Financial Data and Key Metrics Changes - Collaboration revenue from the Veracurin partnership for 2025 was $15.3 million compared to no revenue for 2024 [33] - Research and development expenses for 2025 were $62.8 million compared to $39.7 million for 2024, driven by spending on ZiftoMenib combination clinical trials [33] - General and administrative expenses for 2025 were $25.2 million compared to $16.7 million for 2024, primarily due to pre-commercial activities [33] - Net loss for 2025 was $66.1 million compared to a net loss of $50.8 million for 2024 [34] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of $630.7 million compared to $727.4 million as of December 31, 2024 [34] Business Line Data and Key Metrics Changes - The company is focused on the development of ZiftoMenib for relapsed or refractory NPM1 mutant AML, with positive monotherapy data presented at ASCO [6][7] - The FDA accepted the NDA for ZiftoMenib, granting priority review with a PDUFA target action date of November 30, 2025 [7] - The company is preparing for potential approval by building commercial supply and quality systems and recruiting a sales force [9][30] Market Data and Key Metrics Changes - The total addressable market for NPM1 mutated relapsed refractory AML is estimated to be between $350 million to $400 million annually [30] - The company believes that menin inhibitors can reach fifty percent of newly diagnosed AML patients, representing a total addressable U.S. market potential of over $7 billion per year [32] Company Strategy and Development Direction - The company is committed to transforming outcomes for patients with AML and is accelerating the development of ZiftoMenib in frontline AML [6][8] - The strategic focus includes advancing menin inhibitors for diabetes and cardiometabolic diseases, as well as farnesyl transferase inhibitors for solid tumors [10][22] - The company aims to establish ZiftoMenib as a market leader in the relapsed refractory AML space and is preparing for a rapid launch upon FDA approval [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a successful review outcome by the PDUFA date and highlighted the collaborative interactions with the FDA [40][41] - The company anticipates robust enrollment in upcoming trials and believes the combination of ZiftoMenib with other therapies will address significant unmet needs in the AML patient population [55][56] Other Important Information - The company has $375 million in potential near-term milestones under the Kyowa Kirin collaboration, which includes significant milestones tied to the initiation of Phase three frontline trials [12] - The company is actively preparing for the ESMO Congress with three clinical abstracts accepted for presentation [11][36] Q&A Session Summary Question: Can you provide color on regulatory interactions for ZiftoMenib? - Management indicated that interactions have been collaborative and constructive, aligning with the timeline for priority review [40][41] Question: What is the scope of the farnesyl transferase inhibitor opportunity? - Management discussed ongoing evaluations in various tumor types and indicated that some areas may be better suited for partnerships [42][43] Question: Thoughts on the Menin class launch and KMT2A market opportunity? - Management expressed optimism about the competitive landscape and the potential for ZiftoMenib to be best in class [50][51] Question: What are the biggest potential risks to pivotal program timelines? - Management acknowledged that while unexpected events could push timelines, they are confident in their ability to meet the projected dates [80][81] Question: How is the FDA dialogue proceeding? - Management confirmed that interactions with the FDA have been consistent and productive, with no significant changes in frequency or quality [85][86] Question: What are the expectations regarding the evolution of NCCN guidelines? - Management plans to submit applications for ZiftoMenib to be included in the guidelines as soon as data is published and approval is obtained [75][76]

Core Insights - Kura Oncology and Kyowa Kirin announced that clinical data from the KOMET-007 trial of ziftomenib will be presented at the EHA2025 Congress, highlighting its potential as a treatment for acute myeloid leukemia (AML) patients with specific mutations [1][2][3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed or refractory NPM1-m AML [6][7] - Kyowa Kirin is a Japan-based global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation, focusing on high unmet medical needs in various therapeutic areas [8] Clinical Trial Details - The KOMET-007 trial is a multicenter Phase 1 study evaluating ziftomenib in combination with standard care treatments for newly diagnosed AML patients with NPM1-m or KMT2A-r mutations [2][3] - The upcoming oral presentation will include updated data from the Phase 1a and Phase 1b portions of the trial, specifically focusing on the combination of ziftomenib with the 7+3 chemotherapy regimen [2][4] Future Developments - The results from the KOMET-007 trial are expected to support the initiation of a pivotal Phase 3 trial, KOMET-017, aimed at further evaluating the combination treatment for AML patients [3][5] - Kura and Kyowa Kirin are also conducting additional clinical trials to assess ziftomenib in various combinations for both newly diagnosed and relapsed/refractory AML patients [7]