greeksoup/ stock research

Ideaya Biosciences, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 3 November 2026: press release. Guidance figures: 2 new, 2 kept. The quarter’s numbers.

Key takeaways

  • R&D spend rose on clinical trials: R&D expenses were $121.6 million, up from $108.7 million, driven by higher clinical trial and development costs and personnel-related expenses. Source
  • Net loss widened to $125.7 million: The net loss was $125.7 million, compared with $112.5 million in the prior quarter. Source
  • NDA filed for darovasertib combination: The NDA for darovasertib plus crizotinib in metastatic uveal melanoma was submitted in the third quarter under the RTOR program. Source
  • $100-125 million savings to be reallocated: Estimated savings from the closure are to fund other programs, including potential registrational trials for IDE849 and IDE892. Source
  • IDE849 shows survival benefit in SCLC: Hengrui's Phase 1 China data showed anti-tumor activity, more mature PFS and median overall survival of 17.4 months in 2L SCLC. Source
  • Cash fell to $1.15 billion: Cash, cash equivalents and marketable securities were about $1.15 billion, down from $1.24 billion, with the decrease primarily from net cash used in operations. Source

“We are encouraged by the continued momentum at IDEAYA during the third quarter, marked by the successful completion of our first NDA filing for darovasertib in metastatic uveal melanoma”

Yujiro S. Hata, Chief Executive Officer of IDEAYA

Guidance

AreaPeriodFigureAgainst last quarter
Cash runway Sourceinto 2030into 2030Kept
Cost savings from closing OptimUM-010 Sourcenot stated$100-125 millionNew
IDE849 first clinical data, global Phase 1/2 Sourceby end of 2026 or early 2027by the end of 2026 or early in 2027
IDE849 ES-SCLC Phase 3 enrollment Sourcenot stated400 patientsNew
IDE034 initial clinical data Source20272027
IDE397 combination expansion Sourceby first half of 2027by the first half of 2027
OptimUM-011 enrollment Sourcenot statedapproximately 450 patientsKept
IDE892 with RG6505 Phase 1 trial start Sourceby end of 2026by the end of 2026

What changed from last quarter

  • Guidance kept: Cash runway guidance into 2030 was kept unchanged from the prior quarter. Source
  • New guidance: A savings estimate of $100-125 million was given for closing the OptimUM-010 trial. Source
  • Ended: Enrollment in the Phase 3 OptimUM-010 trial was stopped and the trial is being closed. Source
  • New: The NDA for the darovasertib combination in metastatic uveal melanoma was submitted in the quarter. Source
  • New: A Clinical Supply Collaboration Agreement with Genentech was entered into in August, covering IDE892 with RG6620. Source
  • New: Dr. Michael White was promoted to President, Research and Development. Source
  • New: The IDE849 ES-SCLC Phase 3 design was set out, with 400 patients and randomization to IDE849 or investigator's choice. Source
  • New: Plan changed from evaluating to submitting OptimUM-09 published data to support guideline inclusion. Source

Results and operating expenses

  • Collaboration revenue rose to $10.2 million: Collaboration revenue was $10.2 million, up from $8.9 million in the prior quarter, recognized over time under the Servier license for darovasertib. Source
  • R&D spend rose on clinical trials: R&D expenses were $121.6 million, up from $108.7 million, driven by higher clinical trial and development costs and personnel-related expenses. Source
  • G&A rose on staffing and commercial prep: G&A expenses were $26.3 million, up from $22.5 million, due to personnel costs for company growth and darovasertib commercial preparation. Source
  • Net loss widened to $125.7 million: The net loss was $125.7 million, compared with $112.5 million in the prior quarter. Source
  • Stock compensation rose to $17.7 million: Total stock-based compensation expense was $17.7 million, compared with $16.7 million in the prior quarter. Source

Darovasertib in uveal melanoma

  • NDA filed for darovasertib combination: The NDA for darovasertib plus crizotinib in metastatic uveal melanoma was submitted in the third quarter under the RTOR program. Source
  • ESMO data across HLA and line settings: The OptimUM-01 ESMO update covered 101 HLA-A*02:01-positive patients, including treatment-naive patients and second-line patients after tebentafusp. Source
  • Eye preservation data in primary UM: In the OptimUM-09 neoadjuvant trial, more than 85% of patients had tumor shrinkage, with a 57% eye preservation rate in the enucleation cohort. Source

“Looking ahead, we are excited to share new preclinical data on our extensive MTAP/CDKN2A franchise in RAS-mutant cancers that provides the scientific rationale in support of the two clinical collaborations we established with Roche and Genentech.”

Yujiro S. Hata, Chief Executive Officer of IDEAYA

Trial closure and cost reallocation

  • Phase 3 OptimUM-010 closed to enrollment: Enrollment in the Phase 3 OptimUM-010 trial was stopped, citing site activation and enrollment challenges. Source
  • $100-125 million savings to be reallocated: Estimated savings from the closure are to fund other programs, including potential registrational trials for IDE849 and IDE892. Source
  • Adjuvant Phase 3 started with Servier: The partner Servier and IDEAYA started the OptimUM-011 trial of the combination versus observation, with relapse-free survival as the primary endpoint. Source

ADCs: IDE849 and IDE161

  • IDE849 shows survival benefit in SCLC: Hengrui's Phase 1 China data showed anti-tumor activity, more mature PFS and median overall survival of 17.4 months in 2L SCLC. Source
  • IDE849 Phase 3 endpoints defined: The ES-SCLC Phase 3 uses ORR by BICR for accelerated approval and median OS for full approval. The NEC trial design will be provided later. Source
  • IDE161 combination cohort evaluating IDE849: A Phase 1 combination cohort tests IDE849 with IDE161, a PARG inhibitor, in ES-SCLC, NEC and other DLL3-overexpressing tumors. Source

MTAP and KRAS programs

  • Roche collaboration Phase 1 targeted by year-end: A Phase 1 trial of IDE892 with Roche's RG6505 in MTAP-deleted, RAS-mutant PDAC is targeted to start by the end of 2026. Source
  • Genentech supply deal in PDAC: Genentech will sponsor a trial of IDE892 with its RG6620 in KRAS G12D-mutant PDAC, with IDEAYA supplying IDE892. Source
  • IDE892 expansion at target exposure: The IDE892 monotherapy expansion in NSCLC and PDAC began at target exposures with 24-hour EC90 coverage. Maximum tolerated dose has not been reached. Source
  • MAT2A plus PRMT5 preclinical data: Preclinical models showed durable tumor regressions with dual MAT2A and PRMT5 inhibition, including in NSCLC. Source

Early programs: KAT6/7 and IDE034

  • IDE574 selectively inhibits KAT6 and KAT7: IDE574 is a dual KAT6 and KAT7 inhibitor designed to spare related paralogs KAT5 and KAT8, which are required for normal cell function. Source
  • IDE574 first combination patient dosed: In October the first patient was dosed in an IDE574 combination cohort with fulvestrant in ER-positive metastatic breast cancer. Source
  • IDE034 initial data planned for 2027: IDE034, a B7H3/PTK7 bispecific TOP1 ADC, is expected to produce initial Phase 1 safety and efficacy data in 2027. Source

Cash, capital and leadership

  • Cash fell to $1.15 billion: Cash, cash equivalents and marketable securities were about $1.15 billion, down from $1.24 billion, with the decrease primarily from net cash used in operations. Source
  • Michael White named R&D president: Dr. Michael White, previously Chief Scientific Officer since 2021, was promoted to President, Research and Development. Source
  • R&D Day set for November 16: An R&D Day in London will present preclinical data on MTAP/CDKN2A deficiency in KRAS-mutant cancers. Source

Coming up, as management said on 3 November 2026

  • R&D Day in London on November 16: The R&D Day will present preclinical data on combination strategies in KRAS-mutant cancers, with Dr. Frank McCormick joining management. Source
  • IDE849 first global clinical data: Management plans first clinical data from the global Phase 1/2 IDE849 monotherapy trial in ES-SCLC and NEC. Source
  • IDE849 Phase 3 trials to begin: Two Phase 3 registrational IDE849 trials are planned to start by year end, after Type C meetings with the FDA. Source
  • OptimUM-09 data to guideline bodies: Management plans to submit published OptimUM-09 data to support possible inclusion in clinical practice guidelines. Source

Figures management reported

FigureReported
R&D expense, third quarter 2026 Source$121.6 million
Median OS, IDE849 in 2L SCLC (Hengrui Phase 1) Source17.4 months
ORR, IDE849 in NEC (19 patients) Source52.6%
Median PFS, IDE849 in NEC Source7.0 months
Eye preservation rate, enucleation cohort (OptimUM-09) Source57%
Cash, cash equivalents and marketable securities Source$1.15 billion

Risks management discussed

  • External: Guideline inclusion for neoadjuvant darovasertib is intended to support payor coverage, but is not assured. Source

Earlier plans management reported on

  • Met: The NDA was submitted in the third quarter, earlier than the H2 2026 completion expected in the prior quarter. Source
  • Met: Data from two metastatic UM trials were presented at ESMO 2026 in Madrid, as planned in the prior quarter. Source
  • Not stated: Management plans to start two Phase 3 IDE849 trials by year end, with the goal stated in the prior quarter. Source
  • Not stated: The Roche combination trial start is now targeted by the end of 2026, compared with H2 2026 in the prior quarter. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.