Kura Oncology Reports Fourth Quarter and Full Year 2024 Financial Results

Core Insights - Kura Oncology's KOMET-001 registrational trial for ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) achieved its primary endpoint, paving the way for a New Drug Application (NDA) submission in the upcoming quarter [2][3] - The company has reached alignment with the FDA and EMA on the KOMET-017 trial protocol, which includes the use of minimum residual disease (MRD)-negative complete response (CR) as a primary endpoint for potential accelerated approval in the U.S. [2][3] - Kura Oncology reported a cash position of $727.4 million, which, along with anticipated collaboration payments, is expected to support the commercialization of ziftomenib through frontline AML combination settings [1][7] Clinical Development - The KOMET-001 trial demonstrated a targeted complete response (CR) rate of 20-30%, with positive topline results submitted for presentation at ASCO [3] - The KOMET-017 trial is set to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy regimens, with topline results anticipated in 2028 [1][2] - Positive clinical data from the Phase 1 trial (KOMET-007) showed that 91% of patients achieved a CR when ziftomenib was combined with standard treatments [3][4] Financial Performance - Collaboration revenue for the fourth quarter and full year 2024 was$ 53.9 million, compared to no revenue in 2023 [6] - Research and development (R&D) expenses for Q4 2024 were $52.3 million, up from$ 32.5 million in Q4 2023, while full-year R&D expenses reached $170.0 million compared to$ 115.2 million in the prior year [6] - The net loss for Q4 2024 was $19.2 million, a decrease from a net loss of$ 42.8 million in Q4 2023, with a full-year net loss of $174.0 million compared to$ 152.6 million in 2023 [6][14] Strategic Collaborations - Kura Oncology entered a global strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib, retaining leadership and strategic rights in the U.S. [6][10] - The collaboration aims to fund an expansive AML development program through U.S. commercialization in first-line combinations [6][10] Future Milestones - The company plans to submit an NDA for ziftomenib in R/R NPM1-mutant AML in Q2 2025 and present topline data from the KOMET-001 trial in the same timeframe [11] - Initiation of the KOMET-015 trial evaluating ziftomenib and imatinib in advanced gastrointestinal stromal tumors (GIST) is expected in the first half of 2025 [11] - Two independent Phase 3 trials for first-line intensive and non-intensive AML are anticipated to start in the second half of 2025 [11]