IDEAYA Biosciences (IDYA) investor relations material

Key program updates and catalysts

• Top-line data for darovasertib plus crizotinib in metastatic uveal melanoma expected at end of March, with 130 events triggered for analysis.

• Neoadjuvant and adjuvant studies for darovasertib are enrolling, with adjuvant enrollment to begin in Q2 and neoadjuvant enrollment expected to complete in the first half of next year.

• DLL3 TOPO1 ADC phase I trial is enrolling in the US, with initial data and registrational study initiation planned by year-end.

• IDE397 (MAT2A inhibitor) in combination with Trodelvy for MTAP-deleted urothelial cancer will have an update in 2026.

• Cash position of $1.05 billion provides runway into 2030.

Clinical trial design and expectations

• The pivotal uveal melanoma trial compares darovasertib/crizotinib to standard of care, with a primary endpoint of progression-free survival (PFS).

• Standard of care yields median PFS of 2-3 months and overall survival (OS) of 13 months; darovasertib/crizotinib previously showed median PFS of 7 months and OS of 21 months.

• Success is defined as achieving at least 5.5 months median PFS in the treatment arm, with expectations to exceed this based on prior data.

• OS data will be monitored, with a formal interim analysis at the beginning of 2027; no crossover allowed to preserve OS integrity.

Regulatory and future development plans

• Filing for accelerated approval is targeted within 6 months post-data, with FDA review expected to take another 6 months.

• HLA-A2 positive patient data will be published and submitted to NCCN for guideline consideration, with ongoing discussions for label expansion.

• Neoadjuvant trial readouts expected minimum 2.5 years from start, with enucleation cohort likely to read out first.

• Adjuvant study is being finalized, with launch targeted by mid-year.