IDEAYA Biosciences (IDYA) investor relations material

Pipeline overview and strategic focus

• Precision medicine oncology pipeline includes lead agent darovasertib, DLL3 ADC, and MTAP deletion programs.

• Darovasertib is nearing NDA submission under RTOR, with a projected launch in the first half of next year and multiple phase III studies ongoing.

• DLL3 ADC program is advancing to a randomized phase III study in small cell lung cancer, with additional opportunities in neuroendocrine carcinoma.

• Two collaborations with Roche focus on pan-RAS and KRAS G12D inhibitors in pancreatic cancer.

• Additional assets include KAT6/7, CDKN2A, and PRMT5 programs targeting various solid tumors.

Darovasertib clinical and regulatory progress

• NDA submission for darovasertib is nearly complete, with label strategy discussions ongoing; FDA is receptive to an all-comers approach.

• Darovasertib shows a confirmed response rate near 40%, PFS of about 7 months, and OS over 21 months, outperforming current therapies.

• Oral administration offers convenience over existing weekly IV treatments.

• Commercial launch preparations include physician education, patient identification, and leveraging KOL networks and technology.

• Phase III adjuvant study is underway, targeting relapse prevention with a well-powered design of 450 patients.

DLL3 ADC and combination strategies

• DLL3 ADC aims for best-in-class status by balancing efficacy and safety, targeting higher response rates and improved PFS compared to competitors.

• Upcoming ESMO presentation will provide data on response rate, PFS, and 12-month OS for about 100 patients.

• Phase III study will focus on post-Imdelltra population in small cell lung cancer; registrational study in neuroendocrine carcinoma is under FDA discussion.

• Combination strategies include novel PARG (IDE161) and PD-L1, with go/no-go decisions expected by end of next year.

• PARG/IDE161 combinations aim to enhance durability and could be applied across topoisomerase-based therapies.