[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) The company reports Q2 2025 results, highlighting key clinical catalysts, upcoming IND submissions, and a strong cash position [Company Overview](index=1&type=section&id=Company%20Overview) IDEAYA Biosciences is a precision oncology company focused on developing and commercializing transformative cancer medicines - IDEAYA Biosciences is an oncology company focused on advancing the discovery, development, and commercialization of transformative precision medicines to address unmet medical needs in cancer[2](index=2&type=chunk) [Key Highlights & Upcoming Catalysts](index=1&type=section&id=Key%20Highlights%20%26%20Upcoming%20Catalysts) The company anticipates multiple clinical data updates, three IND submissions, and key trial results by year-end 2025 - **Six clinical data updates** are guided from now to year-end across three clinical stage programs, including two oral presentations accepted at major medical conferences[3](index=3&type=chunk) - Targeted top-line randomized median PFS results for the darovasertib and crizotinib combination in 1L HLA-A2 negative MUM are expected by year-end 2025, with potential to enable a **U.S. accelerated approval filing**[3](index=3&type=chunk) - **Three IND submissions** are on track by year-end 2025, including IDE892 (PRMT5), IDE034 (B7H3/PTK7 bispecific TOP1i ADC), and IDE574 (KAT6/7)[3](index=3&type=chunk) - The company held approximately **$992 million** in cash, cash equivalents, and marketable securities as of June 30, 2025, anticipated to fund operations into 2029[3](index=3&type=chunk) [Pipeline Developments and Upcoming Milestones](index=2&type=section&id=Pipeline%20Developments%20and%20Upcoming%20Milestones) This section details progress across key clinical programs including darovasertib, IDE397, and IDE849, with significant milestones expected [Darovasertib](index=2&type=section&id=Darovasertib) Darovasertib is advancing in metastatic and neoadjuvant uveal melanoma, with key data readouts and a Phase 3 trial underway [Metastatic Uveal Melanoma (MUM)](index=2&type=section&id=Metastatic%20Uveal%20Melanoma%20(MUM)) The Phase 2/3 trial for MUM is progressing toward key PFS and OS data readouts by year-end 2025 - Median progression-free survival (PFS) data from the Phase 2/3 trial of darovasertib in combination with crizotinib in first-line (1L) HLA-A2-negative MUM is on track to be reported by year-end 2025, with potential to enable a **U.S. accelerated approval filing**[5](index=5&type=chunk) - **Over 350 patients** have been enrolled in the Phase 2/3 trial as of August 4, 2025, with full enrollment of approximately 400 patients expected by year-end[5](index=5&type=chunk) - Median overall survival (OS) data from a single-arm, Phase 2 trial of darovasertib in combination with crizotinib will be presented at a medical conference in Q4 2025, including data from **over 40 patients** (HLA-A2-negative and positive)[5](index=5&type=chunk) [Neoadjuvant Therapy for Primary Uveal Melanoma (UM)](index=2&type=section&id=Neoadjuvant%20Therapy%20for%20Primary%20Uveal%20Melanoma%20(UM)) Initial data for neoadjuvant darovasertib will be presented soon, with a Phase 3 registration trial initiated in Q3 2025 - Initial safety and visual benefit data from the Phase 2 clinical trial of darovasertib monotherapy in **over 20 plaque brachytherapy-eligible patients** will be reported at IDEAYA's R&D Day on September 8th[5](index=5&type=chunk) - Additional data from **over 90 patients** in both enucleation-eligible and plaque brachytherapy-eligible cohorts will be shared as a Proffered Paper Oral Presentation at ESMO (October 17-21, 2025)[5](index=5&type=chunk) - A randomized **Phase 3 registration-enabling trial (OptimUM-10)** of darovasertib in the neoadjuvant setting for primary UM was initiated in Q3 2025, following a successful Type D meeting with the FDA[5](index=5&type=chunk)[6](index=6&type=chunk) [IDE397 (MAT2A)](index=3&type=section&id=IDE397%20(MAT2A)) IDE397 is being evaluated in combination with Trodelvy®, with initial data from urothelial cancer cohorts expected shortly - IDEAYA is conducting a Phase 1/2 clinical trial with Gilead to evaluate IDE397 in combination with Trodelvy® in patients with MTAP-deletion urothelial cancer (UC) and non-small cell lung cancer (NSCLC)[10](index=10&type=chunk) - Initial Phase 1 safety and efficacy data from two expansion cohorts in MTAP-deletion UC patients will be provided at IDEAYA's R&D Day on September 8th, with additional data targeted for a medical conference in the first half of 2026[10](index=10&type=chunk) [IDE849 (DLL3 TOP1i ADC)](index=3&type=section&id=IDE849%20(DLL3%20TOP1i%20ADC)) Clinical data for IDE849 in SCLC will be presented by partner Hengrui Pharma, while a U.S. Phase 1 trial is underway - Hengrui Pharma, IDEAYA's partner, will present clinical safety and efficacy data from **over 70 patients** in a multi-site, open-label Phase 1 clinical trial for IDE849 in China for SCLC at the IASLC 2025 World Conference on Lung Cancer (September 6-9, 2025)[10](index=10&type=chunk) - IDEAYA initiated a Phase 1 trial in the U.S. in SCLC in May 2025, with patient dosing in NETs and other DLL3-expressing tumors targeted by year-end 2025[10](index=10&type=chunk) [Other Programs](index=3&type=section&id=Other%20Programs) The pipeline includes PARG, Werner Helicase, and Pol Theta Helicase inhibitors, with several programs in Phase 1 trials - IDE161, a potential first-in-class PARG inhibitor, is in Phase 1 dose optimization, with plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025[10](index=10&type=chunk) - IDE275 (GSK959), a Werner Helicase inhibitor, is in Phase 1 dose escalation in patients with MSI-High solid tumors, developed in collaboration with GSK[10](index=10&type=chunk) - IDE705 (GSK101), a Pol Theta Helicase inhibitor, is in a Phase 1 clinical trial in combination with niraparib (PARP inhibitor) in BRCA-positive or other HRD-positive tumors, also developed with GSK[10](index=10&type=chunk)[11](index=11&type=chunk) - A Phase 2 expansion in HRD-positive solid tumors would trigger a **$10 million milestone payment** from GSK[14](index=14&type=chunk) [Corporate Updates](index=4&type=section&id=Corporate%20Updates) The company announces its upcoming R&D Day, strategic organizational scaling, and plans for three IND submissions by year-end [R&D Day](index=4&type=section&id=R%26D%20Day) An R&D Day in September 2025 will feature clinical data updates and highlight future growth drivers - IDEAYA will host an in-person and virtual R&D Day on September 8th, 2025, from 8:00-10:00 AM ET in New York City[14](index=14&type=chunk) - The event will feature multiple clinical data updates across the pipeline and highlight future growth drivers and upcoming milestones, with speakers including senior leadership and key opinion leaders[14](index=14&type=chunk) [Strategic Initiatives & Personnel](index=4&type=section&id=Strategic%20Initiatives%20%26%20Personnel) The organization is scaling its commercial and medical affairs functions ahead of a potential product launch - IDEAYA continues efforts to scale the organization in preparation for the potential U.S. launch of darovasertib, including key hires within the commercial, medical affairs, and market access functions[14](index=14&type=chunk) - Gary Palmer, M.D., joined as Senior Vice President, Medical Affairs, bringing over 25 years of global leadership experience in medical affairs across multiple therapeutic areas, including oncology[14](index=14&type=chunk) [Investigational New Drug (IND) Submissions](index=4&type=section&id=Investigational%20New%20Drug%20(IND)%20Submissions) Three IND applications for novel oncology candidates are planned for submission by the end of 2025 - IDEAYA plans to submit three IND applications before the end of the year:[14](index=14&type=chunk) - IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-2025[14](index=14&type=chunk) - IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025[14](index=14&type=chunk) - IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025[14](index=14&type=chunk) [Financial Results for the Quarter Ended June 30, 2025](index=5&type=section&id=Financial%20Results%20for%20the%20Quarter%20Ended%20June%2030%2C%202025) This section details the company's Q2 2025 financial performance, including its cash position, operating expenses, and net loss [Cash Position](index=5&type=section&id=Cash%20Position) The company maintains a strong cash position of $991.9 million, expected to fund operations into 2029 **Cash, Cash Equivalents, and Marketable Securities** | Date | Amount (Millions USD) | | :--- | :--- | | June 30, 2025 | $991.9 | | March 31, 2025 | $1,050.0 | - The decrease was primarily driven by net cash used in operations[15](index=15&type=chunk) - The company's cash position is anticipated to **fund operations into 2029**[3](index=3&type=chunk) [Operating Expenses](index=5&type=section&id=Operating%20Expenses) R&D and G&A expenses increased due to higher clinical trial activity and personnel-related costs **Operating Expenses (QoQ)** | Expense Category | Q2 2025 (Millions USD) | Q1 2025 (Millions USD) | Change (QoQ) | Primary Reason | | :--- | :--- | :--- | :--- | :--- | | Research and development | $74.2 | $70.9 | +$3.3 | Higher clinical trial and personnel-related expenses | | General and administrative | $14.6 | $13.5 | +$1.1 | Higher personnel-related expenses | [Net Loss](index=5&type=section&id=Net%20Loss) Net loss increased to $77.5 million for the quarter, driven by higher operating expenses **Net Loss (QoQ)** | Metric | Q2 2025 (Millions USD) | Q1 2025 (Millions USD) | Change (QoQ) | | :--- | :--- | :--- | :--- | | Net Loss | $77.5 | $72.2 | +$5.3 | | Net Loss per Share (basic & diluted) | $(0.88) | $(0.82) | $(0.06) | - Total stock compensation expense for the three months ended June 30, 2025, was **$11.9 million**, compared to $10.2 million for the same period in 2024[18](index=18&type=chunk) [About IDEAYA Biosciences](index=5&type=section&id=About%20IDEAYA%20Biosciences) This section outlines the company's mission to develop transformative precision oncology therapies [Company Mission and Approach](index=5&type=section&id=Company%20Mission%20and%20Approach) IDEAYA leverages expertise in drug discovery and biomarkers to develop targeted, first-in-class cancer therapies - IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer[19](index=19&type=chunk) - Their approach integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers[19](index=19&type=chunk) - The company's mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer[19](index=19&type=chunk) - IDEAYA has built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications[19](index=19&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains important disclaimers regarding forward-looking statements and associated risks [Disclaimer and Risks](index=5&type=section&id=Disclaimer%20and%20Risks) Forward-looking statements are subject to substantial risks and uncertainties inherent in drug development - The press release contains forward-looking statements related to the timing and content of clinical program updates, regulatory updates, clinical trial data readouts, potential therapeutic benefits, timing of development and regulatory milestones, timing of new IND applications, and the extent to which existing cash will fund operations[20](index=20&type=chunk) - Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ significantly, including those inherent in the drug development process, early stage of development, trial design, regulatory approval, manufacturing, intellectual property, and cash sufficiency[20](index=20&type=chunk)[21](index=21&type=chunk) - IDEAYA undertakes no obligation to update or revise any forward-looking statements[21](index=21&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section provides the unaudited condensed statements of operations and balance sheet data [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statement details operating expenses and net loss for the three and six months ended June 30, 2025 **Condensed Statements of Operations and Comprehensive Loss (Unaudited, in thousands, except per share data)** | | Three Months Ended June 30, 2025 | Three Months Ended March 31, 2025 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Operating expenses:** | | | | | | Research and development | $74,226 | $70,886 | $145,112 | $97,338 | | General and administrative | $14,580 | $13,503 | $28,083 | $18,606 | | **Total operating expenses** | **$88,806** | **$84,389** | **$173,195** | **$115,944** | | Loss from operations | $(88,806) | $(84,389) | $(173,195) | $(115,944) | | Interest income and other income, net | $11,315 | $12,211 | $23,526 | $23,600 | | **Net loss** | **$(77,491)** | **$(72,178)** | **$(149,669)** | **$(92,344)** | | Unrealized (losses) gains on marketable securities | $(64) | $773 | $709 | $(1,978) | | **Comprehensive loss** | **$(77,555)** | **$(71,405)** | **$(148,960)** | **$(94,322)** | | Net loss per share, basic and diluted | $(0.88) | $(0.82) | $(1.69) | $(1.21) | | Weighted-average shares outstanding | 88,472,197 | 88,356,335 | 88,414,586 | 76,535,607 | [Condensed Balance Sheet Data](index=8&type=section&id=Condensed%20Balance%20Sheet%20Data) The balance sheet shows cash and total assets as of June 30, 2025, compared to December 31, 2024 **Condensed Balance Sheet Data (Unaudited, in thousands)** | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, equivalents and marketable securities | $991,869 | $1,082,151 | | Total assets | $1,041,270 | $1,124,091 | | Total liabilities | $81,617 | $64,944 | | Total liabilities and stockholders' equity | $1,041,270 | $1,124,091 |

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 announced that results from a global Phase 2 study of neoadjuvant darovasertib in primary uveal melanoma will be presented at the 2025 ESMO meeting in Berlin [1][2] - The presentation will focus on the effects of darovasertib across plaque brachytherapy and enucleation cohorts, highlighting its potential impact on disease management [2][3] - The company has initiated a randomized Phase 3 neoadjuvant registrational trial (OptimUM-10) for darovasertib in primary uveal melanoma [6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on developing transformative therapies for cancer [3] - The company integrates drug discovery, structural biology, and bioinformatics to create targeted therapies for specific patient populations [3] - IDEAYA has a robust pipeline that includes therapies based on synthetic lethality and antibody-drug conjugates [3] Clinical Study Details - The upcoming presentation will include data from over 90 patients in both plaque brachytherapy and enucleation-eligible cohorts [6] - Darovasertib has received U.S. FDA Breakthrough Therapy Designation for neoadjuvant use in uveal melanoma patients requiring enucleation [6]

Core Insights - IDEAYA Biosciences, Inc. will host an in-person and virtual R&D Day on September 8, 2025, to present clinical data updates and discuss growth drivers and upcoming milestones [1][2] - The event will feature members of IDEAYA's senior leadership team and key opinion leaders [3] - IDEAYA is celebrating its ten-year anniversary and aims to highlight its strategic vision and emerging clinical pipeline [2] Company Overview - IDEAYA is a precision medicine oncology company focused on discovering, developing, and commercializing transformative therapies for cancer [4] - The company integrates small molecule drug discovery, structural biology, and bioinformatics to develop potentially first-in-class targeted therapies [4] - IDEAYA has a robust pipeline that includes targeted therapies focused on synthetic lethality and antibody-drug conjugates (ADCs) [4]

Core Insights - IDEAYA Biosciences and Jiangsu Hengrui Pharmaceuticals announced an oral presentation on IDE849 (SHR-4849) at the IASLC 2025 World Conference on Lung Cancer, focusing on its efficacy and safety in small-cell lung cancer (SCLC) patients [1][3] - IDE849 is a potential first-in-class DLL3-targeting Topoisomerase-1 (TOP1) payload antibody drug conjugate (ADC), addressing significant unmet medical needs in various solid tumors [1][3] Group 1: Presentation Details - The oral presentation will take place on September 7, 2025, from 4:45-6:00 PM (CET) and will cover a Phase 1 study of SHR-4849 (IDE849) in relapsed SCLC [4] - A poster presentation will also be held on September 8, 2025, discussing the combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161, a proprietary PARG inhibitor [2][5] Group 2: Clinical Development - The Phase 1 trial for IDE849 is ongoing in China, with data from over 70 SCLC patients expected to be presented, including results from dose escalation and multiple expansion doses [6] - The U.S. Phase 1 trial of IDE849 in SCLC patients was initiated in the third quarter of 2025 [6] Group 3: Company Strategy - IDEAYA aims to evaluate rational combinations of therapies to improve clinical outcomes for cancer patients, including the use of IDE849 as a monotherapy and in combination with immunotherapy and IDE161 [2][3] - The company has a robust pipeline focused on synthetic lethality and ADCs, including bispecifics, to address unmet medical needs in cancer [7]

Group 1 - IDEAYA Biosciences, Inc. is participating in the 2025 BTIG Virtual Biotechnology Conference on July 29, 2025, at 4:40 PM ET, featuring a fireside chat with CEO Yujiro S. Hata [1] - The conference will be accessible via a live audio webcast on the IDEAYA website, with a replay available for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, aiming to discover, develop, and commercialize transformative therapies for unmet medical needs in cancer [2] - The company integrates small molecule drug discovery, structural biology, and bioinformatics to develop targeted therapies, including synthetic lethality and antibody-drug conjugates (ADCs) [2] - IDEAYA has established a robust pipeline of targeted therapies aimed at improving clinical outcomes for cancer patients [2]

Summary of IDEA Biosciences Conference Call Company Overview - **Company**: IDEA Biosciences - **Focus**: Development of innovative therapies for cancer treatment, with six clinical programs currently and a target of nine by year-end [2][1]. Key Value Drivers - **Lead Program**: Derobicertib, targeting metastatic human melanoma, currently in a registrational trial [2][1]. - **Enrollment Status**: Completed enrollment for the trial, with over 320 patients enrolled, exceeding the target of 250 [12][13]. - **Primary Endpoint**: Median progression-free survival (PFS) is crucial for potential accelerated approval, with historical PFS around 2-3 months and a target of over 5.5 months for the current study [3][8]. Clinical Data and Updates - **PFS Results**: Previous studies showed a PFS of approximately 7 months, with a specific setting achieving nearly 11 months [10][11]. - **Overall Survival (OS)**: Anticipated update on OS data from the phase two study, with historical OS in treatment-naive settings around 12-13 months [17][18]. - **Market Opportunity**: Targeting the HLA A2 negative population, with an estimated annual incidence of 4,000 to 5,000 patients in the US and Europe [20][19]. Commercial Strategy - **Commercial Organization**: Building a commercial team with key hires, including a Chief Commercial Officer and heads of various departments [24][25]. - **Regulatory Strategy**: Fast track designation from the FDA for expedited review, with ongoing discussions regarding NDA submission [14][16]. Pipeline and Future Developments - **Additional Programs**: Focus on MTAP deletion space and DLL3, with several data catalysts expected [5][6][51]. - **Combination Therapies**: Emphasis on rational combinations, particularly with PRMT5 inhibitors in lung cancer [70][71]. - **IND Filings**: Targeting multiple INDs, with a goal of one IND per year, and a record of four INDs planned for the current year [86][87]. Financial Position - **Cash Reserves**: Reported over $1 billion in cash, providing a strong financial position for ongoing and future clinical activities [88][87]. Conclusion - IDEA Biosciences is positioned for significant growth with multiple clinical programs, a robust commercial strategy, and a strong financial foundation, aiming to address unmet needs in cancer treatment through innovative therapies and strategic partnerships.

Summary of IDEAYA Biosciences (IDYA) Conference Call Company Overview - IDEAYA Biosciences is a leading precision medicine oncology company founded about a decade ago with six clinical programs and a target of nine by the end of the year [4][5] Key Clinical Programs - **Durovacertib**: Currently in a pivotal registration enabling trial targeting frontline approval in HLA A2 negative metastatic melanoma, with a potential readout for accelerated approval by year-end based on median progression-free survival (PFS) [5][7] - **Clinical Data**: Historical median PFS in metastatic uveal melanoma is 2-3 months; IDEAYA reported a median PFS of approximately 7 months at ESMO 2023, aiming for a PFS of over 5.5 months in their study [7][21] - **Enrollment**: Target enrollment for the PFS study was 250 patients, but over 320 patients have been enrolled, with expectations to complete full enrollment by year-end [9][10] Upcoming Data and Regulatory Plans - **OS Readout**: The overall survival (OS) readout is expected to occur concurrently with the PFS readout, with preliminary data anticipated by mid-2026 [14][15] - **NDA Filing**: Fast track designation in the metastatic setting and breakthrough therapy designation in the neoadjuvant setting will facilitate NDA submission post-results [19][20] Market Opportunity - **HLA A2 Negative Population**: The company sees a significant commercial opportunity in the HLA A2 negative patient population, with approximately 70% of screened patients being HLA A2 negative [26][29] - **Chemtrac Comparison**: Chemtrac from Immunocor has shown strong growth with a run rate of $375 million, indicating a robust market potential for IDEAYA's products [26] Neoadjuvant Study - **Phase III Study Design**: The study includes two cohorts (enucleation and plaque therapy) with primary endpoints focused on eye preservation and vision tests, respectively [34][35] - **Enrollment Timeline**: Anticipated enrollment of 520 patients over five quarters, with the first readout expected within a year [38][40] DLL3 Topical ADC - **Differentiation**: IDEAYA's DLL3 ADC is expected to differentiate based on its tetrapeptide cleavable linker, which cleaves upon internalization, compared to competitors [49][50] - **Data Expectations**: A medical conference update is expected in the third quarter, with data on response rates and adverse event profiles [51][56] MAT2A Inhibitor and Combination Studies - **Combination with Trodelvy**: IDEAYA is optimistic about achieving a response rate above 40% in combination studies with Gilead's Trodelvy in urothelial carcinoma [65] - **PRMT5 Inhibitor**: The company plans to submit an IND for a combination therapy with its PRMT5 inhibitor, aiming for greater response rates compared to monotherapy [67][70] Financial Position - **Cash Reserves**: As of March, the company reported over $1 billion in cash, providing runway into 2029 and flexibility for continued investment in its pipeline [78][79] Upcoming Catalysts - **Data Readouts**: IDEAYA anticipates four data readouts for durovacertib and a substantial update on DLL3 in the third quarter, along with plans for an R&D day by year-end [82][83]

Group 1 - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events: the 2025 Jefferies Global Healthcare Conference on June 4th and the Goldman Sachs 46th Annual Global Healthcare Conference on June 9th [1] - The CEO, Yujiro S. Hata, will be featured in fireside chats at both conferences, hosted by equity research analysts from Jefferies and Goldman Sachs [1] - A live audio webcast of the events will be available on the IDEAYA website, with replays accessible for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [2] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to optimize patient selection for its therapies [2] - IDEAYA is particularly focused on synthetic lethality, an emerging class of precision medicine targets [2]

Summary of IDEAYA Biosciences (IDYA) 2025 Conference Call Company Overview - IDEAYA Biosciences is celebrating its 10-year anniversary in 2025, positioning itself for a transformational year with its lead program, drovosertib, targeting metastatic melanoma [4][5][6] Key Developments and Pipeline Updates - **Drovosertib**: - Anticipated readout for the frontline metastatic melanoma study in HLA A2 negative patients by year-end 2025 [4] - Phase two study to report median overall survival data for over 40 patients, including both HLA A2 negative and positive [5] - Additional data readouts planned for neoadjuvant uveal melanoma studies in mid and late 2025 [6] - **Clinical Trials**: - Enrollment for the randomized PFS readout has exceeded the required number, with over 300 patients enrolled [12] - Historical PFS data suggests a target of over 5.5 months for accelerated approval, with previous studies showing approximately 7 months [14][15] - The objective for overall survival (OS) is ideally 6 months or greater, with historical OS in the range of 12-13 months [16][17] - **Commercialization Strategy**: - Focus on HLA A2 negative population for initial accelerated approval, with plans to include HLA A2 positive data in NDA submission [20][21] - Estimated annual incidence of metastatic uveal melanoma is approximately 45,000 patients [23] Neoadjuvant Setting - FDA granted breakthrough therapy designation for the neoadjuvant setting, indicating strong potential for the treatment [28] - Eye preservation rate currently exceeds 50%, significantly above the target of 10% [29] - Upcoming data will include simulated visual prediction and actual vision outcomes from neoadjuvant treatment [30][31] Pipeline Expansion - IDEAYA is working on multiple clinical programs, with a goal of having nine clinical programs by year-end [8] - DLL3 ADC in Phase one shows a response rate of over 70%, with plans for further studies in small cell lung cancer [47][48] - PRMT5 inhibitor and Werner helicase inhibitor are also in development, with IND submissions expected soon [56][57] Market Insights - Uveal melanoma primarily affects Caucasian populations, with a need for approved therapies in both metastatic and premetastatic settings [36][37] - The company is focused on understanding the epidemiology and total prevalence of uveal melanoma to better target its therapies [36][37] Conclusion - IDEAYA Biosciences is poised for significant developments in 2025, with multiple data readouts and a strong focus on commercialization strategies for its lead assets in precision oncology [58][59]