Financial Data and Key Metrics Changes - Collaboration revenue from the Kyowa Kirin partnership for Q3 2025 was $20.8 million compared to no revenue in Q3 2024 [16] - Research and development expenses for Q3 2025 were $67.9 million, up from $41.7 million in Q3 2024 [16] - General and administrative expenses for Q3 2025 were $32.8 million, compared to $18.2 million in the same period of 2024 [16] - Net loss for Q3 2025 was $74.1 million, compared to a net loss of $54.4 million in Q3 2024 [16] - Pro forma cash as of September 30, 2025, was $609.7 million, down from $727.4 million as of December 31, 2024 [17] Business Line Data and Key Metrics Changes - The company is advancing its clinical pipeline, particularly with Zifduminib, a menin inhibitor for acute myeloid leukemia (AML) [3][4] - Zifduminib's clinical data from the COMET-001 study showed a favorable benefit-risk profile, with high rates of complete remission and minimal residual disease negativity [5][6] - The company is targeting enrollment at over 150 global sites for its COMET-017 frontline phase 3 trials [7] Market Data and Key Metrics Changes - The company is preparing for the anticipated commercial launch of Zifduminib, with disease awareness campaigns exceeding targets [9] - The commercial organization is fully mobilized and ready to execute upon approval, with a focus on specialty hematologists and large academic institutions [23] Company Strategy and Development Direction - The company aims to position Zifduminib as the menin inhibitor of choice for eligible patients, with a focus on addressing unmet needs beyond the relapsed refractory setting [4] - The dual pipeline strategy includes both menin inhibition and farnesyl transferase inhibitors, which are seen as strategically important for growth [12] - The company plans to submit data for Zifduminib to the NCCN guidelines shortly after FDA approval [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a successful review outcome for Zifduminib, with a PDUFA target action date of November 30, 2025 [3][18] - The company remains in a strong financial position to support its pipeline and commercialization activities, expecting significant milestone payments in the near term [14][17] - Management highlighted the importance of safety and tolerability in differentiating Zifduminib from competitors, especially in the context of the recent black box warning for Torsades [28][30] Other Important Information - The company plans to host a virtual investor and analyst event to discuss ASH presentations on December 8, 2025 [6] - The company has received two $30 million milestone payments for the COMET-017 trials, bringing total milestones received this year to $105 million [14] Q&A Session Summary Question: What account types are being targeted for Zifduminib launch? - The focus is on specialty hematologists, with a mix of large academic institutions and community oncology practices [23][24] Question: What to expect from the ASH update? - The ASH presentations will include more evaluable patients, updated MRD negativity data, and longer follow-up information [25][26] Question: How does the new label impact the NPM1 launch? - The black box warning for Torsades is significant, especially for the NPM1 population, and differentiates Zifduminib based on its favorable safety profile [30][31] Question: What market share is expected relative to competitors? - While specific market share expectations were not provided, the company anticipates capturing a majority share based on Zifduminib's best-in-class profile [39] Question: What are the dynamics with FDA regulatory engagement? - The company has not noticed any changes in cadence with the FDA and remains on track for the November 30 PDUFA date [67]