On March 5, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported fourth quarter and full year 2025 financial results and provided a corporate update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are encouraged by the early launch trajectory of KOMZIFTI and the positive feedback from physicians, pharmacists and payers on its differentiated clinical profile," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With a compelling combination of efficacy, safety, compatibility, and simplicity, we believe KOMZIFTI is well positioned to lead in R/R NPM1-mutated AML. In 2026, we expect multiple clinical milestones in the combination and frontline settings that could significantly broaden the opportunity for ziftomenib across the AML treatment continuum. In addition, our solid tumor programs, including ziftomenib in gastrointestinal tumors and darlifarnib in both renal cell carcinoma and KRASG12C-mutated solid tumors, continue to advance, representing a potential addressable population of more than 200,000 patients. Importantly, our strong balance sheet, bolstered by anticipated collaboration milestones, provides the capital required to reach key value-inflecting frontline Phase 3 data and advance our next wave of novel therapies."
2025 Highlights and Recent Developments
KOMZIFTI Commercial Launch
Granted full approval by the U.S Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutant (NPM1-m) AML.
Generated $2.1 million in net product revenue in the fourth quarter of 2025, based on approximately five weeks of commercial sales following November 13 approval.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 2A recommended treatment option for adults with R/R NPM1-m AML.
Delivered product in channel within five business days of FDA approval, triggering a $135 million milestone payment from Kyowa Kirin.
Received rapid payer coverage within the first 90 days – approximately 80% of private payers had established published coverage policies, all aligned with the label with no additional restrictions.
Added to the FDA Orange Book, with listed patents extending up to July 2044, which support long-term market exclusivity in the United States.
Advancing Ziftomenib Across the AML Treatment Continuum
Initiated pivotal KOMET-017 Phase 3 frontline trials evaluating ziftomenib in combination with intensive and non-intensive chemotherapy in patients with NPM1-m or KMT2A-rearranged (KMT2A-r) AML in the frontline setting. Received two $30 million milestone payments from Kyowa Kirin in connection with first patient dosing in each of the two Phase 3 trials.
Presented positive Phase 1a/1b KOMET-007 (NCT05735184) data at ASH (Free ASH Whitepaper) 2025 demonstrating a favorable safety profile and encouraging antileukemic activity for ziftomenib in combination with venetoclax and azacitidine (ven/aza) in newly diagnosed NPM1-m AML as well as patients with R/R NPM1-m or KMT2A-r AML.
Dosed the first patient in the FLT3 inhibitor cohort of KOMET-007 trial evaluating ziftomenib combined with quizartinib plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1 co-mutations.
Solid Tumor Pipeline Progress
Initiated Phase 1b dose expansion in the FIT-001 trial evaluating darlifarnib plus cabozantinib in advanced renal cell carcinoma (RCC).
Presented preclinical and preliminary clinical data at ESMO (Free ESMO Whitepaper) 2025 highlighting the potential of darlifarnib to enhance the anti-tumor activity of PI3Kα inhibitors, KRAS inhibitors, and antiangiogenic tyrosine kinase inhibitors across multiple solid tumor indications.
2026 Strategic Priorities and Anticipated Milestones
Kura expects 2026 to be a data-rich year with multiple potential value inflection points:
KOMZIFTI Commercial Execution
Establish clear differentiation in the menin inhibitor class
Deliver strong quarter-over-quarter growth in revenue and adoption
Achieve leading class share in R/R NPM1-m AML setting
Ziftomenib – Development in Frontline AML
Continue enrollment in the pivotal KOMET-017 Phase 3 trials
Present updated KOMET-007 data for ziftomenib plus 7+3 in frontline NPM1-m/KMT2A-r AML (1H 2026)
Advance enrollment of KOMET-007 cohort for ziftomenib, quizartinib, and 7+3 quadruplet combination in frontline NPM1-m/FLT3-ITD AML
Ziftomenib – Development in R/R AML
Publish data for ziftomenib plus ven/aza in R/R NPM1-m AML (1H 2026)
Present preliminary KOMET-008 data for ziftomenib and gilteritinib combination in R/R NPM1-m/FLT3-m AML (2H 2026)
Ziftomenib and Menin Inhibition – Expansion into Solid Tumors
Advance enrollment of KOMET-015 for ziftomenib and imatinib combination in gastrointestinal stromal tumors (GIST)
Progress preclinical development of a next-generation menin inhibitor for use in combination therapy for solid tumors
Darlifarnib
Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors (1H 2026)
Present updated Phase 1a data with ~ 1 year of additional follow-up for darlifarnib plus cabozantinib in advanced RCC (2H 2026)
KO-7246 (Next-Generation Menin Inhibitor)
Advance KO-7246 into IND-enabling studies for diabetes and cardiometabolic disease
Present additional preclinical data for menin inhibitors in Type 1 and Type 2 diabetes
Fourth Quarter 2025 Financial Results
Net product revenue: $2.1 million (first five weeks of commercial sales following November 13 approval of KOMZIFTI).
Collaboration revenue: $15.2 million, compared to $53.9 million for Q4 2024, reflecting non-cash revenue recognition under the collaboration agreement with Kyowa Kirin.
R&D expenses: $64.4 million, compared to $52.3 million for Q4 2024, primarily driven by advancement of ziftomenib combination trials, including KOMET-017.
SG&A expenses: $39.1 million, compared to $24.1 million for Q4 2024, reflecting commercialization-related investments.
Net loss: $81.0 million, compared to $19.2 million for Q4 2024. Net loss includes $11.3 million in non-cash, share-based compensation expense, compared to $8.6 million for the same period in 2024.
As of December 31, 2025, Kura had $667.2 million in cash, cash equivalents and short-term investments, compared to $727.4 million as of December 31, 2024.
The Company believes that its cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund its current operating plan into the fourth quarter of 2027. When combined with the anticipated $180 million in payments under the collaboration agreement with Kyowa Kirin, these resources are expected to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028.
Conference Call and Webcast
Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, March 5, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available here or online from the Investors section of the Company’s website at www.kuraoncology.com.
(Press release, Kura Oncology, MAR 5, 2026, View Source [SID1234663300])