Kura Oncology (KURA) TD Cowen 46th Annual Health Care Conference summary

Company overview and strategic priorities

• 2026 is expected to be a pivotal year, with a focus on driving quarter-over-quarter growth for Komzifti and establishing market leadership in NPM1-mutated AML.

• Two phase III trials are underway in intensive and non-intensive frontline AML, with combinations involving FLT3 inhibitors.

• Expansion into solid tumors is ongoing, including dose escalation studies in GIST and multiple clinical data sets expected from darlifarnib combinations in 2024.

• Discovery platform includes a next-generation menin inhibitor for solid tumors and programs targeting diabetes and cardiometabolic disease, with an IND expected in the first half of 2027.

• Strong cash position, with over $650 million and additional milestone opportunities, providing runway through key phase III readouts.

Komzifti commercial launch and feedback

• Komzifti approved for relapsed/refractory NPM1-mutant AML, showing over 21% complete response rate and strong safety profile in the KOMET-001 trial.

• Early clinician feedback highlights differentiation in efficacy, safety, compatibility, and dosing simplicity, with positive responses from physicians, pharmacists, and payers.

• $2.1 million in early revenue reported, with further payer data and leading indicators to be shared in upcoming earnings.

• Total addressable market for relapsed/refractory NPM1-mutant AML estimated at $350–400 million, with expectations to build market leadership over time.

• EU regulatory strategy focuses on combination data for approval and reimbursement.

Clinical development and trial updates

• Phase III KOMET-017 trial covers both intensive and non-intensive regimens under one protocol, with over 200 sites planned globally and robust site engagement.

• Primary endpoints include CR rate for unfit patients and MRD-negative CR for fit patients, targeting 10–15% improvements over standard of care.

• Three-arm design in intensive chemotherapy aims to support a label for post-consolidation maintenance, with initial data expected in 2028.

• Frontline AML market opportunity estimated at $7 billion, with a 55/45 split between intensive and non-intensive patients.

• Phase II data in fit patients showed 90–100% CR rates and high MRD negativity; updates on responder longevity and MRD rates expected this year.