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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.
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Q3 2025 earnings summary4 Nov, 2025

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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Frequently asked questions

Kura Oncology, Inc. is a clinical-stage biopharmaceutical company that develops medicines for the treatment of cancer in the United States. Its lead product candidates are ziftomenib, a small molecule inhibitor of the menin-Lysine K-specific Methyltransferase 2A protein-protein interaction for the treatment of genetically defined subsets of acute leukemias, including acute myeloid leukemia and acute lymphoblastic leukemia; and tipifarnib, an orally bioavailable inhibitor of farnesyl transferase that is in Phase II clinical trials for the treatment of solid tumors and hematologic indications.

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