December 14, 2017, to the license agreement. This amendment changed the dates by which the Company, using commercially reasonable efforts, was to achieve the goals of submitting a New Drug Application to the FDA for a licensed product to December 31, 2024 (from December 31, 2023) and commencing commercialization of an FDA approved product by December 31, 2025 (from December 31, 2024). If the Company were to fail to use commercially reasonable effort and fail to meet either goal, the licensor would have the right to terminate the license. The Company executed a further amendment to the license agreement, dated December 18, 2018, changing the date at which the Company must have initiated a Phase 3 trial to December 31, 2019. At December 31, 2018, the Company had accrued $40,000 in minimum royalties due under this agreement, which were subsequently paid. At June 30, 2019, the Company had accrued $20,000 in minimum royalties. Crown CRO Master Services Agreement & Service Order On October 31, 2018, the Company entered into a master services agreement (“MSA”) with Crown CRO Oy (“Crown) for contract clinical research and consulting services. The MSA has a term of five years, automatically renewed for two year periods, unless either party gives written notice of a decision not to renew the agreement three months prior to automatic renewal. The agreement can be terminated by the Company if, in the Company’s reasonable opinion, clinical or non-clinical data support termination of the clinical research for safety reasons. On November 16, 2018, the Company and Crown entered into Service Agreement 1 under the MSA for a 24 week, multi-centered, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical study of the Company’s lead compound, AD04. The MSA or a service agreement under it may be terminated by the Company, without penalty, on fourteen days written notice. On June 28, 2019, the Company and Crown Executed a change order to Service Agreement 1 increasing Crown’s fee from $3,363,308 (€2,958,835 converted to dollars at the Euro/US Dollar exchange rate of 1.1367 as of June 30, 2019, as are all other Euro-denominated amounts below) to $3,602,083 (€3,168,895) and rescheduling future milestone payments as shown below. On November 21, 2018, the Company made the prepayment under the agreement, at a cost of $505,960, after exchange to US dollars at the rate then prevailing, capitalized as a prepaid expense. The remaining fees are to be paid as milestones are reached on the following schedule. At June 30, 2019, none of these milestones had yet been reached. Milestone Event Percent Amount First submission date 10 % $ 306,839 First site initiation visit 10 % $ 306,839 First patient in 10 % $ 306,839 30% patients randomized 10 % $ 306,839 50% sites initiated 10 % $ 306,839 60% patients randomized 10 % $ 306,839 100% sites initiated 10 % $ 306,839 100% of patients randomized 10 % $ 306,839 90% of case report form pages monitored 5 % $ 153,419 PE analysis 5 % $ 153,419 Database is locked 10 % $ 306,839 Service Agreement 1 also estimates approximately $2.5 million (€ 2,172,000) in pass-through costs, mostly fees to clinical investigators and sites, which will be billed as incurred. In the event that the MSA or Service Order are terminated, the Crown’s actual costs up the date of termination will be payable by the Company, but any unrealized milestones shall not be. During the six months ended June 30, 2019, the Company recognized $234,273 in expenses associated with the Service Agreement 1, classified as R&D expense, leaving a $271,687 prepaid expense asset. Lease Commitments On January 1, 2019, the Company adopted, ASU 2016-02 which amends existing lease accounting guidance, and requires recognition of most lease arrangements on the balance sheet. (See Note 2.) The adoption of this standard would result in the Company recognizing a right-of-use asset representing its rights to use the underlying asset for the lease term with an offsetting lease liability for all leases with term greater than twelve months. At June 30, 2019, the Company was not party to any leases of term greater than 12 months at the time of the agreement, and therefore did not record any right-to-use assets as a result of adopting this guidance. On October 9, 2018, the Company entered into a license and membership agreement with Jelly Works X Zero-Ten, LLC for membership in a coworking space and use of an office located at 307A Kamani Street, Honolulu, HI 96813. The Company agreed to pay a monthly fee of $1,152 for membership and use of these facilities, committing to do so for a term of one year. In the six months ended June 30, 2019, the Company rent expense associated with this agreement was approximately $6,911. On December 19, 2018, the Company entered into an office service agreement with the University of Virginia Foundation for the use of an office and a workstation located at 1001 Research Park Boulevard, Suite 100, Charlottesville, VA 22911. The Company agreed to pay a fee of $1,150 per month for use of these facilities. The agreement is on a month-to-month basis. For the six months ended June 30, 2019, the Company rent expense associated with this agreement was approximately $6,900. Consulting Agreements – Related Party On March 24, 2019, the Company entered into a Consulting Agreement with Dr. Bankole A. Johnson, who at the time of the agreement was serving as the Chairman of the Board of Directors, for his service as Chief Medical Officer of the Company. The Consulting agreement has a term of three years, unless terminated by mutual consent or by the Company for cause. Dr. Johnson resigned as Chairman of the Board of Directors at the time of execution of the consulting agreement. Under the terms of the consulting agreement, Dr. Johnson’s annual fee of $375,000 per year is paid twice per month. On execution, Dr. Johnson received a signing bonus of $250,000 and option to purchase 250,000 shares of common stock. Dr. Johnson’s participation in the Grant Incentive Plan (see below) continues unaffected. The total expense to the company under this agreement in the six months ended June 30, 2019 was $392,215. Other Consulting and Vendor Agreements The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between 12 and 30 months. These agreements, in aggregate, commit the Company to approximately $1.3 million in future cash payments and future issuance of 68,750 shares of common stock over their respective terms. Grant Incentive Plan On April 1, 2018, the board of directors approved a Grant Incentive Plan to provide incentive for Bankole A. Johnson (together, the “Plan Participant”), to secure grant funding for the Company. Under the Grant Incentive Plan, the Company will make a yearly payment to the Plan Participant, based on the grant funding received by the Company in the preceding year from grants originated by the Plan Participants, in an amount equal to 10% of the first $1 million of grant funding received and 5% of grant funding received in the preceding year above $1 million. Amounts to be paid to the Plan Participants will be paid to each as follows: 50% in cash and 50% in stock no later than March 31, each year. During the six months ended June 30, 2019, no grant funding that would result in a payment to the Plan Participants had been obtained. Litigation The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows. At June 30, 2019, the Company did not have any pending legal actions. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2019 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 11 — SUBSEQUENT EVENTS On July 5, 2019, the Company entered into a Master Services Agreement (the "MSA") and attached statement of work with Psychological Education Publishing Company ("PEPCO") to administer a behavioral therapy program during the Company's upcoming Phase 3 clinical trial. PEPCO is owned by a related party, Dr. Bankole Johnson, the Company's Chief Medical Officer, and currently the largest stockholder in the Company. It is anticipated that the compensation to be paid to PEPCO for services under the MSA will be approximately $300,000, of which, subject to approval of the Nasdaq Capital Market, shares of the Company's common stock having a value equal to twenty percent (20%) of the fees due thereunder will be issued to Dr. Johnson. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Liquidity and Other Uncertainties | Liquidity and Other Uncertainties The unaudited condensed financial statements have been prepared in conformity with generally accepted accounting principles ("GAAP"), which contemplate continuation of the Company as a going concern. The Company is in a development stage and has not generated any revenues. The Company had an accumulated deficit of approximately $16.8 million and $12.0 million as of June 30, 2019 and December 31, 2018, respectively, and had incurred net losses of approximately $4.8 million and $2.2 million, for the six months ended June 30, 2019 and 2018, respectively. Based on the current development plans for AD04 in both the U.S. and foreign markets and the Company's other operating requirements, management believes that the existing cash at June 30, 2019 will be sufficient to fund operations for at least the next twelve months following the issuance of these financial statements. However, while the Company's existing cash is sufficient to fund the Company's operations over the next twelve months, the Company continues to face significant uncertainly as to its longer term liquidity needs, which depend upon a number of factors, including, but not limited to, trial costs, the time required to complete planned trials, and the use of cash in pursuit of non-dilutive funding sources and the success or failure of such pursuit. The Company's longer term, continued operations will depend on its ability to raise additional capital through equity and/or debt financings, grant funding, strategic relationships, or out-licensing of its products in order to complete its current clinical trial and the subsequent research and development requirements for its lead compound, AD04. Generally, the Company's operations are subject to a number of uncertainties which can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company's product candidates; the ability to obtain regulatory approval to market the Company's products; the ability to manufacture the Company's products successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the ability to raise capital to support its operations. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2018, included in the Annual Report on Form 10-K filed on February 19, 2019. |
Use of Estimates | Use of Estimates The preparation of unaudited condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include the valuation of equity-based compensation, intangible assets useful life, clinical trial expense recognition, and contingent liabilities. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these condensed financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes. |
Basic and Diluted Earnings (Loss) per Share | Basic and Diluted Earnings (Loss) per Share Basic and diluted earnings (loss) per share are computed based on the weighted-average outstanding shares of stock, which are all voting shares. Common stock equivalents consist of outstanding warrants and options. Stock equivalents of warrants to purchase approximately 6,723,240 common shares and 1,400,967 common shares to be issued upon exercise of options outstanding on June 30, 2019, and stock equivalents of warrants to purchase approximately 782,555 common shares to be issued upon exercise of 174,282 options outstanding were all excluded from the computation of diluted earnings (loss) per share for the three months ended June 30, 2018, because their effect on the loss per share is anti-dilutive. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company's cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. At June 30, 2019, the Company held a balance in a checking and a money market account that exceeded federally insured limits by approximately $10.0 million. These same accounts exceeded federally insured limits by approximately $3.6 million on December 31, 2018. The Company maintains an investment brokerage account for the purposes of investing its cash in accordance with its investment policy. At June 30, 2019, the cash balance of this account did not exceed Securities Investor Protection Corporation limits. |
Intangible Assets | Intangible Assets Intangible assets consist primarily of the trademarks and copyrights. The trademarks and copyrights will be amortized using the straight-line method based on an estimated useful life of 20 years. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company's long-lived assets (consisting primarily of trademarks) are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the undiscounted future net cash flows expected to be generated by that asset. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. Research and development expenses includes fees associated with direct trial expenses such as fees due to contract research organizations, consultants supporting the Company's research and development endeavors, the acquisition of certain technology rights, and compensation of clinical development personnel. |
Equity-Based Compensation | Equity-Based Compensation The Company measures the cost of awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the employee was required to provide service in exchange for the entire award. The fair value of options is calculated using the Black-Scholes option pricing model, based on key assumptions such as the fair value of shares of common stock, expected volatility, and expected term. The Company's estimates of these assumptions are primarily based on historical data, peer company data and the judgment of management regarding future trends. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and tax carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. See Note 9. |
Fair Value of Financial Instruments and Fair Value Measurements | Fair Value of Financial Instruments and Fair Value Measurements The fair value of financial instruments held by the Company are disclosed using the three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements. The carrying amounts reported in the balance sheets for current assets and liabilities are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization. The carrying value of all other financial liabilities at cost approximates fair value. The three levels of valuation hierarchy are defined as follows: ● Level 1: Observable inputs such as quoted prices in active markets; ● Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and ● Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Leases — Earnings per Share, Distinguishing Liabilities from Equity, and Derivatives and Hedging Fair Value Fair Value |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible assets, net | Useful June 30, December 31, Trademarks and Copyrights 20 years $ 11,300 $ 11,300 Less: Accumulated amortization (4,848 ) (4,565 ) Intangible Assets, net $ 6,452 $ 6,735 |
Shareholders' Deficit (Tables)
Shareholders' Deficit (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Schedule of stock options activity | Total Options Outstanding Weighted Average Remaining Term (Years) Weighted Average Exercise Price Weighted Average Fair Value at Issue Outstanding December 31, 2017 174,282 9.50 5.70 4.84 Issued 68,900 10.00 $ 2.80 $ 2.21 Outstanding December 31, 2018 243,182 8.93 $ 4.88 $ 4.09 Issued 1,173,000 10.00 3.31 2.56 Cancelled (15,215 ) 8.26 5.70 4.23 Outstanding June 30, 2019 1,400,967 9.62 3.55 2.81 Outstanding June 30, non-vested 1,177,732 9.63 $ 3.39 $ 2.61 |
Schedule of black scholes valuation model to determine the fair value of the options issued | Q2 2019 2018 Fair Value per Share $ 3.01-3.39 $ 2.80 Expected Term 6.5 years 6.5 years Expected Volatility 97.37-97.48 % 95.77 % Risk free rate 2.32-2.51 % 2.79 % |
Schedule of stock-based compensation expense | Six Months ended June 30 2019 2018 Research and development Options Expense 141,703 - Total research and development expenses 141,703 - General and administrative Options Issuance Expense 297,657 138,797 Stock issued granted for Performance Bonus Plan cancellation - 1,461,545 Stock issued to consultants 309,104 - Total general and administrative expenses 606,761 1,600,342 Total stock-based compensation expense $ 748,464 $ 1,600,342 |
Schedule of activity in warrants | Total Warrants Weighted Average Remaining Term (Years) Weighted Average Exercise Price Average Intrinsic Value Outstanding December 31, 2017 482,555 11.20 5.51 1.38 Issued 4,547,204 5.00 5.82 0.00 Cancelled – NA NA NA Exercised (25,000 ) 4.59 6.25 0.06 Outstanding December 31, 2018 5,054,759 5.13 $ 5.79 0.61 Issued 2,133,750 5.00 4.06 0.00 Cancelled – NA NA NA Exercised 465,269 4.39 4.54 1.29 Outstanding June 30, 2019 6,723,240 4.67 5.33 0.03 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of milestone payment | Milestone Event Percent Amount First submission date 10 % $ 306,839 First site initiation visit 10 % $ 306,839 First patient in 10 % $ 306,839 30% patients randomized 10 % $ 306,839 50% sites initiated 10 % $ 306,839 60% patients randomized 10 % $ 306,839 100% sites initiated 10 % $ 306,839 100% of patients randomized 10 % $ 306,839 90% of case report form pages monitored 5 % $ 153,419 PE analysis 5 % $ 153,419 Database is locked 10 % $ 306,839 |
Description of Business (Detail
Description of Business (Details) - USD ($) | 1 Months Ended | |
Feb. 28, 2019 | Jul. 31, 2018 | |
IPO [Member] | ||
Description of Business (Textual) | ||
Proceeds from initial public offering | $ 8,200,000 | $ 6,300,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Significant Accounting Policies (Textual) | |||||
Accumulated deficit | $ (16,852,428) | $ (16,852,428) | $ (12,035,370) | ||
Net losses | (2,134,407) | $ (1,792,356) | (4,817,058) | $ (2,171,306) | |
Cash in hand | $ 10,000,000 | $ 10,000,000 | $ 3,600,000 | ||
Intangible assets estimated useful life | 20 years | ||||
Potentially dilutive common shares | 6,723,240 | 782,555 | |||
Exercise of options outstanding | 1,400,967 | 174,282 |
Intangible Assets, Net (Details
Intangible Assets, Net (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Trademarks and Copyrights | $ 11,300 | $ 11,300 |
Less: Accumulated amortization | (4,848) | (4,565) |
Intangible Assets, net | $ 6,452 | $ 6,735 |
Useful life of intangible assets, net | 20 years |
Intangible Assets, Net (Detai_2
Intangible Assets, Net (Details Textual) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Intangible Assets, Net (Textual) | ||
Amortization of trademarks and copyrights | $ 283 | $ 281 |
Useful life of intangible assets, net | 20 years | |
Trademarks [Member] | ||
Intangible Assets, Net (Textual) | ||
Useful life of intangible assets, net | 12 years |
Senior Secured Notes (Details T
Senior Secured Notes (Details Textual) - USD ($) | May 01, 2017 | Jul. 31, 2018 | Feb. 22, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jan. 31, 2019 | Jan. 22, 2019 |
Senior Secured Notes (Textual) | |||||||
Amortized to interest expense | $ 60,993 | ||||||
Warrants exercise price | $ 6.25 | $ 4.99 | $ 3.75 | ||||
Senior Secured Bridge Note [Member] | |||||||
Senior Secured Notes (Textual) | |||||||
Principal amount | $ 287,500 | ||||||
Debt proceeds | 250,000 | ||||||
Original issue discount | $ 37,500 | ||||||
Maturity date at issue | Nov. 1, 2017 | ||||||
Interest expense | $ 23,363 | ||||||
Senior Secured Bridge Note [Member] | IPO [Member] | |||||||
Senior Secured Notes (Textual) | |||||||
Issuance of common stock | 10,020 | ||||||
Warrants to purchase of common stock | 65,130 | ||||||
Warrants exercise price | $ 4.99 | ||||||
Extinguishment of net loss | $ 97,593 | ||||||
Senior Holder Paying [Member] | |||||||
Senior Secured Notes (Textual) | |||||||
Settlement cash payment | $ 100,000 | ||||||
Additional cash payment | $ 100,000 | ||||||
Issuance of common stock | 100,000 | ||||||
Settlement agreement | $ 150,000 |
Senior Secured Notes (Details_2
Senior Secured Notes (Details Textual 1) - USD ($) | Mar. 01, 2018 | Jul. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 03, 2018 |
Senior Secured Notes (Textual) | |||||||
Interest and financing charges | $ 50,889 | $ 102,567 | |||||
Senior Secured Notes (Related Parties $470,000) [Member] | |||||||
Senior Secured Notes (Textual) | |||||||
Debt, description | The principal and interest outstanding of the Secured Notes was paid in full and 408,000 units (376,000 units to related parties), each unit consisting of a share of common stock and a warrant to purchase of a share of common stock at an exercise price of $6.25 per share and 408,000 Unit Warrants (376,000 Unit Warrants to related parties) were issued, as a result of which the obligation of the Company with respect to Senior Secured Notes were fully satisfied. The loss on extinguishment of the Secured Notes was $3,399,902. | ||||||
Interest and financing charges | $ 30,255 | ||||||
Security Purchase Agreements [Member] | Senior Secured Notes (Related Parties $470,000) [Member] | |||||||
Senior Secured Notes (Textual) | |||||||
Principal amount for related parties | $ 510,000 | $ 325,000 | |||||
Interest rate | 18.00% | ||||||
Maturity date | Jul. 1, 2018 |
Senior Secured Notes (Details_3
Senior Secured Notes (Details Textual 2) - USD ($) | Jun. 03, 2018 | Dec. 19, 2018 | Jul. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jan. 31, 2019 | Jan. 22, 2019 | Dec. 31, 2018 |
Senior Secured Notes (Textual) | ||||||||
Payment of senior note | $ 150,000 | |||||||
Warrant to purchase of common stock, exercisable per share | $ 6.25 | $ 4.99 | $ 3.75 | |||||
Note discounted amount | 8,287 | |||||||
Additional paid in capital | $ 26,903,002 | $ 16,469,818 | ||||||
Amortization of discounts | $ 28,676 | |||||||
IPO [Member] | ||||||||
Senior Secured Notes (Textual) | ||||||||
Warrant, description | (i) William Stilley, the CEO, who purchased 80,000 units consisting of 80,000 shares of common stock and warrants to purchase 80,000 shares of common stock at an exercise price of $6.25 per share; (ii) Kevin Schuyler, Vice Chairman of the Board of Directors and Lead Independent Director, who purchased 90,000 units consisting of 90,000 shares of common stock and warrants to purchase 90,000 shares of common stock at an exercise price of $6.25 per; (iii) James Newman, a director, who purchased 10,000 units, consisting of 10,000 shares of common stock and warrants to purchase 10,000 shares of common stock at an exercise price of $6.25 per share, personally and 10,000 units, consisting of 10,000 shares of common stock and warrants to purchase 10,000 shares of common stock at an exercise price of $6.25 per share though a Roth IRA for his benefit; (iv) Bankole Johnson, the then Chairman of the Board who currently serves as the Company’s Chief Medical Officer, who purchased 1,400 units consisting of 1,400 shares of common stock and warrants to purchase 1,400 shares of common stock at an exercise price of $6.25 per share; (v) Keller Enterprises LLC, an affiliate of Robertson Gilliland, a director, which purchased 14,000 units consisting of 14,000 shares of common stock and warrants to purchase 14,000 shares of common stock at an exercise price of $6.25 per share; (vi) Tony Goodman, a director, who purchased 7,000 units consisting of 7,000 shares of common stock and warrants to purchase 1,400 shares of common stock at an exercise price of $6.25 per share. | |||||||
Security Purchase Agreements [Member] | June 2018 Senior Note [Member] | ||||||||
Senior Secured Notes (Textual) | ||||||||
Principal amount | $ 325,000 | $ 325,000 | ||||||
Payment of senior note | $ 510,000 | |||||||
Debt instrument, description | The June 2018 Senior Note was issued at an original issue discount of 15.4%, or $50,000, did not bear interest and was payable on March 5, 2019 or upon an earlier event of default, including, without limitation, a change of control of the Company. | |||||||
Shares of common stock issued | 162,500 | |||||||
Conversion price | $ 2 | $ 2 | ||||||
Interest expense | $ 186,397 | |||||||
Warrant to purchase of common stock | 300,000 | |||||||
Warrant to purchase of common stock, exercisable per share | $ 3.75 | |||||||
Exercisable term | 5 years | |||||||
Additional paid in capital | $ 275,000 |
Subordinated Notes - Related _2
Subordinated Notes - Related Parties (Details) - USD ($) | 1 Months Ended | 6 Months Ended | |
Nov. 20, 2017 | Jun. 30, 2018 | Feb. 22, 2018 | |
Subordinated Notes - Related Parties (Textual) | |||
Secured notes | $ 100,000 | ||
Interest expense | $ 435 | ||
Amortization of debt discount | $ 8,287 | ||
Subordinated Notes [Member] | |||
Subordinated Notes - Related Parties (Textual) | |||
Aggregate principal amount | $ 115,000 | ||
Proceeds from related parties | 100,000 | ||
Original issue discount | $ 15,000 |
Convertible Notes - Related P_2
Convertible Notes - Related Parties (Details) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Jul. 31, 2018 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2018 | |
Convertible Notes (Textual) | ||||
Conversion of stock description | Under the terms of the 2016 Convertible Notes, the outstanding principal and accrued interest on the 2016 Convertible Notes was converted to 700,854 shares of common stock and 700,845 warrants to purchase shares of common stock at an exercise price of $6.25 per share, of which 395,118 share of common stock and 395,118 warrants to purchase shares of common stock at an exercise price of $6.25 per share were issued to related parties. | |||
2016 Convertible Notes [Member] | ||||
Convertible Notes (Textual) | ||||
Outstanding unsecured principal amount | $ 235,000 | $ 235,000 | ||
Due date | The principal and interest was originally due in 2029. | The principal and interest was originally due in 2029. | ||
Interest rate | 15.00% | 15.00% | ||
Debt conversion description | The 2016 Convertible Notes were to automatically convert to common stock in the event the Company issued and sold either common or preferred stock of $2,000,000 or more, excluding the value of the conversion of the 2016 Convertible Notes. | The 2016 Convertible Notes were to automatically convert to common stock in the event the Company issued and sold either common or preferred stock of $2,000,000 or more, excluding the value of the conversion of the 2016 Convertible Notes. | ||
Interest expense | $ 22,525 | |||
Preferred stock issued | 2,000,000 | 2,000,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 1 Months Ended | 6 Months Ended | |||
Jul. 31, 2018 | Feb. 22, 2018 | Jan. 29, 2018 | Apr. 25, 2016 | Jun. 30, 2019 | |
Management [Member] | |||||
Related Party Transactions (Textual) | |||||
Description of consulting agreement with consultant | The Company entered into a Consulting Agreement with a consultant, who now serves as the Company’s Chief Operating Officer and Chief Financial Officer. For the period ended June 30, 2018 , total fees charged by this consultant were $25,600. Effective July 25, 2018, this consultant was employed as COO/CFO under the terms of an employment agreement that superseded the consulting agreement. | ||||
IPO [Member] | |||||
Related Party Transactions (Textual) | |||||
Description of related parties that participated | (i) William Stilley, the CEO, who purchased 80,000 units consisting of 80,000 shares of common stock and warrants to purchase 80,000 shares of common stock at an exercise price of $6.25 per share; (ii) Kevin Schuyler, Vice Chairman of the Board of Directors and Lead Independent Director, who purchased 90,000 units consisting of 90,000 shares of common stock and warrants to purchase 90,000 shares of common stock at an exercise price of $6.25 per; (iii) James Newman, a director, who purchased 10,000 units, consisting of 10,000 shares of common stock and warrants to purchase 10,000 shares of common stock at an exercise price of $6.25 per share, personally and 10,000 units, consisting of 10,000 shares of common stock and warrants to purchase 10,000 shares of common stock at an exercise price of $6.25 per share though a Roth IRA for his benefit; (iv) Bankole Johnson, the then Chairman of the Board who currently serves as the Company’s Chief Medical Officer, who purchased 1,400 units consisting of 1,400 shares of common stock and warrants to purchase 1,400 shares of common stock at an exercise price of $6.25 per share; (v) Keller Enterprises LLC, an affiliate of Robertson Gilliland, a director, which purchased 14,000 units consisting of 14,000 shares of common stock and warrants to purchase 14,000 shares of common stock at an exercise price of $6.25 per share; (vi) Tony Goodman, a director, who purchased 7,000 units consisting of 7,000 shares of common stock and warrants to purchase 1,400 shares of common stock at an exercise price of $6.25 per share. | ||||
Medico-Trans Company, LLC [Member] | |||||
Related Party Transactions (Textual) | |||||
Medical translations services agreement, description | The Company entered a Medical Translations services agreement with Medico-Trans Company, LLC (“MTC”), a company under the control of the former Chairman of the Board who currently serves as the Company’s Chief Medical Officer, whereby MTC agreed to perform $67,304 in medical translation services, to be paid on occurrence of a qualified financing of $2,000,000 or more; or, in the event that a qualified financing had not taken place by February 10, 2018, for installment payments of $22,000 on February 10, 2018, $22,000 on March 10, 2018, and the remaining balance on April 10, 2018, and to issue to MTC on consummation of a qualified financing a number of shares of common stock equal to $201,911 divided by the price per share of the qualified financing. | ||||
Payments to MTC | $ 68,540 | ||||
Cash payments | 51,540 | ||||
Principal balance | $ 17,000 | ||||
Medico-Trans Company, LLC [Member] | IPO [Member] | |||||
Related Party Transactions (Textual) | |||||
Shares of common stock issued | 40,463 | ||||
MVA 151 Investors, LLC [Member] | |||||
Related Party Transactions (Textual) | |||||
Backstop commitment, description | The Company executed a Backstop Commitment Agreement ("BCA") with MVA 151 Investors, LLC ("MVA"), a company controlled by a Company director, Kevin Schuyler, pursuant to which MVA agreed to guarantee the purchase of up to $242,000 ("the Backstop Amount") in the principal amount of Secured Notes then offered for subscription and unsubscribed on March 1, 2018 (the "Backstop Commitment"). | ||||
Secured notes investment, description | (i) warrants to purchase a number of shares of the Company’s common stock equal to 150% of the Backstop Amount divided by the price per share of the Next Financing and (ii) a number of units of Company common stock equal to 50% of the Backstop Amount divided by the price per share of the Next Financing. The warrants were to have an exercise price equal to the price per share of the Next Financing and a term of five years. On March 1, MVA invested $92,000 in Secured Notes as a result of the BCA, this amount being the $242,000 backstop amount less $150,000 in additional subscriptions received between February 22, 2018 and March 1, 2018. This investment fully satisfied the Backstop Commitment and left MVA with no further associated obligation to invest. At the time of the IPO, the Company issued MVA 151 24,200 shares of common stock, warrants to purchase 24,200 shares of common stock at an exercise price of $6.25, and warrants to purchase 72,600 units (each unit consisting of a share of common stock and a warrant to purchase a share of common stock at an exercise price of $6.25) at an exercise price of $5.00 per unit. The total cost of the issuances made as a result of the backstop agreement was $385,181, included in the net loss recognized on the Secured Notes. |
Shareholders' Deficit (Details)
Shareholders' Deficit (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Total Options Outstanding | ||
Issued | 508,100 | |
Option [Member] | ||
Total Options Outstanding | ||
Beginning balance | 243,182 | 174,282 |
Issued | 1,173,000 | 68,900 |
Cancelled | (15,215) | |
Ending balance | 1,400,967 | 243,182 |
Outstanding non-vested | 1,177,732 | |
Weighted Average Remaining Term (Years) | ||
Outstanding Beginning | 8 years 11 months 4 days | 9 years 6 months |
Issued | 10 years | 10 years |
Cancelled | 8 years 3 months 4 days | |
Outstanding Ending | 9 years 7 months 13 days | 8 years 11 months 4 days |
Outstanding Ending, non-vested | 9 years 7 months 17 days | |
Weighted Average Exercise Price | ||
Beginning balance | $ 4.88 | $ 5.70 |
Issued | 3.31 | 2.80 |
Cancelled | 5.70 | |
Ending balance | 3.55 | 4.88 |
Outstanding non vested | 3.39 | |
Weighted Average Fair Value at Issue | ||
Beginning balance | 4.09 | 4.84 |
Issued | 2.56 | 2.21 |
Cancelled | 4.23 | |
Ending balance | $ 2.81 | $ 4.09 |
Outstanding, non- vested | 2.61 |
Shareholders' Deficit (Details
Shareholders' Deficit (Details 1) - Black Scholes [Member] - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Fair value of the options | ||
Fair Value per Share | $ 2.80 | |
Expected Term | 6 years 6 months | 6 years 6 months |
Expected Volatility | 95.77% | |
Risk free rate | 2.79% | |
Minimum [Member] | ||
Fair value of the options | ||
Fair Value per Share | $ 3.01 | |
Expected Volatility | 97.37% | |
Risk free rate | 2.32% | |
Maximum [Member] | ||
Fair value of the options | ||
Fair Value per Share | $ 3.39 | |
Expected Volatility | 97.48% | |
Risk free rate | 2.51% |
Shareholders' Deficit (Detail_2
Shareholders' Deficit (Details 2) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Equity [Abstract] | ||||
Research and development Options Expense | $ 141,703 | |||
Total research and development expenses | $ 1,210,436 | $ 76,895 | 1,897,350 | 132,403 |
General and administrative Options Issuance Expense | 297,657 | 138,797 | ||
Stock issued granted for Performance Bonus Plan cancellation | 1,461,545 | |||
Stock issued to consultants | 309,104 | |||
Total general and administrative expenses | $ 948,574 | $ 1,664,572 | 2,510,926 | 1,948,577 |
Total stock-based compensation expense | $ 748,464 | $ 1,600,342 |
Shareholders' Deficit (Detail_3
Shareholders' Deficit (Details 3) - Warrants [Member] - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Total Warrants | ||
Beginning balance | 5,054,759 | 482,555 |
Issued | 2,133,750 | 4,547,204 |
Cancelled | ||
Exercised | 465,269 | (25,000) |
Ending Balance | 6,723,240 | 5,054,759 |
Weighted Average Remaining Term (Years) | ||
Outstanding beginning | 5 years 1 month 16 days | 11 years 2 months 12 days |
Issued | 5 years | 5 years |
Cancelled | ||
Exercised | 4 years 4 months 20 days | 4 years 7 months 2 days |
Outstanding ending | 4 years 8 months 2 days | 5 years 1 month 16 days |
Weighted Average Exercise Price | ||
Beginning balance | $ 5.79 | $ 5.51 |
Issued | 4.06 | 5.82 |
Cancelled | ||
Exercised | 4.54 | 6.25 |
Ending balance | 5.33 | 5.79 |
Average Intrinsic Value | ||
Beginning balance | 0.61 | 1.38 |
Issued | 0 | 0 |
Cancelled | ||
Exercised | 1.29 | 0.06 |
Ending balance | $ 0.03 | $ 0.61 |
Shareholders' Deficit (Detail_4
Shareholders' Deficit (Details Textual) - USD ($) | Mar. 31, 2018 | Feb. 22, 2019 | Jan. 31, 2019 | Jan. 22, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Shares of common stock issued | 22,311 | 250,000 | 93,100 | |||||
Warrants for purchase | $ 65,130 | $ 300,000 | $ 93,100 | $ 93,100 | ||||
Outstanding options intrinsic value | $ 0 | $ 0 | ||||||
Options granted | 508,100 | |||||||
Stock options issued | $ 1,173,000 | |||||||
Common stock exercise price | $ 4.99 | $ 3.75 | $ 6.25 | $ 6.25 | ||||
Interest and financing charges | $ 50,889 | $ 102,567 | ||||||
Weighted average remaining vesting period | 2 years 5 months 27 days | |||||||
Common stock issued price | $ 581,875 | |||||||
Warrant purchase, description | Warrants to purchase 93,100 shares of common stock with an exercise price of $6.25 per share of common stock were exercised for $581,875, warrants to purchase 125,000 shares of common stock with an exercise price of $3.75 per share of common stock were exercised for $468,750, 7,039 warrants to purchase 7,039 shares of common stock with an exercise price of $0.005 per share of common stock were exercised for $38, and 240,130 warrants were exercised on a cashless basis for the issue of 147,311 shares of common stock. The total received in exercise fees for exercise of warrants was $1,050,663, resulting in the issue of a total of 372,450 shares of common stock on the exercise of 465,269 warrants, of which 372,169 shares of common stock were unregistered at the time of issuance. | |||||||
R&D Expense [Member] | ||||||||
Equity-based compensation expense | $ 439,360 | $ 138,797 | ||||||
G&A Expense [Member] | ||||||||
Equity-based compensation expense | 3,007,155 | |||||||
IPO [Member] | ||||||||
Initial public offering, description | The Company concluded the Follow-on Offering of 2,475,000 shares of common stock and warrants to purchase 1,856,250 shares of common stock at an exercise price of $4.0625 per share. The shares of common stock and accompanying warrants were sold to the public at a price of $3.25 per share and warrant. The underwriters were granted an over-allotment option to purchase up to 371,250 shares of common stock and warrant to purchase 278,437 shares of common stock at a price of $3.25 per share of common stock and warrant. The underwriters partially exercised their over-allotment option by purchasing 370,000 shares of common stock and warrants to purchase 277,500 shares common stock. Gross proceeds of the offering, totaled $9,246,249, which after offering expenses, resulted in net proceeds of $8,195,673. | |||||||
Consultant [Member] | ||||||||
Common stock issued price | $ 154,250 | |||||||
Common stock issued, shares | 162,500 | |||||||
Consultants at a total cost | $ 309,104 | $ 309,104 | ||||||
Officers and Director [Member] | ||||||||
Shares of common stock issued | 292,309 | |||||||
Equity-based compensation expense | $ 1,461,545 | |||||||
Common stock issued price | $ 468,750 | |||||||
Warrants [Member] | ||||||||
Shares of common stock issued | 2,133,750 | |||||||
Warrants for purchase | $ 2,133,750 | |||||||
Exercise price | $ 4.0625 | |||||||
Warrant purchase, description | 93,100 previously-registered shares of common stock were issued as a result of the exercise of tradeable warrants to purchase 93,100 shares of common stock at an exercise price of $6.25 per share for cash payments of $581,875 and 7,039 unregistered shares of common stock were issued as a result of the exercise of warrants to purchase 7,039 shares of common stock at an exercise price of $0.005 per share for cash payments of $38. |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Jan. 02, 2018 | Jun. 30, 2019 |
Income Taxes (Textual) | ||
Net operating loss carry-forward for federal and state | $ 11,300,000 | |
Net income loss carry forward taxable income | 80.00% |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 6 Months Ended |
Jun. 30, 2019USD ($) | |
First submission date [Member] | |
Milestone Event | First submission date |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
First site initiation visit [Member] | |
Milestone Event | First site initiation visit |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
First patient in [Member] | |
Milestone Event | First patient in |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
30% patients randomized [Member] | |
Milestone Event | 30% patients randomized |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
50% sites initiated [Member] | |
Milestone Event | 50% sites initiated |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
60% patients randomized [Member] | |
Milestone Event | 60% patients randomized |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
100% sites initiated [Member] | |
Milestone Event | 100% sites initiated |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
100% of patients randomized [Member] | |
Milestone Event | 100% of patients randomized |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
90% of case report form pages monitored [Member] | |
Milestone Event | 90% of case report form pages monitored |
Percent Remaining Fee | 5.00% |
Amount | $ 153,419 |
PE analysis [Member] | |
Milestone Event | PE analysis |
Percent Remaining Fee | 5.00% |
Amount | $ 153,419 |
Database is locked [Member] | |
Milestone Event | Database is locked |
Percent Remaining Fee | 10.00% |
Amount | $ 306,839 |
Commitments and Contingencies_3
Commitments and Contingencies (Details Textual) | Oct. 09, 2018USD ($) | Dec. 14, 2017 | Jun. 28, 2019USD ($) | Mar. 24, 2019USD ($)shares | Dec. 19, 2018USD ($) | Nov. 21, 2018USD ($) | Nov. 16, 2018 | Oct. 31, 2018 | Jan. 31, 2011 | Jun. 30, 2019USD ($)$ / shares | Jun. 30, 2019EUR (€) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) |
Commitments and Contingencies (Textual) | |||||||||||||
Minimum royalties accrued | $ 20,000 | $ 40,000 | |||||||||||
Grant incentive plan, description | The Company will make a yearly payment to the Plan Participant, based on the grant funding received by the Company in the preceding year from grants originated by the Plan Participants, in an amount equal to 10% of the first $1 million of grant funding received and 5% of grant funding received in the preceding year above $1 million. Amounts to be paid to the Plan Participants will be paid to each as follows: 50% in cash and 50% in stock no later than March 31, each year. | The Company will make a yearly payment to the Plan Participant, based on the grant funding received by the Company in the preceding year from grants originated by the Plan Participants, in an amount equal to 10% of the first $1 million of grant funding received and 5% of grant funding received in the preceding year above $1 million. Amounts to be paid to the Plan Participants will be paid to each as follows: 50% in cash and 50% in stock no later than March 31, each year. | |||||||||||
Prepaid research and development | $ 271,687 | $ 505,960 | |||||||||||
Prepaid research and development expenses | (234,273) | ||||||||||||
Master services agreement [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Description of master services agreement | The MSA has a term of five years, automatically renewed for two year periods, unless either party gives written notice of a decision not to renew the agreement three months prior to automatic renewal. The agreement can be terminated by the Company if, in the Company's reasonable opinion, clinical or non-clinical data support termination of the clinical research for safety reasons. | ||||||||||||
Service agreement 1 [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Description of master services agreement | The Company and Crown entered into Service Agreement 1 under the MSA for a 24 week, multi-centered, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical study of the Company’s lead compound, AD04. The MSA or a service agreement under it may be terminated by the Company, without penalty, on fourteen days written notice. On June 28, 2019, the Company and Crown Executed a change order to Service Agreement 1 increasing Crown’s fee from $3,363,308 (€2,958,835 converted to dollars at the Euro/US Dollar exchange rate of 1.1367 as of June 30, 2019, as are all other Euro-denominated amounts below) to $3,602,083 (€3,168,895) and rescheduling future milestone payments as shown below. | ||||||||||||
Estimated cost | 2,500,000 | ||||||||||||
Service agreement 1 [Member] | Euro [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Estimated cost | € | € 2,172,000 | ||||||||||||
Service Order [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Crown’s fee | $ 3,363,308 | $ 3,602,083 | |||||||||||
Euro/US dollar exchange rate | $ / shares | $ 1.1367 | ||||||||||||
Prepayment under the agreement cost | $ 505,960 | ||||||||||||
Service Order [Member] | Euro [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Crown’s fee | $ 2,958,835 | $ 3,168,895 | |||||||||||
Euro/US dollar exchange rate | $ / shares | $ 1.1367 | ||||||||||||
Vendor Agreement [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Vendor Agreements, description | The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between 12 and 30 months. These agreements, in aggregate, commit the Company to approximately $1.3 million in future cash payments and future issuance of 68,750 shares of common stock over their respective terms. | The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between 12 and 30 months. These agreements, in aggregate, commit the Company to approximately $1.3 million in future cash payments and future issuance of 68,750 shares of common stock over their respective terms. | |||||||||||
Licensing & Venture Group [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
License agreement description | The Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense itself. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income. | ||||||||||||
License agreement notice period, description | The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if the Company breaches its obligations thereunder, including failing to make any milestone, the most immediate being initiating Phase 3 clinical trials by December 31, 2019, making required payments or the failure to exercise diligence to bring licensed products to market. | ||||||||||||
License agreement amendment changed dates, description | This amendment changed the dates by which the Company, using commercially reasonable efforts, was to achieve the goals of submitting a New Drug Application to the FDA for a licensed product to December 31, 2024 (from December 31, 2023) and commencing commercialization of an FDA approved product by December 31, 2025 (from December 31, 2024). | ||||||||||||
Consulting Agreement [Member] | Dr. Bankole A. Johnson [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Consultant fees | $ 392,215 | ||||||||||||
Annual salary | $ 375,000 | ||||||||||||
Bonus | $ 250,000 | ||||||||||||
Option to purchase | shares | 250,000 | ||||||||||||
Office Service Agreement [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
Monthly payments of lease | $ 1,150 | ||||||||||||
Rent expense | $ 6,900 | ||||||||||||
License and Membership Agreement [Member] | |||||||||||||
Commitments and Contingencies (Textual) | |||||||||||||
License agreement description | The Company agreed to pay a monthly fee of $1,152 for membership and use of these facilities, committing to do so for a term of one year. | ||||||||||||
Rent expense | $ 6,911 |
Subsequent Events (Details)
Subsequent Events (Details) | Jul. 05, 2019 |
Subsequent Event [Member] | |
Subsequent Events (Textual) | |
Description of office agreement with the Regus Management Group, LLC | The Company entered into a Master Services Agreement (the “MSA”) and attached statement of work with Psychological Education Publishing Company (“PEPCO”) to administer a behavioral therapy program during the Company’s upcoming Phase 3 clinical trial. PEPCO is owned by a related party, Dr. Bankole Johnson, the Company’s Chief Medical Officer, and currently the largest stockholder in the Company. It is anticipated that the compensation to be paid to PEPCO for services under the MSA will be approximately $300,000, of which, subject to approval of the Nasdaq Capital Market, shares of the Company’s common stock having a value equal to twenty percent (20%) of the fees due thereunder will be issued to Dr. Johnson. |