IDEAYA Biosciences (IDYA) investor relations material

Key announcements and collaborations

• Announced a new collaboration with Roche to combine their pan-RAS inhibitor with IDE892, targeting MTAP deletion pancreatic cancer, with potential for a triplet combination including MAT2A.

• Submitted the first RTOR pre-submission module for darovasertib to the FDA, with expedited review anticipated due to fast track designation.

• Ongoing and upcoming presentations at major medical conferences for HLA-A2 positive and neoadjuvant data, as well as DLL3 ADC updates.

Clinical pipeline and trial updates

• Advancing multiple phase III studies in collaboration with Servier, including neoadjuvant and adjuvant settings for uveal melanoma.

• IDE892 PRMT5 inhibitor progressing well in dose escalation, with combination phase starting imminently and monotherapy expansion expected in the second half of the year.

• DLL3 Topo1 ADC in phase II for small cell lung cancer and neuroendocrine carcinoma, with landmark OS data expected from Hengrui's study.

• IDE574, a dual KAT6/7 inhibitor, is being dose escalated in breast, colorectal, prostate, and lung cancers.

Clinical data highlights and regulatory progress

• Darovasertib showed a confirmed response rate trending toward 40% and a hazard ratio of 0.42 in HLA-A2 negative metastatic uveal melanoma, with lower SAE and discontinuation rates than control.

• Median duration of treatment observed at 10 months, with potential for extension in real-world settings.

• Early OS trends are positive, with interim OS analysis projected for mid-next year; no crossover in the study may allow for full approval.

• Discussions with FDA ongoing regarding inclusion of HLA-A2 positive data in the NDA, with further clarity expected at the pre-NDA meeting.