Kura Oncology Reports First Quarter 2026 Financial Results
Rhea-AI Summary
Kura Oncology (Nasdaq: KURA) reported first quarter 2026 results and launch metrics for AML drug KOMZIFTI (ziftomenib). Net product revenue reached $5.8 million with 85 new patient starts, 157 total prescriptions and >93% payer coverage across >12 million lives.
Total collaboration revenue was $12.5 million. Kura reported a net loss of $73.3 million, driven by higher R&D and SG&A expenses. Cash, cash equivalents and short-term investments totaled $580.8 million, and together with $180 million anticipated collaboration payments, are expected to fund the ziftomenib AML program through first KOMET-017 Phase 3 topline results, anticipated in 2028.
AI-generated analysis. Not financial advice.
Positive
- First full-quarter KOMZIFTI net product revenue of $5.8 million
- 85 new patient starts and 157 total prescriptions for KOMZIFTI in Q1 2026
- Payer coverage >93% across plans covering more than 12 million lives
- Collaboration revenue of $12.5 million in Q1 2026
- Cash and investments of $580.8 million as of March 31, 2026
- $180 million anticipated collaboration payments expected to extend funding through 2028 Phase 3 topline readout
- Proof-of-mechanism darlifarnib data showing 44% ORR and 94% DCR in RCC
Negative
- Net loss widened to $73.3 million from $57.4 million year over year
- R&D expenses increased to $65.3 million from $56.0 million year over year
- SG&A expenses rose to $31.6 million from $22.8 million year over year
- Collaboration revenue declined to $12.5 million from $14.1 million year over year
- Cash, cash equivalents and short-term investments decreased to $580.8 million from $667.2 million at year-end 2025
News Market Reaction – KURA
On the day this news was published, KURA declined 2.07%, reflecting a moderate negative market reaction. Argus tracked a trough of -11.4% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $19M from the company's valuation, bringing the market cap to $882.30M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed, mostly muted moves (e.g., AVBP -2.17%, TNGX +1.21%, DAWN +0.14%, GERN 0%, SANA -0.28%), suggesting stock-specific focus on KURA.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 05 | Q4 2025 results | Positive | -0.5% | Reported Q4/FY25, first KOMZIFTI revenue and strong cash to fund KOMET-017. |
| Nov 04 | Q3 2025 results | Positive | +1.9% | Priority Review for ziftomenib, KOMET-017 dosing and solid pro forma cash. |
| Aug 07 | Q2 2025 results | Positive | -7.0% | Priority Review, positive KOMET-001 data and collaboration revenue with net loss. |
| May 01 | Q1 2025 results | Positive | -0.3% | First NDA submission for ziftomenib and $45M milestone with strong cash. |
| Feb 26 | FY 2024 results | Positive | -1.5% | KOMET-001 success, planned NDA, higher R&D and strong year-end cash. |
Earnings-related releases have often been positive on fundamentals but followed by modestly negative price reactions, with 4 of 5 past earnings moves down despite constructive updates.
Over the last five earnings releases, Kura highlighted steady progress for ziftomenib and solid cash resources. Milestones included NDA submission in Q1 2025, FDA approval and first KOMZIFTI revenue by Q4 2025, and ongoing Priority Review and Phase 3 initiation in 2025. Collaboration payments and cash balances (e.g., $667.2M at 2025 year-end) repeatedly supported funding through anticipated KOMET‑017 topline results in 2028. Historically, shares often moved modestly lower on these earnings updates.
Historical Comparison
Past 5 earnings-related releases for KURA saw an average move of about -1.49%. Today’s pre-news gain of +0.96% sits slightly above that pattern, implying a less negative setup versus prior earnings days.
Earnings updates have tracked ziftomenib’s path from registrational success and NDA submission in 2024–2025, through FDA approval and initial KOMZIFTI revenue in late 2025, to today’s first full commercial quarter and continued Phase 3 execution.
Market Pulse Summary
This announcement details Kura’s first full quarter of KOMZIFTI commercialization, generating $5.8M in net product revenue, alongside $12.5M in collaboration revenue and a Q1 2026 net loss of $73.3M. The company reported $580.8M in cash plus $180M in anticipated collaboration payments to support the ziftomenib AML program through expected Phase 3 topline in 2028. Multiple 2026 data readouts and solid tumor updates are key milestones to watch from here.
Key Terms
objective response rate medical
disease control rate medical
phase 3 medical
phase 2 medical
phase 1b medical
relapsed/refractory medical
vegf tki medical
ind-enabling studies regulatory
AI-generated analysis. Not financial advice.
–
– Robust new patient starts and early launch dynamics, including repeat use, switching and combination adoption, reflect strong early momentum –
– Broad and rapid payer access achieved, with >
– Multiple 2026 data readouts expected to support ziftomenib as a broadly combinable backbone across AML –
–
– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, today reported first quarter 2026 financial results and provided a corporate update.
“In its first full quarter of commercial availability, KOMZIFTI generated
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) 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) 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
The Company believes its cash, cash equivalents and short-term investments as of March 31, 2026, when combined with
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.
About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website and follow us on X and LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Kura’s future performance in 2026; the commercial potential of KOMZIFTI; KOMZIFTI’s potential market leadership in R/R NPM1-m AML; KOMZIFTI’s potential as a broadly combinable backbone across the AML treatment continuum; Kura’s research, preclinical and clinical development activities; plans and projected timelines for ziftomenib, darlifarnib, KO-7246 and other preclinical assets; the expected timing and presentation of results and data from clinical trials; and Kura’s anticipated cash runway. Factors that may cause actual results to differ materially include risks associated with market competition, market acceptance and commercialization of KOMZIFTI; risks associated with the conduct of preclinical studies and clinical trials; risks that Kura’s actual future financial and operating results may differ from its expectations or goals; the risk that Kura’s product candidates may not receive regulatory approval; the potential for KOMZIFTI or Kura’s product candidates to have unexpected adverse side effects; the risk that Kura may not be able to obtain additional financing; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
FLT3, Fms-like tyrosine kinase 3 gene; KMT2A, lysine methyltransferase 2A gene; NPM1, nucleophosmin 1 gene; -m, mutant; -r, rearranged; ITD, Internal Random Duplication; KRAS, Kirsten Rat Sarcoma Virus oncogene homolog.
| KURA ONCOLOGY, INC. | |||||||||||||||||
| Statements of Operations Data | |||||||||||||||||
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| (in thousands, except per share data) | |||||||||||||||||
| Three Months Ended | |||||||||||||||||
| March 31, | |||||||||||||||||
| 2026 | 2025 | ||||||||||||||||
| Revenue | |||||||||||||||||
| Product revenue, net | $ | 5,766 | $ | — | |||||||||||||
| Collaboration revenue | 12,499 | 14,108 | |||||||||||||||
| Total revenue | 18,265 | 14,108 | |||||||||||||||
| Operating expenses | |||||||||||||||||
| Cost of product sales | 262 | — | |||||||||||||||
| Research and development | 65,263 | 55,973 | |||||||||||||||
| Selling, general and administrative | 31,555 | 22,835 | |||||||||||||||
| Total operating expenses | 97,080 | 78,808 | |||||||||||||||
| Other income, net | 5,490 | 7,497 | |||||||||||||||
| Income tax expense | 8 | 226 | |||||||||||||||
| Net loss | $ | (73,333 | ) | $ | (57,429 | ) | |||||||||||
| Net loss per share, basic and diluted | $ | (0.83 | ) | $ | (0.66 | ) | |||||||||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 88,610 | 87,415 | |||||||||||||||
| KURA ONCOLOGY, INC. | ||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Cash, cash equivalents and short-term investments | $ | 580,823 | $ | 667,240 | ||||
| Working capital | 522,286 | 591,689 | ||||||
| Total assets | 652,551 | 738,363 | ||||||
| Long-term liabilities | 443,172 | 447,254 | ||||||
| Accumulated deficit | (1,247,421 | ) | (1,174,088 | ) | ||||
| Stockholders’ equity | 107,883 | 174,135 | ||||||
About KOMZIFTI™ (ziftomenib)
KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.
Ziftomenib is in development for the treatment of frontline and R/R AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to be combined with approved therapies and benefit a broad spectrum of patients.
IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION
Boxed WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes.
In the clinical trial, DS occurred in 29 (
In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (
Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment.
QTc Interval Prolongation
KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in
Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death.
Embryo-Fetal Toxicity
Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose.
ADVERSE REACTIONS
Fatal adverse reactions occurred in 4 (
Dosage interruption of KOMZIFTI due to an adverse reaction occurred in
Most common (≥
DRUG INTERACTIONS
Drug interactions may occur when KOMZIFTI is concomitantly used with:
- Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions.
- Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.
- Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time.
- Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist.
- Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid.
- Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI.
Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose.
Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential.
Please see full Prescribing Information, including Boxed WARNING.
Contacts
Investors and media:
Greg Mann
858-987-4046
gmann@kuraoncology.com
