IDEAYA Biosciences (IDYA) investor relations material

Key milestones and clinical updates

• Lead program darovasertib showed positive top-line results in first-line HLA-A2 negative metastatic uveal melanoma, with a 6.9-month PFS vs. 3.1 months for control and a response rate approaching 40%.

• NDA submission process expedited via RTOR, with pre-submission modules underway and a major ASCO presentation scheduled.

• Additional data at ASCO will include detailed waterfall plots, safety tables, and subset efficacy analyses.

• Interim OS analysis is projected for mid-next year, with ongoing data collection for both HLA-A2 negative and positive populations.

• Expansion into adjuvant and neoadjuvant settings is ongoing, with breakthrough therapy designation in neoadjuvant and two randomized Phase III studies underway.

Market opportunity and commercialization plans

• Global annual incidence for metastatic uveal melanoma is estimated at 4,000–5,000, with pre-metastatic at 10,000–12,000; about two-thirds are HLA-A2 negative.

• Commercial strategy includes aiming for HLA-agnostic NCCN guideline inclusion and leveraging an oral tablet formulation for broader community penetration.

• Sales organization is being built, with a new VP of sales and supply chain readiness; U.S. launch will be prioritized with support from global partner Servier.

Pipeline and future directions

• IDE849 (DLL3 Topo ADC) will have two clinical data updates by year-end, including large datasets from both the company and partner Hengrui Pharma, focusing on small cell lung cancer and neuroendocrine carcinoma.

• Phase III registrational studies for DLL3 Topo ADC are planned this year, with potential best-in-class positioning based on response rate, PFS, and safety profile.

• MTAP program includes a first-in-class PRMT5 inhibitor with dose escalation progressing and combination studies starting soon, plus a MAT2A inhibitor in phase II.

• Strategic focus on RAS/KRAS space, especially pancreatic cancer, with ongoing discussions for RAS inhibitor partnerships.

• KAT6/7 dual inhibitor (IDE574) in phase I targets breast, prostate, and colorectal cancers, with emphasis on dual inhibition for superior efficacy.