IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE034, a Potential First-In-Class B7H3/PTK7 Bispecific TOP1 ADC [Accessibility Statement] Skip Navigation- B7H3/PTK7 co-expressed in 30-40% of multiple solid tumor types, including lung, breast, ovarian and colorectal cancers- Potential as a monotherapy and in combination with proprietary PARG inhibitor, IDE161- Phase 1 dose escalation trial to determine safety, tolerability and PK of IDE034SOUTH SAN FRANCISCO, Calif., Feb. 25, 2026 /PRNews ...

PresentationYujiro HataFounder, President, CEO & Director Thank you so much to you and Evercore for hosting this fireside chat today with the IDEAYA management team. So IDEAYA Biosciences, we're a leading precision medicine oncology company. We have 9 programs in the clinic. So a very deep and diversified portfolio. Umer, as you know, our most advanced program is Darovasertib, which is now currently in 2 Phase III randomized studies, one in the first-line metastatic uveal melanoma indication and then next ...

Summary of IDEAYA Biosciences Update - February 23, 2026 Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology - **Programs**: 9 clinical programs, with a focus on darovasertib in phase 3 studies for metastatic uveal melanoma [1][3] Key Points and Arguments Clinical Programs - **Darovasertib**: - Currently in two phase 3 randomized studies for first-line metastatic uveal melanoma and neoadjuvant indications [1] - Upcoming guidance on top-line results expected by the end of March 2026, focusing on median progression-free survival (PFS) as the primary endpoint [4][5] - Reported a solid 7-month PFS in previous presentations, with a follow-up of approximately 2 years [5][11] - **DLL3 Topo ADC (IDE-849)**: - Anticipated clinical data update by the end of 2026, with potential to be a best-in-class asset [2] - **MTAP Deletion Programs**: - Two clinical assets (PRMT5 and MAT2A) with opportunities for both monotherapy and combination therapy [2] - **KAT6/7 (IDE-574)**: - Entered phase 1, targeting a large patient population including breast and colorectal cancer [3] Trial Design and Expectations - **Trial Design**: - Simple randomized phase 3 comparison of darovasertib-crizotinib combination versus standard of care (checkpoint inhibitors) [15] - Control arm expected to show PFS of approximately 2-3 months based on meta-analyses [10][11] - **PFS and OS Analysis**: - The treatment arm is expected to outperform the control arm, with a significant buffer for achieving statistical significance [11][12] - Overall survival (OS) data shows a promising 21-month survival rate, with expectations for positive outcomes in the ongoing study [11][12][128] Patient Population and Disease Characteristics - **Uveal Melanoma**: - Majority of patients (over 90%) present with liver metastases, making liver-directed therapies critical [167][176] - Approximately one-third of patients have elevated LDH levels, indicating disease severity [180][181] Regulatory and Future Plans - **FDA Submission**: - Plans to file for approval based on PFS data, with OS data to be presented during the review process [136][186] - Anticipated timeline for filing and review is approximately 12 months, targeting first half of 2027 for potential approval [187] - **NCCN Guidelines**: - Plans to present data to the NCCN panel to support treatment inclusion for both HLA-A2 negative and positive patients [189] Neoadjuvant Study (OptimUM-09) - **OptimUM-09 Study**: - Focused on neoadjuvant treatment with promising results in tumor shrinkage and vision preservation [191] - Aims to change the treatment paradigm from surgical interventions to pharmacological management [195] Additional Important Information - **Safety Profile**: - Expected to be comparable to previous studies, with a focus on managing adverse events effectively [155] - Investigators are becoming more adept at handling treatment-related toxicities, which may lead to lower discontinuation rates [156] - **Data Review Process**: - The independent review of PFS is ongoing, with a target completion by the end of March 2026 [144] This summary encapsulates the key points from the IDEAYA Biosciences update, highlighting the company's focus on innovative oncology treatments, ongoing clinical trials, and strategic regulatory plans.

IDEAYA Biosciences Announces Appointment of Dr. Theodora (Theo) Ross, M.D., Ph.D., as Chief Development Officer [Accessibility Statement] Skip NavigationSOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer. In this role, Dr. Ross will be responsible for leading early clinical development for IDEAYA's ...

Core Insights - The session is part of Citi's 2026 Virtual Oncology Leadership Summit, featuring discussions with various companies in the oncology sector [1][2] - IDEAYA's senior management team, including CFOs Josh Bleharski and Michael White, and CMO Darrin Beaupre, is highlighted for their participation in the summit [2] Company Overview - IDEAYA is represented by key executives who are available for questions from the audience, indicating an open communication approach [2] - The summit includes a variety of companies, suggesting a diverse representation within the oncology industry [1]

Group 1 - Telstra Group reported a 9.4% increase in half-year profit, attributed to steady contributions from its mobile business and cost-cutting initiatives [1] - The profit attributable for the six months ended December 31 was A$1.12 billion (approximately $788.03 million), compared to A$1.03 billion in the previous year [1]

Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Clinical-stage precision medicine oncology - **Key Programs**: Nine clinical programs, with a focus on uveal melanoma and other oncology indications Key Points and Arguments Upcoming Catalysts - **Darovasertib**: Lead molecule for uveal melanoma, with an upcoming top-line data release for the combination with crizotinib in metastatic uveal melanoma expected by the end of March 2026. The company has triggered the required 130 events for analysis [2][5] - **Neoadjuvant and Adjuvant Studies**: Enrollment in a neoadjuvant study is ongoing, with plans to begin an adjuvant study in Q2 2026 [3][4] Clinical Data Expectations - **Control Arm Expectations**: The control arm is expected to show a median progression-free survival (PFS) of 2-3 months and overall survival (OS) of about 13 months based on historical data [9][10] - **Darovasertib and Crizotinib Combination**: Previous data indicated a median PFS of about 7 months and OS of 21 months, significantly better than standard therapies [10][12] - **Response Rates**: Standard therapies show a response rate of around 10%, while the combination therapy has shown a response rate exceeding 30% [10] Study Design and Patient Demographics - The study focuses on HLA-A2 negative patients with metastatic uveal melanoma, comparing the combination therapy to standard care, which varies by region [8][9] - The study design includes frequent patient scans every six weeks, which may lead to earlier detection of progression compared to traditional three-month scans [15] Regulatory and Filing Timelines - **FDA Filing**: The company anticipates a six-month timeline to file for accelerated approval post-data release, with a review period of at least six months [30] - **HLA-A2 Positive Group**: Data from HLA-A2 positive patients will be presented in two chapters, with the first chapter expected to show early efficacy data [31][32] Other Pipeline Developments - **DLL3 TOPO1 ADC**: Currently in phase I studies, with initial data expected by the end of 2026. The U.S. study has launched, and early safety data is anticipated [47][48] - **MTAP Inhibitor IDE397**: Ongoing studies in combination with Trodelvy for MTAP-deleted urothelial cancer, with promising early data [59][60] - **Combination Strategies**: The company is exploring various combination therapies, including those targeting PRMT5 and CDKN2A, to enhance treatment efficacy in MTAP-deficient tumors [66][68] Market Position and Future Outlook - IDEAYA aims to set a new standard for uveal melanoma treatment, addressing a significant unmet medical need with limited existing therapies [22][14] - The company has a strong cash position of approximately $1.05 billion, providing a runway into 2030, positioning it well for upcoming clinical milestones [5] Additional Important Information - The company emphasizes the importance of data integrity and the potential for positive outcomes based on historical performance metrics [12][26] - Discussions with the FDA regarding potential label expansions and real-world data integration are ongoing, particularly for HLA-A2 positive patients [33] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA Biosciences' strategic focus on advancing its oncology pipeline and addressing critical patient needs in uveal melanoma and other cancer indications.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38915 IDEAYA Biosciences, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-4268251 (State or other jurisdictio ...

IDEAYA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2025. "We had a strong quarter of clinical execution, clinical pipeline expansion and commercial readiness activities. The key highlights in ...

Core Insights - IDEAYA Biosciences reported strong clinical execution and pipeline expansion in Q4 and full year 2025, with a focus on advancing its oncology programs and commercial readiness activities [1] Financial Results - As of December 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, a decrease from $1.08 billion in 2024, primarily due to net cash used in operations [2] - Collaboration revenue for Q4 2025 was $10.9 million, up from $7.0 million in Q4 2024, driven by research and development services under the Servier exclusive license agreement [2] - R&D expenses for Q4 2025 totaled $86.6 million, down from $140.2 million in Q4 2024, mainly due to a prior year's upfront payment under a license agreement [2] - G&A expenses for Q4 2025 were $18.8 million, an increase from $11.0 million in Q4 2024, attributed to higher personnel and consulting costs [2] - The net loss for Q4 2025 was $83.3 million, compared to a net loss of $130.3 million in Q4 2024 [2] - For the full year 2025, the net loss was $113.7 million, significantly reduced from $274.5 million in 2024 [2] Clinical Developments - IDEAYA is advancing darovasertib in uveal melanoma, with topline results from the OptimUM-02 trial expected by the end of March 2026, which may enable accelerated approval in the U.S. [1] - The company plans to initiate three Phase 3 registrational trials for darovasertib in uveal melanoma by H1 2026 [1] - IDEAYA has received IND clearance for IDE034, a bispecific ADC, and plans to initiate a Phase 1 trial in Q1 2026 [1] - The company is also targeting the initiation of several other clinical trials, including IDE574 and IDE892, in 2026 [1] Corporate Updates - In December 2025, GlaxoSmithKline notified IDEAYA of its intention to terminate a collaboration agreement, leading to the transfer of certain clinical programs back to IDEAYA [1] - The company is actively preparing for the commercial launch of darovasertib in the U.S. and globally [1]