Kura Oncology (KURA) investor relations material

Commercial progress and product performance

• Achieved market leadership in new patient starts for KOMZIFTI, a menin inhibitor for relapsed refractory NPM1 mutant AML, with $9.1 million in net revenue and 115 new patient starts in the second full quarter.

• KOMZIFTI is differentiated by efficacy, safety, combinability, and simple once-daily dosing, leading to rapid physician adoption and preference.

• Physician-initiated combinations with venetoclax, azacitidine, and FLT3 inhibitors account for about 40% of new patient starts, reflecting strong combinability.

• Ongoing data generation and upcoming presentations aim to further support physician decision-making and expand use in frontline settings.

• The total addressable market in frontline AML is estimated to be 20 times larger than the current relapsed refractory setting.

Clinical development and pipeline updates

• Two phase III trials (KOMET-017) for ziftomenib are enrolling as projected, targeting both intensive and non-intensive chemotherapy settings, with top-line results expected in 2028.

• Accelerated approval endpoints are MRD-negative CR (targeting >44%) and complete response rates (>70%) in respective trial arms, with phase I-B data showing promising results.

• Additional frontline combination data, including ziftomenib with FLT3 inhibitors, will be presented later this year, potentially setting new standards in AML treatment.

• Darlifarnib, a farnesyl transferase inhibitor, is advancing in phase I-B studies for kidney cancer and will enter a combination study in pancreatic cancer next year.

• Early data suggest darlifarnib augments activity of cabozantinib and adagrasib, with plans for further studies in kidney, pancreatic, and colorectal cancers.

Strategic partnerships and financial position

• Partnership with Kirin involves shared development and 50/50 profit split, with $180 million in anticipated milestones supporting ongoing programs.

• Formation of Caspian Therapeutics, focused on menin inhibitors for diabetes and metabolic diseases, with Kura shareholders owning about 50%.

• Caspian's lead candidate KO-7246 is entering phase I studies, with upcoming data at EASD.

• Ended the quarter with $519 million in cash, providing runway through 2028 for key programs and maintaining strategic flexibility for future development.

• Projected peak sales for ziftomenib and darlifarnib could exceed $6 billion, with a focus on maintaining best-in-class and only-in-class positions.