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Kura Oncology (KURA) investor relations material
Kura Oncology Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Ziftomenib advanced with NDA accepted by FDA for relapsed/refractory NPM1-mutated AML; PDUFA date set for November 30, 2025, and pivotal Phase 3 KOMET-017 trials initiated targeting over 50% of AML patients.
Positive clinical data for ziftomenib in both relapsed/refractory and newly diagnosed AML, with high remission and MRD negativity rates, and a favorable safety profile; two oral presentations accepted for the 2025 ASH Annual Meeting.
Collaboration with Kyowa Kirin for global development and commercialization, with $330M upfront and $75M in milestones received as of Q3 2025; commercial teams fully mobilized and launch readiness completed.
Strategic focus on advancing precision oncology pipeline, including farnesyl transferase inhibitors darlifarnib and tipifarnib, showing promising safety and efficacy in solid tumors and head and neck cancer.
Financial highlights
Collaboration revenue for Q3 2025 was $20.8 million, up from zero in Q3 2024; $50.1 million for the nine months ended September 30, 2025.
R&D expenses rose to $67.9 million from $41.7 million year-over-year; G&A expenses increased to $32.8 million from $18.2 million.
Net loss for Q3 2025 was $74.1 million, compared to $54.4 million in Q3 2024; net loss for the nine months was $197.7 million.
Cash, cash equivalents, and short-term investments totaled $609.7 million pro forma as of September 30, 2025, including recent milestone payments.
Total operating expenses for Q3 2025 were $100.7 million, up from $59.9 million in Q3 2024.
Outlook and guidance
Cash and investments expected to fund operations through end of 2027 and support ziftomenib program through topline KOMET-017 results.
Anticipates $315 million in near-term milestone payments, including a substantial payment upon ziftomenib commercial launch.
Key upcoming milestones include FDA decision, ASH data presentations, and further clinical data releases in 2026.
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