Kura Oncology, Inc. Q4 FY2025 earnings call

2025 was a crucial year for Kura Oncology, with FDA approval of Comzifty and the start of its commercial launch. Comzifty had a strong start to its launch, generating $2.1 million in net product revenue in the final weeks of 2025, and feedback from physicians, pharmacists, and payers has been positive regarding its efficacy, safety, simplicity, and combinability. The company is focused on executing commercially, moving into frontline AML and combinations, and building leadership in menin inhibition while advancing its pipeline. Comzifty is listed in the FDA's Orange Book with patent protection through July 2044. Enrollment is ongoing in the COMET - 017 frontline trials. In solid tumors, ziftomenib combination with imatinib in GIST is in dose escalation, and darlafarnib is advancing in combinations. Comzifty's market access has been strong, with rapid coverage by payers and some payers implementing step editing based on Comzifty's differentiation

Comzifty generated $2.1 million in net product revenue in the final weeks of 2025. Collaboration revenue from the Kyowa Kirin partnership was $15.2 million in 2025, while it was $53.9 million in the same period of 2024. Research and development expenses were $64.4 million in 2025 compared to $52.3 million in 2024. Sales, general and administrative expenses were $39.1 million in 2025 versus $24.1 million in 2024. The net loss in 2025 was $81 million, differing from the $19.2 million net loss in 2024. As of 12/31/2025, cash, cash equivalents, and short - term investments stood at $667.2 million. Collaboration revenue guidance for 2026 is $45 million to $55 million, for 2027 it's $90 million to $110 million, and for 2028 it's also $90 million to $110 million

Collaboration revenue is expected to be $45 - $55 million in 2026, $90 - $110 million in 2027, and $90 - $110 million in 2028. Current cash, cash equivalents, short - term investments, and anticipated milestones under the collaboration agreement with Kyowa Kirin are expected to fund the ziftomenib AML program through the first top - line Phase 3 results from COMET - 017 in 2028

Q: Li Watsek inquired about the percentage of payers that have implemented the step - through policy and payer feedback.

A: Brian T. Powl stated that some payers have implemented step editing where patients are recommended to receive Comzifty before other menin inhibitors, based on an IPD Analytics report, driven by Comzifty's differentiation pillars like efficacy, safety, simplicity, and cost predictability.

Q: Roger Song asked about patient demand side versus revenue generation.

A: Brian T. Powl said the launch has been off to a strong start with strong patient demand and they expect to see more data on new patient starts in the future.

Q: Albert Augustines asked about the biggest hurdle for Comzifty to gain market share.

A: Brian T. Powl said it's getting incident patients onto therapy, and Troy Wilson added on the importance of combinations in driving market leadership.

Q: Salim Syed asked about the market feedback regarding the 50% share.

A: Brian T. Powl said feedback on Comzifty's profile as preferred in terms of efficacy, safety, simplicity, combinability, and compatibility with other agents.

Q: Reni Benjamin asked about the importance of FLT3 data.

A: Mollie Leoni and Troy Wilson talked about the need for safety in FLT3 combinations and improving outcomes compared to agents in isolation.

Q: Charles Yu asked about RCC data.

A: Mollie Leoni talked about the Phase 1b study and the mechanism of action of darlafarnib.

Q: Jason Eron Zemansky asked about early prescriber feedback.

A: Brian T. Powl said efficacy is table stakes, and simplicity and dose modification are key factors.

Q: Gustav asked about COMET - 008 and other combinations.

A: Mollie Leoni said they are guiding to release gilteritinib data and are also working on FLAG - IDA and LDAC combinations.

Q: Philip Nadeau asked about menin class penetration.

A: Brian T. Powl said the ramp will be based on incident patients, starting in the third/fourth line but seeing second - line use too.

Q: David Dai asked about duration of therapy.

A: Brian T. Powl said it's early days, with an expectation of average six months of therapy, and combinations expected to give longer duration