Earnings release
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Investor Relations | IDEAYA Biosciences IDEAYA Biosciences , Inc. Reports Third Quarter 2021 Financial Results and Provides Business Update - Strong balance sheet of ~ $ 386 million cash , cash equivalents and marketable securities is anticipated to fund planned operations into 2025 - Observed IDE397 preliminary clinical activity in early Phase 1 dose escalation cohorts , including pharmacodynamic modulation and tumor shrinkage - Enrolling IDE397 Cohort 5 with no observed drug - related serious adverse events and the maximum tolerated dose has not yet been reached - Targeting IDE397 cohort expansions and delivery of GSK option data package in first half of 2022 to trigger a review period for potential $ 50 million opt - in decision - Targeting webcast in Q4 2021 to present darovasertib and crizotinib clinical combination data , including clinical efficacy and tolerability - Selected a potential development candidate PARG inhibitor ; planning to initiate further preclinical development studies , including IND - enabling studies - Targeting development candidate for Pol Theta Helicase program in December 2021 ; $ 20 million in aggregate potential GSK milestone payments from preclinical to early Phase 1 SOUTH SAN FRANCISCO , Calif . , Nov. 15 , 2021 / PRNewswire / -- IDEAYA Biosciences , Inc. ( Nasdaq : IDYA ) , a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics , provided a business update and announced financial results for the third quarter ended September 30 , 2021 . " Early clinical data on our potential best - in - class Phase 1 MAT2A inhibitor , IDE397 , in MTAP - deletion patients shows preliminary signals of clinical activity , including pharmacodynamic modulation and tumor shrinkage in multiple patients . In addition , we selected a lead compound as a potential first - in - class development candidate for IND - enabling studies for our PARG synthetic lethality program and made progress towards our goal to select a potential first - in - class development candidate with GlaxoSmithKline for the Pol Theta Helicase program this year . We are targeting to provide an update in the fourth quarter of 2021 for the Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma , including clinical efficacy and guidance on timing for a potential registration enabling trial , " said Yujiro S. Hata , Chief Executive Officer and President of IDEAYA Biosciences . Program Updates Key highlights for IDEAYA's pipeline programs include : IDE397 ( MAT2A ) IDEAYA is evaluating IDE397 , a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a ( MAT2A ) , in patients having solid tumors with methylthioadenosine phosphorylase ( MTAP ) deletion , a patient population estimated to represent approximately 15 % of solid tumors . IDEAYA is leading early clinical development of IDE397 . Subject to exercise of its option , GlaxoSmithKline ( GSK ) will lead later stage global clinical development . Highlights : • Actively enrolling patients into Cohort 5 of the Phase 1 clinical trial IDE397-001 ( NCT04794699 ) • Patients are being identified by next generation sequencing ( NGS ) or by MTAP immunohistochemistry ( IHC ) assay with confirmatory NGS • Evaluating IDE397 in patients with MTAP deletion across multiple solid tumor types , including non - small cell lung cancer , pancreatic cancer , thymic cancer , adenoid cystic carcinoma and gastroesophageal cancer • IDE397 has been generally well tolerated , with observed drug - related adverse events as of November 5 , 2021 of only grade 1/2 drug - related adverse events ; there were no reported drug - related serious adverse events and no reported myelosuppression or liver toxicity ; IDE397 has yet to reach its Maximum Tolerated Dose • Observed preliminary signals of clinical activity in MTAP - deletion patients in early dose escalation cohorts , including plasma s- adenosyl methionine ( SAM ) pharmacodynamic ( PD ) modulation in IDE397 dose escalation Cohorts 1 through 3 , and tumor shrinkage in multiple patients in early dose escalation Cohorts 2 and 3 • Subject to initiation of an expansion cohort or establishing a maximum tolerated dose , or MTD , targeting submission of IDE397