Annual report pursuant to Section 13 and 15(d)

COMMITMENTS AND CONTINGENCIES (Tables)

v3.22.2
COMMITMENTS AND CONTINGENCIES (Tables)
12 Months Ended
Apr. 30, 2022
Commitments and Contingencies Disclosure [Abstract]  
Original AL001 License:

Original AL001 License:

 

Payment    Due Date    Event
$ 50,000 *  Completed September 2019    Pre-IND meeting
           
$ 65,000 *  Completed June 2021    IND application filing
           
$ 190,000 *  Completed December 2021    Upon first dosing of patient in a clinical trial
           
$ 500,000 *  Completed March 2022    Upon Completion of first clinical trial
           
$ 1,250,000    12 months from completion of the first Phase II clinical trial    Upon first patient treated in a Phase III clinical trial
           
$ 10,000,000    8 years from the effective date of the agreement    Upon FDA approval
* Milestone met and completed

 

 AL002 License:

 

Payment   Due Date   Event
$ 50,000  * Completed January 2022    Upon IND application filing
           
$ 50,000   12 months from IND application filing date    Upon first dosing of patient in first Phase I clinical trial
           
$ 175,000   12 months from first patient dosed in Phase I    Upon completion of first Phase I clinical trial
           
$ 500,000   24 months from completion of first Phase I clinical trial    Upon completion of first Phase II clinical trial
           
$ 1,000,000   12 months from completion of the first Phase II clinical trial    Upon first patient treated in a Phase III clinical trial
           
$ 10,000,000   7 years from the effective date of the agreement    Upon FDA BLA approval

 

The Company has met the pre-IND meeting, IND application filing, and successfully completed the Phase I clinical trial milestones encompassing AL001. If the Company fails to meet a milestone by its specified date, the Licensor may terminate the license agreement. 

 

Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by the Company while Licensor remains the owner of any equity securities of the Company.

 

On June 10, 2020, the Company obtained two (2) additional royalty-bearing exclusive worldwide licenses from the Licensor to a therapy named AL001. One of the additional licenses is for the treatment of neurodegenerative diseases excluding Alzheimer’s and the other license is for the treatment of psychiatric diseases and disorders. There are certain license fees and milestone payments required to be paid pursuant to the terms of the Standard Exclusive License Agreements with Sublicensing Terms, both dated June 10, 2020 and effective as of November 1, 2019, with the Licensor and the University of South Florida (the “June AL001 License Agreements”). Under each of the June AL001 License Agreements, a royalty payment of 3% is required on net sales of products developed from the licensed technology. For the two (2) additional AL001 licenses, in the aggregate, the Company has paid initial license fees of $20,000. Additionally, under each of the June AL001 License Agreements, the Company is required to pay milestone payments on the due dates to the Licensor for the license of the technology, as follows:

 

Additional AL001 Licenses:

 

Payment   Due Date   Event
$ 50,000   Upon IND application filing    IND application filing
           
$ 150,000   12 months from IND filing date    Upon first dosing of patient in a clinical trial
           
$ 400,000   12 months from first patient dosing    Upon Completion of first clinical trial
           
$ 1,000,000   36 months from completion of the first Phase II clinical trial    Upon first patient treated in a Phase III clinical trial
           
$ 8,000,000   8 years from the effective date of the agreement    First commercial sale