On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported first quarter 2026 financial results and provided a corporate update.
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"In its first full quarter of commercial availability, KOMZIFTI generated $5.8 million in net revenue, with early launch dynamics indicating growing physician adoption and utilization patterns based on product profile. We believe these early signals support KOMZIFTI’s potential to become the leading therapy in relapsed/refractory NPM1-mutant AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Supported by a robust clinical development program designed to establish it as a broadly combinable backbone across the AML treatment continuum, and with multiple data readouts expected this year across frontline and combination settings, we are well positioned for the next phase of growth."
Recent Developments
KOMZIFTI Launch Performance (First Quarter 2026)
KOMZIFTI delivered a strong first full quarter of commercial performance, with early indicators supporting adoption and continued momentum:
$5.8 million in net product revenue in the first full quarter of commercial sales
85 new patient starts and 157 total prescriptions, reflective of both uptake and repeat use
> 93% payer coverage achieved, with favorable positioning across plans covering more than 12 million lives
Early market dynamics, including repeat prescribing, expanding use across treatment settings, initial combination use and instances of switching from other menin inhibitors, indicate growing physician adoption based on product profile.
Advancing Ziftomenib Across the Acute Myeloid Leukemia (AML) Treatment Continuum
Kura continues to execute on its strategy to establish ziftomenib as a broadly combinable backbone therapy across AML:
KOMET-017 (Phase 3 Frontline Program): Ongoing site activation and patient enrollment for both studies across global sites with strong early progress
KOMET-008 (FLT3 Relapsed/Refractory [R/R] Population): Ongoing enrollment evaluating ziftomenib combined with gilteritinib in patients with R/R AML harboring FLT3-ITD/NPM1 co-mutations
KOMET-007 (FLT3 Frontline Population): Ongoing enrollment 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
Japanese Registrational Trial: First patient dosed in Phase 2 trial (jRCT2031250550) for treatment of R/R NPM1-m AML, representing a significant step toward bringing a potential new treatment option to patients in Japan
Multiple clinical data readouts expected in 2026 across combination regimens and treatment settings, supporting ziftomenib’s potential use broadly across the AML landscape.
Solid Tumor Pipeline Progress
Kura continues to advance darlifarnib as a novel approach to overcoming resistance in targeted therapy:
Proof-of-mechanism data for darlifarnib in combination with cabozantinib: At the 2026 International Kidney Cancer Symposium: Europe (IKCS) conference, Kura presented proof-of-mechanism data for darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma previously treated with cabozantinib
The data support darlifarnib’s potential to overcome resistance and resensitize tumors to VEGF TKI therapy, with
44% objective response rate (ORR)
94% disease control rate (DCR)
Tumor shrinkage in 75% of patients
FIT-001 Phase 1b dose expansion: Enrollment is ongoing
2026 Commercial Priorities and Anticipated Development Milestones
Kura expects multiple value-driving catalysts in 2026 across commercial development and clinical development:
KOMZIFTI Commercial Execution
Drive clear differentiation within the menin inhibitor class
Deliver sustained quarter-over-quarter growth in revenue and adoption
Establish leading class share in R/R NPM1-m AML
Ziftomenib – Frontline AML
Present updated results for ziftomenib / 7+3 combination in frontline NPM1-m/KMT2A-r AML (KOMET-007) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in June 2026
Ziftomenib – Relapsed/Refractory AML
Publish data for ziftomenib plus venetoclax + azacitidine 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 Beyond AML
Continue enrollment of KOMET-015 evaluating ziftomenib + imatinib in gastrointestinal stromal tumors (GIST)
Progress preclinical development of next-generation menin inhibitor for use in other solid tumors
Darlifarnib
Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in May 2026
Present updated Phase 1a data with the first report of long-term 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 diabetes
First Quarter 2026 Financial Results
Net product revenue: $5.8 million, compared to none for Q1 2025
Collaboration revenue: $12.5 million, compared to $14.1 million for Q1 2025
R&D expenses: $65.3 million, compared to $56.0 million for Q1 2025, primarily driven by advancement of ziftomenib combination trials, including KOMET-017
SG&A expenses: $31.6 million, compared to $22.8 million for Q1 2025, reflecting commercialization-related investments
Net loss: $73.3 million, compared to $57.4 million for Q1 2025. Net loss includes $8.4 million in non-cash, share-based compensation expense compared to $7.8 million for the same period in 2025.
As of March 31, 2026, Kura had $580.8 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.
The Company believes its cash, cash equivalents and short-term investments as of March 31, 2026, when combined with $180 million in anticipated payments under the collaboration agreement with Kyowa Kirin, will be sufficient 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 4:30 p.m. ET / 1:30 p.m. PT today, May 12, 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 from the Investors section of the Company’s website at www.kuraoncology.com.
(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665544])