Quarterly report pursuant to Section 13 or 15(d)

Commitments and Contingencies (Details)

v3.21.1
Commitments and Contingencies (Details)
1 Months Ended 3 Months Ended
Oct. 10, 2020
USD ($)
Dec. 12, 2019
Sep. 30, 2019
USD ($)
Jun. 05, 2019
Nov. 16, 2018
Dec. 31, 2021
USD ($)
Mar. 24, 2021
USD ($)
Feb. 26, 2021
Oct. 20, 2020
USD ($)
Mar. 01, 2020
Feb. 27, 2020
USD ($)
Feb. 27, 2020
EUR (€)
Feb. 01, 2020
USD ($)
Feb. 01, 2020
EUR (€)
Mar. 24, 2019
Nov. 21, 2018
USD ($)
Oct. 31, 2018
Mar. 31, 2021
USD ($)
Mar. 31, 2021
EUR (€)
Mar. 31, 2020
USD ($)
Jun. 15, 2020
Commitments and Contingencies (Details) [Line Items]                                          
License fees and milestone payments, description                                   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. 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.    
Minimum license royalty expenses                                   $ 10,000   $ 10,000  
Master services agreement, description       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.                         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.        
Service agreement, description         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. On June 28, 2019, the Company and Crown Executed a change order to Service Agreement 1 increasing Crown’s fee from $3,469,530 (€2,958,835 converted to dollars at the Euro/US Dollar exchange rate of 1.1726 as of March 31, 2021) to $3,715,846 (€3,168,895) and rescheduling future milestone payments as shown below.                                
Initial prepayment under the agreement amount                               $ 505,960          
Invoice milestone payment, percentage     10.00%                                    
Prepaid expenses                                   $ 3,847   $ 206,278  
Operating lease emaining lease term                                   5 years      
Estimated incremental borrowing rate               9.00%                          
Future lease payments included in the measurement of lease liabilities                                   5 years 5 years    
Lease commitments related party, description                   the Company entered into a sublease with Purnovate, LLC, a private company in which the Company’s CEO had a 28.7% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease had a term of two years, and the monthly rent was $1,400. During the three months ended March 31, 2021, the rent expense associated with this lease was $1,400. On acquisition of Purnovate, the sublease was terminated and the Company assumed the obligations of Purnovate’s lease.                      
Consulting agreement term                             3 years            
Consulting agreement, description                             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 Company recognized $93,750 in compensation expense in the both the three months ended March 31, 2021 and 2020 as a result of this agreement.            
Amendment agreement, description   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 three months ended March 31, 2021, the Company recognized no expenses associated with this agreement. As of March 31, 2021, 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. On April 5, 2021, we entered into another Lock-Up Agreement Extension (the “Second Lock-Up Extension”), which amended the Lock-Up Extension and extended the term of Dr. Johnson’s Lock-Up from April 1, 2021 until such date as the Company shall have publicly released the data from its ONWARD™ Phase 3 pivotal trial of its lead drug candidate, AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder.                                      
Future cash                                   $ 1,000,000      
Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses     $ 294,124                                    
Second Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses                         $ 299,496 € 269,938              
Third Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses                     $ 297,013 € 269,938                  
Fourth Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses                     $ 302,843 € 269,938                  
Sites, percent                                         50.00%
Fifth Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses                 $ 319,310                        
Sites, percent                 100.00%                        
Sixth Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses $ 319,013                                        
Sites, percent 30.00%                                        
Seventh Milestone [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Prepaid expenses             $ 318,905                            
Sites, percent             60.00%                            
Service Agreement 1 [Member]                                          
Commitments and Contingencies (Details) [Line Items]                                          
Direct expenses                                   497,294      
Accrued R&D expenses           $ 53,065                              
Accrued expense liability                                   140,992      
Estimated cost                                   2,500,000 € 2,200,000    
Estimated future site costs                                   3,100,000      
Costs associated amount                                   $ 573,056