Fortress Biotech, Inc. Quarterly report pursuant to Section 13 or 15(d)

Quarterly report pursuant to Section 13 or 15(d)

Sponsored Research and Clinical Trial Agreements

Sponsored Research and Clinical Trial Agreements

9 Months Ended

Sep. 30, 2018

Research and Development [Abstract]

Research, Development, and Computer Software Disclosure

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 and nine months ended September 30, 2018, Aevitas recorded expense of approximately $0.2 million and $0.6 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. No expense related to this Agreement was recorded in 2017.

On July 24, 2018, Aevitas entered into a Sponsored Research Agreement with the Trustees of the University of Pennsylvania (“UPenn SRA”) for certain continued research and development activities related to the development of AAV gene therapies in complement-mediated diseases. The total amount to be funded by Aevitas under the UPenn SRA is $2.0 million. Pursuant to the terms of the UPenn SRA, Aevitas paid $0.3 million which was due upon execution. For the three and nine months ended September 30, 2018, Aevitas recorded expense of approximately $0.3 million and $0.3 million in connection with

the UPenn SRA. The

expense was recorded in research and development expenses in the Company’s Condensed Consolidated Statements of Operations. No expense related to this Agreement was recorded in 2017.

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 and nine months ended September 30, 2018, Caelum recorded expense of approximately $27,000 and $0.1 million, respectively in connection with the agreement. The expense was recorded in research and development expense in the

Company’s

Condensed Consolidated Statements of Operations.

Cellvation

For the three and nine months ended September 30, 2018 and 2017, respectively, Cellvation recorded expense of $0.1 million and $0.2 million and $0.1 million 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

Company’s

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 and nine months ended September 30, 2018 and 2017, approximately nil and approximately $0.1 million and $31,000 and $0.5 million, respectively, was recognized in research and development revenue in connection with the Sponsored Research Agreement in the

Company’s

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 and nine months ended September 30, 2018 and 2017, by agreement as recorded in the Condensed Consolidated Statements of Operations:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
($ in thousands)	2018		2017		2018		2017
COH Triplex clinical research and support	$	–	$	1,300	$	–	$	2,335
COH PepVax clinical research and support		–		327		–		561
COH Pentamer clinical research and support		113		12		317		24
Total licenses acquired expense	$	113	$	1,639	$	317	$	2,920

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

and clinical trial

agreements, for the three and nine months ended September 30, 2018 and 2017, by license as recorded in the Condensed Consolidated Statements of Operations:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
($ in thousands)	2018		2017		2018		2017
COH CAR T	$	500	$	500	$	1,500	$	1,500
COH - CD123		123		642		387		1,237
COH - IL13Rα2		346		194		849		1,204
City of Hope - Manufacturing		114		-		344		-
Fred Hutch – CD20		255		88		938		88
BIDMC – CRISPR		69		–		69		–
Total	$	1,407	$	1,424	$	4,087	$	4,029

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

corneal transplant rejection.

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 and nine months ended September 30, 2018, Tamid recorded expense of $0.2 million and $0.6 million, respectively in connection with the UNC SRA. The expense was recorded in research and development expenses in the Company’s Condensed Consolidated Statements of Operations.