Kura Oncology(US:KURA)2024-05-04 21:28Financial Data and Key Metrics Changes - Research and development expenses for Q1 2024 were $36.3 million, up from $25.2 million in Q1 2023, primarily due to increased clinical trial costs related to ziftomenib and KO-2806 programs [28] - General and administrative expenses for Q1 2024 were $18.2 million compared to $11.4 million in Q1 2023 [51] - Net loss for Q1 2024 was $49.5 million, reflecting an increase from the previous year's loss [51] Business Line Data and Key Metrics Changes - Ziftomenib showed a 53% overall response rate among 15 relapsed refractory patients, with a 40% overall response rate among 10 patients who had prior venetoclax treatment [4] - The complete remission rate among nine menin inhibitor naive patients was 56% [4] - The company is on track to complete enrollment of 85 patients in the KOMET-001 trial by mid-2024 [10][23] Market Data and Key Metrics Changes - The FDA granted Breakthrough Therapy Designation for ziftomenib, indicating its potential as an innovative treatment for patients with NPM1-mutant AML [3] - The company is evaluating ziftomenib in combination with current standards of care, including venetoclax/azacitidine and cytarabine plus daunorubicin [23] Company Strategy and Development Direction - The company aims to identify the recommended Phase II dose of ziftomenib in combination with venetoclax and azacitidine by mid-2024 [10] - There is a focus on developing KO-2806 as a next-generation farnesyl transferase inhibitor, with plans to evaluate it in combination with other targeted therapies [26][50] - The company is also working towards an investigational new drug application for ziftomenib in solid tumor indications in the second half of 2024 [10][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing dialogue with the FDA and the potential for accelerated timelines due to the Breakthrough Therapy Designation [12][32] - The company is optimistic about the enrollment rates across different cohorts and believes that ziftomenib has the potential to be a best-in-class menin inhibitor [90] - Management highlighted the importance of safety and tolerability in ongoing trials, noting no significant toxicities reported thus far [47][74] Other Important Information - The company is preparing to share preclinical data supporting the use of ziftomenib in solid tumors at a medical meeting later this year [49] - The company is assessing the safety and tolerability of ziftomenib in post-transplant maintenance settings [78] Q&A Session Summary Question: What are the implications of ziftomenib receiving Breakthrough Therapy Designation? - Management indicated that the designation validates the unmet need for NPM1-mutant AML and may accelerate the approval process [54][91] Question: Can you provide details on the patients who have remained in the trial? - Management clarified that as of the January data cutoff, 16 of 20 patients remained in the study, with no significant toxicities reported [36][60] Question: What is the status of the post-transplant program? - The post-transplant program is in the hands of investigators and is currently in the study startup phase [120] Question: When can we expect data from the KOMET-001 study? - Management stated that data will be available after completing enrollment and cleaning the data, with no specific timeline provided yet [108] Question: Are there plans for additional studies with KO-2806? - Management confirmed that there is a rationale for combining KO-2806 with other drug candidates, and they are exploring various options [109][130]