Ideaya Biosciences, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 4 August 2026: press release. Guidance figures: 1 raised, 2 new, 4 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss widened to $112.5 million: The net loss was $112.5 million, against $98.5 million in the prior quarter. Net loss per share, basic and diluted, was $(1.22) versus $(1.11). Source
• OptimUM-02 met its primary endpoint: In first-line HLA*A2:01-negative metastatic uveal melanoma, median PFS by blinded independent central review was 6.9 months with the combination versus 3.1 months in the ICT arm. Source
• IDE849 Phase 3 design under FDA discussion: Management is in discussions with the FDA on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC, with more detail due with the second half data update. Source
• Roche pancreatic collaboration with RG6505: A clinical collaboration with Roche tests IDE892 with RG6505, a pan-RAS inhibitor, in MTAP-deleted, RAS-mutant pancreatic cancer. Source
• June public offering raised $323.4 million: The company completed a public offering in June with net proceeds of about $323.4 million after underwriting discounts and expenses. Source
• Cash balance rose to $1.24 billion: Cash, equivalents and marketable securities were about $1.24 billion, up from $972.9 million, also including $33.1 million from at-the-market sales of common stock. Source
• Accelerating DLL3 and MTAP investment: Management is assessing capital allocation across the portfolio and plans to accelerate investment in the DLL3 registrational trial and MTAP/KRAS combination studies. Source

“This quarter marked another successful step forward in our mission to deliver new, potentially best-in-class precision therapies for people with cancer.”

Yujiro S. Hata, President and Chief Executive Officer

Guidance

What changed from last quarter

• New: Management is evaluating whether published OptimUM-09 data could support inclusion in clinical practice guidelines for the neoadjuvant setting. Source
• New: A clinical trial collaboration with Roche was entered in May to test IDE892 with RG6505 in MTAP-deleted, RAS-mutant pancreatic cancer. Source
• New: In June the company completed a public offering of common stock and pre-funded warrants, with net proceeds of approximately $323.4 million. Source
• Guidance raised: The timing for Hengrui's China Phase 3 start of IDE849 moved to the end of 2026, from 2027 in the prior quarter's release. Source
• Guidance kept: The darovasertib NDA completion timing was kept at the second half of 2026, with the filing now described as underway under RTOR. Source
• Guidance kept: The cash runway guidance into 2030 was kept unchanged in this release. Source
• Guidance kept: The IDE849 registrational start goal of year end 2026 was kept, while the planned trial population changed to refractory SCLC and/or NEC. Source
• New: Monotherapy expansion of IDE892 in MTAP-deleted solid tumors has been initiated, according to the release. Source

Results and growth drivers

• Net loss widened to $112.5 million: The net loss was $112.5 million, against $98.5 million in the prior quarter. Net loss per share, basic and diluted, was $(1.22) versus $(1.11). Source
• Collaboration revenue rose on Servier reimbursements: Collaboration revenue was $8.9 million, from research and development services recognized over time under the Servier license for darovasertib. Source
• Operating loss widened on higher R&D: Loss from operations was $122.3 million, against $108.5 million in the prior quarter. Interest and other income, net, was $9.8 million. Source

Darovasertib uveal melanoma program

• OptimUM-02 met its primary endpoint: In first-line HLA*A2:01-negative metastatic uveal melanoma, median PFS by blinded independent central review was 6.9 months with the combination versus 3.1 months in the ICT arm. Source
• Investigator-assessed PFS also improved: Investigator-assessed median PFS was 6.7 months with the combination versus 2.7 months in the ICT arm, with hazard ratio 0.36. Management described the safety profile as generally well-tolerated. Source
• Overall survival data still immature: Overall survival data were immature at the January 23, 2026 cutoff. Management noted an early trend in OS improvement with the combination. Source
• Full primary data shown at ASCO: Complete primary-analysis data from 313 patients were presented as a late-breaking oral at the 2026 ASCO meeting in Chicago. Source

“With over $1.2 billion in cash following our successful financing in June, IDEAYA is well-positioned to continue advancing our precision medicine pipeline through multiple key data updates,”

Yujiro S. Hata, President and Chief Executive Officer

Other darovasertib trials

• OptimUM-01 enrollment completed at about 100: Enrollment in the single-arm Phase 2 OptimUM-01 trial is complete at approximately 100 HLA*A2:01-positive patients. Data from about 85 efficacy-evaluable patients are planned for ESMO. Source
• OptimUM-11 Phase 3 trial initiated: With Servier, the company initiated a global Phase 3 trial, OptimUM-11, in the adjuvant setting of primary uveal melanoma, with about 450 patients and relapse-free survival as the primary endpoint. Source
• OptimUM-09 neoadjuvant update at ESMO: Updated clinical data from the ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib are planned for presentation at ESMO. Source

ADC programs and IDE849

• IDE849 Phase 3 design under FDA discussion: Management is in discussions with the FDA on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC, with more detail due with the second half data update. Source
• IDE849 Hengrui Phase 1 data at ESMO: The partner Hengrui's Phase 1 update in SCLC and NEC will include ORR, PFS, safety, and 12-month landmark OS from about 100 patients. Source
• IDE161 combination trial with IDE849: A Phase 1 combination trial pairs IDE849 with IDE161, a PARG inhibitor, in DLL3-upregulated solid tumors including SCLC, NEC and melanoma. Source
• IDE034 bispecific ADC in dose escalation: IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to internalize only when both targets are co-expressed on the same cell. A Phase 1 dose escalation trial is ongoing. Source

MTAP and KAT6/7 programs

• IDE892 monotherapy expansion started: The monotherapy expansion of IDE892 started at projected efficacious target exposures, with 24-hour target EC90 coverage achieved. The maximum tolerated dose has not yet been reached. Source
• IDE892 with IDE397 combination cohort: A Phase 1/2 combination cohort of IDE892 with IDE397, the company's MAT2A inhibitor, was initiated in MTAP-deleted cancers. Source
• Roche pancreatic collaboration with RG6505: A clinical collaboration with Roche tests IDE892 with RG6505, a pan-RAS inhibitor, in MTAP-deleted, RAS-mutant pancreatic cancer. Source
• IDE574 dose escalation underway: A Phase 1 dose escalation of IDE574, a KAT6/7 inhibitor that spares KAT5 and KAT8, is underway in breast, prostate, colorectal and lung tumors. Source

Costs and expenses

• R&D expenses rose on trials and staff: R&D expenses were $108.7 million, against $95.7 million in the prior quarter, driven by higher clinical trial and personnel-related expenses. Source
• G&A rose on personnel and commercial preparation: G&A expenses were $22.5 million, against $19.4 million, due to personnel costs for company growth and darovasertib commercial preparation. Source
• Stock compensation rose to $16.7 million: Total stock compensation expense was $16.7 million, against $14.5 million in the prior quarter. Source

Capital, cash and financing

• June public offering raised $323.4 million: The company completed a public offering in June with net proceeds of about $323.4 million after underwriting discounts and expenses. Source
• Cash balance rose to $1.24 billion: Cash, equivalents and marketable securities were about $1.24 billion, up from $972.9 million, also including $33.1 million from at-the-market sales of common stock. Source
• Servier reimbursement balance of $147.0 million: The remaining performance obligation for research and development services under the Servier license is $147.0 million, to be recognized as collaboration revenue over time. Source

Strategy and capital allocation

• Accelerating DLL3 and MTAP investment: Management is assessing capital allocation across the portfolio and plans to accelerate investment in the DLL3 registrational trial and MTAP/KRAS combination studies. Source
• OptimUM-09 guideline pathway under evaluation: Management is evaluating whether OptimUM-09 data could support guideline inclusion for neoadjuvant darovasertib, which could reduce the investment needed for clinical utility. Source
• OptimUM-10 recruitment shapes allocation: Ongoing patient recruitment considerations for the global Phase 3 OptimUM-10 trial are part of the company's assessment of allocation across its portfolio. Source

Coming up, as management said on 4 August 2026

• ESMO presentations in October: Updated OptimUM-01 ORR, PFS and OS data are planned for the ESMO Congress in Madrid in October 2026. Source
• R&D Day in the fourth quarter: An MTAP/CDKN2A, KRAS and pancreatic cancer R&D Day is targeted for the fourth quarter of 2026, with agenda details to follow. Source
• Roche Phase 1 combination trial start: A Phase 1 combination trial of IDE892 with RG6505 is planned to start in the second half of 2026. Source
• IDE849 Phase 1/2 first clinical data: First clinical data from the global Phase 1/2 IDE849 trial are planned for the second half of 2026. Source
• OptimUM-02 overall survival update: An overall survival update from the pre-specified interim analysis is expected in mid-2027. Source
• Hengrui China Phase 3 start: Hengrui is targeting the start of a Phase 3 registrational trial of IDE849 in refractory SCLC in China by the end of 2026. Source

Figures management reported

Risks management discussed

• Operational: Patient recruitment considerations for the OptimUM-10 Phase 3 trial are part of a portfolio capital allocation review. Source
• Regulatory: The design of the IDE849 Phase 3 registrational trial is still under discussion with the FDA, so the timing and scope of the trial depend on that alignment. Source
• Demand: Guideline inclusion for darovasertib is not assured, and any resulting payer coverage would depend on it. Source

Earlier plans management reported on

• Met: The company states the OptimUM-11 Phase 3 trial was initiated with Servier, in line with the first-half 2026 timing given in the prior release. Source
• Met: The company states a Phase 1/2 combination cohort of IDE892 with IDE397 was initiated, consistent with the mid-2026 timing in the prior release. Source
• Not stated: Management gave the goal of starting the registrational trial by the end of 2026, with the trial population now described as refractory SCLC and/or NEC. Source
• Not stated: The prior release gave a clinical data update by the end of 2026. The current release gives the end of 2026 or early 2027. Source

Other quarters

• Q3 FY2026 earnings call
• Q1 FY2026 earnings call
• Q3 FY2025 results
• Q4 FY2024 results

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.