On August 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported second quarter 2026 financial results and provided a corporate update.
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"In only its second full quarter of launch, KOMZIFTI established early leadership in relapsed or refractory NPM1-mutant AML, achieving a majority share of new patient starts in the menin inhibitor class," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Increasing physician preference for KOMZIFTI, combined with outstanding commercial execution and encouraging frontline data, establish a strong foundation for ziftomenib as a potential market leader throughout the AML treatment continuum. In parallel, darlifarnib is emerging as a differentiated precision combination platform across multiple targeted therapies in major solid tumor indications. Together, these programs position Kura to build long-term value while advancing innovative therapies for patients with significant unmet need."
Recent Developments
KOMZIFTI Commercial Launch
Commercial highlights for the quarter included:
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$9.1 million in net product revenue, a 57% increase from 1Q 2026
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Approximately 115 new patient starts (NPS), a 35% increase from 1Q 2026
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More than 250 total prescriptions (TRx) in 2Q 2026, including repeat prescriptions, a 59% increase from 1Q 2026
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In its second full quarter on the market, KOMZIFTI achieved a majority share of new patient starts in the R/R NPM1-m AML menin inhibitor class
New patient starts are a key indicator of physician preference, future prescription growth, and overall market leadership. Additional indicators of KOMZIFTI’s commercial momentum included broader adoption across academic and community treatment centers, increasing repeat prescribing, and physician-directed use of KOMZIFTI in combination with established standards of care.
Advancing Ziftomenib Across the Broader AML Treatment Landscape
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EHA 2026
Long-term KOMET-007 data demonstrated high and durable clinical activity with 600 mg ziftomenib plus intensive chemotherapy (7+3) in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML, including:
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CRc rates of 96% and 90%, respectively
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12-month OS rates of 94% and 71%, respectively
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Deep MRD negativity, no new safety signals, and median overall survival not reached in either molecular subgroup
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Blood Publication (June 2026)
Updated KOMET-007 results demonstrated deep and durable responses with 600 mg ziftomenib plus venetoclax and azacitidine in R/R NPM1-m AML. Venetoclax-naïve patients achieved an 87% ORR and 70% CRc rate, with 75% of composite complete responders achieving central MRD negativity. Median duration of CRc was 9.2 months. Median OS in these patients was not reached after 10.7 months of follow-up. The regimen was generally well tolerated, with low rates of differentiation syndrome and QTc prolongation.
Together, these results support the potential of ziftomenib in combination with standard-of-care regimens, increasing confidence in the ongoing KOMET-017 frontline program.
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Registrational and Combination Programs
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Site activation and patient enrollment across KOMET-017 frontline registrational studies for intensive and non-intensive chemotherapy eligible patients ongoing
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Enrollment in KOMET-008 evaluating ziftomenib plus gilteritinib in patients with R/R FLT3-ITD/NPM1 co-mutated AML continues
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Enrollment in the KOMET-007 cohort evaluating ziftomenib plus quizartinib and intensive chemotherapy in patients with newly diagnosed FLT3/NPM1 co-mutated AML ongoing
Advancing Darlifarnib as a Precision Combination Platform Across Solid Tumors
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KRAS G12C-mutated Solid Tumors (ASCO 2026)
First-in-human Phase 1 FIT-001 data evaluating darlifarnib plus adagrasib provided clinical proof of mechanism, including tumor shrinkage in 77% of response-evaluable patients and confirmed ORRs of:
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67% in pancreatic cancer
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50% in non-small cell lung cancer
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29% in KRAS inhibitor-naïve colorectal cancer
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Cabozantinib-naïve Clear Cell Renal Cell Carcinoma (KCRS 2026)
Updated Phase 1 FIT-001 results demonstrated encouraging and durable clinical activity with darlifarnib plus cabozantinib, with ORRs of up to 50% across dose levels and an mPFS of 13 months.
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Cabozantinib-exposed Clear Cell Renal Cell Carcinoma (IKCS 2026)
Phase 1 FIT-001 data demonstrated darlifarnib’s potential to overcome resistance to VEGFR-targeted therapy. Despite prior cabozantinib exposure, patients on the combination of darlifarnib plus cabozantinib, across multiple dose levels of each, achieved a:
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44% ORR
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94% disease control rate (DCR)
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Tumor shrinkage in 75% of patients
Collectively, these data continue to support darlifarnib’s potential as a precision combination platform capable of enhancing multiple targeted therapy classes while creating opportunities for future development opportunities, potential strategic collaborations and multiple registrational paths.
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FIT-001 Phase 1b Dose Expansion
Enrollment continues in the global, randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib versus cabozantinib alone to establish the recommended Phase 3 dose in patients with cabozantinib-naïve ccRCC.
Anticipated Milestones: Commercial and Development Priorities
Kura expects multiple commercial and clinical catalysts over the next 12 to 18 months.
KOMZIFTI 2026 Commercial Execution
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Expand physician adoption across academic and community treatment centers
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Increase repeat prescribing and broaden physician adoption
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Deliver sustained quarter-over-quarter growth
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Strengthen leadership within R/R NPM1-m AML menin inhibitor market
Building on Emerging Leadership Across the AML Treatment Continuum
Kura’s strategy is to build on KOMZIFTI’s early commercial success by moving ziftomenib into earlier lines of therapy, combining it with multiple standards of care and expanding its use across genetically defined AML populations.
Key near-term milestones include anticipated presentation of:
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Updated long-term KOMET-007 Phase 1b data evaluating ziftomenib with venetoclax and azacitidine in newly diagnosed, intensive chemotherapy-ineligible NPM1-m AML patients, including durability, survival, and MRD outcomes – 2H 2026
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Initial data from the KOMET-007 Phase 1b study evaluating ziftomenib with 7+3 intensive chemotherapy and quizartinib in patients with newly diagnosed NPM1-m/ FLT3-ITD AML– 2H 2026
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Initial KOMET-008 data evaluating ziftomenib with gilteritinib in patients with R/R NPM1-m/FLT3-m AML, including activity in patients previously treated with FLT3 inhibitors– 2H 2026
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An exploratory analysis from the KOMET-001 study evaluating ziftomenib monotherapy activity in molecularly defined, MEIS1-associated AML subtypes beyond NPM1-m and KMT2A-r disease – 2H 2026
Ziftomenib and Menin Inhibition – Expansion Beyond AML
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Continue enrollment of KOMET-015 study evaluating ziftomenib plus imatinib in patients with gastrointestinal stromal tumors
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Progress preclinical development of next-generation menin inhibitor for use in other solid tumors
KO-7246 (Next-Generation Menin Inhibitor)
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Advance KO-7246, a next-generation menin inhibitor specifically designed for use in diabetes and cardiometabolic disease, into IND-enabling studies
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Present additional scientific data characterizing menin inhibitors in preclinical models of diabetes
Darlifarnib – Precision Combination Platform in Solid Tumors
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Complete enrollment in the randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naïve ccRCC in 1H 2027 and report initial clinical data in 2H 2027
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Initiate a platform study of darlifarnib plus daraxonrasib in patients with KRAS-mutant 2L+ PDAC in 1H 2027
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Advance darlifarnib as a precision combination platform across additional targeted therapy classes
Second Quarter 2026 Financial Results
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Net product revenue: $9.1 million, compared to none for 2Q 2025
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Collaboration revenue: $11.8 million, compared to $15.3 million for 2Q 2025
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R&D expenses: $61.9 million, compared to $62.8 million for 2Q 2025
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SG&A expenses: $31.8 million, compared to $25.2 million for 2Q 2025
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Net loss: $68.3 million, compared to $66.1 million for 2Q 2025. Net loss includes $8.2 million in non-cash, share-based compensation expense compared to $6.9 million for the same period in 2025.
As of June 30, 2026, Kura had $519.0 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.
Combined with $180 million in anticipated collaboration payments from Kyowa Kirin, the Company believes its current cash resources will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 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, August 12, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available on the Investors section of the Company’s website at www.kuraoncology.com.
(Press release, Kura Oncology, AUG 12, 2026, View Source [SID1234670006])