January 2026 Improving Lives Through Transformative Precision Medicines JPM 2026 | 44th Annual Healthcare Conference NASDAQ: IDYA Safe Harbor Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of IDEAYA Biosciences, Inc. (the "Company") and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, perfor ...

Core Viewpoint - The approval of the IND for IDEAYA's dual-target ADC project IDE034 by the FDA marks a significant advancement in the development of innovative cancer therapies, potentially enhancing the company's market position and investor interest [1][2]. Group 1: Company Developments - 百奥赛图-B's stock rose over 3%, reaching 31.86 HKD with a trading volume of 12.99 million HKD following the announcement of FDA IND approval for IDEAYA's IDE034 project [1]. - IDEAYA Biosciences, Inc. plans to initiate patient enrollment for the Phase I clinical trial in Q1 2026, focusing on solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1]. Group 2: Clinical Research Insights - Preclinical studies indicate that IDE034 demonstrates deep and durable tumor regression in various B7H3/PTK7 positive tumor models, showcasing strong anti-tumor activity [2]. - IDEAYA intends to explore a combination therapy strategy with its PARG inhibitor IDE161 to enhance the durability of treatment effects, with plans to present additional data on the combined treatment mechanism at a major medical conference in H1 2026 [2]. - The co-expression rates of B7H3/PTK7 in solid tumors are approximately 30% in lung cancer, 46% in colorectal cancer, and 27% in head and neck cancer, indicating broad clinical applicability [2].

Core Viewpoint - The stock of Baiaosaitu-B (02315) has seen an increase of over 3%, currently trading at 31.86 HKD, following the announcement of FDA approval for a clinical trial by its partner IDEAYA Biosciences, Inc. for a novel dual-targeting antibody-drug conjugate project [1][2]. Group 1: Company Developments - IDEAYA Biosciences has received FDA approval for its Investigational New Drug (IND) application to advance the Phase I clinical trial of the B7H3/PTK7 dual-specific antibody-drug conjugate (ADC) [1]. - The patient enrollment for the trial is expected to begin in Q1 2026, focusing on solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1][2]. Group 2: Clinical Research Insights - Preclinical studies indicate that IDE034 monotherapy shows deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, demonstrating strong anti-tumor activity [2]. - IDEAYA plans to explore a combination treatment strategy of IDE034 with its PARG inhibitor IDE161 to enhance the durability of efficacy, with data supporting the combination treatment mechanism to be shared at a major medical conference in H1 2026 [2]. - The co-expression rates of B7H3/PTK7 in solid tumors are approximately 30% for lung cancer, 46% for colorectal cancer, and 27% for head and neck cancer, indicating broad clinical applicability [2].

Core Insights - IDEAYA Biosciences has received IND approval from the FDA for its first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC) project, IDE034, marking a significant milestone in its clinical development [1][2] Group 1: Clinical Development - The Phase I clinical trial for IDE034 is expected to begin patient enrollment in Q1 2026, targeting solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1] - Preclinical studies have shown that IDE034 monotherapy exhibits deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, indicating strong anti-tumor activity [2] Group 2: Technological Advancements - The IND approval validates IDEAYA's RenLite platform and proprietary linker-payload technology, showcasing its leading capabilities in the discovery and optimization of bispecific ADCs [2] - The company plans to explore combination therapy strategies with its PARG inhibitor, IDE161, to enhance the durability of treatment effects [2] Group 3: Market Potential - The co-expression rates of B7H3 and PTK7 in solid tumors are approximately 30% in lung cancer, 46% in colorectal cancer, and 27% in head and neck cancer, highlighting the broad clinical applicability of IDE034 [2] - The company aims to provide high-quality source molecules to partners and actively seek external licensing opportunities for early-stage assets [2]

Core Viewpoint - IDEAYA Biosciences has received IND approval from the FDA for its dual-target B7H3/PTK7 ADC project, IDE034, marking a significant milestone in its collaboration with 百奥赛图-B [1][2] Group 1: Clinical Development - IDEAYA plans to initiate patient enrollment for the Phase I clinical trial of IDE034 in Q1 2026, targeting solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1] - The IND approval signifies a crucial step in advancing the clinical development of IDE034, showcasing the company's technical strength in the dual-antibody ADC discovery and development field [1][2] Group 2: Research and Development Progress - The approval of IDE034's IND represents an important R&D advancement for IDEAYA, validating its RenLite® platform and proprietary linker-payload technology in the discovery and optimization of dual-antibody ADCs [2] - Preclinical studies indicate that IDE034 demonstrates deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, highlighting its strong anti-tumor activity [2] Group 3: Future Plans and Collaborations - IDEAYA intends to explore combination therapy strategies with its PARG inhibitor IDE161 to enhance the durability of treatment effects, with plans to present supporting data at major medical conferences in the first half of 2026 [2] - The co-expression rates of B7H3 and PTK7 in lung cancer, colorectal cancer, and head and neck cancer are approximately 30%, 46%, and 27%, respectively, indicating the broad clinical applicability of IDE034 [2] - The company aims to provide high-quality source molecules to partners and actively seek external licensing opportunities for early-stage potential assets [2]

Core Insights - IDEAYA Biosciences has received IND approval from the FDA for its first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC) project, IDE034, marking a significant milestone in its collaboration with 百奥赛图-B [1][2] - The clinical trial for IDE034 is expected to begin patient enrollment in Q1 2026, targeting solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1][2] Group 1 - The IND approval represents an important advancement in IDEAYA's strategy to expand its first-in-class TOP1 ADC pipeline into bispecific, precision-targeted therapies [2] - The approval validates the company's RenLite® platform and proprietary linker-payload technology in the discovery and optimization of bispecific ADCs [2] - IDE034 has shown deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, indicating strong anti-tumor activity [2] Group 2 - IDEAYA plans to explore combination therapy strategies with its PARG inhibitor IDE161 to enhance the durability of treatment effects [2] - The company intends to present more data supporting the combination treatment mechanism of PARG and TOP1 ADC at major medical conferences in the first half of 2026 [2] - The co-expression rates of B7H3 and PTK7 in solid tumors such as lung cancer, colorectal cancer, and head and neck cancer are approximately 30%, 46%, and 27%, respectively, highlighting the broad clinical applicability of IDE034 [2] Group 3 - The company aims to provide high-quality source molecules to partners under its "千鼠万抗" initiative, facilitating the clinical translation of licensed projects [2] - IDEAYA is actively exploring additional external licensing opportunities for early-stage potential assets [2]

Core Insights - Biocytogen's partner IDEAYA Biosciences has received FDA IND clearance for IDE034, a bispecific antibody-drug conjugate targeting B7H3 and PTK7, marking a significant milestone in its clinical development [1][2][3] Group 1: Product Development - IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024 [2] - The IND clearance allows IDEAYA to initiate a Phase 1 clinical trial, with patient enrollment expected to begin in Q1 2026, focusing on solid tumors expressing B7H3 and PTK7 [1][3] - Preclinical studies indicate that IDE034 monotherapy shows strong anti-tumor activity, inducing deep and durable tumor regressions in multiple tumor models [3] Group 2: Clinical Strategy - IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response, with additional preclinical data to be presented at a major medical conference in H1 2026 [3] - B7H3 and PTK7 are co-expressed in various cancers, with expression rates of approximately 30% in lung, 46% in colorectal, and 27% in head and neck cancers, indicating broad clinical potential for IDE034 [3] Group 3: Company Capabilities - The IND clearance validates Biocytogen's RenLite platform and proprietary linker-payload technologies, showcasing its capabilities in bispecific ADC discovery and development [2][3] - Biocytogen continues to provide high-quality source antibodies through its RenBiologics platform to support clinical translation and is actively seeking additional early-stage assets for licensing opportunities [4]

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]

Core Insights - IDEAYA Biosciences has received FDA clearance for an IND application to initiate a Phase 1 clinical trial for IDE034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate, expected to start patient enrollment in Q1 2026 [1][2] - The drug targets solid tumors expressing B7H3 and PTK7, with co-expression rates in lung, colorectal, and head and neck cancers reported at approximately 30%, 46%, and 27% respectively [1][5] - IDE034 has shown strong anti-tumor activity in preclinical studies, supporting its advancement into clinical development [3][5] Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to develop targeted therapies that are aligned with the genetic drivers of cancer [4] - The company has a robust pipeline of product candidates, particularly in synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications [4] Clinical Development Strategy - The company is advancing a differentiated clinical strategy with three potentially first-in-class clinical-stage programs aimed at enhancing the efficacy of TOP1 ADCs through a PARG DDR combination mechanism [2][3] - Preclinical studies suggest that combining IDE034 with IDE161, a PARG inhibitor, may enhance anti-tumor activity in patients with solid tumors co-expressing B7H3 and PTK7 [3][5]

Core Insights - IDEAYA Biosciences is focused on advancing precision medicines for cancer, with a strong pipeline and upcoming clinical data updates expected by year-end 2025 [1][2]. Pipeline Developments - The Phase 2/3 trial of darovasertib and crizotinib in 1L HLA-A2-negative metastatic uveal melanoma (MUM) is on track to report median progression-free survival (PFS) data by year-end 2025, which could enable a U.S. accelerated approval filing [4][5]. - Initial median overall survival data from over 40 patients in a single-arm Phase 2 trial will be presented at a medical conference in Q4 2025 [4][5]. - A randomized Phase 3 trial, OptimUM-10, will enroll approximately 520 patients in the neoadjuvant setting for primary UM, initiated in Q3 2025 [6]. Upcoming Milestones - IDEAYA will host a 10-year Anniversary R&D Day on September 8, 2025, to present multiple clinical data updates and strategic vision [2][10]. - Three investigational new drug (IND) applications are on track for submission by year-end 2025, including IDE892, IDE034, and IDE574 [4][11]. Financial Results - As of June 30, 2025, IDEAYA had approximately $991.9 million in cash, cash equivalents, and marketable securities, down from $1.05 billion as of March 31, 2025 [14][23]. - Research and development expenses for Q2 2025 totaled $74.2 million, an increase from $70.9 million in Q1 2025, primarily due to higher clinical trial expenses [15]. - The net loss for Q2 2025 was $77.5 million, compared to a net loss of $72.2 million in Q1 2025 [17].