Summary of IDEAYA Biosciences FY Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology Key Points Lead Program: Darovasertib - **Current Status**: In first-line registrational study for metastatic uveal melanoma - **Upcoming Milestones**: Randomized median progression-free survival (PFS) results expected by year-end 2025, with full enrollment for median overall survival (OS) component nearly complete, targeting over 450 patients [2][3][4] - **Breakthrough Therapy Designation**: Received for a phase 3 randomized neoadjuvant trial, which is now active with patients in screening [3][4] Patient Journey in Uveal Melanoma - **Lack of Approved Therapies**: No systemic approved therapies in neoadjuvant or adjuvant settings, with most metastatic patients also lacking approved options [5][6] - **Treatment Options**: Initial treatments include eye resection or plaque therapy, followed by adjuvant phase with no available therapies [7][8] Objectives for Neoadjuvant and Adjuvant Trials - **Primary Endpoint**: Eye preservation rate exceeding 10% with 95% confidence interval for the enucleation cohort [9][10] - **Visual Acuity Goals**: Aim for 20% or more patients in treatment arm passing a 15-letter BCVA vision test [10] DLL3 Topo ADC Program - **Efficacy Data**: Confirmed response rate of 70% in second-line small cell lung cancer at a dose of 2.4 mg/kg [15] - **Safety Profile**: Grade three or higher adverse events (AEs) below 20%, indicating potential for dose escalation [16] Future Development Plans - **Focus Areas**: Small cell lung cancer and neuroendocrine tumors (NETs) with plans to share more data in 2026 [20][23] - **MAT2A and MTAP Pathway**: Ongoing phase two trials for IDE397 (MAT2A inhibitor) and phase one for PRMT5 inhibitor, with updates expected in the first half of next year [24][25] Bispecific ADC Development - **B7-H3 and PTK7**: First-in-class bispecific ADC targeting co-expressed antigens in various tumor types, including non-small cell lung cancer and colorectal cancer [32][34] - **Patient Population**: Approximately one-third of lung cancer patients and 40%-50% of colorectal cancer patients are expected to express both antigens [34] Key Takeaways - **Upcoming Focus**: Randomized PFS results are critical for transitioning towards commercialization [38] - **Overall Strategy**: Emphasis on combination therapies and targeting co-alterations to enhance treatment efficacy [29][30] This summary encapsulates the essential insights from the IDEAYA Biosciences FY Conference Call, highlighting the company's strategic focus, ongoing clinical trials, and future development plans in the oncology sector.

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IDEAYA Biosciences (NasdaqGS:IDYA) FY 2025 Conference December 02, 2025 09:00 AM ET Company ParticipantsYujiro Hata - CEOJoshua Bleharski - CFOConference Call ParticipantsYigal Nochomovitz - Biotech AnalystYigal NochomovitzAll right. Okay. All right, welcome everyone to Day One of Citi's Global Healthcare Conference here in sunny and hopefully very warm Miami. I'm Yigal Nochomovitz, one of the biotech analysts at Citi. The first session today, it's my pleasure to have with me the management of IDEAYA Biosci ...

IDEAYA Biosciences (NasdaqGS:IDYA) FY 2025 Conference December 02, 2025 09:00 AM ET Company ParticipantsYujiro Hata - CEOJoshua Bleharski - CFOConference Call ParticipantsYigal Nochomovitz - Biotech AnalystYigal NochomovitzAll right. Okay. All right, welcome everyone to Day One of Citi's Global Healthcare Conference here in sunny and hopefully very warm Miami. I'm Yigal Nochomovitz, one of the biotech analysts at Citi. The first session today, it's my pleasure to have with me the management of IDEAYA Biosci ...

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 2.5 months, while the company has reported a PFS of approximately 7 months in its trials, indicating a significant improvement [6][8] 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 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 target market for darovasertib includes approximately 4,000-5,000 patients, with a significant portion being HLA negative, which the company aims to address [10] - The annual incidence of neoadjuvant uveal melanoma is estimated to be 10,000-12,000 patients, highlighting a substantial unmet need in this area [14] Company Strategy and Development Direction - The company is focusing on expanding its pipeline in the MTAP deletion space, which represents about 10% of all solid tumors, and is pursuing rational combinations to enhance treatment efficacy [39] - The company is also exploring the DLL3 program for small cell lung cancer, aiming to differentiate based on efficacy and durability compared to competitors [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for darovasertib, and highlighted the potential for further upside based on patient baseline characteristics [11][12] - The company is optimistic about the adjuvant study, which is expected to target high-risk populations and could potentially be the largest market segment among its three indications [32] Other Important Information - The company is preparing to initiate an adjuvant study in collaboration with Servier, targeting approximately 450 patients and focusing on relapse-free survival as the primary endpoint [30] - The company is also advancing its KAT6/7 inhibitor program, which aims to enhance activity and durability in cancer treatment [75] Q&A Session Summary Question: What are the expected timelines for the neoadjuvant and adjuvant studies? - The company anticipates eye preservation data in about six months and expects to enroll the neoadjuvant study in roughly five quarters [21][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 [58] Question: What is the strategy for the MTAP deletion program? - The company aims to implement rational combinations and believes it is an industry leader in this area with multiple clinical stage assets [39]

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]

Group 1 - Ideaya Biosciences, Inc. (IDYA) is a precision medicine oncology company that went public in May 2019, raising $57.5 million by issuing 5.75 million shares at $10 per share [1] - The current stock valuation of Ideaya Biosciences is $35 per share, indicating significant appreciation since its IPO [1] - The investing group Haggerston BioHealth, led by biotech consultant Edmund Ingham, provides insights and analysis on over 1,000 companies in the biotech, healthcare, and pharma sectors [1] Group 2 - Haggerston BioHealth offers catalysts for investors to monitor, along with buy and sell ratings, product sales forecasts, and integrated financial statements [1] - The group also conducts discounted cash flow analysis and market-by-market analysis for major pharmaceutical companies [1]

Core Insights - Ideaya Biosciences, Inc. (IDYA) is a precision medicine oncology company that went public in May 2019, raising $57.5 million by issuing 5.75 million shares at $10 per share, with the current stock valued at $35 per share [1] Group 1 - Ideaya Biosciences focuses on precision medicine within the oncology sector [1] - The company has been supported by a biotech consultant with over 5 years of experience in the biotech, healthcare, and pharma industries [1] - The investing group Haggerston BioHealth provides insights and forecasts for major pharmaceutical companies, including product sales and integrated financial statements [1]

Core Insights - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events, showcasing its commitment to engaging with investors and stakeholders in the healthcare sector [1][5]. Company Overview - IDEAYA is a precision medicine oncology company focused on discovering, developing, and commercializing transformative cancer therapies. The company integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics to create targeted therapies aligned with genetic disease drivers [2]. Upcoming Events - The company will participate in Citi's 2025 Global Healthcare Conference on December 2, 2025, at 9:00 AM ET, featuring a fireside chat with CEO Yujiro S. Hata [1]. - IDEAYA will also be present at the 8th Annual Evercore Healthcare Conference on December 3, 2025, at 10:50 AM ET, with another fireside chat led by CEO Yujiro S. Hata [1]. Communication Channels - A live audio webcast of the conference events will be available on the IDEAYA website, and a replay will be accessible for 30 days post-event [1].

Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology - **Lead Program**: Darovasertib, currently in a registrational trial for frontline metastatic uveal melanoma, with an expected median progression-free survival (PFS) readout by year-end 2025 to Q1 2026 [2][4] Key Clinical Programs - **Pipeline**: IDEAYA has a deep pipeline with eight clinical stage programs, targeting nine by year-end 2025 [2] - **MTAP Deletion Focus**: - ID397 (Phase 2 MAT2A inhibitor) - ID892 (Phase 1 MTAP-cooperative PRMT5 inhibitor) [3] - **Antibody-Drug Conjugates (ADC)**: - DLL3 topo ADC with recent presentations at major conferences - Bispecific B7H3 PTK7 ADC (Phase 1) - ID161 (PARG inhibitor) [3] Upcoming Data and Expectations - **PFS Events**: Approximately 130 PFS events are needed for top-line results, with expectations for results in early 2026 [4] - **Control Arm Expectations**: Anticipated PFS in the control arm is 2-3 months, while treatment arm results have shown consistent 7-month PFS [5][6] - **Overall Survival (OS) Data**: OS data from the Society of Melanoma Research (SMR) indicated potential for median OS to increase to 22 months, pending further patient follow-up [13] Regulatory and Market Considerations - **NDA Submission**: Plans for a pre-NDA meeting with the FDA are anticipated as PFS results are finalized [12] - **Pricing Strategy**: Expected pricing in the low $50,000s per month, with considerations for the robustness of the dataset and unmet medical needs in the market [14] - **Compendia Strategy**: Plans to submit HLA-A*02 positive data for potential inclusion in the label, which would enhance promotional capabilities [18][20] Neoadjuvant and Adjuvant Studies - **Neoadjuvant Study**: Enrollment is expected to accelerate with increased site activation, aiming for completion in approximately five quarters [21] - **Adjuvant Program**: Planning to start a phase three adjuvant study in collaboration with Servier, targeting 400-450 patients [26] ADC Programs and Future Directions - **DLL3 ADC**: Positive data supports a potential path for accelerated approval in small cell lung cancer and neuroendocrine tumors [28] - **Combination Studies**: Plans to explore combinations with standard care agents to enhance treatment durability [34] Additional Pipeline Developments - **MAT2A Program**: Updates on Trodalvy combo data in urothelial carcinoma expected in the first half of 2026 [39] - **CAT67 Program**: IND filing planned by year-end 2025, focusing on dual inhibition of CAT6 and CAT7 [45] Conclusion - **Key Catalysts**: Investors should focus on upcoming PFS results, NDA submission timelines, and ongoing clinical trials across various programs through 2026 [48]