8. 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 years ended December 31, 2019 and 2018, Aevitas recorded expense of approximately nil and $0.8 million, respectively, in connection with the UMass SRA. The expense was recorded in research and development expenses in the Company’s Consolidated Statements of Operations.

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 years ended December 31, 2019 and 2018, Aevitas recorded expense of approximately $1.1 million and $0.5 million, respectively, in connection with the UPenn SRA. The expense was recorded in research and development expenses in the Company’s Consolidated Statements of Operations.

On September 1, 2019, Aevitas entered into a Sponsored Research Arrangement (“SRA”) with Duke University School of Medicine (“Duke”). For the year ended December 31, 2019, Aevitas recorded approximately $0.1 million for the purpose of conducting a study to identify a dose range for AAV8 vectors in Dry Age-related Macular Degeneration (“Dry AMD”) in research and development expense on the consolidated statement of operations.  No expense related to this SRA was recorded in 2018.

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 year ended December 31, 2018, Caelum recorded expense of approximately $0.1 million in connection with the agreement in research and development expense in the Company’s Consolidated Statements of Operations.  In January 2019, in connection with the Alexion DOSPA  the Company ceased to consolidate Caelum (see Note 4).

Cellvation

In October 2016, Cellvation entered research funding agreement with the University of Texas in connection with the license for a method and apparatus for conditioning cell populations for cell therapies. In connection with this agreement Cellvation agreed to fund $0.8 million of research quarterly through March 31, 2018. The agreement was revised effective May 1, 2017, with quarterly payments extended through December 31, 2018. For the years ended December 31, 2019 and 2018, Cellvation recorded an expense of $0.1 million and $0.3 million, respectively, representing amounts due under this arrangement.

Checkpoint

In connection with its license agreement with NeuPharma, Checkpoint entered into a Sponsored Research Agreement with NeuPharma for certain research and development activities. Effective January 11, 2016, TGTX, a related party, agreed to assume all costs associated with this Sponsored Research Agreement and paid Checkpoint for all amounts previously paid by the Company. For the year ended December 31, 2019 and 2018, approximately nil and $35,000, respectively, was recognized in revenue from a related party in connection with the Sponsored Research Agreement in the Consolidated Statements of Operations.

Helocyte

PepVax Clinical Research and Support Agreements

In March 2016, Helocyte entered into an Investigator-Initiated Clinical Research Support Agreement, as amended, with the COH, to support a Phase 2 clinical study of its PepVax immunotherapy for CMV control in allogeneic stem cell transplant recipients (“PepVax Research Agreement”). The Phase 2 study is additionally supported by grants from the National Institutes of Health/National Cancer Institute (“NCI”). During 2018, Helocyte elected to discontinue the further development of its HLA-restricted, single-antigen PepVax program and as such ceased to incur costs associated with this program. For the years ended December 31, 2019 and 2018, Helocyte recorded nil and $0.1 million, respectively, in connection with the PepVax Research Agreement, recorded in research and development expenses in the Company’s Consolidated Statements of Operations. In 2018 Helocyte discontinued the development of PepVax and terminated this arrangement.

ConVax (Pentamer) Sponsored Research Agreement

On May 1, 2017, Helocyte and COH entered in a Sponsored Research Agreement for preclinical studies in connection with the development of ConVax. In June 2017, Helocyte made an upfront payment of $1.5 million to fund the development plan, the payment was recorded as a prepayment on the Consolidated Balance Sheets. For the years ended December 31, 2019 and 2018, Helocyte recorded approximately nil and $1.3 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations. This agreement expired during 2018.

Mustang

For the years ended December 31, 2019 and 2018 Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements:

 

 

City of Hope Sponsored Research Agreement

In March 2015, in connection with Mustang’s license with COH for the development of CAR T, Mustang entered into a Sponsored Research Agreement in which Mustang will fund continued research in the amount of $2.0 million per year, payable in four equal annual installments, until 2020. The research covered under this arrangement is for IL13Rα2 (MB-101), CD123 (MB-102) and the Spacer technology. For the years ended December 31, 2019 and 2018, Mustang incurred expense of $2.0 million and $2.0 million, respectively and recorded as research and development expense in the Company’s Consolidated Statement of Operations.

CD123 (MB-102) Clinical Research Support Agreement

On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for CD123. Pursuant to the terms of this agreement, Mustang made an upfront payment of approximately $20,000 and will contribute an additional $0.1 million per patient in connection with the on-going investigator-initiated study. Further, Mustang agreed to fund approximately $0.2 million over three years pertaining to the clinical development of CD123. For the years ended December 31, 2019 and 2018 Mustang recorded approximately $1.2 million and $0.8 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations.

IL13Rα2 (MB-101) Clinical Research Support Agreement

Also, on February 17, 2017, Mustang entered into a Clinical Research Support Agreement for IL13Rα2 (“IL13Rα2 CRA”). Pursuant to the terms of this agreement Mustang made an upfront payment of approximately $9,300 and will contribute an additional $0.1 million per patient in connection with the on-going investigator-initiated study. Further, Mustang agreed to fund approximately $0.2 million over three years pertaining to the clinical development of IL13Rα2. For the years ended December 31, 2019 and 2018, Mustang recorded approximately $0.9 million and $1.1 million, respectively, in research and development expenses under the IL13Rα2 CRA in the Company’s Consolidated Statements of Operations.

City of Hope Sponsored Research Agreement - Manufacturing

On January 3, 2018, Mustang entered into a Sponsored Research Agreement with COH to optimize and develop CAR T cell processing procedures. Pursuant to the SRA, the Company will fund continued research in the amount of $0.9 million for the program, which has an initial term of two  (2) years. For the years ended December 31, 2019 and 2018 Mustang recorded approximately $0.5 million and $0.5 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations.

CRISPR Sponsored Research Agreement with Beth Israel Deaconess Medical Center, Inc.

On November 28, 2017, Mustang entered into a Sponsored Research Agreement with Beth Israel Deaconess Medical Center Inc. (“BIDMC”) to perform research relating to gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of chimeric antigen receptor T (CAR T) cell therapies for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and solid tumor indications. Mustang agreed to fund approximately $0.8 million over a three-year period. Mustang recorded $0.1 million and $0.1 million in 2019 and 2018, respectively, related to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations.  The CRISPR license was terminated in 2019, see Note 7.

CD20 (MB-106) Clinical Trial Agreement with Fred Hutch

Also, on July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutch, Mustang entered into an investigator-initiated clinical trial agreement (“CD20 CTA”) to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 Technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. In connection with the CD20 CTA, Mustang agreed to fund up to $5.3 million of costs associated with the clinical trial, which commenced during the fourth quarter of 2017. For the years ended December 31, 2019 and 2018 Mustang recorded $0.8 million and $1.3 million of expense, respectively, related to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations.

MB-107 (XSCID) Non-International Services Agreement with St. Jude

In December 2019, Mustang entered into a Non-Interventional Services Agreement with Children's CGMP, LLC ("CGMP"), an affiliate of St. Jude Children's Research Hospital, pursuant to which CGMP provides lentiviral vector for non-clinical XSCID research purposes, as well as related advisory services. Mustang agreed to fund approximately $0.8 million upon execution of the agreement, which was recorded in research and development expenses for the year ended December 31, 2019 in the Company's 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 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 years ended December 31, 2019 and 2018, Tamid recorded expense of nil and $0.7 million respectively in connection with the UNC SRA. The expense was recorded in research and development expenses in the Company’s Consolidated Statements of Operations. Effective December 2019, Tamid returned the license to UNC and ceased to incur costs associated with the development of products under this license.