Kura Oncology (KURA) Wells Fargo 21st Annual Healthcare Conference summary

Commercial performance and product positioning

• KOMZIFTI achieved $9.1 million in net revenue in Q2, a 57% increase over Q1, with 115 new patient starts and about 250 total prescriptions, capturing majority share in the NPM1 mutant population.

• KOMZIFTI is recognized for its efficacy, safety, tolerability, and once-daily dosing, with 40% of patients receiving it in combination with standard therapies, mainly venetoclax/azacitidine and gilteritinib.

• Market access is strong, with over 95% coverage of covered lives in the U.S. and favorable formulary positioning for 16 million lives.

• Gross-to-net is in the 20%-30% range, consistent with other oral therapies, and the company expects to maintain this range.

• The relapsed/refractory NPM1 mutant market is estimated at $350-$400 million annually, with median therapy duration expected at six months.

Clinical development and pipeline updates

• Two phase III studies for ziftomenib (KOMZIFTI) are underway in acute leukemia, with initial top-line results expected in 2028, targeting both intensive and non-intensive chemotherapy settings.

• Phase I-B data showed a 56% MRD-negative complete response rate for the triplet regimen, with phase III endpoints focused on MRD-negative CR and survival-based outcomes.

• Upcoming data readouts in Q4 include non-intensive chemotherapy combinations and combinations with FLT3 inhibitors, aiming to demonstrate safety, response rate, and durability.

• Differentiation from competitors is highlighted by the ability to combine ziftomenib with gilteritinib without dose-limiting toxicity, targeting a third of AML patients.

• Regulatory strategy for FLT3-mutant AML is focused on data generation and clinician feedback before pursuing registrational studies.

Pipeline expansion and financial position

• Darlifarnib is advancing in kidney cancer (with cabozantinib) and KRAS-driven tumors (with adagrasib and deruxantinib), with phase I-B dose optimization ongoing and a first-in-human study with divarasib planned for mid-next year.

• Darlifarnib combinations are positioned to enhance existing therapies with minimal added toxicity, representing a $5-$6 billion peak sales opportunity.

• KO-2806, a next-generation menin inhibitor for diabetes, will have preclinical data presented at EASD in September, including comparisons to BioMarin's icovamenib.

• The company holds $518 million in cash and expects $180 million in milestones from partners, supporting development of two potential blockbuster assets.

• Leadership emphasizes strong execution across commercial and development fronts, with a favorable risk-reward profile and significant insider ownership.