IDEAYA Biosciences(IDYA) - 2025 Q1 - Quarterly Results

Executive Summary & Business Update IDEAYA Biosciences reported strong Q1 2025 progress, extending cash runway into 2029 and advancing oncology programs Company Overview and Strategic Highlights IDEAYA, a precision oncology company, extended its cash runway to 2029 and achieved FDA Breakthrough for darovasertib - IDEAYA Biosciences is a precision medicine oncology company focused on discovering and developing targeted therapeutics[2] - The company has updated its cash runway guidance into 2029[3][5] - Significant progress was made on the darovasertib program, including U.S. FDA Breakthrough Therapy Designation and enrollment of over 300 patients in the 1L HLA-A2-negative MUM registrational trial[3][5] Recent Key Developments and Upcoming Milestones Significant clinical pipeline advancements and strategic corporate developments, including collaborations and leadership Research and Clinical Development Clinical pipeline updates highlight darovasertib's rapid advancement and progress across multiple other programs Darovasertib Program Darovasertib, a PKC inhibitor, advances in Phase 2/3 trials for MUM and neoadjuvant UM, with FDA Breakthrough - Darovasertib is a potential first-in-class PKC inhibitor in Phase 2/3 clinical testing for metastatic uveal melanoma (MUM) and neoadjuvant treatment for primary uveal melanoma (UM)[4] - Over 300 patients enrolled in darovasertib and crizotinib registrational 1L HLA-A2-negative MUM trial, targeting median PFS results by YE 2025 to enable potential accelerated approval filing[5][6] - U.S. FDA granted Breakthrough Therapy Designation for single agent darovasertib for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended[5][6] Other Clinical Programs Updates on IDE397, IDE849, IDE275, and other pipeline assets, including new collaborations, Phase 1 initiations, and targeted IND filings in 2025 - IDE397 (MAT2A inhibitor) entered into an additional clinical study collaboration and supply agreement with Gilead to evaluate its combination with Trodelvy® in MTAP-deletion NSCLC[7][11] - IDE849 (DLL3 TOP1 ADC) Phase 1 initiated in U.S., and partner Hengrui targeting clinical data update in over 40 SCLC patients at a medical conference in Q3 2025[5][8][11] - Oral presentation of potential best-in-class Phase 1 WRN inhibitor IDE275 at AACR 2025, demonstrating selectivity to treat MSI-H solid tumors[5][9][11] - Three additional IND-filings targeted in 2025: PRMT5 (IDE892), B7H3/PTK7 ADC (IDE034), and KAT6/7 (IDE574)[5][13][16] Corporate Development and Operations IDEAYA formed a research collaboration with ATTMOS and strengthened its leadership team with key executive appointments - Formed a research collaboration with ATTMOS to develop a physics-based computational platform for small molecule discovery, aimed at swiftly unlocking oncology targets traditionally considered undruggable[14] - Joshua Bleharski, Ph.D., joined IDEAYA as Chief Financial Officer from J.P. Morgan[20] - Shanthakumar Tyavanagimatt, Ph.D., joined IDEAYA as Senior Vice President, Technical Operations, to lead IDEAYA's darovasertib global commercial supply chain readiness activities[20] Financial Results The company reported a strong cash position extending into 2029, with a reduced net loss driven by lower R&D expenses Cash Position and Runway IDEAYA maintained a strong cash position of approximately $1.05 billion as of March 31, 2025, extending its runway into 2029 Cash, Cash Equivalents and Marketable Securities | Metric | March 31, 2025 | December 31, 2024 | | :----- | :------------- | :---------------- | | Cash, cash equivalents and marketable securities | ~$1.05 billion | ~$1.08 billion | - The cash balance is projected to be sufficient to fund planned operations into 2029, based on the current operating plan and pipeline prioritization[3][5][18] - The decrease in the cash balance was primarily driven by net cash used in operations, partially offset by $25.0 million in net proceeds from at-the-market financings during the quarter[17] Condensed Statements of Operations Analysis Q1 2025 saw no collaboration revenue, a significant decrease in R&D expenses, and an improved net loss Key Financials (Three Months Ended) | Metric | March 31, 2025 | December 31, 2024 | Change (QoQ) | | :-------------------------- | :------------- | :---------------- | :----------- | | Collaboration revenue | $0 | $7.0 million | -$7.0 million | | Research and development | $70.9 million | $140.2 million | -$69.3 million | | General and administrative | $13.5 million | $11.0 million | +$2.5 million | | Net loss | $(72.2) million | $(130.3) million | +$58.1 million | | Net loss per share (basic & diluted) | $(0.82) | $(1.49) | +$0.67 | - The decrease in R&D expenses was primarily due to a one-time $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma that occurred in December 2024, offset by higher clinical trial, consulting and personnel-related expenses[21] - The increase in G&A expenses was primarily due to higher personnel-related, consulting and legal patent expenses to support our growth[22] Condensed Balance Sheet Highlights Total assets slightly decreased to $1.10 billion, while total liabilities increased to $76.5 million as of March 31, 2025 Condensed Balance Sheet Data | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------- | :---------------------------- | :------------------------------- | | Total assets | $1,100,641 | $1,124,091 | | Total liabilities | $76,506 | $64,944 | Company Information and Disclosures This section provides an overview of IDEAYA Biosciences, outlines forward-looking statements, and lists investor contact information About IDEAYA Biosciences IDEAYA Biosciences is a precision medicine oncology company focused on targeted therapeutics and synthetic lethality targets - IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics[24] - IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets[24] Forward-Looking Statements This section details forward-looking statements, highlighting inherent risks and uncertainties in drug development and financial projections - This press release contains forward-looking statements related to clinical program updates, therapeutic benefits, regulatory approvals, development and regulatory milestones, and the extent to which IDEAYA's existing cash will fund its planned operations[26] - Such forward-looking statements involve substantial risks and uncertainties inherent in the drug development process, including early stage development, trial design, regulatory processes, manufacturing, intellectual property, and financial sufficiency[27] Investor and Media Contact Contact information for investor and media inquiries is provided, directed to Andres Ruiz Briseno, Chief Accounting Officer - For investor and media inquiries, contact Andres Ruiz Briseno, Chief Accounting Officer, at investor@ideayabio.com[28]