IDEAYA Biosciences(IDYA) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update The company reports Q2 2025 results, highlighting key clinical catalysts, upcoming IND submissions, and a strong cash position Company Overview 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] Key Highlights & Upcoming Catalysts 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] - 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] - Three IND submissions are on track by year-end 2025, including IDE892 (PRMT5), IDE034 (B7H3/PTK7 bispecific TOP1i ADC), and IDE574 (KAT6/7)[3] - 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] Pipeline Developments and Upcoming Milestones This section details progress across key clinical programs including darovasertib, IDE397, and IDE849, with significant milestones expected Darovasertib Darovasertib is advancing in metastatic and neoadjuvant uveal melanoma, with key data readouts and a Phase 3 trial underway Metastatic Uveal Melanoma (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] - 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] - 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] Neoadjuvant Therapy for Primary Uveal Melanoma (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] - 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] - 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][6] IDE397 (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] - 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] IDE849 (DLL3 TOP1i ADC) 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] - 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] Other Programs 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] - 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] - 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][11] - A Phase 2 expansion in HRD-positive solid tumors would trigger a $10 million milestone payment from GSK[14] Corporate Updates The company announces its upcoming R&D Day, strategic organizational scaling, and plans for three IND submissions by year-end R&D Day 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] - 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] Strategic Initiatives & Personnel 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] - 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] Investigational New Drug (IND) Submissions 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] - IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-2025[14] - IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025[14] - IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025[14] Financial Results for the Quarter Ended June 30, 2025 This section details the company's Q2 2025 financial performance, including its cash position, operating expenses, and net loss Cash Position 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] - The company's cash position is anticipated to fund operations into 2029[3] Operating Expenses 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 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] About IDEAYA Biosciences This section outlines the company's mission to develop transformative precision oncology therapies Company Mission and Approach 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] - Their approach integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers[19] - 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] - 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] Forward-Looking Statements This section contains important disclaimers regarding forward-looking statements and associated risks Disclaimer and Risks 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] - 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][21] - IDEAYA undertakes no obligation to update or revise any forward-looking statements[21] Financial Statements This section provides the unaudited condensed statements of operations and balance sheet data Condensed Statements of Operations and Comprehensive Loss 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 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 |