On November 4, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported third quarter 2025 financial results and provided a corporate update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our momentum is accelerating across the ziftomenib program and our broader precision oncology pipeline," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer. "With the initiation of the pivotal KOMET-017 Phase 3 trials, we are executing a robust, focused development strategy to unlock ziftomenib’s best-in-class potential across the continuum of unmet need in AML. Bolstered by a strong balance sheet and our productive partnership with Kyowa Kirin, we are well positioned to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value across our pipeline for patients and other key stakeholders."
Recent Highlights
In September 2025, we announced the first patient was dosed in the Phase 3 KOMET-017 trial of ziftomenib in frontline AML (NCT07007312). KOMET-017 comprises two global, randomized, double-blind, placebo-controlled trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-r) AML.
In October 2025, we announced the first patient was dosed in the FLT3 inhibitor cohort of the KOMET-007 clinical trial (NCT05735184). The cohort evaluates ziftomenib combined with the FDA-approved FLT3 inhibitor, quizartinib, plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD / NPM1 co-mutations.
In September 2025, the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib as a monotherapy in adult patients with R/R NPM1-m AML. (Reprint)
Two abstracts featuring clinical data from ziftomenib in combination with venetoclax / azacitidine (ven/aza) chemotherapy in patients with newly diagnosed and R/R NPM1-m or KMT2A-r AML were accepted for oral presentation at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) to be held in December 2025. (Abstract ID 764; Abstract ID 766)
In October 2025, preliminary clinical data were presented at ESMO (Free ESMO Whitepaper) 2025, highlighting the potential of Kura’s farnesyl transferase inhibitors, darlifarnib (KO-2806) and tipifarnib, to enhance the anti-tumor activity of PI3Ka inhibitors, KRAS inhibitors and antiangiogenic tyrosine kinase inhibitors across a range of diverse tumor types by addressing a common resistance pathway.
Data from the FIT-001 Phase 1 trial evaluating darlifarnib and cabozantinib in patients with renal cell carcinoma (RCC) reflect a manageable safety profile across multiple dose levels of each agent, including at the full label dose of cabozantinib. Antitumor activity was observed across all dose combinations tested, including in patients with prior exposure to cabozantinib. The objective response rate (ORR) was 33-50% in ccRCC, and 17-50% in patients with prior cabozantinib exposure. (Poster)
Data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in patients with PIK3CA-dependent HNSCC also reflect a manageable safety profile. An ORR of 47% was observed at a dose of tipifarnib 1200 mg/day and alpelisib 250 mg/day. Robust antitumor activity was observed in a heavily pretreated patient population where clinical benefit is not expected from either alpelisib or tipifarnib as monotherapy. (Poster)
In October and November 2025, Kura received two $30 million milestone payments under its agreement with Kyowa Kirin in connection with first patient dosing in the pivotal KOMET-017 clinical trial of ziftomenib with intensive and non-intensive chemotherapy in patients with frontline AML.
Forecasted Milestones
Continued regulatory interactions with the FDA ahead of the November 30, 2025 PDUFA target action date for ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-m AML.
Present preliminary clinical data in newly diagnosed NPM1-m AML and updated clinical data in R/R NPM1-m and KMT2A-r AML from KOMET-007 cohorts evaluating ziftomenib in combination with ven/aza at ASH (Free ASH Whitepaper) Annual Meeting to be held in December 2025.
Present preliminary data from the KOMET-008 cohort evaluating ziftomenib in combination with the FLT3 inhibitor gilteritinib in patients with R/R NPM1-m AML in 2026.
Initiate FIT-001 Phase 1b expansion cohorts of darlifarnib and cabozantinib in patients with advanced RCC in the first half of 2026.
Present updated dose-escalation data from the combination of darlifarnib and cabozantinib in patients with advanced RCC in 2026.
Present preliminary clinical data from the combination of darlifarnib and adagrasib in patients with KRASG12C-mutated solid tumor indications in 2026.
Financial Results
Collaboration revenue from our Kyowa Kirin partnership for the third quarter of 2025 was $20.8 million, compared to no revenue for the third quarter of 2024.
Research and development expenses for the third quarter of 2025 were $67.9 million, compared to $41.7 million for the third quarter of 2024.
General and administrative expenses for the third quarter of 2025 were $32.8 million, compared to $18.2 million for the third quarter of 2024.
Net loss for the third quarter of 2025 was $74.1 million, compared to a net loss of $54.4 million for the third quarter of 2024. Net loss for the third quarter included non-cash share-based compensation expense of $11.0 million, compared to $8.3 million for the same period in 2024.
As adjusted for the two $30 million clinical trial milestone payments earned under our collaboration agreement with Kyowa Kirin, Kura had, on a pro forma basis, cash, cash equivalents and short-term investments of $609.7 million as of September 30, 2025.
Based on our current plans, we believe that our cash, cash equivalents and short-term investments as of September 30, 2025 will be sufficient to enable us to fund our current operating expenses into 2027, and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, should support our ziftomenib AML program through topline results from KOMET-017.
Conference Call and Webcast – Third Quarter 2025 Financial Results
Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, November 4, 2025, to discuss the financial results for the third quarter of 2025 and to provide a corporate update. A live webcast and archived replay of the event will be available here or online from the investor relations section of the Company’s website at www.kuraoncology.com.
Conference Call and Webcast – ASH (Free ASH Whitepaper) 2025 Annual Meeting
Kura plans to host a virtual analyst and investor event at 12:30 p.m. ET / 9:30 a.m. PT on Monday, December 8, 2025, to discuss the Company’s presentations from ziftomenib in combination with ven/aza chemotherapy in patients with newly diagnosed and R/R NPM1-m or KMT2A-r AML at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). A live webcast and archived replay of the event will be available online from the investor relations section of the Company’s website at www.kuraoncology.com.
(Press release, Kura Oncology, NOV 4, 2025, View Source [SID1234659361])