Kura Oncology(KURA)2022-05-05 00:22Financial Data and Key Metrics Changes - Research and development expenses for Q1 2022 were $20.9 million, an increase from $20.3 million in Q1 2021, primarily due to higher clinical trial and personnel costs [14] - General and administrative expenses rose to $11.9 million in Q1 2022 from $10.6 million in Q1 2021, mainly due to increased professional fees and non-cash share-based compensation [14] - The net loss for Q1 2022 was $32.5 million, compared to a net loss of $30.7 million in Q1 2021, which included non-cash share-based compensation of $6.7 million versus $5.1 million in the prior year [15] - As of March 31, 2022, cash, cash equivalents, and short-term investments totaled $480.1 million, down from $518 million as of December 31, 2021, with a cash runway expected to fund operations through 2024 [15] Business Line Data and Key Metrics Changes - The Menin Inhibitor program, Ziftomenib, is progressing with the completion of enrollment in the Phase 1b study, with top-line data expected in Q3 2022 and a full data presentation planned for Q4 2022 [4][6] - The Farnesyl Transferase Inhibitor (FTI) programs are being developed, with ongoing trials for Tipifarnib in combination with Alpelisib targeting head and neck squamous cell carcinoma (HNSCC) [8][10] Market Data and Key Metrics Changes - The company is expanding its clinical development strategy in the U.S. and Europe, anticipating a larger patient population for Ziftomenib through combination therapies [8] - The combination of Tipifarnib and Alpelisib is expected to increase the total addressable patient population for Tipifarnib to as much as 50% of HNSCC patients [10] Company Strategy and Development Direction - The company aims to register Ziftomenib as a monotherapy while exploring combination opportunities to enhance treatment efficacy [8] - A comprehensive development strategy is being pursued for the FTI programs, focusing on both monotherapy and combination therapies to address larger patient populations [11][47] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the company's position despite a challenging market environment, highlighting a strong team and a well-designed clinical strategy [4] - The anticipated milestones for 2022 include identifying the recommended Phase 2 dose for Ziftomenib and initiating several key trials [16] Other Important Information - The company has implemented an enhanced mitigation strategy for managing differentiation syndrome associated with Ziftomenib, which is seen as a marker of clinical activity [23][60] - The company is preparing to submit an IND application for its next-generation FTI candidate, KO-2806, in Q4 2022 [13] Q&A Session Summary Question: What can investors expect in the top-line third quarter data versus the medical meeting presentation in the fourth quarter? - The top-line data will focus on safety, tolerability, and clinical activity at the recommended Phase 2 dose, while the medical meeting will provide a more comprehensive dataset including genetic subtype breakdowns [18] Question: Can you provide details on the enrollment completion and patient demographics in the Phase 1b expansion cohorts? - There is a good balance between the two populations (NPM1 mutation and KMT2A rearrangement), with no disproportionate enrollment observed [19] Question: How much safety data will be available in the Q3 update, and what is the management strategy for differentiation syndrome? - The safety data will be high-level, with an encouraging safety profile reported, and an enhanced mitigation strategy in place for differentiation syndrome [23] Question: What are the top combination studies being considered for Ziftomenib? - Venetoclax and FLT3 inhibitors are identified as attractive combination partners, with ongoing activities to support these studies [46] Question: What are the primary endpoints for the current lung trial? - The primary endpoint is progression-free survival (PFS), with safety and tolerability also being key metrics [55]