Annual report pursuant to Section 13 and 15(d)

Commitments and Contingencies (Details Textual)

v3.21.1
Commitments and Contingencies (Details Textual)
1 Months Ended 12 Months Ended
Nov. 10, 2020
USD ($)
Jul. 05, 2019
Oct. 09, 2018
Dec. 14, 2017
Oct. 20, 2020
USD ($)
Jun. 15, 2020
USD ($)
Mar. 01, 2020
Feb. 27, 2020
USD ($)
Feb. 01, 2020
USD ($)
Dec. 12, 2019
Jun. 28, 2019
USD ($)
Jun. 28, 2019
EUR (€)
Mar. 24, 2019
Dec. 19, 2018
USD ($)
Oct. 31, 2018
Jan. 31, 2011
Dec. 31, 2020
USD ($)
$ / shares
Dec. 31, 2020
EUR (€)
Dec. 31, 2019
USD ($)
Commitments and Contingencies (Textual)                                      
Milestone payment                                     $ 20,000
Minimum license royalty expense                                 $ 40,000   40,000
Sublease, description             The Company entered into a sublease with Purnovate, LLC, a private company in which the Company's CEO had a 30% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease has a term of two years, and the monthly rent is $1,400. During the year ended December 31, 2020, the rent expense associated with this lease was $14,000.                        
Prepaid expenses                                 (303,881)   30,956
Future cash                                 900,000    
Master services agreement, description                             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.        
Second Milestone [Member]                                      
Commitments and Contingencies (Textual)                                      
Prepaid expenses                 $ 299,496                    
Third Milestone [Member]                                      
Commitments and Contingencies (Textual)                                      
Prepaid expenses               $ 297,013                      
fourth milestone [Member]                                      
Commitments and Contingencies (Textual)                                      
Prepaid expenses           $ 302,843                          
Sites, percent           50.00%                          
fifth milestone [Member]                                      
Commitments and Contingencies (Textual)                                      
Prepaid expenses         $ 319,310                            
Sites, percent         100.00%                            
sixth milestone [Member]                                      
Commitments and Contingencies (Textual)                                      
Prepaid expenses $ 319,013                                    
Sites, percent 30.00%                                    
Consulting Agreement [Member] | Dr. Bankole A. Johnson [Member]                                      
Commitments and Contingencies (Textual)                                      
Contract research organizations, description                         The Company entered into a consulting agreement (the "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) and 2017 Equity Incentive Plan continue unaffected. The total expense to the Company under this agreement was $375,000 and $676,664 in the years ended December 31, 2020 and 2019, respectively.            
Service Agreement [Member]                                      
Commitments and Contingencies (Textual)                                      
Crown’s fee                     $ 3,614,513           $ 3,871,122    
Euro/US dollar exchange rate | $ / shares                                 $ 1.2216    
Service Agreement [Member] | Euro [Member]                                      
Commitments and Contingencies (Textual)                                      
Crown’s fee | €                       € 2,958,835           € 3,168,895  
Service Agreement 1 [Member]                                      
Commitments and Contingencies (Textual)                                      
Estimated cost                                 $ 2,700,000    
Estimated future site costs                                 3,100,000    
Fees to investigators and sites                                 1,317,766    
Prepaid research and development                                 214,633   214,633
Direct expenses                                 1,850,495    
Accrued R&D expenses                                 $ 53,065    
Service Agreement 1 [Member] | Euro [Member]                                      
Commitments and Contingencies (Textual)                                      
Estimated cost | €                                   € 2,172,000  
Master Services Agreement [Member]                                      
Commitments and Contingencies (Textual)                                      
Description of master services agreement   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 current 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 total approximately $300,000, of which shares of the Company's common stock having a value equal to twenty percent (20%) of this total can be issued to Dr. Johnson in lieu of cash payment.                                  
Amendment Agreement [Member]                                      
Commitments and Contingencies (Textual)                                      
Amendment agreement, description                   The Company entered into an Amendment (the "Amendment") to the statement of work ("SOW"). The Company had paid PEPCO $39,064 under the SOW for services rendered as of the Amendment date, leaving as estimated balance of $274,779 to be paid under the SOW. The Amendment provided the Company with a 20% discount on the remaining fees owed for services and fixed the price of any remaining services at a total of $219,823 for all services required for the use of Brief Behavioral Compliance Enhancement Treatment (BBCET) in support of the Trial. In addition, Dr. Johnson executed a guaranty, dated December 12, 2019, of PEPCO's performance under the MSA and SOW (the "Guaranty"), together with a pledge and security agreement, dated December 12, 2019 (the "Pledge and Security Agreement"), to secure the Guaranty with 600,000 shares of the Company's common stock beneficially owned by him and a lock-up agreement, dated December 12, 2019 (the "Lock-Up"), pursuant to which he agreed not to transfer or dispose of, directly or indirectly, any shares of the Company's common stock, as currently owned by him, until after January 1, 2021. On August 19, 2020, the Company entered into a Lock-Up Agreement Extension and Right of First Refusal with Dr. Johnson (the "Lock-Up Extension"), which amended the Lock-Up Agreement that had been entered into dated December 12, 2019 (the "Lock-Up"). The Lock-Up Extension extended the term of Dr. Johnson's Lock-Up from January 1, 2021 until April 1, 2021. In connection with the Lock-Up Extension, Dr. Johnson was released from his Lock-Up restrictions with respect to 350,000 shares of the Company's common stock. During the years ended December 31, 2020 and 2019, the Company recognized $147,120 and $39,064 in expenses associated with this vendor agreement, respectively. As of December 31, 2020, the Company had recognized $147,120 in expenses, of which $108,056 were charged against cash advanced under the terms of the Amendment, leaving a net prepaid expense asset of $111,767 associated with this vendor agreement.                  
Lease Commitments – Related Party [Member]                                      
Commitments and Contingencies (Textual)                                      
Monthly rent payment of lease                           $ 1,150          
Sublease, description     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. At the end of this period, the agreement reverted to a month-to-month rental of a dedicated desk space, without office, for a monthly fee of $393 per month. In the year ended December 31, 2019, the Company rent expense associated with this agreement was approximately $12,304.                                
Rent expense                                     $ 12,650
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 ourselves. 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, failure to make 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.      
License agreement amendment changed dates, description       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.