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.

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 ...

IDEAYA Biosciences (NasdaqGS:IDYA) FY 2025 Conference December 02, 2025 09:00 AM ET Speaker2All 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 Biosciences. We've been covering them for quite a long time, I think since the first day they were public, if I'm not mistaken. I have Yu ...

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]

Group 1 - IDEAYA Biosciences, Inc. (NASDAQ:IDYA) is recognized as one of the best stocks to buy for the next three months according to hedge funds, with a price target of $41 set by Citizens JMP analyst Ivan Tuerkcan [1] - The company has initiated a Phase 1/2 clinical trial for a combination therapy involving IDE397, a potential first-in-class MAT2A inhibitor, and Trodelvy, targeting non-small cell lung cancer (NSCLC) patients with MTAP deletion [2][3] - The trial initially focused on MTAP-deletion urothelial cancer but expanded to include NSCLC in April 2025, conducted in collaboration with Gilead Sciences, which supplies Trodelvy [3]

Core Insights - IDEAYA Biosciences has enrolled its first patient with non-small cell lung cancer (NSCLC) in a Phase 1/2 combination trial of IDE397 and Trodelvy, focusing on patients with methylthioadenosine phosphorylase (MTAP)-deletion solid tumors [1][2] - The collaboration with Gilead Sciences aims to explore the potential of this combination therapy across multiple solid tumors with MTAP-deletion, an area currently lacking approved targeted therapies [3][4] Company Overview - IDEAYA is a precision medicine oncology company dedicated to developing transformative cancer therapies, utilizing expertise in small-molecule drug discovery and bioinformatics to create targeted therapies aligned with genetic disease drivers [7] - The company has a robust pipeline focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications, aiming to improve clinical outcomes for cancer patients [7] Product Information - Trodelvy is currently approved in over 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 40 countries for certain pre-treated HR+/HER2-metastatic breast cancer patients [5] - The use of Trodelvy in MTAP-deletion NSCLC and urothelial cancer (UC) is investigational, with safety and efficacy yet to be established [6]

Core Insights - IDEAYA Biosciences has submitted an IND application to the FDA for IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5, targeting MTAP-deleted lung cancer [1][2] - The company plans to initiate a Phase 1 dose escalation trial for IDE892 in Q4 2025 and aims to start combination trials with IDE397 in H1 2026 [1][6] Company Overview - IDEAYA is focused on precision medicine in oncology, developing transformative therapies for cancer through small-molecule drug discovery, structural biology, and bioinformatics [4] - The company has a robust pipeline targeting synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications [4] Market Opportunity - Approximately 15-20% of non-small cell lung cancer (NSCLC) cases are MTAP-deleted, presenting a significant unmet need for targeted therapies [2] - The combination of IDE892 and IDE397 is expected to enhance anti-tumor activity, creating a promising combination therapy opportunity [2][3] Upcoming Events - IDEAYA will present the preclinical profile of IDE892 and its combination rationale with IDE397 at the 10-Year Anniversary R&D Day on September 8, 2025 [6]

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].

Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].