Kura Oncology, Inc. Q1 FY2025 earnings call

• Troy Wilson highlighted progress in the pipeline, including NDA submission for ziftomenib in AML, clinical and regulatory milestones, and appointment of Samir Vattompadam. - Mollie Leoni discussed ziftomenib development, including KOMET-001 data at ASCO, combinations like ziftomenib with imatinib in GIST, and progress in FTI programs. - Tom Doyle provided financial highlights, including collaboration revenue, expenses, and cash position.

Collaboration revenue from Kyowa Kirin partnership for Q1 2025 was $14.1 million (vs $0 in Q1 2024). R&D expenses in Q1 2025 were $56 million (vs $36.3 million in Q1 2024). General and administrative expenses in Q1 2025 were $22.8 million (vs $18.2 million in Q1 2024). Net loss in Q1 2025 was $57.4 million (vs $49.5 million in Q1 2024). As of March 31, 2025, cash, cash equivalents, and short-term investments were $658.2 million, adjusted to $703.2 million with the $45 million NDA submission milestone from Kyowa Kirin. Cash is sufficient to fund operating expenses into 2027 and advance ziftomenib AML program to commercialization.

• Anticipated upcoming milestones include presenting KOMET-001 data at ASCO and EHA, preliminary combo data from KOMET-007 at EHA and later meetings, initiating KOMET-007 Phase 3 frontline trials in second half 2025, and nominating a development candidate for a menin inhibitor program in diabetes in mid-2025. - For FTI programs, milestones include initiating expansion cohorts of KO-2806 and cabozantinib in RCC, presenting data from FIT-001 trials, and sharing data from HN trial in second half 2025.

Q: Dan [ph] asked about combo data coming later this year, especially the aza/ven cohort, and timing of initiating the frontline trial.

A: Mollie Leoni said safety is a priority, and they look forward to establishing the combinability of ziftomenib with ven in frontline. Troy Wilson said they remain on track to start the study in the second half of 2025.

Q: Jonathan Chang asked about FDA impact on ziftomenib approval process and timelines, and expectations for ASCO presentation of KOMET-001 results.

A: Troy Wilson said no impact from FDA changes, requested priority review, and expected PDUFA date in second quarter. Mollie Leoni said CR, CRh rate will be between 20%-30%, with ASCO presentation having more fulsome data than the abstract.

Q: Salim Syed asked about market share and competition for ziftomenib in NPM1 setting.

A: Troy Wilson and Brian Powl said they will mount a significant commercial strategy, work with Kyowa Kirin, and compete for patients, focusing on risk-benefit profile.

Q: Cameron Bozdog asked about combo data from KOMET-007 and MRD negativity for ziftomenib.

A: Mollie Leoni said they look for safety first, expect CRc rates of 60%-90%, and MRD data will be a key consideration.

Q: Charles Zhu asked about KO-2806 in combination development for RCC.

A: Mollie Leoni said KO-2806 is synergistic with current RCC treatments, aiming for deeper, longer responses.

Q: Ellen Horste asked about Kyowa Kirin's strategy and ziftomenib's differentiation.

A: Troy Wilson said they and Kyowa Kirin will fight for every patient, focusing on relapsed/refractory and earlier lines of therapy.

Q: Peter Lawson asked about GIST patient segments responsive to ziftomenib combination.

A: Mollie Leoni said ziftomenib is mutationally agnostic, working with imatinib regardless of patient's imatinib status, targeting deeper and longer responses.

Q: David Dai asked about Phase 3 trial gating and site activations for 017.

A: Mollie Leoni said site reception has been positive, with clinicians excited about ziftomenib's addition to backbone therapies.

Q: Jeet Mukherjee asked about pulling clinicians to ziftomenib post-approval.

A: Brian Powl said they will communicate ziftomenib's risk-benefit profile to physicians.

Q: George Farmer asked about priority review, ODAC meeting, and endpoints in Phase 3 trials.

A: Troy Wilson said they'll know priority review when dossier is accepted, no ODAC anticipated. Mollie Leoni said endpoints are dual primary, with survival endpoints as backup.

Q: Roger Song asked about ASCO data cut and frontline enrollment for 017.

A: Troy Wilson said ASCO abstract and presentation have the same data cut, and enrollment in frontline trials is robust as no menin inhibitor is approved for first line.