Kura Oncology, Inc. Q4 FY2024 earnings call

Troy Wilson highlighted the momentum in the pipeline, including positive top-line results from KOMET-001 for ziftomenib in relapsed/refractory NPM1-mutant AML, with submission of NDA expected next quarter and alignment with FDA and EMA on KOMET-017 protocol. Mollie Leoni discussed frontline AML trials KOMET-017-NIC (non-intensive chemotherapy) and KOMET-017-IC (intensive chemotherapy), emphasizing unmet needs in AML. Troy also mentioned the KOMET-015 trial for ziftomenib and imatinib in GIST, and progress on farnesyl transferase inhibitor programs, with upcoming clinical data updates.

Collaboration revenue from Kyowa Kirin partnership for Q4 2024 was $53.9 million. Research and development expenses were $52.3 million, general and administrative expenses were $24.1 million. Net loss for Q4 2024 was $19.2 million. Cash, cash equivalents, and short-term investments as of December 31, 2024, were $727.4 million, including a $330 million upfront payment from Kyowa Kirin.

Anticipates submitting NDA for ziftomenib in relapsed/refractory NPM1-mutant AML in Q2 2025, presenting top-line data from KOMET-001 in Q2, initiating KOMET-015 trial in first half of 2025, initiating Phase 3 registration-enabling trials in frontline intensive and non-intensive AML in second half, and various milestones for farnesyl transferase inhibitor programs, including data presentations and expansion cohorts.

Not explicitly detailed in the transcript as a separate section, but general risks related to clinical trial outcomes, regulatory approvals, and market competition are implied.

Q: Troy, you guided to the Phase 3 top-line in frontline intensive AML setting in 2028. Just curious what assumptions went into that guidance? And anything you can share on the trial size, that plan or enrollment timeline?

A: Troy Wilson mentioned they are being conservative, with more detail on trial size, powering, etc., to come later as studies start.

Q: When we look at the commercial opportunities for ziftomenib, the most important variable is the treatment duration. Could you share the reason behind your confidence that frontline AML patients will be able to stay on the treatment for more than a year?

A: Mollie Leoni discussed the 007 trial's informativeness on treatment duration, noting prolonged use observed in patients, more significant than initial expectations.

Q: As you look to the additional dose expansion data from the 007 study, what in your view would be encouraging from the 7+3 combo as you start to expand into the non-adverse risk group?

A: Mollie Leoni explained that encouraging data would include MRD negativity rates, with expected 40%-45% currently, and incremental increases to 50%-60% being positive.

Q: On the frontline development, do you expect EMA to have an entirely different opinion than the FDA on MRD negativity as a regulatory endpoint?

A: Mollie Leoni stated there could be differences, but accelerated approval endpoints are for the US, while survival-based endpoints support EU approvals.

Q: Just a follow-up on Charles' earlier question. I also find the FTIs quite interesting and also important given that you have wholly owned economics on the programs and are the only companies developing the programs. Troy, you mentioned the combination approach with KRAS, which I find quite compelling. Can you talk to whether you have preclinical data with a pan-KRAS inhibitor?

A: Troy Wilson discussed non-clinical data with mutant selective and pan-RAS inhibitors, noting synergistic activity, and plans to evaluate clinical activity in various indications.