Annual report pursuant to Section 13 and 15(d)

Licensing, Sublicensing and Collaborative Agreements

v3.20.2
Licensing, Sublicensing and Collaborative Agreements
12 Months Ended
Mar. 31, 2020
Tax effect of warrant modifications  
Licensing, Sublicensing and Collaborative Agreements

License Agreements with Pherin Pharmaceuticals, Inc. (Pherin)

 

In September 2018 we issued 1,630,435 shares of our unregistered common stock having a fair market value of $2,250,000 to Pherin to acquire an exclusive worldwide license to develop and commercialize PH94B for social anxiety disorder and an option to acquire a similar license for PH10 for MDD. In October 2018, we exercised our option to acquire an exclusive worldwide license to develop and commercialize PH10 by issuing an additional 925,926 shares of our unregistered common stock having a fair market value of $2,000,000 to Pherin under the terms of the PH10 license agreement. Under the terms of the PH94B and PH10 license agreements, we are obligated to make additional cash payments and pay royalties to Pherin in the event that certain regulatory and performance-based milestones and commercial sales are achieved. Additionally, in connection with the license agreements, we are obligated to pay to Pherin monthly support payments of $10,000 for a term of 18 months, however no monthly support payment is required during the 18-month period identified in the PH10 license agreement if support payments are being made under the terms of the PH94B license agreement. The support payments required under the PH94B license agreement terminated in March 2020 and will terminate in April 2020 under the PH10 license agreement.

 

BlueRock Therapeutics Sublicense Agreement

 

In December 2016, we entered into an Exclusive License and Sublicense Agreement with BlueRock Therapeutics, LP, a next generation regenerative medicine company established in December 2016 by Bayer AG and Versant Ventures (BlueRock Therapeutics), pursuant to which BlueRock Therapeutics received exclusive rights to utilize certain technologies exclusively licensed by us from University Health Network (UHN) for the production of cardiac stem cells for the treatment of heart disease. As a result of its acquisition of BlueRock Therapeutics in 2019, Bayer AG now holds the rights to develop and commercialize our hPSC technologies relating to the production of heart cells for the treatment of heart disease (the Bayer Agreement).  We retained rights to cardiac stem cell technology licensed from UHN related to small molecule, protein and antibody drug discovery, drug rescue and drug development, including small molecules with cardiac regenerative potential, as well as small molecule, protein and antibody testing involving cardiac cells. To date, we have recognized $1.25 million in sublicense revenue, in our fiscal year ended March 31, 2017, under the Bayer Agreement.

 

Cato Research Ltd.

 

We have built a long-term strategic development relationship with Cato Research Ltd. (CRL), now known as Cato Research LLC, a global contract research and development organization, or CRO, and an affiliate of one of our larger institutional stockholders. CRL has provided us with access to essential CRO services and regulatory expertise supporting our AV-101 preclinical and clinical development programs, including our AV-101 MDD clinical study, and other significant development projects related to PH94B and PH10.  We recorded research and development expenses for CRO services provided by CRL in the amounts of $3,802,600 and $3,969,100 for the fiscal years ended March 31, 2020 and 2019, respectively.