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Dec 31, 2024
Kura Oncology Q4 2024 Earnings Report
Kura Oncology reported its fourth quarter and full year 2024 financial results.
Key Takeaways
Kura Oncology reported positive topline results from its KOMET-001 registrational trial, achieving its primary endpoint, and announced alignment with the FDA and EMA on key aspects of the KOMET-017 protocol for potential U.S. accelerated approval. The company also reported a significant increase in collaboration revenue due to its partnership with Kyowa Kirin.
KOMET-001 registrational trial in R/R NPM1-mutant AML achieved its primary endpoint.
Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol, including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline intensive chemotherapy trial.
Collaboration revenue from the Kyowa Kirin partnership for Q4 2024 was $53.9 million, compared to no revenue in 2023.
Net loss for Q4 2024 was $19.2 million, an improvement from a net loss of $42.8 million in Q4 2023.
Revenue by Segment
Forward Guidance
Kura Oncology anticipates submitting an NDA for ziftomenib in R/R NPM1-m AML in Q2 2025 and initiating two independent Phase 3 registration-enabling trials in 1L AML in H2 2025. The company expects its current cash to fund operations into 2027.
Positive Outlook
- Submit an NDA for ziftomenib in R/R NPM1-m AML in the second quarter of 2025.
- Present topline data from KOMET-001 Phase 2 registration-directed trial in R/R NPM1-m AML in the second quarter of 2025.
- Initiate the KOMET-015 trial evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025.
- Initiate two independent Phase 3 registration-enabling trials in 1L intensive (KOMET-017-IC) and non-intensive (KOMET-017-NIC) AML in the second half of 2025.
- Current cash, cash equivalents and short-term investments are sufficient to fund operating expenses into 2027, supported by anticipated collaboration funding.
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