Milestones and Sponsored Research Agreements |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Research and Development [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Milestones and Sponsored Research Agreements |
7. Milestones and Sponsored Research Agreements The Company has a license agreement with the University College London Business PLC (“UCLB”) under which the Company received an exclusive, worldwide license to develop and commercialize CNDO-109 to activate NK cells for the treatment of cancer-related and other conditions. In consideration for the license, the Company made upfront payments totaling $0.1 million and may be required to make future milestone payments totaling up to approximately $22.0 million upon the achievement of various milestones related to regulatory or commercial events In the event that CNDO-109 is commercialized, the Company is obligated to pay to UCLB annual royalties ranging from 3% to 5% based upon various levels of net sales of the product. Under the terms of the license agreement, the Company is allowed to grant sublicenses to third parties without the prior approval of UCLB. In the event that the Company sublicenses CNDO-109 to a third party, the Company is obligated to pay to UCLB all or a portion of the royalties the Company receives from the sub-licensee. Through December 31, 2018, the Company has not sub-licensed CNDO-109 to a third party. 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 year ended December 31, 2018, Aevitas recorded expense of approximately $0.8 million in connection with the UMass SRA. The expense was recorded in research and development expenses in the Company’s 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 year ended December 31, 2018, Aevitas recorded expense of approximately $0.5 million in connection with the UMass SRA. The expense was recorded in research and development expenses in the Company’s 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 year ended December 31, 2018, Caelum recorded expense of approximately $0.1 million in connection with the agreement. The expense was recorded in research and development expense in the Company’s Consolidated Statements of Operations. No expense related to this Agreement was recorded in 2017. 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 year ended December 31, 2018 and 2017 Cellvation recorded an expense of $0.3 million and $0.1 million, respectively, representing amounts due under this arrangement. Checkpoint NeuPharma, Inc. Sponsored Research Agreement 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, 2018 and 2017, approximately $35,000 and $0.6 million, respectively, was recognized in revenue in connection with the Sponsored Research Agreement in the Consolidated Statements of Operations. Helocyte PepVax and Triplex 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”). Under the terms of the agreement, Helocyte made an upfront payment to COH of $1.0 million, recorded as sponsored research expense, and will pay COH up to an additional $2.0 million upon the achievement of certain clinical milestones. Unless earlier terminated, the agreement expires upon the delivery of a final study report or December 31, 2018. 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. In February 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 Triplex immunotherapy for CMV control in allogeneic stem cell transplant recipients (“Triplex Research Agreement”). The Phase 2 study is additionally supported by grants from the NCI. Under the terms of the agreement, Helocyte made an upfront payment to COH of $1.0 million, recorded as sponsored research expense, and will pay COH up to an additional $3.4 million upon the achievement of certain clinical milestones. For the years ended December 31, 2018 and 2017, Helocyte recorded approximately $0.1 million and $3.7 million, consisting of nil and $2.6 million in connection with the Triplex Research Agreement and $0.1 million and $1.1 million in connection with the PepVax Research Agreement and nil, respectively, recorded in research and development expenses in the Company’s Consolidated Statements of Operations in connection with these agreements. 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, 2018 and 2017, Helocyte recorded approximately $1.3 million and $0.2 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, 2018 and 2017 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, CD123 and the Spacer technology. For the year ended December 31, 2018 and 2017, 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. CD 123 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 year ended December 31, 2018 and 2017 Mustang recorded approximately $0.8 million and $1.4 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations. IL13R2 Clinical Research Support Agreement Also, on February 17, 2017, Mustang entered into a Clinical Research Support Agreement for IL13R2 (“IL13R2 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 IL13R2. For the year ended December 31, 2018 and 2017, Mustang recorded approximately $1.1 million and $1.4 million, respectively, in research and development expenses under the IL13R2 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 year ended December 31, 2018 and 2017 Mustang recorded approximately $0.5 million and nil, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations. CD20 Clinical Trial Agreement 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 year ended December 31, 2018 and 2017 Mustang recorded $1.3 million and $0.6 million of expense, respectively, related to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations. CRISPR Sponsored Research Agreement 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. The Company agreed to fund approximately $0.8 million over a three-year period. The Company recorded $0.1 million and $0.1 million in 2018 and 2017, respectively, related to this arrangement related to this agreement in research and development expenses 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 year ended December 31, 2018 and 2017, Tamid recorded expense of $ 0.1 million 0.7 million and $respectively in connection with the UNC SRA. The expense was recorded in research and development expenses in the Company’s Consolidated Statements of Operations.
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