Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Date**: November 06, 2025 - **Context**: Discussion led by CEO Yujiro Hata regarding recent developments in the company's pipeline and strategic direction. Key Industry and Company Insights Pipeline Developments - IDEAYA reported one of its most productive quarters since its founding, with significant updates presented at major medical conferences, including the World Conference on Lung Cancer and ESMO [3][4] - The lead program is nearing randomized progression-free survival (PFS) results, with expectations for an accelerated approval filing in the U.S. by year-end or early next year [3][4] - Enrollment for clinical trials is progressing well, with full enrollment expected soon for both overall survival (OS) and randomized OS studies [4] Uveal Melanoma Focus - IDEAYA aims for darovasertib to become the standard of care across the uveal melanoma patient journey, with plans for a phase three randomized study in the adjuvant setting in the first half of next year [7][9] - The annual incidence of metastatic uveal melanoma is estimated at 4,000-5,000 patients, with potential for higher numbers in neoadjuvant and adjuvant settings [7][8] - The company has received Breakthrough Therapy Designation from the FDA based on promising data from clinical cohorts [10] Clinical Trial Data and Expectations - In the enucleation cohort, the eye preservation rate exceeded the 10% threshold required for full approval, indicating strong efficacy [10][11] - The plaque therapy cohort showed a median vision improvement of 14 letters, significantly higher than previous reports [11] - The company anticipates that the first data from the enucleation cohort will be available in approximately five quarters, with visual acuity results expected 18 months after the last patient is enrolled [19][20] MTAP Deletion Market - IDEAYA is focusing on MTAP deletion across multiple tumor types, prioritizing lung cancer, urothelial cancer, and pancreatic ductal adenocarcinoma (PDAC) [35] - The confirmed response rate for ID 397 in monotherapy is in the 25-30% range, with combination therapy showing a response rate of approximately 50% [37][38] - The company is exploring co-alterations in MTAP, particularly with RAS and CDK N2A, to enhance treatment efficacy [50][51] DLL3 Asset Development - IDEAYA's DLL3 ADC has shown a confirmed response rate of 70% in the second-line setting, with a PFS of approximately 6.7 months [55] - The company is considering a monotherapy accelerated approval path, which could provide a competitive advantage over other companies requiring comparator arms [57] Other Assets and Future Directions - IDEAYA is advancing several other assets, including poltheta partnered with GSK, and a bispecific ADC targeting B7H3 and PTK7, which has shown promising preclinical results [63][64] - The company is leveraging machine learning to enhance drug discovery efficiency, aiming for a 30% acceleration in time to IND [73][74] Additional Important Points - The collaboration with the FDA has been positive, allowing for adjustments in trial design that reduce patient enrollment numbers without compromising study integrity [24] - The company is focused on building a world-class precision oncology portfolio and is actively seeking partnerships to advance its pipeline [66] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA Biosciences' strategic focus, pipeline advancements, and market opportunities.

Core Insights - IDEAYA Biosciences reported significant progress in its pipeline and business operations, including a partnership with Servier that extends its runway into 2030 and enables potential commercialization of darovasertib outside the U.S. [2] Pipeline Developments - The Phase 2/3 trial (OptimUM-02) of darovasertib/crizotinib in metastatic uveal melanoma is on track to report median progression-free survival (PFS) data by year-end 2025 to Q1 2026, with enrollment expected to be completed by year-end [4][5] - The single-arm Phase 2 trial (OptimUM-01) reported a median overall survival (OS) of 21.1 months and a median PFS of 7.0 months, with a confirmed overall response rate (ORR) of 34% [5] - IDEAYA has initiated a randomized Phase 3 trial (OptimUM-10) for darovasertib as a neoadjuvant therapy in primary uveal melanoma, targeting approximately 450 patients [8] Financial Highlights - As of September 30, 2025, IDEAYA had approximately $1.14 billion in cash, cash equivalents, and marketable securities, an increase from $991.9 million as of June 30, 2025, primarily due to a $210 million upfront payment from Servier [11] - Collaboration revenue for Q3 2025 totaled $207.8 million, compared to zero in the previous quarter, driven by the Servier license agreement [11] - The net income for Q3 2025 was $119.2 million, a significant improvement from a net loss of $77.5 million in Q2 2025 [14] License Agreement with Servier - IDEAYA entered into an exclusive license agreement with Servier for darovasertib outside the U.S., receiving an upfront payment of $210 million and being eligible for up to $320 million in milestone payments [10] Research and Development Expenses - R&D expenses for Q3 2025 totaled $83.0 million, an increase from $74.2 million in Q2 2025, primarily due to higher clinical trial and manufacturing expenses [12] General and Administrative Expenses - G&A expenses for Q3 2025 were $16.4 million, up from $14.6 million in Q2 2025, mainly due to increased legal and commercial preparation expenses [13]

Core Insights - IDEAYA Biosciences presented positive clinical data from the Phase 2 OptimUM-09 trial of neoadjuvant darovasertib for primary uveal melanoma, highlighting its potential as the first systemic therapy for this condition [1][2][10] Clinical Trial Data - The trial involved 95 primary uveal melanoma patients, with 94 evaluable for efficacy as of June 13, 2025 [2] - 83% of patients demonstrated ocular tumor shrinkage, with 54% achieving at least 20% tumor shrinkage [5][10] - Among patients recommended for enucleation, the eye preservation rate was 57%, increasing to 95% for those achieving 20% tumor shrinkage [5][10] - 70% of plaque brachytherapy eligible patients showed a reduction in predicted radiation dose, leading to a 65% lower risk of vision loss at three years post-treatment [5][10] Visual Acuity Improvement - Approximately 55% of enucleation eligible patients and 61% of plaque brachytherapy eligible patients showed improvement in visual acuity scores during treatment, with mean gains of 17 and 10 letters, respectively [5][10] Safety Profile - Darovasertib was generally well tolerated, with manageable adverse events; 16.8% of patients experienced grade 3 or higher treatment-related adverse events [10] Future Developments - IDEAYA is conducting a Phase 3 trial (OptimUM-10) of darovasertib and plans to report topline median progression-free survival data from another trial (OptimUM-02) by the end of 2025 to Q1 2026 [7][10]

Core Insights - IDEAYA Biosciences reported the first median overall survival results from their Phase 1/2 clinical trial (OptimUM-01) for darovasertib in combination with crizotinib for metastatic uveal melanoma, showing a median OS of 21.1 months [1][7] - The data will be presented at the 2025 Society for Melanoma Research Congress in Amsterdam [1] Clinical Trial Results - The trial included 44 first-line mUM patients with a median follow-up of 25 months, revealing a median progression-free survival (PFS) of 7.0 months [2] - The confirmed overall response rate (ORR) was 34% with a median duration of response (mDOR) of 9 months, and a disease control rate (DCR) of 90% [2][7] - The combination therapy demonstrated manageable tolerability, with common treatment-related adverse events including diarrhea, nausea, and fatigue [2] Comparison to Historical Data - The reported median OS of 21.1 months is significantly higher than the historical median OS of approximately 12 months for treatment-naïve patients with metastatic uveal melanoma [5][7] Future Developments - IDEAYA is conducting a registration-enabling Phase 2/3 trial (OptimUM-02) targeting HLA*A2:01-negative mUM, with median PFS data expected by the end of 2025 to early 2026 [5] - The company aims to support a potential U.S. accelerated approval filing based on the trial results [5]

Core Insights - IDEAYA Biosciences, Inc. (NASDAQ:IDYA) is recognized as a promising healthcare stock with significant upside potential, supported by recent analyst ratings [1][2] - The company is focused on oncology and precision medicine, particularly through its lead asset, darovasertib, which targets uveal melanoma [3][4] Group 1: Analyst Ratings - Citizens JMP analyst Silvan Tuerkcan maintained a Buy rating for IDEAYA with a price target of $45 [1] - J.P. Morgan analyst Anupam Rama also assigned a Buy rating with a higher price target of $74 [2] Group 2: Product Development - IDEAYA's lead asset, darovasertib, is expected to have notable updates in various treatment settings, which could lead to significant value creation [3] - The company is developing IDE196, a protein kinase C inhibitor aimed at genetically defined cancers with GNAQ or GNA11 gene mutations [4]

Group 1 - IDEAYA Biosciences, Inc. (NASDAQ:IDYA) is recognized as a promising biotech stock with high potential, receiving a Buy rating from J.P. Morgan analyst Anupam Rama with a price target of $74 [1] - The bullish rating is supported by anticipated updates on the company's lead asset, darovasertib, which is expected to create significant value [2] - UBS analyst David Dai also reiterated a Buy rating for IDEAYA Biosciences with a price target of $50, highlighting the company's focus on oncology precision medicine and targeted therapeutics [3] Group 2 - IDEAYA's product candidate, IDE196, is a protein kinase C inhibitor targeting genetically defined cancers associated with GNAQ or GNA11 gene mutations [3]

Core Viewpoint - Servier and IDEAYA Biosciences have entered into an exclusive license agreement for darovasertib, a treatment for uveal melanoma, granting Servier regulatory and commercial rights outside the United States while IDEAYA retains rights in the U.S. [1][7] Company Overview - Servier is an independent international pharmaceutical group focused on delivering transformative therapies and has a strong commitment to oncology, allocating nearly 70% of its R&D budget to this field [10][12] - IDEAYA Biosciences specializes in precision medicine for oncology, focusing on the discovery and development of targeted therapies aligned with genetic drivers of cancer [14] Product Development - Darovasertib is a selective protein kinase C (PKC) inhibitor aimed at treating primary and metastatic uveal melanoma, which is a rare and aggressive form of eye cancer [1][5] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the US FDA, indicating its potential as a significant treatment option [6] Financial Terms of the Agreement - IDEAYA will receive an upfront payment of $210 million, with potential additional payments of up to $320 million based on regulatory and commercial milestones, plus double-digit royalties on net sales outside the U.S. [7][8] Clinical Trials - Darovasertib is currently undergoing multiple global clinical trials, including a Phase 2/3 trial in combination with crizotinib and a Phase 3 trial evaluating it as a monotherapy [4][6] - A global Phase 3 randomized clinical trial is planned for 2026 to assess adjuvant darovasertib in primary uveal melanoma patients [4]

Core Insights - IDEAYA Biosciences announced that an abstract from its Phase 1/2 trial of darovasertib combined with crizotinib for first-line metastatic uveal melanoma has been accepted for oral presentation at the 2025 Society for Melanoma Research Congress [1][2] - The presentation will include data from over 40 patients, marking the first reported median overall survival data for the combination treatment in this indication [1][2] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover, develop, and commercialize transformative cancer therapies [2] - The company integrates small-molecule drug discovery, structural biology, and bioinformatics to identify and validate translational biomarkers for developing targeted therapies [2] - IDEAYA has a pipeline that emphasizes synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications, with a mission to enhance clinical outcomes for cancer patients [2]

Core Insights - IDEAYA Biosciences, Inc. is hosting an in-person R&D Day on September 8, 2025, in New York to celebrate its 10-Year Anniversary and discuss its progress and future growth strategy [1][2]. Company Overview - IDEAYA is a precision medicine oncology company focused on discovering and developing targeted therapeutics for cancer, integrating small-molecule drug discovery, structural biology, and bioinformatics [6]. R&D Day Agenda - The R&D Day will feature presentations on new clinical data for darovasertib in neoadjuvant uveal melanoma, IDE849 (DLL3 TOP1 ADC), and IDE397 (MAT2A) [2][8]. - Dr. Arun D. Singh from the Cleveland Clinic will present data from the Phase 2 trial of darovasertib and discuss the Phase 3 OptimUM-10 trial [4]. - The agenda includes discussions on various drug candidates, including initial Phase 1 clinical data for IDE397/Trodelvy combination in MTAP-deletion urothelial cancer and the application of AI/ML in discovery capabilities [8].

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].