IDEAYA Biosciences (IDYA) Wells Fargo 21st Annual Healthcare Conference summary

Regulatory and clinical development updates

• Darovasertib NDA submission is progressing, with the final module to be submitted soon and commercial preparations on track; expedited review may allow for an earlier launch, with most projections targeting the first half of next year.

• Positive FDA engagement on label inclusion for HLA-A2 positive and negative patients; significant unmet need exists, especially in HLA-A2 negative where no approved agents are available.

• Interim overall survival analysis for phase III OptimUM-02 is expected around mid-next year; ex-U.S. regulatory submissions will follow OS readout.

• Phase II data for HLA-A*02 positive patients will be released soon, providing efficacy and safety data for about 100 patients, with 80% later-line and 20% frontline.

• Market opportunity in metastatic uveal melanoma (MUM) estimated at 1,500 annual U.S. patients, with global potential and additional opportunities in neo-adjuvant and adjuvant settings.

Pipeline and strategic portfolio updates

• PRMT5 inhibitor IDEAYA 892 has entered expansion phase after successful dose escalation, showing response-level activity and target engagement; focus remains on MTAP deletion lung cancer.

• Two collaborations with Roche are advancing, targeting Pan-RAS and KRAS G12D in pancreatic cancer, with first patient dosing for Pan-RAS expected soon.

• Differentiation strategy for PRMT5 and RAS combinations centers on selectivity, clean drug interaction profile, and non-brain penetrance, aiming for best-in-class assets.

• R&D Day will focus on clinical strategy and preclinical data for PRMT5, RAS, KAT6/7, and CDKN2A, with clinical data for RAS combinations expected next year.

DLL3 franchise and future catalysts

• DLL3 program shows consistent preliminary data across regions; phase III design confirmed with FDA, targeting post-IMDELLTRA population for a cleaner data set and higher probability of success.

• Sizable data update at ESMO will include efficacy and safety for about 100 patients; both U.S. and ex-U.S. phase III studies planned to start by year-end.

• Accelerated approval for DLL3 based on response rate could provide a near-term commercial opportunity; neuroendocrine population seen as a meaningful business opportunity.

• Key catalysts over the next 12 months include darovasertib NDA progress and launch, decisions in the neoadjuvant space, adjuvant trial enrollment, and initiation of DLL3 registrational study.

• Additional MTAP combination data, including IDE397 and Roche collaborations, expected in 2027.