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]

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 - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is priced at $49 per month, with a discounted annual plan available for $399, representing a 33.50% savings [1]. Group 2: Analyst Background - The author of the article runs the Biotech Analysis Central service and emphasizes the importance of deep analysis for informed investment decisions in the healthcare sector [2]. - The article does not indicate any personal investment positions in the companies mentioned, ensuring an unbiased perspective [3].

Core Insights - IDEAYA Biosciences has received FDA clearance for an IND application to initiate a Phase 1 clinical trial for IDE849, a potential first-in-class DLL3-targeting Topo-I-payload ADC in solid tumors [1][2] Group 1: Clinical Development - IDE849 is advancing into a Phase 1 study in the U.S., targeting DLL3, which is upregulated in various solid tumors such as SCLC, NETs, and NSCLC, indicating a strong potential for a single asset pipeline [2][6] - The ongoing multi-site open label Phase 1 clinical trial for IDE849 has shown multiple partial responses, with treatment-related adverse events primarily being Grade 1 or 2, and no drug-related discontinuations reported [4][8] - IDEAYA plans to present clinical efficacy and safety data on IDE849 from over 40 SCLC patients at a medical conference in Q3 2025 [4][10] Group 2: Combination Therapies - IDE849 aligns with IDEAYA's strategy to develop rational combination therapies, particularly with the potential first-in-class Phase 1 PARG inhibitor IDE161, which has shown preclinical synergy with TOP1-based ADCs [3][5] - The company aims to evaluate IDE849 in combination with IDE161/PARG to enhance the durability of its ADC pipeline [5][7] Group 3: Market Potential - DLL3's limited expression in normal tissues and its upregulation in multiple solid tumor types highlight its promise as a therapeutic target, addressing significant unmet medical needs in oncology [6][11] - IDEAYA's approach integrates capabilities in identifying translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies [11]