Summary of IDEAYA Biosciences FY Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **CEO**: Yujiro Hata Key Focus Areas 1. **Darovasertib**: - Currently in a registrational study with top-line results expected this quarter for potential accelerated approval in the U.S. [2][8] - Targets uveal melanoma, a rare and aggressive cancer with a poor prognosis (5-year survival rate of 15%-20%) [6][7] - Reported an overall response rate of approximately 35% and a median duration of response of nine months [7] - Progression-free survival (PFS) reported at seven months, with overall survival (OS) over 21 months [7] - Received Breakthrough Therapy Designation from the FDA for the neoadjuvant setting [9] 2. **Antibody-Drug Conjugates (ADCs)**: - Focus on DNA damage repair and enhancing durability of ADCs [11][12] - DLL3 TOPO-ADC program (ID849) aims to address unmet needs in small cell lung cancer, with a confirmed response rate of approximately 70% in second-line settings [15][16] - Plans to initiate a registrational study for ID849 targeting monotherapy accelerated approval [17] 3. **MTAP Deletion**: - Represents a significant opportunity as it is co-deleted with CDKN2A in various cancers, including lung and pancreatic cancers [19][20] - No FDA-approved therapies currently exist for patients with MTAP deletion [20] - Response rates of approximately 40% reported in ongoing studies, with a focus on non-small cell lung cancer [21][22] 4. **KAT6/7 Inhibitors**: - New dual KAT6/7 inhibitor (ID574) has entered phase one trials, targeting tumor heterogeneity [24] - Expected to address significant patient populations in breast cancer, prostate cancer, and colorectal cancer [24] Clinical Development and Strategy - IDEAYA has a pipeline of nine clinical stage molecules, focusing on precision medicine in oncology [5] - Emphasis on combination therapies to enhance treatment efficacy and durability [29] - Plans to complete enrollment for the neoadjuvant study by the first half of 2027 [11] Market Insights - IDEAYA aims to learn from the Kimmtrak launch in the uveal melanoma market to enhance its market entry strategy for darovasertib [28] - The company is focused on addressing challenges in community access and market penetration [28] Financial and Operational Highlights - IDEAYA is positioned for potential accelerated approval filings and is investing in future growth areas, including TOPO-ADCs and MTAP deletion biology [25] Additional Considerations - The company is exploring the safety and efficacy of various combinations, including the potential for reduced doses to optimize therapeutic windows [40][41] - The focus on systemic therapies versus dual payload approaches highlights a strategic differentiation in their clinical development [42] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA's strategic focus, clinical developments, and market positioning.

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 2-3 months, while the company has reported a PFS of approximately 7 months in its trials, 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 pipeline and potential for accelerated development [4] 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, highlighting a substantial unmet need in this area [12] Company Strategy and Development Direction - The company is focusing on expanding its pipeline in the MTAP deletion space, with a phase two MAT2A inhibitor and a phase one PRMT5 inhibitor, aiming to position itself as a leader in this competitive area [36] - The company is also exploring the DLL3 program for small cell lung cancer, with plans to differentiate based on efficacy and durability compared to competitors [53] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for darovasertib, and believes that the combination of strong efficacy data and a robust pipeline will position the company favorably in the market [19][20] - The company is optimistic about the potential for its adjuvant study to become a blockbuster opportunity, targeting patients earlier in their treatment journey [29] Other Important Information - The company is preparing to initiate an adjuvant study in collaboration with Servier, targeting high and high medium metastatic risk populations [27] - The company has a unique bispecific ADC targeting B7-H3 and PTK7, which is expected to amplify efficacy in dual expression populations [66] Q&A Session Summary Question: What is the expected timeline for the neoadjuvant study? - The company anticipates enrolling 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 it can differentiate based on response rates and durability, leveraging a unique linker system that allows for higher dosing [53][54] Question: What is the competitive landscape for the MTAP deletion space? - The company sees itself as an industry leader in the MTAP deletion area, with a diverse pipeline that includes multiple clinical stage assets [36][37]

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]