Earnings release
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Investor Relations | IDEAYA Biosciences - IDEAYA Biosciences , Inc. Reports Second Quarter 2021 Financial Results and Provides Business Update Strong balance sheet of ~ $ 400 million cash , cash equivalents and marketable securities is anticipated to fund planned operations into 2025 - Enrolling MTAP - deletion solid tumors patients into the IDE397 Phase 1 dose escalation and tumor biopsy cohorts ; targeting to obtain additional clinical pharmacodynamic data , including plasma SAM and tumor SDMA , in the fourth quarter of 2021 - Targeting development candidate nomination for each of potential first - in - class PARG and Pol Theta synthetic lethality ( SL ) programs in the fourth quarter of 2021 , and advancing chemistry optimization of Werner Helicase and second MTAP - SL programs - Targeting clinical data update for darovasertib combination ( s ) in the fourth quarter of 2021 ; amended Pfizer clinical trial collaboration and supply agreement to enable expansion for 40 additional patients on darovasertib / crizotinib combination - Targeting FDA clearance in the first half of 2022 to initiate a Phase 1 clinical trial to evaluate darovasertib in GNAQ mutation - mediated rare diseases SOUTH SAN FRANCISCO , Calif . , Aug. 10 , 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 second quarter ended June 30 , 2021 . " We reported clinical data across multiple programs in the second quarter of 2021 , including early clinical pharmacodynamic data for IDE397 in MTAP - deletion patients , as well as overall survival data for darovasertib monotherapy and early clinical efficacy for the darovasertib / binimetinib and darovasertib / crizotinib combinations in metastatic uveal melanoma patients . We also continued to advance our broad synthetic lethality pipeline and platform , with two potential development candidates anticipated in the fourth quarter of 2021 and multiple potential first - in - class preclinical targets and programs advancing against genetically defined patient populations . These clinical data and our synthetic lethality pipeline demonstrate our clinical progress and commitment to deliver precision medicine oncology therapies to patients with high unmet medical needs , " 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 the dose escalation and tumor biopsy cohorts of the Phase 1 clinical trial IDE397-001 ( ClinicalTrials.gov Identifier : NCT04794699 ) • Patients are being identified by next generation sequencing ( NGS ) or by MTAP immunohistochemistry ( IHC ) assay with confirmatory NGS • Enrolled patients having multiple solid tumor types with MTAP - deletion , including non - small cell lung cancer , pancreatic cancer , thymic cancer and adenoid cystic carcinoma • IDE397 has been generally well tolerated , with observed drug - related adverse events as of June 25 , 2021 of only grade 1 drug- related adverse events , including constipation , nausea and fatigue ; there were no reported drug - related serious adverse events and no reported myelosuppression , or changes to bilirubin or to aminotransaminase ( AST ) or alanine aminotransferase ( ALT ) enzymes • Observed reduction of plasma S - adenosylmethionine , or SAM , a proximal pharmacodynamic marker , in each of the first two cohorts of the IDE397 Phase 1 dose escalation study , satisfying the clinical protocol threshold of approximately 60 % or greater to initiate the tumor biopsy cohort of the IDE397 Phase 1 clinical trial