Kura Oncology (NASDAQ:KURA) reported $5.8 million in first-quarter net product revenue from KOMZIFTI, its first commercial product, and said the launch is showing early signs of physician uptake, broad payer coverage and use in combination regimens, according to management’s earnings call for the first quarter of 2026.
President and Chief Executive Officer Dr. Troy Wilson described the company as being “at an inflection point,” citing the commercial launch, phase III programs that he said are ahead of plan and an expected flow of clinical data over the next 12 to 24 months. Wilson said KOMZIFTI’s first full quarter of launch came in ahead of company expectations, with revenue supported by repeat prescriptions, use across treatment centers and what the company described as early instances of physicians switching patients from other menin inhibitors.
“This is not just a class story anymore,” Wilson said. “Physicians are starting to differentiate based on product profile, and we believe KOMZIFTI is standing out.”
KOMZIFTI launch generates $5.8 million in first full quarter
Chief Commercial Officer Brian Powl said Kura recorded 85 new patient starts and nearly 160 total prescriptions during the quarter. Patients were treated across approximately 60 activated accounts, including ziftomenib trial sites, centers with prior menin inhibitor experience and accounts new to the class.
Powl said the company is focused on establishing relapsed or refractory NPM1-mutant acute myeloid leukemia as a $350 million to $400 million market opportunity. He said Kura’s early launch strategy is centered on broad awareness of KOMZIFTI’s profile, consistent quarter-over-quarter growth and expansion within the approved setting.
Management said approximately 40% of patients were receiving KOMZIFTI in combination, based on early data, including with venetoclax and azacitidine or, in FLT3 co-mutated patients, with gilteritinib. Powl emphasized that the company’s commercial teams promote KOMZIFTI only as an approved monotherapy, and that the combination use reflects physician discretion.
On the question of treatment duration, Powl said it is too early to draw conclusions after one full quarter, but reiterated Kura’s expectation of approximately six months of treatment. He said the company will need additional quarters to better understand duration, particularly among patients receiving combination therapy. Wilson said there was no meaningful inventory stocking reflected in first-quarter revenue.
Access and payer coverage show early traction
Powl said Kura has secured coverage at parity or better for more than 93% of covered lives, with no label restrictions. He also said more than 10 plans representing more than 12 million lives have placed KOMZIFTI in a favorable policy position.
Time from prescription to patient receipt is approximately three days, Powl said. He added that feedback from physicians, pharmacists and nurses has highlighted KOMZIFTI’s once-daily dosing and convenience, which management said may be important in real-world treatment decisions when monotherapy efficacy is viewed as similar.
During the question-and-answer portion of the call, Tom Doyle, senior vice president of finance and accounting, said gross-to-net dynamics were within normal ranges, in the 20% to 30% range. Wilson said prescriptions referenced on the call were one-month scripts.
Clinical pipeline updates focus on AML combinations
Chief Medical Officer Dr. Mollie Leoni said Kura expects a continued cadence of data in 2026 for ziftomenib and darlifarnib. The company’s ziftomenib strategy is to establish the drug as a broadly combinable backbone therapy across the AML treatment landscape.
At the European Hematology Association meeting in June, Kura plans to present updated data from ziftomenib in combination with 7+3 chemotherapy in newly diagnosed NPM1-mutant and KMT2A-rearranged AML. Leoni said the update will include extended follow-up with a median of approximately 16 months, including treatment course and response durability.
Kura also expects to publish data on ziftomenib with venetoclax and azacitidine in relapsed or refractory NPM1-mutant AML. Leoni referenced prior ASH 2025 data showing a 70% composite complete remission rate in patients without prior venetoclax exposure. The company also expects preliminary data in the second half of the year from ziftomenib with gilteritinib in relapsed or refractory NPM1-mutant, FLT3-mutated AML.
Leoni said the company’s KOMET-017 frontline program, which uses a “one-stop-shop” design to enroll patients into two independent phase III trials at each activated site, is ahead of projections. She cited strong participation from leading academic centers in the U.S., Europe and Asia. Wilson said Kura continues to guide to initial top-line results from the intensive chemotherapy combination portion of KOMET-017 in 2028.
Darlifarnib data expected at ASCO
Beyond AML, Leoni said Kura continues to evaluate ziftomenib plus imatinib in gastrointestinal stromal tumors and is exploring menin inhibition in other solid tumors.
For darlifarnib, Leoni said recent data in cabozantinib-pretreated clear cell renal cell carcinoma supported the drug’s mechanism and its potential to restore sensitivity to targeted therapies through the RAS/mTORC1 resistance pathway. Enrollment is underway in the phase Ib portion of a darlifarnib plus cabozantinib trial, and Kura plans to provide an update on the full phase Ia data set later this year.
At ASCO, the company plans to present preliminary data evaluating darlifarnib with adagrasib in KRAS G12C-mutated solid tumors. Leoni said the data will include dose escalation results across multiple tumor types, including non-small cell lung cancer, pancreatic ductal adenocarcinoma and colorectal cancer.
Quarterly loss widens as launch and trials advance
Kura reported collaboration revenue of $12.5 million from its Kyowa Kirin partnership, compared with $14.1 million in the prior-year quarter. Research and development expenses rose to $65.3 million from $56 million, which Doyle attributed to ziftomenib combination trials and enrollment in KOMET-017. Selling, general and administrative expenses increased to $31.6 million from $22.8 million, driven by the KOMZIFTI launch.
The company posted a first-quarter net loss of $73.3 million, compared with a net loss of $57.4 million a year earlier. The latest quarter included $8.4 million of non-cash share-based compensation expense.
As of March 31, 2026, Kura had $580.8 million in cash, cash equivalents and short-term investments, down from $667.2 million at the end of 2025. Doyle said Kura is maintaining its collaboration revenue guidance of $45 million to $55 million for 2026, $90 million to $110 million for 2027 and $90 million to $110 million for 2028. He said current cash and investments, together with anticipated $180 million in payments under the Kyowa Kirin collaboration, are expected to fund the ziftomenib AML program through the first top-line phase III results from KOMET-017, anticipated in 2028.
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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