IDEAYA Biosciences(IDYA) - 2025 FY - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company is approaching top line results for its lead program, darovasertib, with guidance for an accelerated approval filing in the U.S. by year-end this year to Q1 next year [3][4] - Historical median progression-free survival (PFS) for metastatic uveal melanoma is about 2 to 3 months, while the company has reported a PFS of approximately 7 months in their studies, indicating a significant improvement [6][7] Business Line Data and Key Metrics Changes - The company has eight programs in clinical development, with darovasertib being the lead program in a registrational trial for metastatic uveal melanoma [3] - The company has received breakthrough therapy designation for darovasertib in the neoadjuvant setting, indicating a strong focus on this area [4] - The next key program is DLL3, with recent data presented at the World Conference on Lung Cancer, highlighting its potential in small cell lung cancer [4][55] Market Data and Key Metrics Changes - The market for darovasertib targets approximately 4,000-5,000 patients, with a significant portion being HLA negative, which the company aims to address [9] - The annual incidence of neoadjuvant uveal melanoma is estimated to be 10,000-12,000 patients, indicating a substantial unmet need in this market [12] Company Strategy and Development Direction - The company is focusing on a diversified pipeline, with plans to initiate an adjuvant study in collaboration with Servier in the first half of next year, targeting high-risk metastatic patients [28] - The company aims to implement rational combinations in the MTAP deletion space, positioning itself as a leader in this area with multiple clinical stage assets [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for eye preservation rates and event-free survival in the neoadjuvant setting [19][13] - The company believes it is well-positioned to address the unmet needs in the neoadjuvant space due to limited competition [15][17] Other Important Information - The company is developing a bispecific ADC targeting B7H3 and PTK7, which is unique in its AND format, aiming to enhance efficacy in dual expression populations [68][69] - The company is also advancing its KAT6/7 inhibitor program, which targets chromatin remodeling, with a focus on breast cancer and potentially other indications [76][77] Q&A Session Summary Question: What is the timeline for the neoadjuvant study? - The company plans to enroll the study in roughly five quarters, with the first eye preservation data expected in about six months [19][20] Question: How does the company plan to differentiate its DLL3 program? - The company believes its linker system allows for higher dosing and reduced toxicity compared to competitors, which could lead to better efficacy and durability [55][56] Question: What is the market potential for the adjuvant study? - The adjuvant market could potentially be the largest of the three indications, with a path to becoming a blockbuster opportunity [30]