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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) 5000 Shoreline Court, Suite 300 South San Francisco, California 94080 (Address of principal executive offices) (Zip Code) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 ...

Exhibit 99.1 IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update SOUTH SAN FRANCISCO, Calif., May 6, 2025 -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update and announced financial results for the first quarter that ended March 31, 2025. "We have provided an updated cash runway guidance into 2029, and this past quarter we made significa ...

Core Insights - IDEAYA Biosciences, Inc. provided a business update and announced financial results for Q1 2025, highlighting significant progress in its clinical programs and financial position [1][2]. Financial Overview - As of March 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, down from $1.08 billion at the end of 2024, primarily due to operational cash usage [4][16]. - The company projects that its current cash balance will fund operations into 2029 based on its updated operating plan [17]. - The net loss for Q1 2025 was $72.2 million, a decrease from a net loss of $130.3 million in Q4 2024 [22]. Clinical Development Highlights - The darovasertib program received U.S. FDA breakthrough therapy designation, with over 300 patients enrolled in the registrational trial for HLA-A2-negative metastatic uveal melanoma (MUM) [2][4]. - The company is targeting a median progression-free survival (PFS) readout by the end of 2025 to enable a potential accelerated approval filing [4][5]. - IDEAYA is advancing multiple clinical programs, including IDE849 for lung cancer, IDE275 for MSI-high colorectal and endometrial cancer, and IDE397 for MTAP-deletion lung and urothelial cancer [2][4]. Research and Development Updates - The Phase 3 trial for darovasertib as neoadjuvant therapy for primary uveal melanoma is expected to enroll approximately 520 patients, with a focus on eye preservation and visual acuity outcomes [5][6]. - IDEAYA plans to present clinical data updates at medical conferences throughout 2025, including results from darovasertib and other pipeline candidates [4][5]. - The company has initiated a Phase 1 study for IDE849 in small cell lung cancer (SCLC) and is collaborating with Gilead to evaluate IDE397 in combination with Trodelvy® [12][19]. Corporate Developments - IDEAYA appointed Joshua Bleharski as Chief Financial Officer and Shanthakumar Tyavanagimatt as Senior Vice President of Technical Operations, enhancing its leadership team [21]. - The company formed a collaboration with ATTMOS to develop a computational platform for small molecule discovery, aiming to unlock oncology targets [21].

Investment Rating - The report does not explicitly provide an investment rating for the industry. Core Insights - The report emphasizes the importance of understanding the funding side of the U.S. innovative drug market, particularly how capital flows influence the industry dynamics [4][7]. - It highlights that large multinational corporations (MNCs) dominate the market due to their substantial cash reserves, enabling them to make significant upfront payments for innovative drug licenses [9][13]. - The report discusses the reliance of biotech companies on capital market financing, indicating that these firms often lack sufficient cash reserves to support their operations independently [18][30]. Summary by Sections Section 1: Where Does the Money for Innovative Drug Licensing Come From? - The report explores the sources of funding for innovative drug licensing, focusing on the role of MNCs and their financial capabilities [7][9]. Section 2: Financing Dependency - Biotech companies are heavily reliant on financing, with their cash flow primarily supported by capital market activities rather than product sales [18][30]. Section 3: U.S. Fiscal Support and Ecological Monopoly - The report discusses how the U.S. government and fiscal policies create an ecosystem that supports the dominance of MNCs in the innovative drug market [7][30]. Section 4: Liquidity Clock - The concept of a "liquidity clock" is introduced, illustrating how the interplay between funding and assets shapes the investment landscape in the U.S. innovative drug sector [4][7].

Company Participation in Investor Events - IDEAYA Biosciences, Inc. will participate in investor relations events including a fireside chat on May 8, 2025, and another on May 20, 2025 [1] - The events will feature Yujiro S. Hata, President and CEO, and will be hosted by notable analysts from Barclays and RBC Capital Markets [1] Company Overview - IDEAYA is a precision medicine oncology company focused on discovering and developing targeted therapeutics using molecular diagnostics [2] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its therapies [2] - IDEAYA is particularly focused on synthetic lethality, an emerging class of precision medicine targets [2]

Core Insights - IDEAYA Biosciences (NASDAQ: IDYA) is a developmental biotech company that has generated interesting data but may be overvalued based on previous assessments [1] Company Analysis - The company is involved in the biotech sector, focusing on clinical trials and innovative data generation [1] - The analyst has a background in biochemistry and extensive experience in analyzing biotech companies, indicating a strong foundation for evaluating IDEAYA's potential [1] Market Position - IDEAYA's valuation has been questioned, suggesting that while the company has promising data, its market price may not reflect its actual value [1]

Core Insights - IDEAYA Biosciences announced a successful FDA Type D meeting regarding the Phase 3 trial design for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM) [1][2] - The trial aims to assess safety and efficacy with primary endpoints focused on eye preservation and vision loss, alongside secondary endpoints related to Event-Free Survival (EFS) [2][6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company dedicated to developing targeted therapeutics through molecular diagnostics [8] - The company integrates capabilities in identifying translational biomarkers with drug discovery to optimize patient selection for its therapies [8] Drug Development Details - Darovasertib is a selective protein kinase C (PKC) inhibitor targeting both primary and metastatic UM [3] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the FDA for its use in neoadjuvant therapy and in combination with crizotinib for metastatic UM [3] Phase 3 Trial Design - The Phase 3 trial is projected to enroll approximately 520 patients, randomized in a 2:1 ratio between darovasertib and control [5][6] - Two cohorts will be included: 120 enucleation-eligible UM patients and 400 plaque brachytherapy (PB) eligible UM patients [5][6] Clinical Endpoints - Primary endpoints include eye preservation rate for enucleation patients and vision loss for PB patients, with no detriment to EFS as a secondary endpoint [6][7] - Additional secondary endpoints will assess overall response rate, macular edema, and vision loss metrics [7] Regulatory Pathway - The company plans to initiate the Phase 3 trial in the first half of 2025, with potential for earlier regulatory submission of enucleation cohort data [4][11]

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].

Recently, I got a complaint from a frustrated reader who pointed out that since my bullish December coverage of Ideaya Biosciences, Inc. (NASDAQ: IDYA ), the stock has gone down relentlessly and is now down ~50%. A numberAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investor ...