Kura Oncology (KURA) investor relations material

Product pipeline and clinical development

• Ziftomenib (KOMZIFTI) is approved for relapsed/refractory NPM1 mutant AML, with a comprehensive phase III program in both intensive and non-intensive frontline settings; a data update is expected in a few weeks.

• Ziftomenib is also being studied in gastrointestinal stromal tumors (GIST) and other solid tumors, with further data expected next year.

• Darlifarnib targets resistance to therapies and is being evaluated in combination with adagrasib, with new data to be presented at ASCO and a strategy update scheduled for June 3.

• The ziftomenib AML program is partnered with Kyowa Kirin and fully funded through to initial top-line results.

• The KOMET-017 protocol combines two phase III studies, streamlining site activation and accelerating enrollment, with the company ahead of competitors in intensive chemotherapy settings.

Commercial performance and market dynamics

• First full quarter of KOMZIFTI launch generated $5.8 million in net revenue from 85 new patient starts, representing about 40% of new menin inhibitor patient starts.

• Around 40% of patients were treated in combination with other agents, reflecting strong physician interest in combinability.

• Uptake is concentrated in academic centers, with a dual sales force approach (company and Kyowa Kirin) expanding reach and education.

• Over 93% of covered lives are on policy, with some payers giving KOMZIFTI favorable positioning, covering about 12 million lives.

• The relapsed/refractory NPM1 mutated AML market is estimated at $350–400 million, with expectations to lead the menin inhibitor class by year-end.

Clinical data and competitive landscape

• KOMET-007 study update shows a 96% CR rate and 80% MRD negativity in NPM1 patients, with median therapy duration of 17 months; ongoing studies may support long-term use.

• Combination studies with FLT3 inhibitors (KOMET-008) are ongoing, with updates expected at year-end; nearly half of NPM1 mutant patients have FLT3 co-mutations.

• The company is ahead of competitors in both intensive and non-intensive settings, with leading sites in the US, Europe, and Asia-Pacific participating.

• Menin inhibitors are being explored for broader indications, including diabetes and cardiometabolic diseases, due to their epigenetic regulatory role.

• Peak sales for the menin inhibitor class are projected at $7 billion, assuming broad eligibility and extended therapy duration.