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Sep 30, 2024
IDEAYA Q3 2024 Earnings Report
IDEAYA reported third quarter results and provided business update.
Key Takeaways
IDEAYA Biosciences reported its Q3 2024 financial results, highlighting a transformational quarter with significant clinical and corporate developments, including a successful FDA Type C meeting, a late-breaker oral presentation at ENA 2024, and the receipt of IND clearance for Werner Helicase inhibitor IDE275.
Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential Ph2/3 registration-enabling trial is ahead of schedule and has exceeded 150 patients.
IDEAYA is targeting initiation of Ph3 registration-enabling trial for darovasertib in neoadjuvant UM in H1 2025, following a successful FDA Type C meeting.
IDE397 showed confirmed ORR by RECIST 1.1 of 40%, 38%, and 22%, in UC, SqNSCLC, and AdenoNSCLC, respectively, at ENA 2024.
IDEAYA had $1.2 billion of cash, cash equivalents and marketable securities as of September 30, 2024, anticipated to fund operations into at least 2028.
IDEAYA
IDEAYA
Forward Guidance
IDEAYA is focused on advancing its pipeline and precision medicine oncology strategy.
Positive Outlook
- Targeting initiation of Ph3 registration-enabling trial for darovasertib in neoadjuvant UM in H1 2025.
- Targeting expansion of Phase 1/2 study of IDE397 in combination with Trodelvy® in MTAP-deletion UC in Q4 2024.
- Targeting expansion in MTAP-deletion NSCLC in late 2024 to early 2025 for IDE397 + AMG 193 combination study.
- Targeting Phase 1/2 expansion for IDE161 and FPI in combination with Merck's anti-PD-1 therapy KEYTRUDA® in MSI-High and MSS EC in Q4 2024.
- Targeting Development Candidate nomination for MTAP-deletion, KAT6 pathway and B7H3/PTK7 Topo-Payload Bispecific-ADC programs in Q4 2024.
Challenges Ahead
- Uncertainties inherent in the drug development process.
- Challenges associated with manufacturing drug products.
- Ability to successfully establish, protect and defend its intellectual property.
- Risk relating to the business of IDEAYA in general.
- Programs' early stage of development