License Agreement | 8. License agreements The Company's significant license agreements are disclosed in Note 8, "License agreements," in the audited consolidated financial statements for the year ended December 31, 2021, and notes thereto, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 14, 2022. Since the date of those financial statements, there have been no changes to its license agreements, except as noted below. Harvard/Broad license agreement and Broad license agreement In March 2019, the Company simultaneously entered into the Harvard/Broad License Agreement and Broad License Agreement (the “license agreements”) for certain base editing technologies pursuant to which the Company received exclusive, worldwide, sublicensable, royalty-bearing licenses under specified patent rights to develop and commercialize licensed products and nonexclusive, worldwide, sublicensable, royalty-bearing licenses under certain patent rights to research and develop licensed products. The Company agreed to use commercially reasonable efforts to develop licensed products in accordance with the development plans, to introduce any licensed products that gain regulatory approval into the commercial market, to market licensed products that have gained regulatory approval following such introduction into the market, and to make licensed products that have gained regulatory approval reasonably available to the public. The term of the agreements will continue until the expiration of the last to expire valid claim. The Company may terminate either of the license agreements without cause upon four months’ prior written notice to Harvard and Broad, unless terminated earlier. In February 2021, the Company provided written notice to Broad of its intent to terminate the Broad License Agreement, which termination was effective in June 2021. As partial consideration for the rights granted under the Harvard/ Broad License Agreement and Broad License Agreement, the Company paid $ 0.3 million in non-refundable upfront license fees and also issued 276,075 shares of its common stock with a fair value of $ 0.3 million. Additional consideration under the license agreements is as follows: Antidilution Rights —The initial shares of common stock issued to Harvard and Broad were subject to antidilution provisions as further described in Note 5, "Fair value of financial instruments." The antidilution rights associated with the Company achieving a defined aggregate level of preferred stock financing were partially satisfied in 2019 and fully satisfied in 2020, which settlement amounts totaled $ 0.1 million and $ 0.5 million, respectively, and which amounts were settled through issuances of 121,411 and 187,867 shares of common stock, respectively. The remaining antidilution rights obligation was fully satisfied in the three months ended June 30, 2021 with the Company’s IPO. The settlement amount totaled $ 32.5 million, and was settled through issuance of 878,098 shares of common stock. Success Payments —The Company is required to make success payments under the license agreements as further described in Note 5, "Fair value of financial instruments." In September 2021, certain success payments were triggered and amounts due to Harvard and Broad totaled $ 6.3 million. These amounts were settled in cash in November 2021. Other Payments —The Company agreed to pay an annual license maintenance fee ranging from low-to-mid five figures to low six figures, depending on the particular calendar year, for each of the license agreements. The Company is responsible for the payment of certain patent prosecution and maintenance costs incurred by Harvard and Broad related to licensed patents. To the extent achieved, the Company is obligated to pay up to an aggregate of $ 46.2 million and $ 108 million in development and sales-based milestones, respectively. During the three months ended March 31, 2022, the first milestone was triggered and amounts due to Harvard and Broad totaled $ 0.3 million. These amounts remain payable as of March 31, 2022 and will be settled in cash. If the Company undergoes a change of control during the term of the license agreements, then certain of the milestone payments would be increased by a mid-double-digit percentage. To the extent there are sales of a licensed product, the Company is required to pay low single digit royalties on net sales, for each of the license agreements. The Company is entitled to certain reductions and offsets on these royalties with respect to a licensed product in a given country. Beam license agreement In April 2019, the Company and Beam Therapeutics, Inc. ("Beam") entered into a collaboration and license agreement. Pursuant to the agreement, the Company received an exclusive, worldwide, sublicensable license under certain of Beam’s base editing technology, gene editing, and delivery technologies to develop, make, use, offer for sale, sell and import base editing products and nuclease products using Beam’s CRISPR associated protein 12b, or Cas12b technology, in each case, directed to any of four gene targets, including the PCSK9 and ANGPTL3 genes, that are associated with an increased risk of coronary diseases. In addition, the Company granted Beam an exclusive, worldwide, sublicensable license under certain of its delivery technology to develop, manufacture, sell and import product candidates and products, except for base editor products licensed to Verve. Both parties may conduct certain activities in accordance with an agreed-upon research and/or development plan. Following the final dosing of a patient in a Phase 1 clinical trial of a given licensed product, Beam has the right to opt in to share 33% of worldwide expenses of the development of such licensed product, as well as jointly commercialize and share profits and expenses of commercializing such licensed product in the United States on a 50/50 basis. If Beam exercises its opt-in right for a given licensed product, which we refer to following such opt-in as a collaboration product, it will be obligated to pay for a specified percentage of the development and commercialization costs of such collaboration product and will have the right to receive a specified percentage of the profits from any sales of such collaboration product. The term of the agreement continues until the last to expire of any royalty term for any product. The Company has the right to terminate the agreement as to any licensed product, but not for any collaboration product, by delivering a 90-day termination notice to Beam, provided that Beam has elected not to exercise its opt-in right or the period to exercise such opt-in right has expired. The Company is responsible for all costs and expenses incurred in the conduct of activities under the research plan, any development plan and any costs and expenses for the development of a licensed product for which Beam has not elected to opt-in. As partial consideration for the license rights granted by Beam under this agreement, the Company paid a one-time, nonrefundable fee through issuing 276,075 shares of its common stock with a fair value of $ 0.3 million. To the extent achieved, for each licensed product, the Company is also obligated to pay up to $ 11.3 million in development and regulatory-based milestones and $ 15.0 million in sales-based milestones. To the extent there are sales of a licensed product, the Company is required to pay low-to-mid single digit royalties on net sales. To the extent achieved, for each collaboration product outside of the United States, the Company is obligated to pay up to $ 5.6 million in development and regulatory-based milestones and $ 7.5 million in sales-based milestones. To the extent there are ex-U.S. sales of a collaboration product, the Company is required to pay low-to-mid single digit royalties on net sales. The Company has not triggered any milestone payments pursuant to its arrangement with Beam, and no expense has been recorded for milestones as of March 31, 2022. To the extent there are sales of a delivery technology product, each party will pay the other party low-to-mid single digit royalties based on the annual aggregate worldwide net sales resulting from the sale of each delivery technology product of such paying party; provided, however, that such royalty payments will not apply to net sales of the collaboration products or licensed products. The Company concluded the receipt of any milestone or royalty payments under the agreement was not probable as of March 31, 2022. Beam materials exchange letter agreement In October 2020, the Company and Beam entered into a materials exchange agreement wherein the parties agreed that Beam would provide certain mRNA, gRNA, and protein to the Company and that the Company would provide certain gRNAs to Beam at an agreed upon price per each material provided. For the three months ended March 31, 2022 and 2021, the Company did no t purchase any materials from Beam. For the three months ended March 31, 2022 , the Company did not sell any materials to Beam. For the three months ended March 31, 2021, the Company recognized $ 0.2 million as a reduction to research and development expense related to reimbursements received for materials sold to Beam. Acuitas agreements Development and option agreement In December 2019, the Company and Acuitas Therapeutics, Inc. ("Acuitas") entered into a development and collaboration agreement, which agreement was amended and restated in October 2020. The Company agreed to reimburse Acuitas on a quarterly basis for its services performed related to the program activities based on an agreed upon number of fulltime employees committed to work on the program at an annual rate per employee, including reimbursement of reasonable external costs. The Company recognized research and development expense during the three months ended March 31, 2022 and 2021 of $ 0.1 million and $ 0.3 million, respectively, related to the reimbursement of research and development services provided by Acuitas. License agreement In October 2020, the Company paid Acuitas a non-refundable, upfront license fee of $ 2.0 million (less a previously paid target reservation fee) to exercise an option with respect to a licensed product and a licensed genome target and entered into a non-exclusive, worldwide license with Acuitas, with a right to sub-license through multiple tiers, under the licensed LNP technology to research, develop and commercialize the licensed products using the LNP technology in connection with the PCSK9 gene target for all human therapeutic or prophylactic uses. To the extent achieved, the Company is also obligated to pay up to an aggregate of $ 9.8 million in clinical and regulatory milestones and $ 9.5 million in sales-based milestones. The milestones have not been achieved and no expense has been recorded for these milestones as of March 31, 2022. Third-party license agreements In October 2021, the Company entered into a license agreement with a third party to obtain a non-exclusive license to certain technology the Company is using for research and development. As consideration for the license and rights granted under the agreement, the Company made a one-time, non-refundable, upfront payment of $ 0.8 million during the three months ended December 31, 2021. The license agreement provides for specified development milestones relating to the licensed technology and requires the Company to make payments upon achievement of each milestone up to an aggregate amount of $ 10.0 million. |