Kura Oncology, Inc. Q3 FY2025 earnings call

• Ziftomenib's FDA review for relapsed/refractory NPM1-mutated AML is on track with a PDUFA target of November 30, 2025, and has a differentiated benefit-risk profile based on KOMET-001 study data. - Clinical team executing on strategic development plan for ziftomenib beyond relapsed/refractory, including KOMET-017 Phase III trials in frontline settings. - Commercial teams launch ready with disease awareness campaigns, payer exchanges, and aligned distribution network. - Farnesyl transferase inhibitor portfolio with new clinical data showing potential to combine with targeted therapies, including darlafarnib in renal cell carcinoma and tipifarnib in head and neck cancer. - Strong financial position with $609.7 million pro forma cash and upcoming milestone payments.

Collaboration revenue from Kyowa Kirin partnership for Q3 2025 was $20.8 million compared to $0 in Q3 2024. R&D expenses for Q3 2025 were $67.9 million vs $41.7 million in Q3 2024. General and administrative expenses for Q3 2025 were $32.8 million vs $18.2 million in Q3 2024. Net loss for Q3 2025 was $74.1 million vs $54.4 million in Q3 2024. Pro forma cash as of September 30, 2025 was $609.7 million.

• Anticipate continued FDA engagement for ziftomenib leading to PDUFA date in November 2025. - Present ASH Annual Meeting data on ziftomenib in combination regimens. - Initiate expansion cohorts for farnesyl transferase inhibitors in 2026, present updated data from combination trials in 2026.

Forward-looking statements involve risks and uncertainties from regulatory, clinical, and commercial execution that could cause actual results to differ from expectations. Detailed specific risks not extensively discussed in the transcript beyond general SEC filing references.

Q: What do you foresee will be the makeup of account types that you are trying to penetrate for zifto launch? Are there any particular account types that you are focusing on? And also, are there any plans to include zifto in the NCCN guideline?

A: Brian Powl responded that expected account types are specialty hematologists, with 78% in academic settings and focus on community oncology practices. Plans are to submit KOMET-01 data to NCCN soon after FDA approval.

Q: Can you just talk about what we should expect for the actual oral presentations versus what's in the abstract release yesterday?

A: Mollie Leoni responded that the data cut was in June, and the oral presentations will have more evaluable patients, longer follow-up, and new information on MRD negativity and safety.

Q: Just curious, there seems to be varying views on if this actually matters or not. Just what does it mean for you? What does it mean for the space as you think about your own NPM1 launch and also as you progress here towards first line in particular?

A: Troy Wilson and Mollie Leoni discussed the black box warning, risk of sudden cardiac death, and importance of benefit-risk profile in relapsed/refractory and frontline settings.

Q: What kind of level of penetration or market share would you either expect or hope to achieve relative to your first-mover competitor in the space, at least in the near term in the relapsed/refractory setting? And can you also perhaps give a little bit more color around the ongoing points of FDA regulatory engagement that seem to be continuing on as you head close to your PDUFA date?

A: Brian Powl responded on market share potential based on benefit-risk profile and team readiness. Troy Wilson mentioned ongoing constructive FDA engagement towards PDUFA date.

Q: Is having a differentiated label enough to overcome the second mover advantage when you think about sort of prescriber inertia? Is it more so that just, I guess, getting drug to patients? How do you overcome some of the hurdles here just given kind of the time lines?

A: Troy Wilson and Brian Powl discussed physicians' focus on benefit-risk, patients' sophistication, and team readiness to overcome second mover advantage.

Q: I'd love to -- can you provide any sort of color in kind of what goes on in these joint launch meetings? How many people kind of what's the split between you and KK? Do you wait for the -- do you hit the ground running as soon as you get approval? Do you wait until next year?

A: Brian Powl responded that launch meetings bring field teams together for training and readiness, with teams ready to go close to potential approval.

Q: Just a quick one for me on the -- what the label could look like. I guess, is there any potential for the monitoring requirements, the differentiation syndrome to be different from other AML drugs?

A: Mollie Leoni responded that differentiation syndrome guidance is unchanged and monitoring requirements are not unexpectedly different for the patient population.

Q: I'm wondering based on your prelaunch work you and have been doing, could you maybe share some initial feedback from physicians on how they're efficacy and tolerability versus competitor inhibitors in the space, the IPM1 space?

A: Brian Powl responded that efficacy is table stakes, but safety, tolerability, combinability, and simplicity of once-daily dosing differentiate ziftomenib.

Q: Just curious, have you noticed or anticipate any changes in terms of cadence and discussions with the agency?

A: Troy Wilson responded that no differences have been noticed and they remain on track for the November 30 PDUFA date with open and constructive FDA interactions