8. Sponsored Research and Clinical Trial Agreements

Aevitas

In 2018, Aevitas entered into a Sponsored Research Agreement (“SRA”) with the Trustees of the University of Pennsylvania (“UPenn SRA”), as amended in July 2019, for certain continued research and development activities related to the development of adeno-associated virus (“AAV”) gene therapies in complement-mediated diseases. Also in 2018, Aevitas entered into an SRA with the University of Massachusetts (“UMass SRA”), as amended in January 2020, for certain continued research and development activities related to the development of AAV. For the three and six months ended June 30, 2021 and 2020, Aevitas recorded the following expense in connection with its sponsored research and clinical trial agreements:

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Mustang

For the three and six months ended June 30, 2021 and 2020, Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements:

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City of Hope Sponsored Research Agreement

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In March 2015, in connection with Mustang’s license with COH for the development of chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) technology, Mustang entered into a SRA in which Mustang was to fund continued research in the amount of $2.0 million per year, payable in four equal annual installments, through the first quarter of 2020. The research covered under this arrangement is for the IL13Rα2-directed CAR T program (MB-101), the CD123-directed CAR T program (MB-102), and the Spacer technology. For the  six months ended June 30, 2021 and 2020, Mustang recorded expense of nil and $0.5 million, respectively, in research and development expense in the Company’s condensed consolidated statement of operations.

IL13Rα2 (MB-101) Clinical Research Support Agreements

In February 2017, Mustang entered into a clinical research support agreement for the IL13Rα2-directed CAR T program (the “IL13Rα2 CRA”). Pursuant to the terms of the IL13Rα2 CRA, Mustang made an upfront payment of approximately $9,300 and will contribute an additional $0.1 million related to patient costs 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 the IL13Rα2-directed CAR T program.

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In October 2020, Mustang entered into a clinical research support agreement for the IL13Rα2-directed CAR T program for adult patients with leptomeningeal glioblastoma, ependymoma or medulloblastoma (the “IL13Rα2 Leptomeningeal CRA”). Pursuant to the terms of the IL13Rα2 Leptomeningeal CRA, Mustang made an upfront payment of approximately $29,000 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 annually pertaining to the clinical development of the IL13Rα2-directed CAR T program.

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In June 2021, Mustang entered into a clinical research support agreement for an Institutional Review Board-approved, investigator-initiated protocol entitled: “Single Patient Treatment with Intraventricular Infusions of IL13Rα2-targeting and HER2-targeting Chimeric Antigen Receptor (CAR)-T cells for a Single Patient (UPN 181) with Recurrent Multifocal Malignant Glioma”. Pursuant to the terms of this agreement, Mustang will contribute up to $0.2 million in connection with the on-going investigator-initiated study.

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For the three months ended June 30, 2021 and 2020, Mustang recorded $0.3 million and $0.2 million, respectively, pursuant to the terms of these agreements. For the six months ended June 30, 2021 and 2020, Mustang recorded $0.8 million and $0.3 million, respectively, pursuant to the terms of these agreements.

CD123 (MB-102) Clinical Research Support Agreement

In February 2017, Mustang entered into a clinical research support agreement for the CD123-directed CAR T program (the “CD123 CRA”). Pursuant to the terms of the CD123 CRA, Mustang made an upfront payment of $19,450 and will contribute an additional $97,490 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 the CD123-directed CAR T program. For the three months ended June 30, 2021 and 2020, Mustang recorded $0.1 million and $0.1 million, respectively, pursuant to the terms of this agreement. For the six months ended June 30, 2021 and 2020, Mustang recorded $0.2 million and $0.3 million, respectively, pursuant to the terms of this agreement.

CS1 (MB-104) Clinical Research and Support Agreement with COH

In June 2020, Mustang entered into a clinical research and support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients with CS1+ Multiple Myeloma.” Under the terms of the agreement Mustang paid COH $0.8 million for costs incurred and will reimburse COH for costs associated with this trial, when incurred, not to exceed $2.4 million. The agreement will expire upon the delivery of a final study report or earlier. For the three months ended June 30, 2021 and 2020, Mustang recorded $0.2 million and $0.8 million, respectively, pursuant to the terms of this agreement. For the six months ended June 30, 2021 and 2020, Mustang recorded $0.4 million and $0.8 million, respectively, pursuant to the terms of this agreement.

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HER2 (MB-103) Clinical Research Support Agreement

In September 2020, Mustang entered into a clinical research support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “Phase I Study of Cellular Immunotherapy using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients with Recurrent/Refractory Malignant Glioma.” Under the terms of the agreement Mustang paid COH $29,375 upon execution and will reimburse COH for costs associated with this trial not to exceed $3.0 million. The agreement will expire upon the delivery of a final study report or earlier. For the three and six months ended June 30, 2021, Mustang recorded $0.0 million and $0.1 million, respectively, pursuant to the terms of this agreement.

PSCA (MB-105) Clinical Research Support Agreement

In October 2020, Mustang entered into a clinical research support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “A Phase 1b study to evaluate PSCA-specific chimeric antigen receptor (CAR)-T cells for patients with metastatic castration resistant prostate cancer.” Under the terms of the agreement Mustang paid COH $33,000 upon execution and will reimburse COH for costs associated with this trial not to exceed $2.3 million.  The agreement will expire upon the delivery of a final study report or earlier. For the six months ended June 30, 2021 and 2020, Mustang recorded $0.1 million and nil, respectively, pursuant to the terms of this agreement.

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CD20 (MB-106) Clinical Trial Agreement with Fred Hutchinson Cancer Research Center

On July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutchinson Cancer Research Center (“Fred Hutch”), Mustang entered into an investigator-initiated clinical trial agreement (the “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. In November 2020, the CD20 CTA was amended to include additional funding of approximately $0.8 million for the treatment of five patients with chronic lymphocytic leukemia. For the three months ended June 30, 2021 and 2020, Mustang recorded $0.3 million and $0.2 million, respectively, pursuant to the terms of this agreement. For the six months ended June 30, 2021 and 2020, Mustang recorded $1.0 million and $0.7 million, respectively, pursuant to the terms of this agreement.

XSCID (MB-107) Data Transfer Agreement with St. Jude Children’s Research Hospital

In June 2020, Mustang entered into a Data Transfer Agreement with St. Jude Children’s Research Hospital (“St. Jude”) under which Mustang will reimburse St. Jude for costs associated with St. Jude’s clinical trial for the treatment of infants with X-linked Severe Combined Immunodeficiency (“XSCID”).  Pursuant to the terms of this agreement Mustang paid an upfront fee of $1.1 million on July 1, 2020, and will continue to reimburse St. Jude for costs incurred in connection with this trial. For the three months ended June 30, 2021 and 2020, Mustang recorded $0.2 million and $1.6 million, respectively, pursuant to the terms of this agreement. For the six months ended June 30, 2021 and 2020, Mustang recorded $0.3 million and $1.6 million, respectively, pursuant to the terms of this agreement.

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Mayo Foundation for Medical Education and Research

In June 2021, Mustang entered into an SRA with the Mayo Clinic in which the Company will fund research in the amount of $2.1 million over a period of two years. The research covered under this arrangement is to process the development of the in-situ CAR-T technology. For the three and six months ended June 30, 2021, Mustang recorded $0.2 million in expense pursuant to the terms of this agreement.

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Oncogenuity

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Columbia Sponsored Research Agreement

Pursuant to the terms of a SRA entered into with the Trustees of Columbia University in the City of New York (“Columbia”) in May 2020, to develop novel oligonucleotides for the treatment of genetically driven cancers (the “Columbia SRA”), Oncogenuity will make semi-annual research payments to Columbia semiannually for five years ending in November 2024, such payments not to exceed $4.8 million. For the three months ended June 30, 2021, Oncogenuity recorded expense of $0.2 million and $0.1 million, respectively, for the three months ended June 30, 2021 and 2020 and $0.4 million and $0.1 million, respectively, for the six months ended June 30, 2021 and 2020.

The Chancellor Masters and Scholars of the University of Oxford Sponsored Research Agreement

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In December 2020, Oncogenuity entered into a Sponsored Research Agreement with The Chancellor Masters and Scholars of the University of Oxford, (the “Oxford SRA”). For the three and six months ended June 30, 2021, Oncogenuity recorded expense of $0.1 million and $0.2 million, respectively, in research and development in the Company’s condensed consolidated statement of operations. No expense was recorded in 2020.

The Regents of the University of California Sponsored Research Agreement

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In December 2020, Oncogenuity entered into a SRA with The Regents of the University of California, with Frank McCormick PhD, FRS as principal investigator (“McCormick SRA”). For the three and six months ended June 30, 2021 Oncogenuity recorded expense of $0.1 million and $0.1 million, respectively, in research and development in the Company’s condensed consolidated statement of operations. No expense was recorded in 2020.