IDEAYA Biosciences (IDYA) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Pipeline and clinical program updates

• Four clinical-stage programs highlighted, with darovasertib in registrational trials for metastatic and neoadjuvant uveal melanoma, and a key FDA Type C meeting scheduled for Q3 to discuss endpoints and trial design.

• IDE397, a MAT2A inhibitor, is in phase II for MTAP-deleted cancers, with ongoing monotherapy and combination studies; expansion into additional MTAP programs and a second development candidate expected by year-end.

• IDE161 (PARG inhibitor) is in phase I, with monotherapy expansion and a KEYTRUDA combo trial with Merck targeted for the second half of the year.

• Pol Theta and Werner helicase programs, both in collaboration with GSK, are advancing, with Werner targeting MSI-high GI cancers and Pol Theta focused on overcoming PARP resistance.

• A bispecific ADC (B7-H3/PTK7) program was in-licensed, aiming for novel combinations and monotherapy potential.

Key clinical data and regulatory milestones

• Darovasertib showed >30% tumor shrinkage and high eye preservation rates in neoadjuvant uveal melanoma, with a robust safety profile; over 50-patient dataset to be shared in the second half of the year.

• FDA Type C meeting will clarify acceptable clinical endpoints (e.g., eye preservation, visual acuity, EFS, RFS) and trial populations for neoadjuvant studies.

• Integrated phase II/III trial for frontline metastatic uveal melanoma targets 230 patients for PFS and 120 more for OS, with enrollment nearly halfway complete.

• Adjuvant uveal melanoma studies are under consideration, pending regulatory feedback from neoadjuvant discussions.

Market opportunities and unmet needs

• Uveal melanoma remains a high unmet need with no approved systemic therapies in neoadjuvant, adjuvant, or metastatic settings, especially for HLA-A2 negative patients.

• MTAP deletion is present in 15-30% of several major tumor types, representing a large, untapped precision oncology market.

• Rational combinations, especially in MTAP deletion, are seen as the key to unlocking commercial and patient value.

• IDE161 aims to address populations where PARP inhibitors are ineffective, with a focus on endometrial and colorectal cancers.

• The KAT6 pathway program is differentiated from competitors and targets expansion beyond breast cancer, including lung cancer.