Kura Oncology (NASDAQ:KURA) executives used the company’s fourth-quarter and fiscal 2025 earnings call to highlight what CEO Troy Wilson called a “defining year,” driven by the FDA approval of Komzifti and the start of its U.S. commercial launch. Management said early prescription trends and market access have exceeded internal expectations, while the company advances a broad development plan aimed at expanding ziftomenib (Komzifti) across the acute myeloid leukemia (AML) treatment continuum and building a second oncology platform around its farnesyl transferase inhibitor (FTI) program.
Early Komzifti launch and differentiation message
Wilson said Komzifti generated $2.1 million in net product revenue in the “final weeks of 2025,” describing initial feedback from physicians, pharmacists, and payers as consistent around efficacy, safety, simplicity, and “combinability with concomitant medications.” He also noted Komzifti is listed in the FDA’s Orange Book with patent protection through July 2044, which he said strengthens the long-term value of the franchise as Kura expands into frontline AML and combinations.
Powell added that Komzifti was added to NCCN guidelines as a Category 2A recommendation within a week of Kura’s submission, which he said reflected enthusiasm among clinical thought leaders. Operationally, he said the product was shipped within days of approval, and Kura—alongside partner Kyowa Kirin—is targeting more than 4,000 hematology professionals with an experienced sales force.
Payer access, coverage, and “step edit” discussion
Market access was a prominent topic in both prepared remarks and Q&A. Powell said Kura engaged payers covering approximately 90% of insured lives prior to approval, and within 90 days about 84% of private payers had established coverage aligned with the label and without additional restrictions. He said the speed of coverage exceeded industry benchmarks and Kura’s expectations, and he pointed to KuraConnect performance showing an average of two days from prescription to payer decision.
In response to analyst questions, Powell discussed what he characterized as an uncommon oncology development: certain “blue plans” requiring patients to go on Komzifti before allowing coverage for another approved menin inhibitor. He said Kura’s understanding is that a report from IPD Analytics recommended a step edit for adult R/R NPM1-mutant AML patients, and that a handful of payers have begun implementing it. Powell said IPD’s analysis emphasized Komzifti’s differentiation pillars and “predictability of the cost,” citing IPD’s assessment of annual wholesale acquisition cost (WAC) of just under $600,000 for Komzifti versus “almost $1 million a year” for a competing menin inhibitor due to different dosing schemas and SKUs. Powell said Kura could not quantify how many plans may adopt similar policies in the future, but called the development encouraging.
Strategy: move ziftomenib earlier and expand combinations
Chief Medical Officer Mollie Leoni said the FDA approval in R/R NPM1-mutant AML is “just the beginning,” and outlined a strategy to make ziftomenib a “foundational therapy across AML,” including earlier lines of treatment. She cited high relapse rates in AML and said Kura believes deeper, more durable outcomes require moving effective therapies earlier.
Leoni said enrollment is underway in the registrational KOMET-017 program in newly diagnosed AML, recruiting at approximately 200 global sites. She said KOMET-017 includes two independently powered trials—intensive and non-intensive chemotherapy backbones—designed to support potential U.S. accelerated approval and full approval. She also pointed to phase 1 KOMET-007 data in newly diagnosed patients treated with 7+3 or venetoclax plus ziftomenib, describing high complete remission rates and deep MRD negativity, and said ziftomenib did not meaningfully delay platelet or neutrophil recovery in either combination. Updated intensive chemotherapy data from KOMET-007 are expected in the first half of 2026.
In R/R disease, Leoni said Kura is preparing a manuscript detailing ziftomenib combined with venetoclax in R/R NPM1-mutant AML. She referenced data presented in December showing the combination was generally well-tolerated without additive toxicity and improved overall response rate, composite complete remission rate, and overall survival relative to ziftomenib alone.
FLT3 co-mutations were repeatedly framed as a key expansion opportunity. Leoni said Kura is evaluating ziftomenib with gilteritinib in the R/R setting and with quizartinib in the frontline setting, arguing that demonstrating safe combination with FLT3 inhibitors could be a differentiator. She said Kura expects to present R/R gilteritinib combination data toward the end of the year, including dose escalation and expansion. In Q&A, she also said KOMET-008 includes additional cohorts evaluating combinations with FLAG-IDA and low-dose cytarabine (LDAC), though Kura has not guided on timing for releasing those data.
Pipeline beyond AML and financial results
Outside AML, Leoni said KOMET-015 is evaluating ziftomenib with cabozantinib in advanced gastrointestinal stromal tumor (GIST). She said dose escalation is continuing without dose-limiting toxicities across a broad range of doses, and the company plans to provide an update “when appropriate.”
On the FTI platform, Leoni announced initiation of the phase 1B dose expansion portion of FIT-001 combining darlifarnib with cabozantinib in advanced renal cell carcinoma. She said the phase 1B portion includes a three-arm randomization in line with Project Optimus, including a cabozantinib monotherapy control arm, and will evaluate the combination in patients not responding to or beginning to fail cabozantinib therapy. Updated data from phase 1A dose escalation are expected in the second half of the year. She also said Kura plans to present preliminary data from a phase 1A study of darlifarnib with adagrasib in KRAS G12C-mutated lung, colorectal, and pancreatic cancers in the first half of 2026.
On the financials, Senior Vice President of Finance and Accounting Tom Doyle reiterated that fourth-quarter 2025 net product revenue from Komzifti was $2.1 million versus none in the year-ago quarter. The first commercial sale triggered a $135 million milestone payment under Kura’s collaboration with Kyowa Kirin. Collaboration revenue was $15.2 million versus $53.9 million in the same period of 2024.
- R&D expenses: $64.4 million (vs. $52.3 million), driven by ziftomenib combination trials and enrollment start in KOMET-017
- SG&A expenses: $39.1 million (vs. $24.1 million), driven by the Komzifti launch
- Net loss: $81.0 million (vs. $19.2 million), including $11.3 million of non-cash share-based compensation
- Cash, equivalents, and short-term investments: $667.2 million at Dec. 31, 2025 (vs. $727.4 million at Dec. 31, 2024)
Doyle said Kura’s year-end 2025 cash balance reflected fourth-quarter receipts of $195 million tied to the first commercial sale of Komzifti and KOMET-017 enrollment milestone payments. The company guided for collaboration revenue (non-cash accounting recognition) of $45 million to $55 million in 2026, $90 million to $110 million in 2027, and $90 million to $110 million in 2028. He also said Kura’s current cash, together with anticipated $180 million in milestones under the Kyowa Kirin agreement, is expected to fund the ziftomenib AML program through the first top-line phase 3 results from KOMET-017 anticipated in 2028.
Closing the call, Wilson said Kura’s 2026 priorities include accelerating uptake of Komzifti in R/R NPM1-mutant AML, delivering quarter-over-quarter product revenue growth, executing its “first-to-frontline” strategy, publishing combination data to guide treatment decisions, and providing clinical updates across the FTI platform.
About Kura Oncology (NASDAQ:KURA)
Kura Oncology, Inc (NASDAQ: KURA) is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted oncology therapies. Headquartered in La Jolla, California, the company leverages expertise in molecular biology and precision medicine to identify key drivers of cancer growth and design small-molecule inhibitors that block those pathways. Kura’s research platform integrates genomic insights with medicinal chemistry to advance candidates against well-validated targets in solid tumors and hematologic malignancies.
The company’s lead clinical candidate, tipifarnib, is a farnesyltransferase inhibitor being evaluated for the treatment of HRAS-mutant head and neck squamous cell carcinoma and various non-small cell lung cancers.
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