Quarterly report pursuant to Section 13 or 15(d)

Licenses Acquired

v3.19.3
Licenses Acquired
9 Months Ended
Sep. 30, 2019
Licenses Acquired  
Licenses Acquired

7. Licenses Acquired

In accordance with ASC 730‑10‑25‑1, Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future use. The licenses purchased by Fortress, Aevitas, Avenue, Cellvation, Checkpoint, Cyprium, Helocyte, Mustang and Tamid require substantial completion of research and development, and regulatory and marketing approval efforts in order to reach technological feasibility. As such, for the three and nine months ended September 30, 2019 and 2018, the purchase price of licenses acquired was classified as research and development-licenses acquired in the Condensed Consolidated Statements of Operations as reflected in the table below:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Nine Months Ended September 30, 

($ in thousands)

    

2019

    

2018

    

2019

    

2018

Fortress Companies:

 

 

  

 

 

  

 

 

  

 

 

  

Helocyte

 

$

 —

 

$

1,500

 

$

 —

 

$

1,521

Checkpoint

 

 

 —

 

 

1,000

 

 

 —

 

 

1,000

Caelum

 

 

 —

 

 

201

 

 

 —

 

 

201

Mustang

 

 

700

 

 

1,000

 

 

1,350

 

 

1,075

Aevitas

 

 

 —

 

 

 5

 

 

 —

 

 

 6

Cellvation

 

 

 —

 

 

 —

 

 

 —

 

 

 1

Total

 

$

700

 

$

3,706

 

$

1,350

 

$

3,804

 

Checkpoint

The table below provides a summary of Checkpoint’s expense related to its licenses, for the three and nine months ended September 30, 2019 and 2018 by license as recorded in the Condensed Consolidated Statements of Operations:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Nine Months Ended September 30, 

($ in thousands)

    

2019

    

2018

    

2019

    

2018

Dana Farber License CK-301

 

$

 —

 

$

1,000

 

$

 —

 

$

1,000

Total

 

$

 —

 

$

1,000

 

$

 —

 

$

1,000

 

For the three and nine months ended September 30, 2018, Checkpoint recorded a $1.0 million milestone in connection with their license agreement with Dana-Farber, in connection with the achievement of dosing the 12th patient in the Phase 1 trial for CK-301.

Helocyte

For the three and nine months ended September 30, 2019 and 2018, Helocyte recorded expense of nil and $1.5 million, respectively in connection with Helocyte’s amended and restated license agreement for Triplex with City of Hope (“COH ”). The expense in 2018 relates to the achievement of a probable milestone.

Mustang

License with Calimmune

On August 23, 2019, Mustang entered into a Non-Exclusive License Agreement with Calimmune, Inc. (“Calimmune License”) for the rights to the cellbank to be used in the manufacture of the XSCID vector that was separately licensed from St. Jude Children’s Research Hospital, Inc. (“St. Jude”) in August 2018 (the “Mustang XSCID License”). Pursuant to the term of the Calimmune License Mustang paid an upfront fee of $0.2 million. Three additional development milestones are due, upon achievement totaling $1.0 million. Royalty payments in the low-single digits are due on net sales of licensed products. Upon the execution of the Calimmune License Mustang recorded research and development expense of $0.2 million in the condensed consolidated statement of operations for the three and nine months ended September 30, 2019.

License with Nationwide

In February 2019, Mustang announced that it partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital (“Nationwide”) to develop the C134 oncolytic virus (MB‑108) for the treatment of glioblastoma multiforme (“GBM”). Mustang intends to combine MB‑108 with MB‑101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating GBM. Mustang paid $0.2 million in consideration for the license for exclusive, worldwide rights to develop and commercialize products that incorporate data, know-how and/or C134 virus that were developed at Nationwide. Additional payments are due to Nationwide upon achievement of development and commercialization milestones totaling $152.8 million. Royalty payments in the low-single digits are due on net sales of licensed products.

License with University of California

On March 17, 2017, Mustang entered into an exclusive license agreement with the Regents of the University of California ("UCLA License") to acquire intellectual property rights in patent applications related to the engineered anti-prostate stem cell antigen antibodies for cancer targeting and detection. In September 2019, COH commenced its Phase 1 clinical trial resulting in the achievement of a development milestone resulting in Mustang recording an expense of $0.3 million in the condensed consolidated statement of operations for the three and nine months ended September 30, 2019.

Licenses with City of Hope

PSCA License

On May 31, 2017, Mustang entered into an exclusive license a prostate stem cell antigen (PSCA) chimeric antigen receptor ("CAR") T technology or MB-105 with COH, for the treatment of prostate cancer. In September 2019, the first patient in a Phase 1 clinical trial in treating patients with prostate stem cell antigen positive (PSCA+) castration resistant prostate cancer was dosed with MB-105, and Mustang recorded an expense of $0.2 million marking the achievement of this milestone in the condensed consolidated statement of operations for the three and nine months ended September 30, 2019.

CD123 License

In February 2017, Mustang entered into an Amended and Restated License Agreement with COH for the development of CD123 or MB-102, ("CD123 License"). In March 2019, COH dosed the 12th patient in its Phase 1 trial treating patients with relapsed/refractory Acute Myeloid Leukemia ("AML") and recorded expense of nil and $0.3 million in the condensed consolidated statement of operations for the three and nine months ended September 30, 2019, respectively.

CS1 License

In February 2017, mustang entered into an exclusive license agreement with the COH for the use of CS1-specific CAR T or MB-104. In May 2019 mustang expensed a non-refundable milestone payment of $0.2 million upon the first patient dosed in a Phase 1 clinical study of CS1 treating patients with relapsed or treatment-resistant multiple myeloma. For the three and nine months ended September 30, 2019, mustang recorded nil and $0.2 million in the condensed consolidated statement of operations related to the CS1 milestone payment.

For the three and nine months ended September 30, 2019 and 2018, Mustang recorded the following expenses in research and development for licenses acquired on the condensed consolidated statement of operations:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 

 

Nine Months Ended September 30, 

($in thousands)

    

2019

    

2018

    

2019

    

2018

City of Hope

 

 

 

 

 

 

 

 

 

 

 

 

CD123

 

$

 —

 

$

 —

 

$

250

 

$

 —

CSI

 

 

 —

 

 

 —

 

 

200

 

 

 —

Manufacturing

 

 

 —

 

 

 —

 

 

 —

 

 

75

PSCA

 

 

200

 

 

 —

 

 

200

 

 

 —

Calimmune

 

 

200

 

 

 —

 

 

200

 

 

 —

UCLA

 

 

300

 

 

 —

 

 

300

 

 

 —

St. Jude-X-SCID

 

 

 —

 

 

1,000

 

 

 —

 

 

1,000

Nationwide Children's Hospital - C134

 

 

 —

 

 

 —

 

 

200

 

 

 —

Total

 

$

700

 

$

1,000

 

$

1,350

 

$

1,075