Ideaya Biosciences, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 5 May 2026: press release. Guidance figures: 8 new, 3 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss and per-share loss rose: Net loss was $98.5 million, or $(1.11) per share basic and diluted, against a net loss of $83.3 million, or $(0.94) per share, in the prior quarter. Source
• Combination cut progression risk 58%: In OptimUM-02 the combination reduced the risk of disease progression by 58%, with median PFS of 6.9 months versus 3.1 months in the investigator choice arm by blinded central review. Source
• Response rate 37.1% versus 5.8%: Overall response rate was 37.1%, including 5 complete responses, against 5.8% in the investigator choice arm. Median duration of response was 6.8 months. Source
• IDE849 registrational scope changed: The planned IDE849 monotherapy registrational trial is now described for DLL3-positive solid tumors. The prior plan was second line or refractory SCLC and/or NEC. Source
• IDE892 and IDE397 combination planned: IDE892 reached first-patient-in in Phase 1 dose escalation. A combination cohort with IDE397 in MTAP-deleted cancers is planned, and preclinical models showed tumor regressions with dual inhibition. Source
• Cash fell to $973 million: Cash, cash equivalents and marketable securities were $972.9 million at March 31, 2026, against $1.05 billion at December 31, 2025. Management attributed the decrease to net cash used in operations. Source

“This was a transformational quarter for IDEAYA, with positive topline results from the OptimUM-02 registrational trial in first line HLA*A2-negative metastatic uveal melanoma to enable the company’s first NDA submission for potential U.S. accelerated approval.”

Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences

Guidance

What changed from last quarter

• New guidance: NDA submission for darovasertib in the second half of 2026 was given as a dated plan, under the FDA RTOR program. Source
• New: The FDA agreed to review the darovasertib NDA under the RTOR program, which allows pre-submission of NDA components. Source
• New: Topline data from the OptimUM-02 Phase 2/3 trial were reported on April 13, after the prior quarter's guidance of late March. Source
• New: IDEAYA completed a Type C meeting with the FDA on the Phase 3 registrational design of OptimUM-11, in collaboration with Servier. Source
• New: In April IDEAYA entered a clinical collaboration with AstraZeneca to study IDE849 with durvalumab in extensive-stage SCLC. IDEAYA sponsors the trial. Source
• Ended: IDEAYA deprioritized clinical activity with Gilead evaluating IDE397 with Trodelvy and is concluding enrollment in that Phase 1/2 trial. Source
• Ended: IDEAYA plans to discontinue development of IDE275 (WRN) and IDE705 (POLQ) following the GSK termination, and is evaluating strategic options for them. Source
• New: Dr. Theodora (Theo) Ross was appointed to the newly created role of Chief Development Officer. Source

Quarter results and drivers

• Net loss and per-share loss rose: Net loss was $98.5 million, or $(1.11) per share basic and diluted, against a net loss of $83.3 million, or $(0.94) per share, in the prior quarter. Source
• Collaboration revenue declined: Collaboration revenue was $6.6 million, against $10.9 million in the prior quarter. It reflects Servier research and development services recognized over time under the darovasertib license. Source
• Stock compensation rose to $14.5 million: Total stock compensation expense was $14.5 million in the quarter, compared with $11.8 million in the prior quarter. Source

Darovasertib registrational data and filing

• Combination cut progression risk 58%: In OptimUM-02 the combination reduced the risk of disease progression by 58%, with median PFS of 6.9 months versus 3.1 months in the investigator choice arm by blinded central review. Source
• Response rate 37.1% versus 5.8%: Overall response rate was 37.1%, including 5 complete responses, against 5.8% in the investigator choice arm. Median duration of response was 6.8 months. Source
• Overall survival data not yet mature: Overall survival data were not yet mature. Management said the combination showed an early trend in OS improvement versus the investigator choice arm. Source
• Safety profile described as manageable: Management described the combination as generally well-tolerated, with a manageable safety profile consistent with previously reported results and known side-effects of each drug. Source

“We look forward to a catalyst rich second half of 2026, including targeted clinical data updates for the darovasertib combination in HLA*A2-positive mUM, IDE849 in DLL3-positive solid tumors, and IDE034”

Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences

Other uveal melanoma trials

• OptimUM-01 enrollment completed: Enrollment of about 100 HLA*A2-positive mUM patients in the single-arm Phase 2 OptimUM-01 trial of darovasertib with crizotinib is complete. Source
• OptimUM-11 adjuvant design set: The adjuvant Phase 3 OptimUM-11 trial will randomize about 450 patients 1:1 to combination for 12 months or observation, with relapse-free survival as the primary endpoint. Source
• OptimUM-10 enrollment estimate moved: Full enrollment of the neoadjuvant Phase 3 OptimUM-10 trial is now estimated by the end of 2027, revised from the first half of 2027. Site activation and enrollment continue. Source

ADC programs and partnerships

• IDE849 registrational scope changed: The planned IDE849 monotherapy registrational trial is now described for DLL3-positive solid tumors. The prior plan was second line or refractory SCLC and/or NEC. Source
• AstraZeneca durvalumab combination with IDE849: IDEAYA will sponsor a clinical combination trial of IDE849 with durvalumab in extensive-stage SCLC. AstraZeneca supplies the Imfinzi at no cost. Source
• IDE849 and PARG combination dosed: First patient was dosed in a Phase 1 combination trial of IDE849 with IDE161, IDEAYA's PARG inhibitor, to test TOP1 and PARG synergy. Source
• IDE034 bispecific ADC design: IDE034 reached first-patient-in in its Phase 1 dose escalation. It is a B7H3/PTK7 bispecific TOP1 ADC internalized only when both targets are co-expressed. Source
• Biocytogen milestone triggered: Dosing of the first IDE034 patient triggered a $5 million milestone payment from IDEAYA to Biocytogen under their Option and License Agreement. Source

“clinical dose escalation is advancing rapidly for our potential first-in-class KAT6/7 dual inhibitor, IDE574, and our PRMT5 inhibitor, IDE892”

Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences

MTAP pathway and other programs

• IDE892 and IDE397 combination planned: IDE892 reached first-patient-in in Phase 1 dose escalation. A combination cohort with IDE397 in MTAP-deleted cancers is planned, and preclinical models showed tumor regressions with dual inhibition. Source
• Gilead combination deprioritized: IDEAYA deprioritized clinical activity with Gilead on IDE397 with Trodelvy and is concluding enrollment in the Phase 1/2 trial in urothelial and lung cancers. Source
• IDE574 KAT6/7 Phase 1 under way: IDE574, a selective KAT6/7 dual inhibitor, reached first-patient-in in Phase 1 dose escalation across breast, prostate, colorectal and lung cancer. Source
• Two helicase programs being discontinued: Following GSK's termination of its 2020 agreement, IDEAYA plans to discontinue IDE275 (WRN) and IDE705 (POLQ) and is evaluating strategic options for both. Source

Operating costs and net loss

• R&D expense rose to $95.7 million: R&D expense was $95.7 million, against $86.6 million in the prior quarter. Management attributed the increase to higher clinical trial and personnel-related expenses. Source
• G&A rose on commercial preparation: G&A expense was $19.4 million, against $18.8 million, mainly from higher personnel-related expenses and darovasertib commercial preparation activities. Source
• Net loss rose on higher R&D spend: The net loss of $98.5 million compared with $83.3 million in the prior quarter. Operating expenses totaled $115.1 million in the quarter. Source

Cash and liquidity

• Cash fell to $973 million: Cash, cash equivalents and marketable securities were $972.9 million at March 31, 2026, against $1.05 billion at December 31, 2025. Management attributed the decrease to net cash used in operations. Source
• Servier deferred revenue balance: The remaining balance for research and development services performance obligations under the Servier license is $155.3 million, recognized over time as services are completed. Source
• Cash runway into 2030 unchanged: Management said the cash runway guidance into 2030 is unchanged. Source

Corporate and leadership changes

• Chief Development Officer appointed: Dr. Theodora (Theo) Ross was named to the newly created Chief Development Officer role. Source
• New officer from AbbVie: Dr. Ross joins from AbbVie, where she was Vice President, Head of Early Oncology R&D and Site Head for the Bay Area. Source
• Officer to lead early clinical development: Dr. Ross is responsible for leading early clinical development for the emerging oncology pipeline and for guiding long-term R&D strategy. Source

Coming up, as management said on 5 May 2026

• RTOR pre-submission in May: IDEAYA will start the RTOR submission process with a first pre-submission in May. Source
• Late-breaking OptimUM-02 presentation: Complete primary-analysis data will be presented as a late-breaking oral at the 2026 ASCO meeting in Chicago. Source
• OptimUM-02 manuscript planned: A manuscript for the OptimUM-02 primary analysis is planned for submission for publication in the second half of 2026. Source

Figures management reported

Risks management discussed

• Regulatory: Overall survival data are not yet mature, while the planned filing seeks potential accelerated approval. Source
• Operational: The full enrollment estimate for the neoadjuvant OptimUM-10 trial moved to the end of 2027 from the first half of 2027. Source
• Operational: Development of IDE275 and IDE705 is being discontinued, and strategic options for these assets are under evaluation. Source
• Financial: Cash fell by about $76.8 million in the quarter, primarily from net cash used in operations. Source

Earlier plans management reported on

• Not stated: Earlier guidance expected topline PFS results by about the last week of March; the company reported them on April 13.
• Met: Management said first-patient-in was achieved in the Phase 1 dose escalation trial of IDE034. Source
• Met: Management said first-patient-in was achieved in the Phase 1 dose escalation trial of IDE574. Source
• Met: Management said first-patient-in was achieved in the Phase 1 dose escalation trial of IDE892. Source
• Met: Management said enrollment of about 100 HLA*A2-positive patients in OptimUM-01 has been completed. Source
• Not stated: Earlier guidance was Q2 2026; management now expects initiation in the first half of 2026. Source
• Not stated: Management revised the full enrollment estimate for OptimUM-10 to the end of 2027. Source
• Not stated: Earlier guidance was Q2 2026 for the combination trial with IDE397; management now says mid-2026. Source

Other quarters

• Q3 FY2026 earnings call
• Q2 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.