Kura Oncology(KURA)2023-08-06 14:41Financial Data and Key Metrics Changes - As of June 30, 2023, the company had cash, cash equivalents, and short-term investments of 438 million as of December 31, 2022, which includes net proceeds of approximately 37.2 million compared to a net loss of 11.8 million from $11.1 million year-over-year [34] Business Line Data and Key Metrics Changes - The company reported a complete remission (CR) rate of 35% and an overall response rate of 45% in patients with NPM1-mutant acute myeloid leukemia (AML) treated with ziftomenib [3] - The median duration of response for all NPM1-mutant patients was 8.2 months, with a median follow-up of 8.8 months [9] Market Data and Key Metrics Changes - NPM1-mutant AML accounts for approximately 30% of new AML cases annually, representing a significant unmet medical need with no approved targeted therapies [4] - Head and neck cancer is the seventh most common cancer worldwide, with a significant unmet medical need for approved small molecule targeted therapies [5] Company Strategy and Development Direction - The company aims to establish ziftomenib as a foundational therapy that can be combined safely with various commonly used regimens, prioritizing combinations that represent the greatest unmet medical need and potential commercial value [142] - The company is evaluating the combination of tipifarnib and alpelisib in head and neck squamous cell carcinoma, with plans to initiate dose expansion in mid-2024 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the enrollment in the Phase 2 registration-directed trial of ziftomenib, noting that it continues to outperform projections due to strong interest and activity in patients who failed prior treatments [10][19] - Management believes that ziftomenib is well-positioned for the maintenance setting, with a favorable safety profile and no evidence of drug-induced myelosuppression [21][62] Other Important Information - The company plans to begin a post-transplant maintenance program for ziftomenib in the first quarter of 2024 [11] - The company has received FDA clearance for the investigational new drug application for KO-2806 for the treatment of advanced solid tumors, with plans to evaluate its safety and tolerability in a Phase 1 dose escalation study [14] Q&A Session Summary Question: Can you provide more details on enrollment progress for ziftomenib? - Management indicated that they anticipate full enrollment of 85 patients in the study by mid-next year, noting that enrollment is ahead of projections due to physician excitement and the data itself [37][90] Question: What are the expectations for initial data from the combination trial? - Management expects to have preliminary data from the COMET-007 study in the fourth quarter of 2023 or the first quarter of 2024, emphasizing the importance of gathering sufficient data before making meaningful conclusions [137][92] Question: How does the company view resistance mutations in the maintenance setting for ziftomenib? - Management does not believe resistance mutations will significantly impact the use of ziftomenib in the maintenance setting, citing a low rate of resistance mutations observed in their studies [61][62] Question: What is the strategic rationale for starting with renal cell carcinoma (RCC)? - Management explained that RCC is a more mature space with a clear understanding of the landscape, and they have conducted market research to inform their strategy [106] Question: Are there discussions with companies marketing approved drugs for combination therapies? - Management confirmed that they are exploring clinical collaboration or supply agreements to mitigate costs and expedite patient enrollment [121]