Research and License Agreements | 7. Research and License Agreements California Institute of Regenerative Medicine Grants In January 2017, the Company was awarded a research grant from the California Institute of Regenerative Medicine (“CIRM”). The CIRM grant stipulates various milestone-based payments to the Company with the total award of $10.2 million over a period of four years. During the year ended December 31, 2019, the Company received $2.0 million related to this grant. As of December 31, 2019 and 2018, the Company had received $9.2 million and $7.2 million under the award, respectively. In November 2017, the Company was awarded a second research grant from CIRM for a separate clinical trial study. The total amount of the research grant awarded was $5.0 million in various milestone-based payments over a period of five years. During 2018, the award was amended to $3.2 million in various-milestone payments over a period of five years, as was provided for under the terms of the original award because the Company opted not to expand the patient population participating in the study. In July 2019, the award was further amended to include the patient population expansion that the Company previously opted out of in 2018. In connection with the same, the award was reinstated to $5.0 million consistent with the original award amount. During the year ended December 31, 2019, the Company received $1.2 million related to this grant with an additional $0.7 million receivable as of December 31, 2019 that was recorded within prepaid expenses and other current assets. As of December 31, 2019 and 2018, the Company had received $3.6 million and $2.4 million under the award, respectively. Under the terms of the CIRM grants, the Company is obligated to pay royalties and licensing fees based on a low single digit royalty percentage on net sales of CIRM-funded product candidates or CIRM-funded technology. The Company has the option to decline any and all amounts awarded by CIRM. As an alternative to royalty payments, the Company has the option to convert the award to a loan. No such election has been made as of the date of the issuance of these financial statements. In the event that the Company terminates a CIRM-funded clinical trial, it will be obligated to repay any remaining unspent CIRM funds. Leukemia & Lymphoma Society Grants In March 2017, the Company entered into an agreement with the LLS, as amended in June 2018 to include an additional study. The LLS research grant stipulates various milestone-based payments with a total award of $4.2 million through December 2019. During the year ended December 31, 2019, the Company received $0.3 million related to this grant. As of December 31, 2019 and 2018, the Company had received $4.2 million and $3.9 million under the award, respectively. The Company could be required in the future to pay amounts to LLS upon reaching certain development and regulatory approval milestones as well as a low single digit percentage royalty rate on net sales, up to a maximum of $13.7 million in total. In July 2019, the Company entered into an amendment to its agreement with LLS to further advance the treatment of myelodysplastic syndromes (“MDS”). Under the amendment, the Company is eligible for up to $3.0 million in additional grant funding based on milestone payments from LLS upon the achievement of certain clinical or regulatory milestones in addition to the $4.2 million award that the Company has received pursuant to the March 2017 agreement, as amended. As of December 31, 2019, the Company had not received any funding related to this grant. Pursuant to the amendment, the Company could be required in the future to pay amounts to LLS upon reaching certain development and regulatory approval milestones on the additional funding, up to a maximum of $6.0 million in the aggregate. The Company concluded that the contingent milestone payments in its agreement with LLS, as amended, represent a contingent repayment obligation and the Company recorded a liability for the contingent payment obligation of approximately $2.9 million and $0.3 million as of December 31, 2019 and 2018. The value of the contingent repayment obligation was estimated using a valuation model designed to estimate the probability of the occurrence of such contingent milestone payments and incorporating estimated success rates. Estimated payments were then discounted using present value techniques. Significant inputs to the valuation include the discount rate, changes in the assumed achievement or timing of development milestones, changes in the probability of certain clinical events, and changes in the probability of regulatory approval. The Company recognizes research grants as a reduction of research and development expense when the eligible costs are incurred. Under both CIRM and LLS grants, the Company recognized a total of $3.1 million and $8.0 million as a reduction to research and development expenses for research grants for the years ended December 31, 2019 and 2018, respectively. Master Combination Study Agreement with Genentech, Inc. In November 2017, the Company entered into a master clinical trial collaboration agreement with Genentech to evaluate the safety, tolerability and preliminary efficacy of magrolimab combined with Genentech’s cancer immunotherapy, atezolizumab, a fully humanized monoclonal antibody targeting PD-L1, in two separate Phase 1b clinical trials (in patients with bladder cancer and AML, respectively). Pursuant to the agreement, the Company will supply magrolimab for the studies and will partially reimburse Genentech for its costs in connection with the bladder cancer study, and Genentech will supply atezolizumab for the studies and be solely responsible for all of its costs in connection with the AML study. Merck Collaboration Agreement In January 2018, the Company entered into a clinical trial collaboration and supply agreement with Ares Trading S.A, a subsidiary of Merck KGaA (“Merck”), to evaluate magrolimab combined with Merck’s cancer immunotherapy, avelumab, in a Phase 1b clinical trial in patients with ovarian cancer. Pursuant to the agreement, the parties will jointly pay for the cost of the study. As of December 31, 2019, the Company recorded a receivable of $0.3 million from Merck for reimbursement of research and development costs incurred. Reimbursement under this collaboration agreement is recorded as a reduction to research and development expense. For the years ended December 31, 2019 and 2018, the Company recognized $1.7 million and $1.2 million, respectively, as a reduction to research and development expenses under this collaboration agreement. BliNK Purchase Agreement In June 2018, the Company entered into an asset purchase agreement with BliNK Biomedical SAS (“Blink”), under which Blink transferred its patents, intellectual property rights and know-how, and materials related to its CD47 antibody program to the Company. Under the agreement, the Company paid an initial upfront fee of $2.5 million in June 2018, including $0.5 million upon the completion of the transfer of intellectual property rights and know-how. An additional $0.5 million was paid in July 2018 upon completion of material transfers related to its CD47 antibody program to the Company. Additionally, the Company is required to make annual payments of $0.3 million until it receives marketing approval for the first product. The Company could also be required to pay up to $43.0 million in milestone payments in aggregate per product based on the achievement of certain development and regulatory approval milestones. No such milestone payments have been made as of December 31, 2019. In addition, the Company could be required to pay Blink a royalty of single digit percentage on net sales of approved products, which is subject to buy-out provisions for a one-time payment that can be exercised by the Company prior to certain development milestones being achieved. During the year ended December 31, 2019 and 2018, the Company recognized $0.3 million and $3.0 million in research and development expense related to the Blink asset purchase agreement, respectively. Synthon License Agreement In July 2018, the Company entered into a settlement and license agreement with Synthon Biopharmaceuticals B.V. (“Synthon”). Under the agreement, the Company agreed to discontinue its ongoing oppositions and challenges at the European Patent Office (“EPO”) and the U.S. Patent and Trademark Office (“USPTO”) directed towards certain patents licensed by Synthon from Stichting Sanquin Bloedvoorziening (“SSB”) that relate to the use of anti-CD47 products in combination with other antibodies to treat cancer. The Company also agreed to request the withdrawal of such proceedings with the USPTO and EPO. In return Synthon agreed to grant the Company a non-exclusive, worldwide sublicense to certain patents Synthon have licensed from SSB, including the SSB patents the Company was opposing at the USPTO and EPO to commercialize a single anti-CD47 product (such as magrolimab or an alternate anti-CD47 product) to treat cancer in combination with other antibodies. In exchange, for these sublicenses and option rights, the Company agreed to pay Synthon an aggregate of up to approximately 40.0 million Euros comprising an upfront payment upon grant of sublicense and the achievement of future regulatory and commercial milestones which comprise the significant majority of the aggregate payments. The Company also has an option to expand its rights to cover a follow-on anti-CD47 product in exchange for a specified option exercise fee. If the Company exercises its option right, the Company will pay Synthon additional amounts upon the achievement of certain regulatory and commercial milestones related to such follow-on anti-CD47 product. In addition, the Company will be required to pay Synthon an annual license fee and a royalty of a tiered, low single digit percentage on net sales of any approved licensed products. The Company has the right to buy out its royalty obligations for each licensed product in full by paying Synthon specified lump sum amounts prior to the occurrence of certain defined events. Ono License and Collaboration Agreement In July 2019, the Company entered into an exclusive license and collaboration agreement with Ono Pharmaceutical Co., Ltd., (“Ono”). Under the agreement, the Company granted Ono an exclusive license to develop, manufacture and commercialize magrolimab, the Company’s monoclonal antibody against CD47, as well as other anti-CD47 antibodies controlled by the Company in Japan, South Korea, Taiwan and the ASEAN countries (the “Ono Territory”). The Company retains all rights to magrolimab and other licensed antibodies outside of the Ono Territory. Under the agreement, the parties will collaborate on the development, manufacturing and commercialization of magrolimab and other licensed antibodies. Each party will be responsible for conducting development and commercialization of licensed antibodies in its respective territory at its own cost. Further, each party will have the right to participate, at its cost, in global clinical studies of magrolimab and other licensed antibodies conducted by the other party. The Company received a one-time upfront nonrefundable payment from Ono of 1.7 billion Japanese Yen ($15.7 million US Dollars based on the exchange rate as of the date of the agreement) and is eligible to receive up to an additional 11.2 billion Japanese Yen if specified future development and commercial milestones are achieved by Ono. The Company is also eligible to receive tiered percentage royalties spanning from the mid-teens to the low-twenties on future net sales of magrolimab and other licensed antibodies in the Ono Territory, subject to certain offsets. The Company accounts for the Ono Agreement as a collaboration arrangement under ASC 808. The Company concluded that the license delivered to Ono is a distinct unit of account for which there is a vendor-customer relationship. For the license, the Company analogized to ASC 606 for the recognition, measurement and reporting of this unit of account. The up-front payment, future milestones and royalties are attributed to the license component of the Ono Agreement. For the cost-sharing and reimbursement-based activities, the Company follows the presentation and disclosure guidance of ASC 808 and the reimbursement under this collaboration agreement is recorded as a reduction to research and development expense. For the year ended December 31, 2019, the Company recognized $0.9 million as a reduction to research and development expenses under this collaboration agreement. The transaction price at inception included upfront fixed nonrefundable consideration of $15.7 million. All potential future milestones were considered constrained at the inception of the Ono Agreement. Revenue for the license of $15.7 million was recognized upon delivery of the license in July 2019. bluebird bio, Inc. Research Collaboration Agreement In September 2019, the Company entered into a research collaboration with bluebird bio, Inc. (“bluebird”) to pursue clinical proof-of-concept for the Company’s novel antibody-based conditioning regimen, FSI-174 (anti-cKIT antibody) plus magrolimab (anti-CD47 antibody), with bluebird’s ex vivo lentiviral vector hematopoietic stem cell (LVV HSC) gene therapy platform. This collaboration will focus initially on diseases that have the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells. As of December 31, 2019, the Company recorded a receivable of $0.7 million from bluebird for reimbursement of research and development costs incurred. Reimbursement under this collaboration agreement is recorded as a reduction to research and development expense. For the year ended December 31, 2019, the Company recognized $1.2 million as a reduction to research and development expenses under this collaboration agreement. A summary of the reduction of research and development expenses related to grant funding and collaboration agreements for the years ended December 31, 2019 and 2018 is as follows: Year Ended December 31, 2019 2018 (in thousands) CIRM $ 2,756 $ 5,722 LLS 347 2,258 Merck 1,693 1,199 bluebird 1,202 — Ono 866 — Total grant funding and cost share reimbursement $ 6,864 $ 9,179 |