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Fate Therapeutics(FATE) - 2024 Q4 - Annual Report
FATEFate Therapeutics(FATE)2025-03-05 21:03

Financial Performance - The company has incurred net losses since its inception in 2007, with significant expenses related to research and development and general administrative costs [474]. - The company has not generated any revenues from therapeutic product sales or royalties to date, relying on collaboration agreements and government grants for funding [478]. - The company expects to incur significant commercialization expenses if regulatory approval is obtained for any product candidates [476]. - The company reported a net cash used in operating activities of 122.9millionin2024,comparedto122.9 million in 2024, compared to 132.3 million in 2023 [524]. - As of December 31, 2024, the company had an accumulated deficit of 1.4billionandanticipatescontinuednetlosses[524].−Thecompanyexpectstocontinueincurringsignificantlossesasitdevelopsitsproductcandidatesandseeksregulatoryapprovals[535].CollaborationAgreements−CollaborationrevenuerecognizedundertheOnoAgreementwas1.4 billion and anticipates continued net losses [524]. - The company expects to continue incurring significant losses as it develops its product candidates and seeks regulatory approvals [535]. Collaboration Agreements - Collaboration revenue recognized under the Ono Agreement was 13.6 million for the year ended December 31, 2024, and 11.2millionfortheyearendedDecember31,2023[487].−Thecompanyreceivedatotalof11.2 million for the year ended December 31, 2023 [487]. - The company received a total of 100.0 million from the Janssen Agreement, including a 50.0millionupfrontcashpaymentanda50.0 million upfront cash payment and a 50.0 million equity investment [488]. - The company recognized 52.3millionofcollaborationrevenueundertheJanssenAgreementfortheyearendedDecember31,2023[491].−Collaborationrevenuedecreasedto52.3 million of collaboration revenue under the Janssen Agreement for the year ended December 31, 2023 [491]. - Collaboration revenue decreased to 13.6 million in 2024 from 63.5millionin2023,primarilyduetotheterminationofthecollaborationwithJansseninApril2023[522].ResearchandDevelopment−Thecompanyplanstocontinuesignificantinvestmentsinresearchanddevelopmentactivities,focusingonclinicalandpreclinicaldevelopmentofproductcandidates[493].−ThecompanyhasapipelineofiPSC−derived,chimericantigenreceptor(CAR)−targetedT−cellandNKcellproductcandidatescurrentlyunderdevelopment[471].−Researchanddevelopmentexpenseswere63.5 million in 2023, primarily due to the termination of the collaboration with Janssen in April 2023 [522]. Research and Development - The company plans to continue significant investments in research and development activities, focusing on clinical and preclinical development of product candidates [493]. - The company has a pipeline of iPSC-derived, chimeric antigen receptor (CAR)-targeted T-cell and NK cell product candidates currently under development [471]. - Research and development expenses were 135.0 million in 2024, down from 172.6millionin2023,reflectingadecreaseof172.6 million in 2023, reflecting a decrease of 37.6 million [523]. - The aggregate estimated research and preclinical development fees under the Ono Agreement have increased to approximately 38.0millionfollowingrecentamendments[485].−Thecompanyanticipatesongoingcostsrelatedtoclinicaltrials,includingexpensesforresearchanddevelopmentactivitiesandthird−partyserviceproviders[91].GeneralandAdministrativeExpenses−GeneralandadministrativeexpensesareexpectedtoremainsignificantasthecompanyfocusesoninnovationandcompliancewithSECrequirements[496].−Generalandadministrativeexpensesdecreasedto38.0 million following recent amendments [485]. - The company anticipates ongoing costs related to clinical trials, including expenses for research and development activities and third-party service providers [91]. General and Administrative Expenses - General and administrative expenses are expected to remain significant as the company focuses on innovation and compliance with SEC requirements [496]. - General and administrative expenses decreased to 74.2 million in 2024 from 81.4millionin2023,areductionof81.4 million in 2023, a reduction of 7.2 million [523]. Funding and Cash Position - The company received 7.9millionfromtheCaliforniaInstituteforRegenerativeMedicine(CIRM)tosupportthePhase1studyofFT819,withdisbursementsbasedondevelopmentmilestonesfromApril2024toMarch2028[498].−Financingactivitiesprovidedcashof7.9 million from the California Institute for Regenerative Medicine (CIRM) to support the Phase 1 study of FT819, with disbursements based on development milestones from April 2024 to March 2028 [498]. - Financing activities provided cash of 99.9 million in 2024, primarily from the issuance of 14,545,454 shares of common stock at 5.50pershare[529].−Thecompanyhadaggregatecash,cashequivalents,andinvestmentsof5.50 per share [529]. - The company had aggregate cash, cash equivalents, and investments of 306.7 million as of December 31, 2024 [531]. Impairment and Other Income - An impairment charge of 13.4millionagainstpropertyandequipmentand13.4 million against property and equipment and 1.3 million against the right-of-use asset was recorded in 2024 due to a sustained decline in the company's stock price [514]. - The company recorded 5.1millionofotherincomefromtheEmployeeRetentionCreditduringtheyearendedDecember31,2023,butnosuchamountwasrecognizedin2024[503].−TheFT516CIRMAwardof5.1 million of other income from the Employee Retention Credit during the year ended December 31, 2023, but no such amount was recognized in 2024 [503]. - The FT516 CIRM Award of 4.0 million was treated as a grant in Q1 2023, reversing the associated liability and recording it as other income [502]. Future Obligations and Milestones - The company has obligations under various license agreements to make future payments totaling up to 75.0milliontoMSKCCbasedontheachievementofspecifiedclinicalmilestones[543].−ThemaximumaggregatemilestonepaymentsperproductunderthelicenseagreementwiththeWhiteheadInstituteforBiomedicalResearchare75.0 million to MSKCC based on the achievement of specified clinical milestones [543]. - The maximum aggregate milestone payments per product under the license agreement with the Whitehead Institute for Biomedical Research are 2.3 million, with royalties on net sales in the low single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with The Scripps Research Institute are 1.8million,withroyaltiesonnetsalesinthelow−tomid−singledigits[546].−ThemaximumaggregatemilestonepaymentsperproductunderthelicenseagreementwiththeRegentsoftheUniversityofMinnesotaare1.8 million, with royalties on net sales in the low- to mid-single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with the Regents of the University of Minnesota are 4.6 million, with royalties on net sales in the low single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with MSKCC are 12.5million,withroyaltiesonnetsalesuptothehigh−singledigits[546].−ThemaximumaggregatemilestonepaymentsperproductunderthelicenseagreementwithDanaFarberCancerInstituteare12.5 million, with royalties on net sales up to the high-single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with Dana Farber Cancer Institute are 25 million, with royalties on net sales in the low single digits [546]. - The maximum aggregate milestone payments per product under the license agreement with Baylor College of Medicine are 7.0million,withroyaltiesonnetsalesinthelowsingledigits[550].−ThemaximumaggregatemilestonepaymentsperproductunderthelicenseagreementwithMaxDelbruckCenterforMolecularMedicineare7.0 million, with royalties on net sales in the low single digits [550]. - The maximum aggregate milestone payments per product under the license agreement with Max Delbruck Center for Molecular Medicine are 11.0 million, with royalties on net sales in the low single digits [550]. Market and Economic Factors - Inflationary factors may adversely affect the company's operating results, although no material impact has been observed to date [548]. - The company may require additional debt or equity capital to make milestone payments that are contingent upon the achievement of certain development, regulatory, and commercial milestones [545].