Kura Oncology, Inc. Q3 FY2024 earnings call

• Menin inhibitor program: Ziftomenib's KOMET-007 trial shows promising activity in combination with ven/aza and 7+3, with good safety/tolerability. Phase 1a dose escalation cohorts advanced to Phase 1b expansion at 600mg. Breakthrough therapy designation for NPM1-mutant AML. Preclinical data on ziftomenib + imatinib for GIST. Next-gen menin inhibitors for diabetes in development.
• Farnesyl transferase inhibitor programs: KO-2806's Phase 1 FIT-001 trial ongoing, combinations with cabozantinib, adagrasib, and tipifarnib-alpelisib in KURRENT-HN study.

No detailed financial performance breakdown by product segment with revenue contribution % provided. Overall, R&D expenses for Q3 2024 were $41.7M vs $29.3M in 2023, driven by clinical trials for ziftomenib and KO-2806 programs. General and administrative expenses were $18.2M vs $13.1M in 2023. Net loss was $54.4M vs $38.6M in 2023. Cash, cash equivalents, and short-term investments as of 9/30/2024 were $455.3M.

• Menin inhibitor: Present updated KOMET-007 data at ASH 2024; report top-line KOMET-001 results early 2025; present Phase 1b expansion data in 2025; initiate GIST proof-of-concept study first half 2025; nominate diabetes next-gen candidate first half 2025.
• Farnesyl transferase: Identify MTD for KO-2806 monotherapy by end 2024; initiate KO-2806/cabozantinib expansion cohorts in RCC first half 2025; present KURRENT-HN data first half 2025.

Potential risks include clinical trial outcomes not meeting expectations, regulatory approval delays, competition in oncology and diabetes spaces, and safety issues with drug candidates.

Q: How are you thinking about using MRD negativity as frontline endpoints and differences in methodology?

A: Survival is base case, MRD negativity is upside. Methodology differs in relapsed/refractory vs frontline settings with central analysis planned.

Q: What to think about benchmarking combination updates at ASH?

A: Safety focus with efficacy insights expected, DS rate around 20% or less is tolerable.

Q: Timing for pivotal study initiation and NDA filing for ziftomenib monotherapy?

A: Trials designed, regulatory discussions early 2025, NDA filed a few months after topline results with goal of approval second half 2025.

Q: Thoughts on diabetes program next-gen menin inhibitor vs competitors?

A: Focus on safety, therapeutic window, and pharmacology differences like activity persistence post-drug removal compared to competitors.