Kura Oncology, Inc. Q2 FY2025 earnings call

• Ziftomenib Development: Positive monotherapy data from KOMET-001 trial at ASCO with 23% CR/CRh rate in relapsed/refractory NPM1-mutated AML. FDA accepted NDA for ziftomenib with PDUFA date Nov 30, 2025. Updated combination data from KOMET-007 trial at EHA. Accelerating frontline AML development with KOMET-017 Phase III trials.
• Pre-Commercial Activities: Preparing for potential approval by building commercial supply/quality systems, recruiting/training sales force, collaborating with Kyowa Kirin on launch planning.
• Pipeline Progress: KO-2806 FTI program with three clinical abstracts accepted for ESMO Congress 2025. Progress in menin inhibitor program for diabetes and GIST.
• Financials: As of Jun 30, 2025, cash, cash equivalents, and short-term investments were $630.7M. Under Kyowa Kirin collaboration, up to $375M in near-term milestones.

No detailed breakdown of product segments with revenue contribution provided. Focus is on ziftomenib development and pipeline progress.

• Ziftomenib: NDA PDUFA date Nov 30, 2025; initiation of KOMET-017 Phase III trials in second half of 2025; presenting preliminary clinical data from KOMET-007 with venetoclax and azacitidine in second half of 2025.
• FTI Programs: Initiate expansion cohorts of KO-2806 in cabozantinib in second half of 2025; strong presence at ESMO Congress 2025 with three presentations.

• Unforeseen delays in regulatory review or clinical trial enrollment could push back timelines.
• Potential impact of competitive products and changing FDA regulations on trial designs and approvals.

Q: Can you give color on how the regulatory interactions on ziftomenib have progressed as we look towards the PDUFA date later this year?

A: Interactions with FDA have been collaborative and constructive, in line with priority review timeline.

Q: How are you thinking about the scope of the farnesyl transferase inhibitor opportunity? Between the possible combinations and tumor types, what do you see as an area or areas that Kura can move forward with alone? And which do you see as areas better suited for a potential partner?

A: Reshaping FTI story with data in RCC, PI3 kinase, and KRAS; some areas better suited for partners.

Q: What are the biggest potential risk to the pivotal program time lines, if there's anything that could potentially push initial data out past 2028?

A: Unforeseen issues could push initial data out past 2028, but conservative approach minimizes this.

Q: Given all the changes within FDA, have you had any recent interaction with the FDA regarding your Phase III pivotal design?

A: Usual interactions, with no additional concerns or changes to Phase III pivotal design.