Kura Oncology (NASDAQ:KURA) reported third-quarter 2026 net product revenue of $13.9 million for leukemia treatment KOMZIFTI, up 53% from the prior quarter, as the company expanded prescribing accounts and prepared clinical data on combinations with other therapies.
Management also said it had reached alignment with the Food and Drug Administration on a potential path to full approval for darlifarnib in a rare form of salivary gland cancer. Kura plans to begin a single-arm study in the first half of 2027.
“Our priority is to grow our leadership in this setting while building the clinical evidence to support expansion into earlier treatment settings and combinations,” President and CEO Troy Wilson said on the earnings call.
KOMZIFTI Prescriptions and Accounts Grow
KOMZIFTI, also known as ziftomenib, is marketed for relapsed or refractory NPM1-mutated acute myeloid leukemia, or AML. Kura recorded approximately 150 new patient starts in the quarter, up about 30% sequentially, and more than 420 total prescriptions, up 65%.
Chief Commercial Officer Brian Powl said the faster growth in total prescriptions reflected a larger contribution from refills as the treated patient base expanded. A total of 170 accounts had prescribed the drug, up 40% from the prior quarter, he said.
Kura maintained a majority share of menin inhibitor new patient starts in the approved patient population, according to management. Powl estimated that just under half of eligible patients were receiving a menin inhibitor.
In an available claims dataset, nearly half of KOMZIFTI patients received it alongside other approved agents, primarily venetoclax and azacitidine or FLT3 inhibitors, Powl said. He noted that Kura’s commercial teams promote the drug only for its approved indication.
Asked about treatment duration, Powl said the data were not yet mature enough for a full assessment. The company continues to guide to approximately six months of treatment, he said.
Combination Data and Frontline Study Ahead
Kura plans to present eight ziftomenib abstracts, including four oral presentations, at the upcoming American Society of Hematology meeting. Chief Medical Officer Mollie Leoni said the presentations will include the company’s first clinical data combining ziftomenib with two FLT3 inhibitors.
Leoni characterized results from the frontline KOMET-007 study of ziftomenib, quizartinib and intensive chemotherapy as encouraging. She also said the KOMET-008 study of ziftomenib plus gilteritinib showed encouraging activity and tolerability in relapsed or refractory patients, including those previously treated with an FLT3 inhibitor. The call did not provide numerical results for those combinations.
The company said its phase 3 KOMET-017 frontline program remains on track, with most global sites activated and enrollment progressing as planned. Kura expects the first top-line results from the intensive chemotherapy trial in 2028.
Darlifarnib Registration Strategy
For darlifarnib, Kura plans to submit an investigational new drug application by the end of 2026 and start a study of approximately 40 patients with HRAS-mutant salivary gland cancer in the first half of 2027.
Wilson said the FDA was aligned on a path to full approval based on the study. Leoni attributed the approach in part to the small patient population, unmet need and previously observed durable responses. Approval would depend on the study and regulatory review.
Kura is also evaluating darlifarnib with cabozantinib in renal cell carcinoma, with enrollment expected to finish in the first half of 2027 and initial data in the second half. A pancreatic cancer combination study with daraxonrasib is expected to begin dosing patients in the first half of 2027, with potential preliminary data later that year.
Financing and Financial Results
Kura ended September with $492 million in cash, cash equivalents and short-term investments. Chief Financial Officer Jennifer Fulk said a financing agreement with Oberland Capital provides up to $300 million in potential funding. At closing, Kura received $50 million in debt funding and a $5 million equity investment; additional funding is subject to conditions.
The agreement includes a capped single-digit royalty tied to U.S. KOMZIFTI net sales, Fulk said. The debt has a seven-year term, with principal due at maturity.
The company reported a quarterly net loss of $70.2 million, down 5% from a year earlier. Research and development expenses fell 2% to $67 million, while selling, general and administrative expenses declined 8% to $30.2 million.
Kura updated its 2026 collaboration revenue guidance to $40 million to $45 million and maintained guidance of $90 million to $110 million for each of 2027 and 2028. Fulk said the guidance reflects non-cash accounting recognition rather than the timing of cash receipts.
She said September cash resources, subsequent financing proceeds and approximately $180 million in anticipated payments from partner Kyowa Kirin are expected to fund the current operating plan beyond the initial ziftomenib top-line results expected in 2028.
About Kura Oncology (NASDAQ:KURA)
Kura Oncology is a biopharmaceutical company focused on developing precision medicines for cancer. Its research has centered on therapies that target molecular pathways involved in tumor growth and blood cancers. The company’s best-known program is ziftomenib, an oral menin inhibitor developed for acute myeloid leukemia, including forms associated with NPM1 mutations or KMT2A rearrangements. Kura has also worked on other targeted cancer therapies. Based in San Diego, California, Kura conducts drug development and clinical research in the United States and has worked with international partners to advance its programs.
