Sponsored Research and Clinical Trial Agreements | 8. Sponsored Research and Clinical Trial Agreements Aevitas In 2018, Aevitas entered into a Sponsored Research Agreement (āSRAā) with the Trustees of the University of Pennsylvania (āUPenn SRAā), as amended in July 2019, for certain continued research and development activities related to the development of adeno-associated virus (āAAVā) gene therapies in complement-mediated diseases. Also in 2018, Aevitas entered into an SRA with the University of Massachusetts (āUMass SRAā), as amended in January 2020, for certain continued research and development activities related to the development of AAV. For the three and nine months ended September 30, 2021 and 2020, Aevitas recorded the following expense in connection with its sponsored research and clinical trial agreements: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the Three Months Ended September 30, ā For the Nine Months Ended September 30, ($ in thousands) 2021 2020 2021 2020 UMass SRA ā $ 17 ā ā 163 ā $ 289 ā $ 218 UPenn SRA ā ā ā ā ā ā ā ā ā ā ā 567 Total ā $ 17 ā $ 163 ā $ 289 ā $ 785 ā ā ā ā ā ā ā ā ā ā ā ā ā ā Mustang For the three and nine months ended September 30, 2021 and 2020, Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements: ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the Three Months Ended September 30, ā For the Nine Months Ended September 30, ($ in thousands) 2021 2020 2021 2020 City of Hope National Medical Center ā $ ā ā $ ā ā $ ā ā $ 500 IL13RĪ±2 (MB-101) ā 199 ā ā 96 ā ā 992 ā ā 422 CD123 (MB-102) ā 24 ā 48 ā 250 ā 344 CS1 (MB-104) ā ā 138 ā ā 65 ā ā 510 ā ā 835 HER2 (MB-103) ā ā 319 ā ā ā ā ā 473 ā ā ā PSCA (MB-105) ā ā 23 ā ā ā ā ā 69 ā ā ā Fred Hutchinson Cancer Research Center - CD20 (MB-106) ā ā 492 ā ā 418 ā ā 1,490 ā ā 1,134 St. Jude Children's Research Hospital - XSCID (MB-107) ā ā 330 ā ā 107 ā ā 610 ā ā 1,665 Mayo Clinic ā ā 231 ā ā ā ā ā 464 ā ā ā Total ā $ 1,756 ā $ 734 ā $ 4,858 ā $ 4,900 ā City of Hope Sponsored Research Agreement ā In March 2015, in connection with Mustangās license with COH for the development of chimeric antigen receptor (āCARā) engineered T cell (āCAR Tā) 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 IL13RĪ±2-directed CAR T program (MB-101), the CD123-directed CAR T program (MB-102), and the Spacer technology. For the nine months ended September 30, 2021 and 2020, Mustang recorded expense of nil and $0.5 million, respectively, in research and development expense in the Companyās unaudited condensed consolidated statement of operations. IL13RĪ±2 (MB-101) Clinical Research Support Agreements In February 2017, Mustang entered into a clinical research support agreement for the IL13RĪ±2-directed CAR T program (the āIL13RĪ±2 CRAā). Pursuant to the terms of the IL13RĪ±2 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 IL13RĪ±2-directed CAR T program. In October 2020, Mustang entered into a clinical research support agreement for the IL13RĪ±2-directed CAR T program for adult patients with leptomeningeal glioblastoma, ependymoma or medulloblastoma (the āIL13RĪ±2 Leptomeningeal CRAā). Pursuant to the terms of the IL13RĪ±2 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 IL13RĪ±2-directed CAR T program. ā In March 2021, Mustang entered into a clinical research support agreement for an Institutional Review Board-approved, investigator-initiated protocol entitled: āSingle Patient Treatment with Intraventricular Infusions of IL13RĪ±2-targeting and HER2-targeting Chimeric Antigen Receptor (CAR)-T cells for a Single Patient (UPN 181) with Recurrent Multifocal Malignant Gliomaā. Pursuant to the terms of this agreement, Mustang will contribute up to $0.2 million in connection with the on-going investigator-initiated study. ā For the three months ended September 30, 2021 and 2020, Mustang recorded $0.2 million and $0.1 million, respectively, pursuant to the terms of these agreements. For the nine months ended September 30, 2021 and 2020, Mustang recorded $1.0 million and $0.4 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 āCD123 CRAā). 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 September 30, 2021 and 2020, Mustang recorded $24,000 and $48,000, respectively, pursuant to the terms of this agreement. For the nine months ended September 30, 2021 and 2020, Mustang recorded $0.3 million and $0.3 million, respectively, pursuant to the terms of this agreement. CS1 (MB-104) Clinical Research and Support Agreement 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: āPhase 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.ā 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 September 30, 2021 and 2020, Mustang recorded $0.1 million and $0.1 million, respectively, pursuant to the terms of this agreement. For the nine months ended September 30, 2021 and 2020, Mustang recorded $0.5 million and $0.8 million, respectively, pursuant to the terms of this agreement. ā 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: āPhase 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.ā 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 nine months ended September 30, 2021, Mustang recorded $0.3 million and $0.5 million, respectively, pursuant to the terms of this agreement. ā 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: āA Phase 1b study to evaluate PSCA-specific chimeric antigen receptor (CAR)-T cells for patients with metastatic castration resistant prostate cancer.ā 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 three months ended September 30, 2021 and 2020, Mustang recorded approximately $23,000 and nil, respectively, pursuant to the terms of this agreement. For the nine months ended September 30, 2021 and 2020, Mustang recorded $0.1 million and nil, respectively, pursuant to the terms of this agreement. ā 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 (āFred Hutchā), Mustang entered into an investigator-initiated clinical trial agreement (the āCD20 CTAā) 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 September 30, 2021 and 2020, Mustang recorded $0.5 million and $0.4 million, respectively, pursuant to the terms of this agreement. For the nine months ended September 30, 2021 and 2020, Mustang recorded $1.5 million and $1.1 million, respectively, pursuant to the terms of this agreement. XSCID (MB-107) Data Transfer Agreement with St. Jude Childrenās Research Hospital In June 2020, Mustang entered into a Data Transfer Agreement with St. Jude Childrenās Research Hospital (āSt. Judeā) under which Mustang will reimburse St. Jude for costs associated with St. Judeās clinical trial for the treatment of infants with X-linked severe combined immunodeficiency (āXSCIDā). 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 September 30, 2021 and 2020, Mustang recorded $0.3 million and $0.1 million, respectively, pursuant to the terms of this agreement. For the nine months ended September 30, 2021 and 2020, Mustang recorded $0.6 million and $1.7 million, respectively, pursuant to the terms of this agreement. ā Sponsored Research Support Agreement with Mayo Clinic In June 2021, Mustang entered into an SRA with the Mayo Clinic in which Mustang will fund research in the amount of $2.1 million over a period of two years. The research performed pursuant to this agreement will support technology Mustang has licensed from Mayo Clinic for a novel technology that may be able to transform the administration of CAR T therapies and has the potential to be used as an off-the-shelf therapy. For the three and nine months ended September 30, 2021, Mustang recorded $0.2 million and $0.5 million, respectively, in research and development expenses pursuant to the terms of this agreement. ā ā ā Oncogenuity ā ā ā ā ā ā ā ā ā ā ā ā ā ā ā For the Three Months Ended September 30, ā For the Nine Months Ended September 30, ($ in thousands) 2021 2020 2021 2020 Columbia ā $ 187 ā $ 125 ā $ 562 ā $ 250 Oxford ā ā 91 ā ā ā ā ā 265 ā ā ā McCormick Labs ā ā 56 ā ā ā ā ā 178 ā ā ā Total ā $ 334 ā $ 125 ā $ 1,005 ā $ 250 ā 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 (āColumbiaā) in May 2020, to develop novel oligonucleotides for the treatment of genetically driven cancers (the āColumbia SRAā), 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 September 30, 2021 and 2020, Oncogenuity recorded expense of $0.2 million and $0.1 million, respectively; and $0.6 million and $0.3 million, respectively, for the nine months ended September 30, 2021 and 2020. The Chancellor Masters and Scholars of the University of Oxford Sponsored Research Agreement ā In December 2020, Oncogenuity entered into a Sponsored Research Agreement with The Chancellor Masters and Scholars of the University of Oxford, (the āOxford SRAā). For the three and nine months ended September 30, 2021, Oncogenuity recorded expense of $0.1 million and $0.3 million, respectively, in research and development in the Companyās unaudited condensed consolidated statement of operations. No expense was recorded in 2020. The Regents of the University of California Sponsored Research Agreement ā In December 2020, Oncogenuity entered into a SRA with The Regents of the University of California, with Frank McCormick PhD, FRS as principal investigator (āMcCormick SRAā). For the three and nine months ended September 30, 2021Oncogenuity recorded expense of $0.1 million and $0.2 million, respectively, in research and development in the Companyās unaudited condensed consolidated statement of operations. No expense was recorded in 2020. |