IDEAYA Advances Cancer Pipeline as Quarterly Loss Widens
The cancer-drug developer ended June with approximately $1.24 billion in cash and securities.
IDEAYA Biosciences (IDYA), a clinical-stage precision-medicine oncology company, advanced its lead darovasertib program after a combination regimen met the primary endpoint in the OptimUM-02 trial. Median progression-free survival reached 6.9 months with darovasertib and crizotinib, compared with 3.1 months for investigator’s choice, yielding a hazard ratio of 0.42 and p<0.0001.
The clinical progress came as quarterly spending increased and the net loss widened. Collaboration revenue rose about 35% sequentially to $8.9 million from $6.6 million, while the net loss increased to $112.5 million from $98.5 million. The loss was $1.22 a share, compared with $1.11 a share in the first quarter.
Research-and-development expense climbed to $108.7 million from $95.7 million, primarily reflecting higher clinical-trial and personnel costs. General-and-administrative expense increased to $22.5 million from $19.4 million as IDEAYA added personnel costs and prepared for a potential darovasertib commercial launch. For the first half, operating expenses rose to $246.3 million from $173.2 million a year earlier, and the net loss widened to $211.0 million from $149.7 million. First-half collaboration revenue increased to $15.4 million from zero.
IDEAYA’s cash position increased from $972.9 million at the end of March, reversing a decline from about $1.05 billion at year-end. The increase chiefly reflected $323.4 million in net proceeds from a June public offering and $33.1 million raised through at-the-market share sales, partly offset by operating cash use. The company reiterated that its cash runway extends into 2030.
The darovasertib new-drug application entered an active filing process under the Food and Drug Administration’s Real-Time Oncology Review program, with completion still targeted for the second half of 2026. IDEAYA also completed enrollment of about 100 HLA-A2-positive patients in OptimUM-01 and scheduled an October ESMO update covering roughly 85 efficacy-evaluable patients. The global Phase 3 OptimUM-11 adjuvant trial was initiated and is expected to enroll about 450 patients.
The company was evaluating the capital allocated to the neoadjuvant OptimUM-10 trial, which previously targeted full enrollment of about 450 patients by the first half of 2027. Publications from OptimUM-09 and inclusion in practice guidelines could support patient access with less investment.
Beyond darovasertib, IDEAYA initiated IDE892 monotherapy expansion and an IDE892-plus-IDE397 combination cohort. It also disclosed a Roche collaboration to test IDE892 with the pan-RAS inhibitor RG6505 in MTAP-deleted, RAS-mutant pancreatic cancer, targeting a Phase 1 start in the second half of 2026. The larger cash balance gives IDEAYA funding for those studies as it weighs where to concentrate investment across its clinical pipeline.