Commitments and contingencies |
6 Months Ended |
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Jun. 30, 2026 | |
| Commitments and contingencies | |
| Commitments and contingencies | Note 7—Commitments and contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated. FCDI Agreements The Company has a non-exclusive license agreement with FujiFilm Cellular Dynamics, Inc. (“FCDI”). The license provides the Company with certain patents and know-how related to the reprogramming of human somatic cells to iPSCs (the “Reprogramming License Agreement”). Under the Reprogramming License Agreement, the Company is required to make certain developmental and regulatory milestone payments as well as royalty payments upon commercialization. Royalties are in the low single digits on the sale of all licensed products. The Company also has an exclusive license agreement with FCDI (the “Differentiation License Agreement”). The Differentiation License Agreement provides the Company with patents and know-how related to human iPSC exclusively manufactured by FCDI. In October 2019, the Company entered into the Master Collaboration Agreement with FCDI (the “FCDI Collaboration Agreement”), whereby FCDI provides certain services to the Company to develop and manufacture iPSCs and immune cells derived therefrom. FCDI provides services in accordance with the approved research plan and related research budget. The initial research plan covered the period from October 2019 through March 31, 2022. In July 2022, the Company amended the FCDI Collaboration Agreement to extend the term through September 30, 2025, and in September 2023, the Company amended the FCDI Collaboration Agreement in connection with the Autoimmune License (as defined below). In March 2021, the Company entered into a Manufacturing Agreement with FCDI (“Manufacturing Agreement”), pursuant to which FCDI provides certain agreed upon technology transfer, process development, analytical testing and Current Good Manufacturing Practice (“cGMP”) manufacturing services to the Company. In January 2022, the Company and FCDI entered into a letter agreement (the “Letter Agreement”), which amended the Reprogramming License Agreement, Differentiation License Agreement and Manufacturing Agreement (the “FCDI Agreements”) pursuant to the Company’s Research Collaboration and License Agreement with Bristol-Myers Squibb. Pursuant to the Letter Agreement, and in consideration for amending the FCDI Agreements, the Company paid to FCDI an upfront payment of $10,000 and will pay FCDI (i) a percentage of any milestone payments received by the Company under the FCDI Collaboration Agreement in respect of achievement of development or regulatory milestones specific to Japan, and (ii) a percentage of all royalties received by the Company under the FCDI Collaboration Agreement in respect of sales of products in Japan. In September 2023, the Company and FCDI entered into a worldwide license agreement whereby FCDI will grant non-exclusive licenses to the Company for certain patent rights and know-how related to cell differentiation and reprogramming for the development and commercialization of iPSC-derived therapies for the treatment of inflammatory and autoimmune diseases (the “Autoimmune License”). In addition, the Company and FCDI entered into an amendment to each of the Reprogramming License Agreement and the Differentiation License Agreement to expand the licenses related to the development and commercialization of iPSC-derived cancer immunotherapeutic to also include inflammatory and autoimmune diseases. Under the terms of these agreements, FCDI will be eligible to receive certain development and regulatory milestone payments as well as low single-digit royalties related to products developed in connection with such agreements. During the three and six months ended June 30, 2026, the Company did not make any cash payments nor incur research and development expenses, related to the FCDI agreements. During the three and six months ended June 30, 2025, the Company made payments of $397 and $1,915 and incurred research and development expenses of $387 and $1,878, respectively, recorded within research and development expenses in its consolidated statements of operations and comprehensive income (loss). Distributed Bio Master Service Agreement On July 24, 2019, the Company entered into a Master Service Agreement with Distributed Bio, Inc. (“DBio”), whereby DBio will screen for protein binders that bind to specific therapeutic targets (the “Master Service Agreement”). The Company pays for such services according to a payment schedule, and if the Company brings the protein binders into the clinic for further development, DBio will receive milestone payments of up to $16,100 in total for each product as the products move through the clinical development and regulatory approval processes. No milestone payments were due since the inception of the agreement. During the three and six months ended June 30, 2026, the Company did not make any cash payments nor incur research and development expenses, related to the Master Service Agreement. The Company incurred $0 and $66 during the three and six months ended June 30, 2025, respectively. iCELL Inc. Sublicense Agreement In March 2020, the Company entered into a Sublicense Agreement with iCELL Inc. (“iCELL”) whereby iCELL granted the Company a license for certain patents and technology. The Company will pay iCELL royalties in the low single digits on net sales of the licensed product. In addition to the earned royalties, the Company will pay sales milestones, not to exceed $70,000, for the sales of the licensed product. iCELL is also eligible to receive payments of up to $4,250 in development and regulatory approval milestone payments. No milestones or royalties were due as of June 30, 2026 or June 30, 2025. Clade Therapeutics In connection with the acquisition of Clade in 2024, the Company was subject to a contingent milestone payment to the shareholders of Clade. As the clinical milestone was not achieved as of June 30, 2026, the Company derecognized the contingent liability which resulted in a gain within general and administrative expense on the consolidated statements of operations and comprehensive income (loss) of $1,939 and $3,757 for the three and six months ended June 30, 2026, respectively. Catalent Dusseldorf GmbH On December 12, 2022, Clade entered into a non-exclusive license agreement with Catalent Dusseldorf GmbH (“Catalent”), which was subsequently amended in March 2026, pursuant to which Catalent granted Clade a worldwide, non-exclusive, non-transferrable, royalty-bearing license under all rights owned or controlled by Catalent to one of its GMP-grade iPSC cell lines derived from human cord blood CD34+ cells, to develop, have developed, make, have made, use, have used, sell, offer for sale, have sold, distribute, have distributed, import, have imported and otherwise exploit or have exploited cell therapy products. The license (as amended, the “Catalent License”), permits the genetic modification of the licensed cell line and the development and commercialization of resulting cell therapy products for any indication. The Company has a right to use the Catalent License as a result of the Company’s acquisition of Clade. Under the Catalent License, the Company may grant sublicenses to third parties to develop, manufacture and commercialize resulting products, but the Company may not sublicense the original cell line itself. Catalent retains ownership of the original cell line, and the Company owns the modified cells and resulting products that the Company makes from the original cell line, subject to certain restrictions and limited rights granted back to Catalent. In consideration for the rights granted, Clade paid Catalent an upfront fee. The Company is also required to pay certain product-by-product milestone payments upon the achievement of certain development and regulatory milestones up to an aggregate of $16,200 or $12,150 depending on the product. The Company additionally agreed to pay royalties equal to a low single digit percentage of net sales of each product during a defined royalty term, after which royalty term the license automatically becomes fully paid-up, perpetual, irrevocable and royalty-free. The Company also agreed to pay annual minimum fees during a defined period, with milestone payments and royalties paid in a calendar year creditable against the annual minimum fees payable for the same calendar year. The agreement remains in effect until terminated and may be terminated by the Company for convenience upon prior written notice or by either party for material breach, subject to specified cure periods. Certain provisions, including payment obligations, indemnification obligations and confidentiality obligations, survive termination. During the six months ended June 30, 2026 and 2025, no payments were made to Catalent. Memorial Sloan-Kettering In connection with the acquisition of Clade in 2024, the Company acquired rights under an Exclusive License Agreement entered into in August 2023 with Memorial Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and Allied Diseases, and Sloan-Kettering Institute for Cancer Research (collectively “MSK”) (the “MSK Agreement”), under which MSK granted Clade a sublicensable, fee-paying and royalty-bearing license to commercially develop or exploit the licensed patent rights and licensed know-how (as defined in the MSK Agreement) related to MSK technology. The Company is required to pay certain product-by-product milestone payments to MSK upon the achievement of certain development and regulatory milestones up to an aggregate of $86,500 or $43,250 depending on the product. The Company also agreed to pay MSK royalties on a licensed product-by-licensed product and country-by-country basis equal to a low single digit percentage of net sales of each product during a defined royalty term, subject to a guaranteed minimum royalty payment per year, after which royalty term the license automatically becomes fully paid-up, perpetual, irrevocable and royalty-free. Lease Guaranty In connection with the surrender of a leased floor within the Company’s Philadelphia, Pennsylvania headquarters as described in Note 8, the Company executed a guaranty (the “Lease Guaranty”) in favor of the landlord of the payment obligations of the replacement tenant, an unrelated third party, related to a new direct lease between the landlord and that tenant for the floor. The Lease Guaranty covers the replacement tenant's base rent and its pro rata share of operating expenses for the floor, together with the landlord's enforcement costs. The Lease Guaranty runs through March 2034, concurrent with the replacement tenant's payment obligations.
The maximum potential future undiscounted payments the Company may be obligated to make under the Lease Guaranty, including base rent and property operating costs, are approximately $14,949, which is not reduced by any amounts that may be recovered under the recourse provisions described below. Guaranteed base rent payments begin December 1, 2026 following the replacement tenant's rent abatement period. The Company would be required to perform under the Lease Guaranty only upon nonpayment by the replacement tenant of its obligations. Based on the Company's assessment of the replacement tenant's financial condition, the Company considers the likelihood of being required to perform under the guarantee to be remote.
At inception, the Company recognized a liability of $666 for the estimated fair value of the Lease Guaranty, which is included in other long-term liabilities. The estimated fair value was based on a low probability of expected performance on the guarantee, discounted over the term of the guarantee period. No contingent loss has been accrued because a loss under the guaranty is not considered probable. The Company will reduce the liability on a systematic and rational basis as it is released from risk over the term of the guaranty; The replacement tenant has provided the Company an indemnification agreement under which it agrees to reimburse the Company for amounts the Company pays under the Lease Guaranty. The Company will recognize any recovery under the indemnification agreement as an asset only when a loss under the Lease Guaranty is incurred and recovery is probable and reasonably estimable. To date, no such asset has been recognized.
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