License Agreements and Asset Acquisitions | 11. License Agreements and Asset Acquisitions License Agreement with the Centre for Probe Development and Commercialization Inc. In November 2015, the Company entered into a license agreement with the Centre for Probe Development and Commercialization Inc. (“CPDC”), a related party (see Note 16) (the “CPDC Agreement”). Under the CPDC Agreement, the Company was granted an exclusive, sublicensable, nontransferable, worldwide license under CPDC’s patent rights related to CPDC’s radiopharmaceutical linker technology to develop, market, make, use and sell certain products for all disease indications and uses in humans, whether diagnostic or therapeutic. The Company has the right to grant sublicenses of its rights. The CPDC Agreement was amended in 2017; however, there were no material changes to the terms of the CPDC Agreement. Also in 2017, the Company entered into a second license agreement with CPDC, under which the Company was granted an exclusive, sublicensable, worldwide license under CPDC’s patent rights related to certain CPDC radiopharmaceutical linker technology to develop, market, make, use and sell certain products for all disease indications and uses in humans. The Company has the right to grant sublicenses of its rights. The Company has no obligations under any of the agreements with CPDC to make any milestone payments or to pay any royalties or annual maintenance fees to CPDC. During the three and six months ended June 30, 2023 and 2022 , the Company did no t make any payments to CPDC or recognize any research and development expenses under the license agreements with CPDC. License Agreement with ImmunoGen, Inc. In December 2016, the Company entered into a license agreement with ImmunoGen, Inc. (“ImmunoGen”) (the “ImmunoGen Agreement”). Under the ImmunoGen Agreement, the Company was granted an exclusive, sublicensable, worldwide license under ImmunoGen’s patent rights to use, develop, manufacture and commercialize any radiopharmaceutical conjugate that includes a certain compound and any resulting commercialized products. The Company has the right to grant sublicenses of its rights. Under the ImmunoGen Agreement, the Company paid an upfront fee of $ 0.2 million to ImmunoGen. In addition, the Company is obligated to make aggregate milestone payments to ImmunoGen of up to $ 15.0 million upon the achievement of specified development and regulatory milestones and of up to $ 35.0 million upon the achievement of specified sales milestones. The Company is also obligated to pay tiered royalties of a low to mid single-digit percentage based on annual net sales by the Company and any of its affiliates and sublicensees. Royalties will be paid by the Company on a country-by-country basis beginning upon the first commercial sale in such country until ten years following the date of the first commercial sale in the United States and five years following the date of the first commercial sale in all non-U.S. countries. In addition, the Company is responsible for all costs and expenses incurred related to the development, manufacture, regulatory approval and commercialization of all licensed products. Prior to regulatory approval of a licensed product in any country, the Company has the right to terminate the agreement upon 90 days’ prior written notice to ImmunoGen. Upon receipt of its first regulatory approval of a licensed product in any country, the Company has the right to terminate the agreement upon 180 days’ prior written notice to ImmunoGen. If the Company or ImmunoGen fails to comply with any of its obligations or otherwise breaches the agreement, the other party may terminate the agreement. The ImmunoGen Agreement expires upon the expiration date of the last-to-expire royalty term. During the three and six months ended June 30, 2023 and 2022 , the Company did no t make any payments to ImmunoGen or recognize any research and development expenses under the ImmunoGen Agreement. Asset Acquisition from Rainier Therapeutics, Inc. and License Agreement with Genentech, Inc. In March 2020 (the “Closing”), the Company and Rainier Therapeutics, Inc. (“Rainier”) entered into an asset acquisition agreement (the “Rainier Agreement”). Under the Rainier Agreement, the Company purchased all rights, title and interest to Rainier’s, and any of its affiliates’ and sublicensees’, patents and other tangible and intangible assets to perform research and to develop, manufacture and commercialize a specified compound of antibody molecules that bind to targets for the prevention, treatment and diagnosis of all diseases and conditions only using such compound as an antibody drug conjugate. The Company concluded to account for this purchase as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset. In connection with the asset acquisition, the Company paid an upfront fee of $ 1.0 million to Rainier and recognized this amount as research and development expense in the condensed consolidated statement of operations and comprehensive loss during the year ended December 31, 2020, as the IPR&D acquired had no alternative future use as of the acquisition date. Unless the Rainier Agreement was terminated pursuant to its terms, which termination initially could not have occurred later than eight months following the Closing (the “Outside Date”), the Company was obligated to pay Rainier an additional amount of $ 3.5 million and to issue 313,359 of the Company’s common shares on the Outside Date. Since the Rainier Agreement was not terminated by the Outside Date, as further described below, the Company is also obligated to make aggregate milestone payments to Rainier of up to $ 22.5 million and to issue up to 156,679 of the Company’s common shares upon the achievement of specified development and regulatory milestones and of up to $ 42.0 million upon the achievement of specified sales milestones. In the event the Company enters into a transaction with a non-affiliated party relating to the license or sale of substantially all the Company’s rights to develop the specified compound of antibody molecules, the Company will be obligated to pay Rainier a specified percentage of the revenue from such transaction, in an amount ranging from 10 % to 30 %, based on how long after the Closing the transaction takes place. The Rainier Agreement could have been terminated at any time prior to the Outside Date upon 30 days’ notice by the Company to Rainier or upon the mutual written consent of both parties. In October 2020, the Company and Rainier entered into a first amendment to the Rainier Agreement (the “First Amended Rainier Agreement”) to extend certain terms of the Rainier Agreement. Specifically, the Outside Date was amended such that termination may not occur later than eleven months following the Closing, or February 10, 2021 (the “Revised Outside Date”). In February 2021, the Company and Rainier entered into a second amendment to the First Amended Rainier Agreement, as amended (the “Second Amended Rainier Agreement”). Pursuant to the Second Amended Rainier Agreement, the Outside Date was further amended such that termination may not occur later than July 1, 2021, and such amendment was made in consideration for early payment of the additional $ 3.5 million owed to Rainier which the Company paid and recorded as research and development expense during the year ended December 31, 2021. In May 2021, the Company notified Rainier of its intent to continue development of the asset and issued 313,359 of its common shares to Rainier on July 1, 2021. In August 2022, the Company announced the dosing of the first patient in a Phase 1 study of FPI-1966 and paid a $ 2.0 million milestone payment and issued 156,679 common shares to Rainier. In May 2023, the Company ceased further clinical development of FPI-1966 as a result of a portfolio prioritization decision. During the three and six months ended June 30, 2023 and 2022 , the Company did no t recognize any research and development expense associated with the Second Amended Rainier Agreement. In connection with the Rainier Agreement, in March 2020, the Company was assigned all of Rainier’s rights and obligations under an exclusive license agreement between BioClin Therapeutics, Inc. and Genentech, Inc. (“Genentech”) (the “Genentech License Agreement”). Pursuant to the Genentech License Agreement, the Company has an exclusive, worldwide, sublicensable license to make, use, research, develop, sell and import certain intellectual property and technology of Genentech relating to a specified antibody and any mutant antibody thereof (the “Licensed Antibodies”), including any products that contain a Licensed Antibody as an active ingredient (the “Products”), for all human uses. Pursuant to the Genentech License Agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize at least one Product and the Company is solely responsible for the costs associated with the development, manufacturing, regulatory approval and commercialization of any Products. The manufacture of the antibody by any third-party contract development and manufacturing organization (“CDMO”) must be approved in advance by Genentech. Additionally, Genentech retains the right to use the Licensed Antibodies solely to research and develop molecules other than the Licensed Antibodies. Under Genentech License Agreement, the Company is obligated to make aggregate milestone payments to Genentech of up to $ 44.0 million upon the achievement of specified sales milestones. The Company is also obligated to pay to Genentech tiered royalties of a mid to high single-digit percentage based on annual net sales by the Company, and any of its affiliates and sublicensees, for the specified compound of antibody molecules and of a mid to high single-digit percentage based on annual net sales by the Company, and any of its affiliates and sublicensees, for any other compound containing mutant antibody molecules of the specified compound. In addition, the Company is obligated to pay to Genentech royalties of a low single-digit percentage based on quarterly net sales in any country in which the specified compound is not covered by a valid patent claim, and those sales will not be subject to the tiered royalties described above. All royalties may be reduced if the Company obtains a license under a third-party patent that includes the specified compound. Royalties will be paid by the Company on a country-by-country basis beginning upon the first commercial sale in such country until the later of (i) ten years following the date of the first commercial sale of a Product or (ii) the date the specified compound is no longer covered by an enforceable patent. Upon the expiration of the royalty term, the Company will have a fully paid-up license. The Company has the right to terminate the Genentech License Agreement upon written notice to Genentech if the Company determines in its sole discretion that development or commercialization of Products is not economically or scientifically feasible or appropriate. In addition, if the Company or Genentech fails to comply with any of its obligations or otherwise breaches the agreement, the other party may terminate the agreement. The Genentech License Agreement expires on the date on which all obligations under the agreement related to milestone payments or royalties have passed or expired. In May 2023, the Company ceased further clinical development of FPI-1966 as a result of a portfolio prioritization decision. During the three and six months ended June 30, 2023 and 2022 , the Company did no t make any payments to Genentech or recognize any research and development expenses under the Genentech License Agreement. Collaboration Agreement and Supply Agreement with TRIUMF Innovations, Inc. On December 10, 2020, the Company entered into a Collaboration Agreement and Supply Agreement (the “Collaboration Agreement”) with TRIUMF Innovations Inc. and TRIUMF JV (collectively, “the TRIUMF entities”) for the development, production and supply of actinium-225 (“ 225 Ac”) to the Company. Under the Collaboration Agreement as executed in December 2020, the Company is obligated to pay the TRIUMF entities an aggregate of $ 5.0 million CAD upon the achievement of certain milestones. The Collaboration Agreement contemplated that the parties would enter into an amendment thereto to expand the scope of the project and provide for additional milestone payments. As of June 30, 2023 , the TRIUMF entities had achieved certain milestones under the Collaboration Agreement totaling $ 3.0 million CAD (equivalent to $ 2.3 million at the time of payment) which were paid during the year ended December 31, 2021 and are being recognized as research and development expense over the period of performance by the TRIUMF entities. During each of the three and six months ended June 30, 2023 and 2022 , the Company recognized the amortization of less than $ 0.1 million as research and development expense under the Collaboration Agreement. As previously contemplated, on August 12, 2021, the parties amended the Collaboration Agreement in order to expand the scope of the project and the Company agreed to make an additional financial investment of up to $ 15.0 million CAD in connection with development of new process technology for the manufacture of 225 Ac upon the achievement of certain milestones under an amendment to the Collaboration Agreement (the “Amended Collaboration Agreement”). In connection with the Amended Collaboration Agreement, the parties have formed a company (“NewCo”) to hold certain intellectual property derived from the collaboration. NewCo is jointly owned and managed by the Company and the TRIUMF entities and its purpose is to manufacture 225 Ac for the research, clinical and commercial needs of the Company, and in certain circumstances, other third parties. The supply of 225 Ac by NewCo to the Company shall be done under a commercial supply agreement, to be negotiated by NewCo and the Company. The Company is expected to purchase at least 50 % of its annual 225 Ac requirements from NewCo, unless NewCo is unable to supply such necessary quantities to the Company, in which case the Company may use other 225 Ac suppliers to meet its commercial needs. As of June 30, 2023 , there were no assets held by NewCo. As of June 30, 2023 , the TRIUMF entities had achieved certain milestones under the Amended Collaboration Agreement totaling $ 8.5 million CAD (equivalent to $ 6.6 million at the time of payment), of which $ 2.6 million was paid during the year ended December 31, 2022 and $ 3.9 million was paid during the year ended December 31, 2021. These amounts are being recognized as research and development expense over the period of performance by the TRIUMF entities. During the three and six months ended June 30, 2023 , the Company recognized the amortization of $ 0.5 million and $ 0.8 million, respectively, as research and development expense under the Amended Collaboration Agreement. During the three and six months ended June 30, 2022 , the Company recognized the amortization of $ 0.4 million and $ 0.5 million, respectively, as research and development expense under the Amended Collaboration Agreement. The Company recorded $ 2.1 million and $ 1.6 million of milestone payments in prepaid expenses and other current assets and other non-current assets, respectively, as of June 30, 2023 based on its estimate of costs to be incurred over the 12 months following the balance sheet date for both the Collaboration Agreement and the Amended Collaboration Agreement. Asset Acquisition from Ipsen Pharma SAS In March 2021, the Company and Ipsen Pharma SAS (“Ipsen”) announced that the parties had entered into an asset purchase agreement (the “Ipsen Agreement”) whereby the Company agreed to acquire Ipsen’s intellectual property and assets related to IPN-1087, a small molecule targeting neurotensin receptor 1 (“NTSR1”), a protein expressed on multiple solid tumor types. The Company intends to combine its expertise and proprietary TAT platform with IPN-1087 to create an alpha-emitting radiopharmaceutical targeting solid tumors expressing NTSR1. The Company and Ipsen submitted a pre-merger notification and report form with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice in accordance with the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”). The acquisition closed after completion of this antitrust review in April 2021. The Company concluded to account for this purchase as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset. Upon closing of the asset acquisition, the Company paid € 0.6 million ($ 0.8 million at the date of payment) and issued an aggregate of 600,000 common shares to Ipsen under a share purchase agreement which was entered into concurrently with the Ipsen Agreement. Such common shares were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”). The Company is also obligated to pay Ipsen up to an additional € 67.5 million upon the achievement of certain development and regulatory milestones; low single digit royalties on potential future net sales; and up to € 350.0 million in net sales milestones, in each case, relating to products covered by the asset purchase agreement. The Company is responsible for paying to a third-party licensor up to a total of € 70.0 million in development milestones for up to three indications and mid to low double-digit royalties on potential future net sales of products covered by the license agreement. During the three and six months ended June 30, 2023 and 2022 , the Company did no t make any payments to Ipsen or recognize any research and development expenses under the Ipsen Agreement. The Ipsen Agreement includes a royalty step down whereby royalties owed to Ipsen will be reduced by certain percentages not to exceed 50 %, in the aggregate, of the royalty owed under certain circumstances relating to loss of patent exclusivity, loss of regulatory exclusivity or generics entering a market. Under the asset purchase agreement Ipsen has agreed not to develop a molecule that targets NTSR1 and combines at least one NTSR1 binding moiety and a radionuclide or cytotoxic agent until the earlier of (i) the seventh anniversary of the closing date or (ii) the date of data base lock after completion of the first phase 3 clinical trial for IPN-1087. Agreement with Merck & Co. In May 2021, the Company entered into an agreement with two subsidiaries of Merck & Co. (“Merck”). Pursuant to the agreement, Merck will provide to the Company, at no cost, its anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab) to evaluate in combination with the Company’s lead candidate, FPI-1434. The planned Phase 1 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the agreement, the Company will sponsor, fund and conduct the combination trial in accordance with an agreed-upon protocol and Merck agreed to manufacture and supply its compound, at its cost and for no charge to the Company, for use in the clinical trial. Collaboration and Supply Agreement with Niowave, Inc. On June 9, 2022, the Company entered into a Collaboration and Supply Agreement with Niowave, Inc. (“Niowave”) (as amended from time to time, the “Niowave Agreement”) for the development, production and supply of 225 Ac to the Company. Under the Niowave Agreement, the Company is obligated to pay Niowave an aggregate of $ 5.0 million upon the achievement of certain milestones. On September 26, 2022, the Company entered into an amendment to the Niowave Agreement to amend certain terms of the Niowave Agreement, but made no change to the aggregate milestone payments owed under the Niowave Agreement. As of June 30, 2023 , Niowave had achieved certain milestones under the Niowave Agreement totaling $ 2.8 million, of which $ 1.9 million was paid during the six months ended June 30, 2023 and $ 0.9 million was paid during the year ended December 31, 2022. These amounts are being recognized as research and development expense over the period of performance by Niowave. During the three and six months ended June 30, 2023 , the Company recognized $ 0.5 million and $ 0.7 million, respectively, as research and development expense under the Niowave Agreement. During the three and six months ended June 30, 2022 , the Company recognized $ 0.1 million as research and development expense under the Collaboration and Supply Agreement. The Company recorded $ 1.2 million of milestone payments in prepaid expenses and other current assets as of June 30, 2023 based on its estimate of costs to be incurred over the 12 months following the balance sheet date for the Niowave Agreement. RadioMedix Option and Asset Purchase Agreement On November 14, 2022, the Company and RadioMedix, Inc. (“RadioMedix”) entered into an option and asset purchase agreement (the “RadioMedix Agreement”), pursuant to which RadioMedix granted to the Company the exclusive right, but not the obligation (the “RadioMedix Option”), to acquire certain of RadioMedix’s assets related to its on-going Phase 2 clinical trial evaluating 225 Ac PSMA I&T (the “TATCIST Study”), a small molecule targeting prostate specific membrane antigens, expressed on prostate tumors. Such assets include, among other things, the investigational new drug application for the TATCIST Study, any third-party license held, or later acquired, by RadioMedix relating to 225 Ac PSMA, and clinical and other data for the TATCIST Study (collectively, the “RadioMedix Assets”). The Company paid RadioMedix an option fee of $ 0.8 million upon the execution of the RadioMedix Agreement, which was recorded as research and development expense in its consolidated statements of operations and comprehensive loss during the year ended December 31, 2022. On February 10, 2023, the Company notified RadioMedix of its decision to exercise the RadioMedix Option, paid the $ 1.5 million option exercise fee and closed the acquisition. During the six months ended June 30, 2023 , the Company recognized the $ 1.5 million option exercise fee as research and development expense under the RadioMedix Agreement. The alpha-emitting radiopharmaceutical being evaluated in the TATCIST Study is now referred to as FPI-2265. Pursuant to the terms of the RadioMedix Agreement, the Company is obligated to pay RadioMedix (i) up to an additional $ 10.5 million upon the achievement of certain clinical and regulatory milestones, (ii) low single-digit royalties on potential future net sales, subject to specified reductions, and (iii) up to an additional $ 50.0 million in net sales milestones; in each case, relating to products covered by the RadioMedix Agreement. In addition, in the event RadioMedix or the Company is successful in obtaining certain intellectual property rights from a third party relating to 225 Ac PSMA I&T, the amount of the clinical and regulatory milestone payments will be increased by up to an aggregate of $ 4.0 million and the royalty rates will increase but remain in the low- to mid-single digits. Pursuant to the RadioMedix Agreement, the Company is prohibited from terminating or deprioritizing the development of 225 Ac PSMA I&T, subject to specified exceptions. If the Company terminates or deprioritizes the development of 225 Ac PSMA I&T, and does not sell, license or otherwise transfer its rights to a third-party within 12 months of such termination, the Company and RadioMedix are required to negotiate the return of 225 Ac PSMA I&T and related assets to RadioMedix in return for specified reimbursement costs to the Company. RadioMedix has agreed, subject to certain exceptions, not to develop or research a molecule that targets PSMA for a certain period of time following the closing date. Additionally, the Company and RadioMedix have entered into manufacturing agreements under which RadioMedix will supply FPI-2265 to the Company for use in clinical trials. RadioMedix will not be the sole manufacturer to supply FPI-2265 for use in clinical trials. Asset Purchase Agreement with Undisclosed Third-Party On June 1, 2023, the Company and an undisclosed, unrelated third-party entered into an asset purchase agreement (the “Third-Party Agreement”), pursuant to which the undisclosed third-party granted to the Company the rights to all know-how and information related to an unspecified target, including governmental authorizations, regulatory materials, books and records, patents, third party claims and causes of action, and all other assets, rights and properties. The Company concluded to account for this purchase as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset. During the three and six months ended June 30, 2023 , the Company paid an upfront payment of $ 0.7 million under the Third-Party Agreement which was recognized as research and development expense. Pursuant to the terms of the Third-Party Agreement, the Company is obligated to pay (i) up to an additional $ 7.5 million upon the achievement of certain clinical and regulatory milestones, (ii) low single-digit royalties on potential future net sales, subject to specified reductions, and (iii) up to an additional $ 50.0 million in net sales milestones; in each case, relating to products covered by the Third-Party Agreement. |