Significant Agreements | 7. Significant Agreements Moderna strategic collaboration and license agreement Terms of the agreement On October 29, 2021, the Company entered into a Strategic Collaboration and License Agreement with ModernaTX, Inc. (“ Moderna”) (the “Moderna Agreement”). On April 26, 2024, the Company and Moderna mutually terminated the Moderna Agreement (the “Termination”). The Moderna Agreement was terminated pursuant to a Mutual Termination Agreement (the “Termination Agreement”), dated as of April 26, 2024, by and between the Company and Moderna. Pursuant to the Termination Agreement, the Company regained full development and commercialization rights to its wholly-owned base editing and RNA-mediated integration systems (“RIGS”) that were subject to the Moderna Agreement. Prior to the Termination, the parties collaborated on the research and development of in vivo genome editing therapies directed at certain targets and the commercialization of such genome editing therapies. The collaboration provided Moderna with exclusive access to the Company’s technology platform during the research period in (1) the field of in vivo genome editing technology for a therapeutic, ameliorative or prophylactic application by way of knock-out through InDel formation or base editing or insertion of an exogenous DNA template (such field, “DT Field”) and (2) the field of in vivo genome editing technology for a therapeutic, ameliorative or prophylactic application outside the use of (a) DNA donor templates and (b) no exogenous template at all but including (c) correction by base editing (such field, “RT Field”). The use of RIGS with messenger RNA (“mRNA”) and base editing correction with mRNA was within the RT Field exclusive to Moderna within the term. The parties formed a joint steering committee, a joint research subcommittee and a joint patent subcommittee to oversee the collaboration activities. Under the terms of the Moderna Agreement, the parties agreed to collaborate on one or more programs in the RT Field (the “Moderna RT program”) and two programs in the DT Field (the “Moderna DT program” and the “DT Co-Co program”). With respect to the Moderna RT program and Moderna DT program, the parties agreed to collaborate on the research and development of product candidates under the approved research plans. The initial research term of the Moderna RT program was four years , which could have been extended by Moderna for an additional three years upon written notice and a payment of extension fees. The initial research term of the Moderna DT program was four years . The Company granted Moderna an option to obtain an exclusive license to develop, manufacture and commercialize up to ten Moderna RT program candidates and up to two Moderna DT program candidates at any time during the research term and prior to filing of an IND application with the FDA or any similar application filed with a regulatory authority in a country other than the U.S., subject to Moderna’s payment of an option exercise fee of $ 10.0 million per target. With respect to the DT Co-Co program, the parties agreed to work together on the co-development and commercialization of products and shared costs and profits equally. The Company maintained commercialization rights in the U.S. (subject to Moderna’s right to appoint up to 50 % of the U.S. sales force for the DT Co-Co program), while Moderna maintained these rights in countries other than the U.S. The initial research term for the DT Co-Co program was four years , and each party had a right to opt-out of the DT Co-Co program at any time, at which point the other party had the right to solely continue the development and commercialization activities. If there was no development candidate nomination by the end of the initial research term, the DT Co-Co program would have expired, unless the parties had mutually agreed to continue the program. During the year ended December 31, 2021, the Company received a non-refundable upfront payment of $ 40.0 million and a $ 5.0 million payment for the first year of research costs. Concurrent with the Moderna Agreement, Moderna also provided $ 30.0 million in cash in the form of a convertible promissory note pursuant to a convertible promissory note agreement dated October 29, 2021 (the “Moderna Convertible Promissory Note Agreement”). The convertible promissory note was converted into shares of Series B redeemable convertible preferred units in January 2022. Moderna rei mbursed the Company up to $ 5.0 million in annual research and development costs related to the Moderna RT program and Moderna DT program, or up to the agreed amount of expenses per the budget. As of September 30, 2024, the Company has received a total of $ 56.6 million under the Moderna Agreement, not including cost-sharing payments under the DT Co-Co program. For the Moderna RT program and Moderna DT program, the Company was eligible to receive (i) technology milestone fees related to the achievement of certain preclinical research objectives, of up to $ 75.0 million, (ii) development and regulatory milestones of up to $ 100.0 million per target, (iii) sales milestones of up to $ 200.0 million per target and (iv) royalties ranging from a mid-single digit to a low-teens percentage of annual net sales of a licensed product. Any profits and losses from the co-development and commercialization of the DT Co-Co program were shared equally between the Company and Moderna. With respect to the DT Co-Co program for which the opt-out party had exercised its opt-out right, the continuing party would have paid to the opt-out party, certain development, regulatory and sales milestone payments that would not have exceeded an aggregate $ 239.0 million per DT Co-Co target, and opt-out royalties ranging from a high-single digit to a low-teens percentage of annual net sales of a licensed product. Accounting analysis and revenue recognition The Company concluded that the Moderna RT program and Moderna DT program are in the scope of ASC 606. The Company determined that the licenses granted to Moderna, and its participation in the joint steering committee are not capable of being distinct from the preclinical research and development services and therefore concluded that there are two performance obligations: (1) the Moderna RT program and (2) the Moderna DT program. The Company also concluded that the option to obtain an exclusive license and options to extend the Moderna RT program term do not include significant incremental discounts, and as such, the options do not provide material rights. The Company concluded that the DT Co-Co program research activities are within the scope of ASC 808, as the Company and Moderna were both active participants in the research, development and commercialization activities, were exposed to significant risks and rewards that were dependent on the success of the DT Co-Co program activities and share costs and profits equally. The Company determined that the guidance in ASC 730, Research and Development , was appropriate to apply to the DT Co-Co program research activities by analogy, based on the nature of the cost sharing provisions of the agreement. The Company concluded that DT Co-Co program is one unit of accounting, as the co-exclusive license is not distinct from the research and development and the participation in joint steering committee activities. The Company recognized payments to or from Moderna related to the DT Co-Co program cost sharing research activities as an increase to or reduction of research and development expenses, respectively. The Company concluded that the Moderna Agreement and the Moderna Convertible Promissory Note Agreement should be combined and treated as a sin gle arrangement for accounting purposes as the agreements were entered into contemporaneously and in contemplation of one another. The Company estimated the contract consideration to be $ 90.0 million, which consisted of: 1) the non-refundable upfront collaboration payment of $ 40.0 million received in 2021, 2) $ 30.0 million in cash received in 2021 in exchange for the convertible promissory note and 3) the estimated cost reimbursements for the Moderna RT program and Moderna DT program of $ 20.0 million. The Company constrained future milestones, as it assessed that it was probable that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. During the year ended December 31, 2021, the Company recorded $ 30.0 million of the contract consideration for the convertible promissory note based on the fair value and allocated the transaction price of $ 60.0 million to each of the following programs on a relative standalone selling price basis: 1) $ 49.5 million to the Moderna RT program, 2) $ 5.5 million to the Moderna DT program and 3) $ 5.0 million to the DT Co-Co program. The variable consideration is reevaluated at each reporting period and as changes in circumstances occur. The Company recognized revenue for each of the Moderna RT program and Moderna DT program as collaboration revenue based on the measure of progress using an estimated cost-based input method each reporting period. The Company also amortized the allocation consideration for the DT Co-C o program of $ 5.0 million as a credit to research and development expenses during the discovery and lead optimization phases for the DT Co-Co program. Due to the Termination of the Moderna Agreement, the Company recognized all remaining deferred revenue as revenue during the nine months ended September 30, 2024 . The final $ 5.0 million payment related to the fourth year of research costs was forfeited. The Company recognized collaboration revenue of zero and $ 18.7 million in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024, respectively, and $ 5.3 million and $ 14.2 million for the three and nine months ended September 30, 2023, respectively, which was included in deferred revenue as of December 31, 2023 and 2022, respectively. The Company recorded no accounts receivable on the condensed consolidated balance sheets as of September 30, 2024 and $ 0.5 million as of December 31, 2023, related to services performed. As of September 30, 2024 and December 31, 2023, deferred revenue related to the Moderna Agreement was zero and $ 18.7 million , respectively. As of September 30, 2024 , there were no remaining unsatisfied performance obligations. During the three and nine months ended September 30, 2023, the Company recognized zero and $ 0.3 million in credits to research and development expenses related to the cost sharing allocation, respectively, and $ 0.1 million and $ 0.5 million in credits related to the amortization of the collaboration advance, respectively. During the three and nine months ended September 30, 2024 , the Company recognized zero and $ 0.1 million in credits related to the cost sharing allocation, respectively, and zero and $ 0.7 million in credits related to the amortization of the collaboration advance, respectively. As of September 30, 2024 and December 31, 2023, the collaboration advance balance was zero and $ 0.7 million , respectively, and the cost-sharing payable balance was zero and $ 0.1 million , which were presented as a collaboration advance on the Company’s condensed consolidated balance sheets. Affini-T development, option and license agreement Terms of the agreement Pursuant to the Affini-T Agreement entered into on June 14, 2022, the parties have agreed to identify, develop or optimize certain reagents using the Company’s proprietary technology for Affini-T to use such reagents to develop and commercialize gene edited T-cell receptor (“TCR”)-based therapeutic products exclusively in the field of treatment, prevention or diagnosis of any human cancer using products with any engineered primary TCR alpha/beta T cells and non-exclusively in the field of treatment, prevention or diagnosis of any human cancer using products with certain other engineered immune cells worldwide. A joint steering committee was established by both parties to assign alliance managers and project leaders to oversee the collaboration activities. Pursuant to the Affini-T Agreement, the Company granted Affini-T options to receive, on a pre-specified target-by-pre-specified target basis, for up to six pre-specified targets, either (i) an exclusive, royalty-bearing, sublicensable worldwide license under all of the Company’s applicable intellectual property to research, develop, manufacture, use, commercialize and otherwise exploit any TCR-based therapy, preventative treatment, or diagnostic for humans that is directed to such pre-specified target, contains or comprises Primary TCR alpha/beta T Cells and is derived from ex vivo application of a Company reagent (the “Exclusive Option”) or a non-exclusive, royalty-bearing, sublicensable worldwide license under all of the Company’s applicable intellectual property to research, develop, manufacture, use, commercialize and otherwise exploit any TCR-based therapy, preventative treatment, or diagnostic for humans that is directed to such pre-specified target, contains or comprises TCR natural killer (“NK”) cells derived from iPSC immune cells or TCR T cells derived from donor-derived or iPSC immune cells. Affini-T can exercise its options for either an exclusive license or a non-exclusive license, or both, for each pre-specified target by providing written notice prior to the earlier of (x) the end of the Affini-T Agreement term or (y) 90 days following the filing of an IND for a licensed product directed to a pre-specified target, subject to the payment of certain fees per each option exercised. After the option exercise, Affini-T has agreed to use commercially reasonable efforts to conduct all development and commercialization activities for a licensed product, and development and commercialization of all licensed products will be at Affini-T’s sole cost and expense. In connection with the Affini-T Agreement, the Company received upfront equity consideration of 719,920 shares of Affini-T’s common stock with an estimated fair value of $ 1.3 million in June 2022. Upon achievement of a regulatory milestone in July 2024 r elated to the submission of drug master files to the FDA in support of an IND for Affini-T’s T-cell receptor-based therapy, the Company received additional equity consideration of 933,650 shares of Affini-T common stock with an estimated fair value of $ 1.6 million in July 2024 . The fair value of Affini-T’s shares of common stock was estimated by management, considering the most recent third-party valuation at the time of each grant. Affini-T has also agreed to reimburse the Company for expenses incurred while performing research activities under the research plans. As of September 30, 2024, the Company has received a total of $ 7.4 million from Affini-T related to reimbursable expenses. Additionally, the Company is eligible to receive (i) up to $ 18.8 million in future developmental milestone payments depending on the completion of or the number of patients dosed in, the relevant human clinical trial, or the initiation of a pivotal trial, and $ 40.6 million in future regulatory approval milestone payments, which include regulatory approvals in the U.S. and other markets for licensed products directed to a pre-specified target if options for both exclusive and non-exclusive licenses are exercised with respect to such target, (ii) up to $ 250.0 million in sales-based milestones for aggregate sales of all licensed products directed to a given pre-specified target and (iii) royalties ranging from a low-single digit to high-single digit percentage of worldwide annual net sales of licensed products. The initial term of the Affini-T Agreement is five years from the effective date. If Affini-T exercises an Exclusive Option with respect to any pre-specified target during the initial term, the initial term will be extended by an additional five years. Following the expiration of the extended term, if any, the agreement will continue on a target-by-target basis and expire with respect to such target upon the expiration of the royalty term for all licensed products directed to such target. The Affini-T Agreement may be terminated during the term by either party for an uncured material breach by, or bankruptcy of, the other party. Additionally, Affini-T may terminate the Affini-T Agreement for convenience, in its entirety, on a research plan-by-research plan basis, on a target-by-target basis or on a licensed product-by-licensed product basis, by providing prior written notice. Accounting analysis and revenue recognition The Company concluded that the Affini-T Agreement is in the scope of ASC 606 and that there is one performance obligation to perform research activities under the Affini-T Agreement. Exclusive and non-exclusive licenses are optional contingent purchases that do not include significant incremental discounts, and therefore do not provide a material right. At the effective date, the transaction price consisted of the upfront equity consideration with an estimated fair value of $ 1.3 million and estimated research reimbursement costs. Research reimbursement costs represent variable consideration, and the Company’s management estimates what portion to include in total consideration at the end of each reporting period. Other payments under the Affini-T Agreement, including additional equity consideration and development and regulatory milestones, also represent variable consideration, and were constrained at the effective date to the extent that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. In June 2023, the joint steering committee approved the budget for estimated research reimbursement costs for the Affini-T Agreement, which resulted in a $ 2.4 million reduction to variable consideration. In July 2024, the Company included previously constrained additional equity consideration related to the regulatory milestone with an estimated fair value of $ 1.6 million in the transaction price, resulting in an increase to variable consideration. As of September 30, 2024 and December 31, 2023, future development and regulatory milestone payments were excluded from the estimated total transaction price as they were considered constrained. In addition, the equity consideration related to the regulatory milestone was also excluded from the estimated total transaction price as of December 31, 2023, as it was also considered constrained. The transaction price is reevaluated in each reporting period and as changes in circumstances occur. The Company recognizes revenue each reporting period based on the measure of progress using an estimated cost-based input method. The Company recognized collaboration revenue of $ 1.6 million and $ 2.9 million for the three and nine months ended September 30, 2024, respectively, and $ 1.1 million and $ 3.7 million for the three and nine months ended September 30, 2023, respectively. As of September 30, 2024 and December 31, 2023, the Company recorded $ 0.1 million and $ 2.0 million in accounts receivable on the condensed consolidated balance sheet, respectively, related to services performed. There was no contract asset related to services performed as of September 30, 2024 and December 31, 2023. As of September 30, 2024 and December 31, 2023, deferred revenue related to the Affini-T Agreement was $ 0.3 million and $ 0.2 million , respectively. The value of the transaction price allocated to the remaining unsatisfied portion of the performance obligation was approximately $ 0.9 million as of September 30, 2024 , which the Company expects to recognize as revenue over the next four -to-five years. Ionis collaboration and license agreement Terms of the agreement On November 10, 2022 the Company entered into a Collaboration and License Agreement with Ionis Pharmaceuticals, Inc. (“ Ionis”) (the “Ionis Agreement”) to collaborate on drug discovery and exploratory research activities to advance new medicines using genome editing strategies, with the goal of discovering novel medicines. Pursuant to the terms of the Ionis Agreement, the Company granted Ionis and its affiliates a worldwide exclusive, royalty-bearing license, with the right to grant sublicenses, to use all licensed systems and licensed products in the field of in vivo genome editing for all therapeutic, prophylactic, palliative, and analgesic uses in humans. In connection with the Ionis Agreement, the Company also has the right to exercise an exclusive option to co-develop and co-commercialize certain products under a drug discovery program. A joint steering committee was established by both parties to coordinate, oversee and monitor the research and drug discovery activities under the Ionis Agreement. The parties will collaborate to discover therapeutic products under a drug discovery program and develop a drug discovery plan for each target, selected by Ionis. The target selection is divided into two waves: up to four targets in Wave 1 and up to four targets in Wave 2. For each drug discovery program, once the parties identify a development candidate that is suitable for further development, Ionis will be responsible for the development and commercialization of products resulting from such program. Per the terms of the Ionis Agreement, at any time prior to the designation of a development candidate for a drug discovery program and for any reason, Ionis may replace the collaboration target, provided such target has not previously been substituted out. Ionis may substitute (i) up to two Wave 1 targets and (ii) up to two Wave 2 targets. The drug discovery activities for a program commence on the selection of a target and expire upon the earlier of (a) completion of all drug discovery activities for such program, (b) the fifth anniversary of the effective date and (c) selection of a development candidate for such drug discovery program. If one or more Wave 2 targets become collaboration targets as a result of the parties achieving enabled delivery and less than two years are remaining in the drug discovery term, then the term will be extended to the earlier of (i) the time that the Company completes all of its activities under the applicable drug discovery plan and (ii) the seventh anniversary of the effective date, subject to the Company’s consent. The parties will also conduct an exploratory research program, and will jointly optimize gRNA and select delivery technologies and other activities. The exploratory research activities commence on the effective date and expire upon the earlier of (a) completion of all exploratory research activities established in the exploratory research plan, and (b) the fifth anniversary of the effective date. The Company has the exclusive option to co-develop and co-commercialize the licensed products under a drug discovery program (the “Co-Co Option”) with Ionis. The Co-Co Option may be exercised for (a) the initial Wave 1 target (“Target 1”), (b) no more than one of the other three discovery programs for the Wave 1 targets, and (c) no more than two drug discovery programs for the Wave 2 targets that become collaboration targets. If the Company exercises the Co-Co Option for a particular drug discovery program, that drug discovery program will automatically be deemed a “Co-Co Program”, all corresponding licensed products be deemed “Co-Co Products,” the Company will be obligated to pay Ionis an option exercise fee, and the parties will enter into a separate co-development and co-c ommercialization agreement. The Co-Co Option exercise fee will equal 50% of Ionis’ internal costs and out-of-pocket costs incurred in the conduct of the drug discovery activities prior to the exercise of the Co-Co Option and be reduced by 50% of the Company’s corresponding costs incurred. Future development and commercialization costs will be shared equally. The Company may elect to reduce its cost-share percentage anywhere between 50% and 25% on a go-forward basis, provided the Company will continue to bear 50% of the costs of any clinical trials ongoing at the time of the election through the completion of the clinical trials. The Company will manufacture all licensed systems and certain components of the applicable licensed products that are needed by Ionis for use in its development activities and all of the Company’s manufactured components needed by Ionis for use in its commercialization activities. The Company will provide the manufactured components at a price that represents the cost of goods plus 15 %. Pursuant to the terms of the Ionis Agreement, the Company has also been granted an option to obtain a non-exclusive, royalty-bearing license, with the right to grant sublicenses, for certain Ionis’ background technology to use in up to eight therapeutic products discovered by the Company in the field of in vivo genome editing and directed to a Collaboration Target (each such product, a “Metagenomi Product” and each such option an “Ionis IP Option”), but subject to encumbrance checks with respect to particular targets. A Collaboration Target is a target that is selected by Ionis, and, with respect to the Company is not the subject of discussions with a third party, is not the subject of a contractual grant of rights to a third party nor the subject to an internal research and development program. If the Company exercises its Ionis IP Option, the Company will pay to Ionis up to several million dollars per Metagenomi Product upon achievement of certain clinical and regulatory milestones. The Company is also obligated to pay Ionis royalties in an amount equal to a low single-digit royalty on the net sales of the applicable Metagenomi Product on product-by-product and country-by-country basis. In November 2022, the Company received an $ 80.0 million upfront payment from Ionis for the Wave 1 drug discovery research collaboration and selected Target 1. Ionis selected its second target (“Target 2”) in Wave 1 in December 2022, its third target (“Target 3”) in Wave 1 in November 2023, and its fourth target (“Target 4”) in Wave 1 in February 2024. Ionis has an option to select up to four Wave 2 targets at any time during the drug discovery term, if (a) an IND for any licensed product directed to a Wave 1 target is filed with the applicable regulatory authority or (b) the parties achieve enabled delivery for a non-liver target under the exploratory research activities, by providing written notice and by paying a Wave 2 target selection fee of $ 15.0 million or $ 30.0 million, depending on and per the selected target. Ionis is obligated to reimburse the Company for all internal costs and out-of-pocket costs incurred in the performance of the exploratory research activities, up to an aggregate of $ 10.0 million, which is pay able in quarterly installments of $ 0.5 million during the exploratory research term. As of September 30, 2024, the Company received a total of $ 3.8 million related to the reimbursable expenses. The Company is also eligible to receive (a) up to $ 29.0 million in future development milestone payments for each licensed product; (b) up to $ 60.0 million in future regulatory milestone payments for each licensed product; (c) up to $ 250.0 million in sales-based milestones for each licensed product; and (d) royalties on annual net sales of licensed products from a mid-single-digit to low-teens percentage, subject to customary reductions. The term of the Ionis Agreement will continue (i) with respect to the drug discovery programs, until the expiration of all applicable royalty terms for a licensed product, (ii) with respect to the Co-Co Programs, until the parties cease all exploitation for the Co-Co Products that are the subject to such Co-Co Program, and with respect to the Metagenomi Products, until the expiration of the royalty term for a Metagenomi Product. The royalty term ends on the latest of the following two dates: (i) the expiration of (A) the last claim of any issued and unexpired patent, or (B) a claim within a patent application that has not been pending for more than seven years from the earliest date to which the claim or applicable patent application is entitled to claim priority and which claim has not been revoked, canceled, withdrawn, held invalid, or abandoned, or (ii) 12 years following the first commercial sale of a licensed product. The Ionis Agreement may be terminated during the term by either party for an uncured material breach or bankruptcy by the other party. Additionally, Ionis may terminate the Ionis Agreement for convenience and without penalty, in its entirety or on a licensed product-by-licensed product basis, by providing 90 days’ written notice. Accounting analysis and revenue recognition The Company concluded that the Ionis Agreement is in the scope of ASC 606 at the effective date and until the Company exercises its Co-Co Option for any drug discovery program, which was determined to not be probable at the effective date and as of September 30, 2024 and December 31, 2023. The Company also concluded that exclusive licenses and participation in a joint steering committee are not distinct from discovery research services and should thus be combined into one performance obligation (the “discovery program”). The Company also concluded that exploratory research services are a separate and distinct performance obligation (the “exploratory program”). The Ionis options for Wave 2 targets are optional purchases and do not have significant incremental discounts, as such, the options do not provide material rights. The Company allocated the total estimated transaction price of $ 90.0 million, which consisted of an $ 80.0 million upfront payment received in November 2022 and $ 10.0 million in reimbursements for research costs, into two performance obligations, which was determined based on their estimated standalone selling prices. The Company concluded that future development and commercial supply agreements are at market terms, as the terms were consistent with industry standards as of the effective date. The Company constrains future milestone payments under the arrangement to the extent that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. The Company constrained all development and regulatory milestone payments at the effective date and as of September 30, 2024 and December 31, 2023 . The Company is recognizing revenue of $ 80.0 million related to the discovery program and $ 10.0 million related to exploratory program over the research terms using an estimated cost-based input method as a measure of progress for each obligation. In June 2024, the Company included previously constrained estimated manufacturing costs in the transaction price, resulting in a $ 3.4 million increase to variable consideration. The Company recognized collaboration revenue of $ 9.9 million and $ 21.0 million for the three and nine months ended September 30, 2024, respectively, of which $ 9.5 million and $ 19.4 million , respectively, was included in deferred revenue as of December 31, 2023. The Company recognized collaboration revenue of $ 6.0 million and $ 14.4 million for the three and nine months ended September 30, 2023, respectively, which was included in deferred revenue as of December 31, 2022 for both periods. As of September 30, 2024 and December 31, 2023, deferred revenue related to the Ionis Agreement was $ 41.2 million and $ 60.0 million , respectively. The value of the transaction price allocated to the remaining performance obligations was approximately $ 50.3 million as of September 30, 2024, which the Company expects to recognize as revenue over the next three-to- four years. |