Quarterly report pursuant to Section 13 or 15(d)

Sponsored Research and Clinical Trial Agreements

v3.8.0.1
Sponsored Research and Clinical Trial Agreements
3 Months Ended
Mar. 31, 2018
Research and Development [Abstract]  
Research, Development, and Computer Software Disclosure
9. Sponsored Research and Clinical Trial Agreements
 
Aevitas
 
On January 25, 2018, Aevitas entered into a Sponsored Research Agreement with the University of Massachusetts (“UMass SRA”) for certain continued research and development activities related to the development of adeno-associated virus (“AAV”) gene therapies in complement-mediated diseases. The total amount to be funded by Aevitas under the UMass SRA is $0.8 million. Pursuant to the terms of the UMass SRA, Aevitas paid $0.8 million which was due upon execution. For the three months ended March 31, 2018, Aevitas recorded expense of $0.1 million in connection with the UMass SRA. The expense was recorded in research and development expenses in the Company’s Condensed Consolidated Statements of Operations.
 
Caelum
 
On March 12, 2018, Caelum entered into a Sponsored Research Agreement with Columbia University to conduct preclinical research in connection with CAEL 101. The total cost of the study approximates $0.1 million. For the three months ended March 31, 2018 and 2017, respectively, Caelum recorded expense of approximately $11,000 and nil, respectively in connection with the agreement. The expense was recorded in research and development expense in the Condensed Consolidated Statements of Operations.
 
Cellvation
 
For the three months ended March 31, 2018 and 2017, respectively, Cellvation recorded expense of $82,500 and nil, respectively in connection with its sponsored research arrangement with the University of Texas. The expense was recorded in research and development expense in the Condensed Consolidated Statements of Operations.
 
Checkpoint
 
In connection with its license agreement with NeuPharma, Inc. (“NeuPharma”), Checkpoint entered into a Sponsored Research Agreement with NeuPharma for certain research and development activities and subsequently entered into an agreement with TGTX, a related party, to assume all costs associated with this Sponsored Research Agreement, including all amounts previously paid by the Company. For the three months ended March 31, 2018 and 2017, approximately $31,000 and $0.2 million, respectively, was recognized in research and development expense in connection with the Sponsored Research Agreement in the Condensed Consolidated Statements of Operations.
 
In addition, for the three months ended March 31, 2018 and 2017, approximately $31,000 and $0.2 million, respectively, was recognized in revenue in connection with the Sponsored Research Agreement in the Condensed Consolidated Statements of Operations.
 
Helocyte
 
The table below provides a summary of Helocyte’s expense related to its clinical research arrangements, for the three months ended March 31, 2018 and 2017, by agreement as recorded in the Condensed Consolidated Statements of Operations:
 
($ in thousands)
 
For the three months ended March 31
 
 
 
2018
 
2017
 
COH Triplex clinical research and support
 
$
–
 
$
500
 
COH PepVax clinical research and support
 
 
–
 
 
235
 
Total licenses acquired expense
 
$
–
 
$
735
 
 
During the first quarter of 2018, Helocyte elected to discontinue the further development of its HLA-restricted, single-antigen PepVax program and as such will cease to incur costs associated with this program.
 
Mustang
 
The table below provides a summary of Mustang’s expense related to its sponsored research agreements, for the three months ended March 31, 2018 and 2017, by license as recorded in the Condensed Consolidated Statements of Operations:
 
($ in thousands)
 
For the three months ended March 31
 
 
 
2018
 
2017
 
COH CAR T
 
$
500
 
$
500
 
COH - CD123
 
 
150
 
 
20
 
COH - IL13Ra2
 
 
360
 
 
9
 
City of Hope - Manufacturing
 
 
114
 
 
–
 
Fred Hutch - CD20
 
 
266
 
 
 
 
Total
 
$
1,390
 
$
529
 
 
COH Sponsored Research Arrangement Related to Manufacturing Methods
 
On January 3, 2018, in connection with the Manufacturing License, Mustang entered into a Sponsored Research Agreement (the “Manufacturing SRA”) with COH in connection with the optimization and development of CAR T cell manufacturing processes and procedures. Pursuant to the terms of Manufacturing SRA, Mustang paid $0.9 million to fund the research program thereunder, which has an initial term of two (2) years. For the three months ended March 31, 2018 Mustang recorded approximately $0.1 million, in research and development expenses in the Company’s Condensed Consolidated Statements of Operations. Additionally, Mustang recorded the upfront payment of $0.9 million as an asset in the Company’s Condensed Consolidated Balance Sheets.
 
Fred Hutch Sponsored Research Agreement Related to the Manufacturing Process
 
On March 17, 2018, due to Fred Hutch’s operation of a process development research organization whose primary focus is on the development and optimization of processes and systems associated with the manufacture of cellular therapies, Mustang entered into a Sponsored Research Agreement (the “Fred Hutch Manufacturing SRA”) with Fred Hutch in order to conduct a research program titled “Optimization of the anti-CD20 CART (Protocol 9738) manufacturing process.” Pursuant to the terms of the Fred Hutch Manufacturing SRA, Mustang will fund $0.6 million for the research program thereunder, which has an initial term of one year. For the three months ended March 31, 2018 Mustang recorded approximately $12,000, in research and development expenses in the Company’s Condensed Consolidated Statements of Operations. 
 
Tamid
 
On November 30, 2017, in connection with its three separate license agreements with UNC, Tamid entered into a Sponsored Research Agreement with UNC (“UNC SRA”) for certain continued research and development activities related to Nanodysferlin for treatment of Dysferlinopathy, and AAV-HLA-G for ocular diseases. Total amount to be funded by Tamid under the UNC SRA is $2.3 million over a term of three years. Pursuant to the terms of the UNC SRA, Tamid paid $0.8 million which was due upon execution. For the three months ended March 31, 2018, Tamid recorded expense of $0.2 million in connection with the UNC SRA. The expense was recorded in research and development expenses in the Company’s Condensed Consolidated Statements of Operations.