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IDEAYA Q1 2025 Earnings Report
IDEAYA Biosciences, Inc. reported its financial results for the first quarter ended March 31, 2025, highlighting progress in its clinical programs and an updated cash runway.
Key Takeaways
IDEAYA Biosciences reported a net loss of $72.2 million for Q1 2025, with no collaboration revenue. The company maintained a strong cash position of approximately $1.05 billion, extending its cash runway into 2029. Significant progress was made in the darovasertib program, including achieving Breakthrough Therapy Designation and advancing patient enrollment in registrational trials.
Cash, cash equivalents, and marketable securities totaled approximately $1.05 billion as of March 31, 2025, with an updated cash runway guidance into 2029.
Over 300 patients were enrolled in the darovasertib and crizotinib registrational 1L HLA-A2-negative MUM trial, targeting median PFS results by year-end 2025 for potential accelerated approval filing.
The FDA granted Breakthrough Therapy Designation for single-agent darovasertib for neoadjuvant treatment of primary uveal melanoma (UM).
IDE849 (DLL3 TOP1 ADC) Phase 1 was initiated in the U.S., with partner Hengrui targeting a clinical data update in Q3 2025 for over 40 SCLC patients.
IDEAYA
IDEAYA
Forward Guidance
IDEAYA Biosciences projects its existing cash, cash equivalents, and marketable securities will fund planned operations into 2029, supported by pipeline prioritization and upcoming clinical milestones.
Positive Outlook
- Targeting median PFS results for darovasertib in 1L HLA-A2-negative MUM by year-end 2025 to enable potential accelerated approval filing.
- Commencement of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is targeted for the first half of 2025.
- Targeting three darovasertib program clinical data updates at medical conferences in 2025, including 1L MUM mOS results and neoadjuvant UM data.
- Partner Hengrui targeting clinical data update for IDE849 in over 40 SCLC patients at a medical conference in Q3 2025.
- Three additional IND-filings targeted in 2025: PRMT5, B7H3/PTK7 ADC, and KAT6/7.
Challenges Ahead
- No collaboration revenue is projected for the current quarter, indicating reliance on existing cash reserves.
- The company anticipates continued high R&D expenses to support its broad clinical pipeline.
- Potential for delays in clinical trial readouts or regulatory approvals.
- Challenges associated with manufacturing drug products could impact timelines.
- The need to successfully establish, protect, and defend intellectual property for its drug candidates.