License and Research and Development Agreements | 8. License and Research and Development Agreements Stanford license agreement In August 2022, the Company entered into a license agreement with the Board of Trustees of the Leland Stanford Junior University (“Stanford University”) relating to the Company’s platform technologies relating to CAR T-cell therapies (the “Stanford License”). Pursuant to the Stanford License, Stanford University granted the Company a worldwide, exclusive license under certain patent rights, and a worldwide non-exclusive license under certain technology, in each case, owned or controlled by Stanford University, to make, use and sell products, methods or services in the field of human therapeutic and diagnostic products. The licensed patent rights cover platform technology relating to the use of CD2/CD58 co-stimulatory signaling in cell therapy. As consideration for the licenses granted under the Stanford License, the Company made an upfront payment of $ 50,000 and issued 67,605 shares of its common stock with a fair value of $ 0.1 million, of which 22,317 shares were issued to Stanford University, 27,100 shares were issued to two non-profit organizations that supported the research, and 18,188 shares were issued to various Stanford University inventors. The Company determined that the purchase of the licenses under the Stanford License represented an asset acquisition as it did not meet the definition of a business. As the acquired licenses represented in-process research and development (“IPR&D”) assets with no alternative future use, the Company recorded the upfront consideration of $ 0.2 million as research and development expense in August 2022, upon entering into the Stanford License. No research and development expense pursuant to the Stanford License was recorded during both the three and six months ended June 30, 2024, and 2023. In addition to annual license maintenance fees of up to $ 0.1 million per year, the Company may be required to pay up to $ 7.5 million upon achievement of sales milestones, up to $ 4.0 million upon achievement of development milestone events for each product covered by licensed patent rights, including upon initiation of specific clinical trials or receipt of regulatory approvals, up to $ 50,000 in a milestone payment upon achievement of a certain commercial milestone event, up to $ 0.5 million in a milestone payment upon achievement of certain additional development milestone events, and a double-digit percentage of development and sales milestone payments on the first two licensed non-patent products and, subject to certain royalty reductions, as applicable, low single-digit percentage royalties on net sales of products that are covered by the licensed patent rights or licensed technology. Subject to the terms of the Stanford License, the Company also agreed to pay Stanford University a certain percentage of non-royalty sublicense-related revenue that the Company receives from third-party sublicenses. Oxford license and supply agreement In June 2022, the Company entered into a License and Supply Agreement (the “Oxford Agreement”), with Oxford Biomedica (UK) Limited (“Oxford”) for the manufacture and supply of lentiviral vectors for clinical and potentially commercial purposes by the Company. Pursuant to the Oxford Agreement, Oxford granted to the Company a non-exclusive worldwide, sub-licensable, royalty-bearing license under certain intellectual property rights for the purposes of research, development, manufacturing and commercialization of products transduced with the vectors manufactured by Oxford or by the Company following a technology transfer by Oxford, which products are directed against certain initial targets, and upon payment of certain fees, additional targets as agreed by Oxford and the Company. As consideration for the license granted under the Oxford Agreement, the Company paid an upfront license fee of $ 0.2 million. The Company determined that the purchase of the license under the Oxford Agreement represented an asset acquisition as it did not meet the definition of a business. As the acquired license represented IPR&D assets with no alternative future use, the Company recorded the upfront payment of $ 0.2 million as research and development expense in June 2022. In March 2024, the Company entered into an amendment to the Oxford Agreement pursuant to which Oxford and the Company agreed to an amended royalty payment structure for certain lentiviral vectors manufactured by Oxford. Under the firi-cel program the Company may be obligated to pay up to an aggregate amount of $ 4.8 million in regulatory and commercial milestones. This includes reduced regulatory and commercial milestones for the firi-cel program, as part of the amendment. In addition, the Company is no longer obligated to pay earned royalties on net sales of licensed products manufactured by Oxford under its firi-cel program and remains obligated to pay an earned royalty at low single-digit percentages of net sales of licensed products under its firi-cel program that are manufactured by an affiliate or a third party. Under its CRG-023 program, the Company may be obligated to pay up to an aggregate amount of $ 9.5 million in additional target fees, regulatory and commercial milestones and pay an earned royalty at low single-digit percentages of net sales. No research and development expense related to the license was recorded during both the three and six months ended June 30, 2024, and 2023. Unless terminated earlier, the Oxford Agreement will expire when no further payments are due to Oxford. The Company can terminate the agreement at will upon advance written notice and may be subject to certain manufacturing slot cancellation fees. National Cancer Institute In March 2022, the Company entered into an exclusive license agreement (the “2022 NCI License”) with the U.S. Department of Health and Human Services, as represented by The National Cancer Institute (“NCI”), pursuant to which the Company obtained a worldwide, royalty-bearing, exclusive license under certain patent rights to make, use, sell, offer for sale, and import certain autologous products covered by such licensed patents in the field of CAR-T immunotherapies for the treatment of B-cell malignancies that express CD22, and a non-sublicensable exclusive license for evaluation purposes only to make, use, and import, but not sell, certain allogenic products and to practice processes in the field of certain CAR-T immunotherapies for the treatment of B-cell malignancies that express CD22 for evaluation purposes, with an exclusive option to negotiate a non-exclusive or exclusive commercialization license. In March 2024, Company exercised its right to extend the exclusive option one time for an additional year and paid an extension royalty of $ 50,000 . As consideration for the licenses granted under the 2022 NCI License, the Company is required to pay the NCI a non-refundable license fee of $ 0.6 million, of which $ 0.2 million was paid in 2022, $ 0.1 million was paid in 2023 and $ 0.2 million was paid in March 2024, and the remaining balance of $ 0.1 million is payable on the third anniversary of the effective date of the agreement. The Company accrued the non-r efundable upfront fees of $ 0.4 million upon entering into the 2022 NCI License. Non-refundable upfront fees of $ 0.1 million were accrued in accrued expenses and other current liabilities as of both June 30, 2024, and December 31, 2023, and as of December 31, 2023 , $ 0.2 million, is classified as other non-current liabilities on the unaudited condensed balance sheet. The Company determined that the purchase of the license under the 2022 NCI License represented an asset acquisition as it did not meet the definition of a business. As the acquired license represented IPR&D assets with no alternative future use, the Company recorded the initial consideration of $ 0.6 million under the 2022 NCI License as research and development expense in March 2022, upon entering into the 2022 NCI License. The Company recorded research and development expense of $ 0.1 million related to the minimum annual royalty, the option extension fee and the achievement of certain development milestones for each of the six months ended June 30, 2024, and 2023. No research and development expense related to the license was recorded during the three months ended June 30, 2024, and 2023. The Company agreed to pay up to $ 0.2 million in regulatory milestone payments upon achieving specific regulatory filings, up to $ 1.8 million in development milestone payments upon achieving specific clinical trials or registration trials, and up to $ 16.0 million in sales milestones upon achievement of specific commercial milestone events for up to three distinct licensed products, and an earned royalty on net sales of autologous cell therapy products covered by the licensed patent rights and, if the Company chooses to exercise the exclusive option mentioned above, on net sales of allogenic products, at a low single-digit percentage, depending on the amount of annual net sales and subject to the terms of the 2022 NCI License. The Company is also required to make minimum annual royalty payments of $ 50,000 per year, which will be creditable against royalties due for sales in that year. In addition, the Company is obligated to pay the NCI a percentage of non-royalty revenue received by the Company from its right to sublicense. Additionally, in the event the Company is granted a priority review voucher (“PRV”), the Company would be obligated to pay the NCI a minimum of $ 5.0 million upon the sale, transfer or lease of the PRV or $ 0.5 million upon submission of the PRV for use by the U.S. FDA. The Company is also obligated to pay the NCI a royalty based on a percentage of the fair market value of the consideration the Company receives for any assignment of the 2022 NCI License to a non-affiliate (upon the NCI’s prior written consent) or on an allocated portion of the fair value of consideration received in connection with a change in control (including an IPO). On the closing of the Company's IPO in November 2023, the change in control milestone was met, and the Company and the NCI are in discussions regarding the amount of such payment. The NCI may terminate or modify the 2022 NCI License in the event of an uncured material breach, including, but not limited to, if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to the NCI. In February 2023, the Company entered into an exclusive license agreement (the “2023 NCI License”) with the NCI, pursuant to which the Company obtained a worldwide, royalty-bearing, exclusive license under certain patent rights owned by the NCI to make, use, sell and import products and to practice processes in the field of certain CAR-T immunotherapies for the treatment of B-cell malignancies, wherein the T cells are engineered to express CD22 in combination with binders, CARs or other receptors targeting CD19, CD20, and/or CD79b; and at least one of the following: manufacturing the product with the STASH platform technology and/or a technology to activate CD2 signaling in the CAR T cell. As consideration for the licenses granted under the 2023 NCI License, the Company agreed to pay the NCI a non-refundable license fee of $ 0.3 million in three installments whereby the first installment was payable within 60 days of the execution of the agreement and the remaining two payments are due on the first and second anniversaries of the effective date of the agreement. Additionally, the Company agreed to reimburse the NCI for $ 0.1 million in expenses incurred by the NCI prior to January 1, 2022, related to the preparation, filing, prosecution, and maintenance of all patent applications and patents included in the license under the 2023 NCI License. The Company determined that the purchase of the license under the 2023 NCI License represented an asset acquisition as it did not meet the definition of a business. As the acquired license represented IPR&D assets with no alternative future use, upon entering the 2023 NCI License in February 2023, the Company recorded the initial consideration of $ 0.4 million under the 2023 NCI License, consisting of the non-refundable upfront fees, as research and development expense. The Company accrued these amounts upon entering into the 2023 NCI License, of which $ 0.1 million was classified as accrued expenses and other current liabilities on the unaudited condensed balance sheet as of June 30, 2024 , and the remaining $ 0.3 million was paid as of June 30, 2024. The Company recorded research and development expense of $ 50,000 and $ 0.4 million related to the minimum annual royalty, the license issue royalty, the reimbursement of past patent application expenses during the six months ended June 30, 2024, and 2023 , respectively. No research and development expense related to the license was recorded during the three months ended June 30, 2024, and 2023. The Company agreed to pay up to $ 0.1 million in milestone payments upon achievement of certain regulatory milestone events, up to $ 1.7 million in milestone payments upon achievement of certain development milestone events including initiation of specific clinical trials or registration trials, and up to $ 16.0 million in milestone payments upon achievement of specific commercial milestone events. Subject to the terms of the 2023 NCI License, the Company also agreed to pay a low single-digit percentage on earned royalties on net sales of products covered by the licensed patent rights. The Company also agreed to make minimum annual royalty payments of $ 50,000 per year, which will be creditable against royalties due for sales in that year. In addition, the Company is obligated to pay the NCI a percentage of non-royalty revenue received by the Company from its right to sublicense at defined percentages. Additionally, if the Company is granted a PRV, the Company would be obligated to pay the NCI a minimum of $ 5.0 million upon the sale, transfer or lease of the PRV or $ 0.5 million upon submission of the PRV for use by the FDA. The Company is also obligated to pay the NCI a royalty based on a percentage of the fair market value of the consideration the Company receives for any assignment of the 2023 NCI License to a non-affiliate (upon the NCI’s prior written consent) or on an allocated portion of the fair value of consideration received in connection with a change in control (including an IPO). On the closing of the Company's IPO in November 2023, the change in control milestone was met, and the Company and the NCI are in discussions regarding the amount of such payment. Unless earlier terminated, the 2023 NCI License will expire upon the expiration of the last to expire licensed patent right. The NCI may terminate or modify the 2023 NCI License in the event of an uncured material breach, including, but not limited to, if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to the NCI. In connection with the closing of the Company’s IPO in November 2023, the Company accrued a total of $ 0.3 million of research and development expense within accrued clinical and research and development expenses on the balance sheet related to the change in control royalty for both the 2022 NCI License and the 2023 NCI License. |