Quarterly report pursuant to Section 13 or 15(d)

License, Clinical Trial and Sponsored Research Agreements

v3.19.3
License, Clinical Trial and Sponsored Research Agreements
9 Months Ended
Sep. 30, 2019
License, Clinical Trial and Sponsored Research Agreements  
License, Clinical Trial and Sponsored Research Agreements

Note 3 - License, Clinical Trial and Sponsored Research Agreements

Research and Development Expenses - All Licenses

For the three and nine months ended September 30, 2019 and 2018, the Company recorded the following expense in research and development for licenses acquired:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three months ended 

 

For the nine months ended 

 

 

September 30, 

 

September 30, 

($ in thousands)

    

2019

    

2018

    

2019

    

2018

City of Hope

 

 

 

 

 

 

 

 

 

 

 

 

CD123

 

$

 —

 

$

 —

 

$

250

 

$

 —

CS1

 

 

 —

 

 

 —

 

 

200

 

 

 —

Manufacturing

 

 

 —

 

 

 —

 

 

 —

 

 

75

PSCA

 

 

200

 

 

 —

 

 

200

 

 

 —

Calimmune

 

 

200

 

 

 —

 

 

200

 

 

 —

UCLA

 

 

300

 

 

 —

 

 

300

 

 

 —

St. Jude - XSCID

 

 

 —

 

 

1,000

 

 

 —

 

 

1,000

Nationwide Children's Hospital - C134

 

 

 —

 

 

 —

 

 

200

 

 

 —

Total

 

$

700

 

$

1,000

 

$

1,350

 

$

1,075

 

License Agreements

City of Hope

PSCA License (MB-105)

In May 2017, the Company entered into an exclusive license agreement with the City of Hope National Medical Center (“COH”) for the use of prostate stem cell antigen (“PSCA”) chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) technology to be used in the treatment of prostate cancer. Pursuant to this agreement, the Company paid an upfront fee of $0.3 million and pays an annual maintenance fee of $50,000. Additional payments are due for the achievement of ten development milestones totaling $14.9 million and royalty payments in the mid-single digits are due on net sales of licensed products.

In September 2019, the Company expensed a non-refundable milestone payment of $0.2 million upon the first patient dosed in a Phase 1 clinical study of PSCA.

CS1 License (MB-104)

In May 2017, the Company entered into an exclusive license agreement with the COH for the use of CS1-specific CAR T technology. Pursuant to this agreement, the Company paid an upfront fee of $0.6 million and pays an annual maintenance fee of $50,000. Additional payments are due for the achievement of ten development milestones totaling $14.9 million and royalty payments in the mid-single digits are due on net sales of licensed products.

In May 2019 the Company expensed a non-refundable milestone payment of $0.2 million upon the first patient dosed in a Phase 1 clinical study of CS1.

CD123 License (MB-102)

In February 2017, the Company entered into an Amended and Restated Exclusive License Agreement with the COH to acquire intellectual property rights pertaining to CD123-specific CAR T technology. Pursuant to this agreement, the Company and COH acknowledged that an upfront fee was previously paid. In addition, COH is eligible to receive an annual maintenance fee of $25,000 and milestone payments totaling $14.5 million upon the achievement of certain milestones. Royalty payments in the mid-single digits are due on net sales of licensed products.

In the first quarter of 2019, the Company expensed a non-refundable milestone payment of $0.3 million upon the twelfth patient dosed in a Phase 1 clinical study of CD123.

Nationwide Children’s Hospital

In February 2019, Mustang announced that it partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital (“Nationwide”) to develop their C134 oncolytic virus (MB‑108) for the treatment of glioblastoma multiforme (“GBM”). Mustang intends to combine MB‑108 with MB‑101 (IL13Rα2‑specific CAR T) to potentially enhance efficacy in treating GBM. The Company paid $0.2 million in consideration for the license to exclusive, worldwide rights to develop and commercialize products that incorporate data, know-how and/or MB‑108 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.

Calimmune

On August 23, 2019, the Company entered into a Non-Exclusive License Agreement with Calimmune, Inc. (“Calimmune License”) for the rights to the cell bank 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. Pursuant to the terms of the Calimmune License the Company 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 the Company recorded research and development expense of $0.2 million in the condensed statement of operations for the three and nine months ended September 30, 2019.

University of California

On March 17, 2017, the Company entered into an exclusive license agreement with the Regents of the University of California at Los Angeles (“UCLA License”) to acquire intellectual property rights in patent applications related to 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 and we recorded an expense of $0.3 million in the condensed statement of operations for the three and nine months ended September 30, 2019.

Research and Development Expenses - Sponsored Research and Clinical Trial Agreements

For the three and nine months ended September 30, 2019 and 2018, the Company recorded the following expense in research and development for sponsored research and clinical trial agreements:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three months ended September 30, 

 

For the nine months ended September 30, 

 

    

2019

    

2018

    

2019

    

2018

($ in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

City of Hope

 

$

500

  

$

500

 

$

1,500

  

$

1,500

City of Hope - CD123

 

 

269

 

 

123

 

 

1,028

 

 

387

City of Hope - IL13Rα2

 

 

244

 

 

346

 

 

811

 

 

849

City of Hope - Manufacturing

 

 

114

 

 

114

 

 

343

 

 

344

Fred Hutch - CD20

 

 

49

 

 

255

 

 

690

 

 

938

BIDMC - CRISPR

 

 

 —

 

 

69

 

 

69

 

 

69

Total

 

$

1,176

  

$

1,407

 

$

4,441

  

$

4,087