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IDEAYA Biosciences Announces Participation at the 43rd Annual J.P. Morgan Healthcare Conference and 2025 Corporate Guidance
IDYAIDEAYA Biosciences(IDYA) Prnewswire·2025-01-12 17:00

Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on discovering and developing targeted therapeutics for patient populations selected using molecular diagnostics [2] - The company integrates translational biomarker identification and validation with drug discovery to select patient populations most likely to benefit from its targeted therapies [2] - IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality, an emerging class of precision medicine targets [2] Upcoming Events - IDEAYA will participate in the 43rd Annual J P Morgan Healthcare Conference on January 13, 2025, with a presentation by CEO Yujiro S Hata followed by an analyst-hosted Q&A session [5] - A live audio webcast of the presentation and Q&A session will be available on the IDEAYA website, with a replay accessible for 30 days [1] 2025 Corporate Guidance - As of September 30, 2024, IDEAYA has 12billionincash,cashequivalents,andmarketablesecurities,whichisanticipatedtofundoperationsintoatleast2028[5]−Thecompanyplanstomake3INDfilingsin2025,representingits7th,8th,and9thpotentialclinicalstageprecisionmedicineoncologyprogramstargetingsolidtumors[5]PipelineUpdatesDarovasertibProgram−Darovasertibisapotentialfirst−in−classPhase2/3PKCinhibitortargetingMetastaticUvealMelanoma(MUM)andUvealMelanoma(UM)[5]−Medianprogression−freesurvivalreadoutforthePhase2/3trialofdarovasertibandcrizotinibcombinationinfirst−lineMUMpatientsistargetedbyyear−end2025,withenrollmentexceeding200patientsasofJanuary6,2025[5]−Phase2medianoverallsurvivalreadoutforthecombinationinapproximately38first−lineMUMpatientsistargetedin2025[5]−Phase2neoadjuvantUMclinicaldataupdatefordarovasertibinover75patientsandaregulatoryupdatearetargetedin2025[5]−InitiationofthePhase3registration−enablingtrialfordarovasertibinneoadjuvantUMisplannedforthefirsthalfof2025[5]IDE397Program−IDE397isapotentialfirst−in−classPhase2MAT2AInhibitortargetingMTAP−deletionsolidtumors[5]−ClinicalprogramupdatesforthePhase1/2studyofIDE397incombinationwithTrodelvyinMTAP−deletionurothelialcanceraretargetedin2025[5]−ThecompanyaimstoenableawhollyownedIDE397+IDE892(PRMT5)clinicalcombinationinthesecondhalfof2025totargetMTAP−deletionnon−smallcelllungcancer[5]IDE849Program−IDE849isapotentialfirst−in−classPhase1DLL3TOP1iADCtargetingSmallCellLungCancerandNeuroendocrineTumors[5]−Clinicalprogramupdatesaretargetedin2025,withupdatedslidesprovidedintheJPM2025corporatepresentation[5]IDE275Program−IDE275isapotentialfirst−in−classPhase1WernerHelicaseprogramtargetingMSI−highsolidtumors[5]−ApresentationhighlightingIDE275′sdifferentiatedpotentialbest−in−classprofileistargetedinthefirsthalfof2025incollaborationwithGSK[5]IDE161Program−IDE161isapotentialfirst−in−classPhase1PARGinhibitortargetingsolidtumors[5]−Phase1expansionofIDE161incombinationwithKEYTRUDAinMSI−highandMSSendometrialcanceristargetedin2025[5]−ClinicalcombinationsofIDE161withTopo−ADCsarealsotargetedin2025[5]IDE705Program−IDE705isapotentialfirst−in−classPhase1PolThetaHelicaseInhibitortargetinghomologousrecombinationdeficiencysolidtumors[5]−Phase2expansioninHRDsolidtumorsistargeted,enablingapotential1 2 billion in cash, cash equivalents, and marketable securities, which is anticipated to fund operations into at least 2028 [5] - The company plans to make 3 IND filings in 2025, representing its 7th, 8th, and 9th potential clinical stage precision medicine oncology programs targeting solid tumors [5] Pipeline Updates Darovasertib Program - Darovasertib is a potential first-in-class Phase 2/3 PKC inhibitor targeting Metastatic Uveal Melanoma (MUM) and Uveal Melanoma (UM) [5] - Median progression-free survival readout for the Phase 2/3 trial of darovasertib and crizotinib combination in first-line MUM patients is targeted by year-end 2025, with enrollment exceeding 200 patients as of January 6, 2025 [5] - Phase 2 median overall survival readout for the combination in approximately 38 first-line MUM patients is targeted in 2025 [5] - Phase 2 neoadjuvant UM clinical data update for darovasertib in over 75 patients and a regulatory update are targeted in 2025 [5] - Initiation of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is planned for the first half of 2025 [5] IDE397 Program - IDE397 is a potential first-in-class Phase 2 MAT2A Inhibitor targeting MTAP-deletion solid tumors [5] - Clinical program updates for the Phase 1/2 study of IDE397 in combination with Trodelvy in MTAP-deletion urothelial cancer are targeted in 2025 [5] - The company aims to enable a wholly owned IDE397 + IDE892 (PRMT5) clinical combination in the second half of 2025 to target MTAP-deletion non-small cell lung cancer [5] IDE849 Program - IDE849 is a potential first-in-class Phase 1 DLL3 TOP1i ADC targeting Small Cell Lung Cancer and Neuroendocrine Tumors [5] - Clinical program updates are targeted in 2025, with updated slides provided in the JPM 2025 corporate presentation [5] IDE275 Program - IDE275 is a potential first-in-class Phase 1 Werner Helicase program targeting MSI-high solid tumors [5] - A presentation highlighting IDE275's differentiated potential best-in-class profile is targeted in the first half of 2025 in collaboration with GSK [5] IDE161 Program - IDE161 is a potential first-in-class Phase 1 PARG inhibitor targeting solid tumors [5] - Phase 1 expansion of IDE161 in combination with KEYTRUDA in MSI-high and MSS endometrial cancer is targeted in 2025 [5] - Clinical combinations of IDE161 with Topo-ADCs are also targeted in 2025 [5] IDE705 Program - IDE705 is a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor targeting homologous recombination deficiency solid tumors [5] - Phase 2 expansion in HRD solid tumors is targeted, enabling a potential 10 million milestone payment from GSK [5] IDE892 Program - IDE892 is a potential best-in-class MTA-cooperative PRMT5 inhibitor, with combination potential with IDE397, targeted for mid-year 2025 [5][6] IDE034 Program - IDE034 is a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC, with combination potential with IDE161, targeted for the second half of 2025 [5][6] IDE251 Program - IDE251 is a potential first-in-class KAT6/7 dual inhibitor development candidate, with combination potential with multiple programs in IDEAYA's pipeline, targeted for the second half of 2025 [6]