Kura Oncology Reports Second Quarter 2025 Financial Results
Kura Oncology (NASDAQ: KURA) reported Q2 2025 financial results and significant progress in its oncology pipeline. The FDA granted Priority Review for ziftomenib in relapsed/refractory NPM1-mutant AML with a PDUFA date of November 30, 2025. The company reported $15.3 million in collaboration revenue and ended Q2 with $630.7 million in cash.
Key clinical achievements include positive results from the KOMET-001 pivotal trial showing a 23% complete remission rate and promising data from KOMET-007 Phase 1b expansion cohort. The company plans to initiate two Phase 3 trials in frontline AML settings in 2H 2025 and will present three clinical abstracts from its FTI program at the 2025 ESMO Congress.
Q2 2025 resulted in a net loss of $66.1 million, with R&D expenses of $62.8 million and G&A expenses of $25.2 million. Current cash runway extends into 2027.
Kura Oncology (NASDAQ: KURA) ha comunicato i risultati finanziari del secondo trimestre 2025 e importanti progressi nel suo portafoglio oncologico. La FDA ha concesso la Revisione Prioritaria per ziftomenib nel trattamento della leucemia mieloide acuta con mutazione NPM1 recidivante/refrattaria, con una data PDUFA fissata per il 30 novembre 2025. L'azienda ha riportato 15,3 milioni di dollari di ricavi da collaborazioni e ha chiuso il Q2 con 630,7 milioni di dollari in liquidità.
I principali risultati clinici includono dati positivi dallo studio fondamentale KOMET-001, che ha mostrato un tasso di remissione completa del 23%, e dati promettenti dalla coorte di espansione di fase 1b dello studio KOMET-007. L'azienda prevede di avviare due studi di fase 3 in setting di prima linea per la LMA nella seconda metà del 2025 e presenterà tre abstract clinici del programma FTI al Congresso ESMO 2025.
Il secondo trimestre 2025 si è chiuso con una perdita netta di 66,1 milioni di dollari, con spese di ricerca e sviluppo pari a 62,8 milioni di dollari e spese generali e amministrative di 25,2 milioni di dollari. La liquidità attuale garantisce l’operatività fino al 2027.
Kura Oncology (NASDAQ: KURA) informó sus resultados financieros del segundo trimestre de 2025 y avances significativos en su cartera oncológica. La FDA otorgó la Revisión Prioritaria para ziftomenib en leucemia mieloide aguda con mutación NPM1 recidivante/refractaria, con fecha PDUFA para el 30 de noviembre de 2025. La compañía reportó ingresos por colaboraciones de 15,3 millones de dólares y cerró el Q2 con 630,7 millones de dólares en efectivo.
Los principales logros clínicos incluyen resultados positivos del ensayo pivotal KOMET-001, que mostró una tasa de remisión completa del 23%, y datos prometedores de la cohorte de expansión de fase 1b del KOMET-007. La empresa planea iniciar dos ensayos de fase 3 en el tratamiento de primera línea de LMA en la segunda mitad de 2025 y presentará tres resúmenes clínicos de su programa FTI en el Congreso ESMO 2025.
El segundo trimestre de 2025 terminó con una pérdida neta de 66,1 millones de dólares, con gastos en I+D de 62,8 millones de dólares y gastos generales y administrativos de 25,2 millones de dólares. La liquidez actual cubre hasta el año 2027.
Kura Oncology (NASDAQ: KURA)� 2025� 2분기 재무 실적� 종양� 파이프라인에서의 중요� 진전� 발표했습니다. FDA� 재발/불응� NPM1 변� AML� 대� 지프토메닙� 대� 우선 심사(Priority Review)� 승인했으�, PDUFA 날짜� 2025� 11� 30�� 지정되었습니다. 회사� 협력 수익으로 1,530� 달러� 보고했으�, 2분기 � 현금 잔액은 6� 3,070� 달러옶습니�.
주요 임상 성과로는 KOMET-001 중추 임상시험에서 23% 완전 관해율� 보인 긍정적인 결과와 KOMET-007 1b� 확장 코호트에� 유망� 데이터가 포함됩니�. 회사� 2025� 하반기에 1� 치료 AML 환경에서 � 건의 3� 임상시험� 시작� 계획이며, 2025� ESMO 학회에서 FTI 프로그램 관� 임상 초록 � 편을 발표� 예정입니�.
2025� 2분기 순손실은 6,610� 달러였으며, 연구개발비는 6,280� 달러, 일반관리비� 2,520� 달러옶습니�. 현재 현금 유동성은 2027년까지 지속될 전망입니�.
Kura Oncology (NASDAQ : KURA) a publié ses résultats financiers du deuxième trimestre 2025 ainsi que des progrès significatifs dans son pipeline oncologique. La FDA a accordé une examen prioritaire pour le ziftoménib dans la leucémie myéloïde aiguë mutée NPM1 en rechute/réfractaire, avec une date PDUFA fixée au 30 novembre 2025. La société a déclaré un revenu de collaboration de 15,3 millions de dollars et a terminé le deuxième trimestre avec 630,7 millions de dollars en liquidités.
Les principales réalisations cliniques comprennent des résultats positifs de l'essai pivot KOMET-001 montrant un taux de rémission complète de 23% et des données prometteuses de la cohorte d'expansion de phase 1b de KOMET-007. La société prévoit de lancer deux essais de phase 3 en première ligne dans la leucémie myéloïde aiguë au second semestre 2025 et présentera trois résumés cliniques de son programme FTI au Congrès ESMO 2025.
Le deuxième trimestre 2025 s'est soldé par une perte nette de 66,1 millions de dollars, avec des dépenses en R&D de 62,8 millions de dollars et des frais généraux et administratifs de 25,2 millions de dollars. La trésorerie actuelle permet une autonomie jusqu'en 2027.
Kura Oncology (NASDAQ: KURA) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 sowie bedeutende Fortschritte in seiner Onkologie-Pipeline. Die FDA gewährte für Ziftomenib bei rezidivierter/refraktärer NPM1-mutierter AML eine ʰǰäٲüڳܲԲ mit einem PDUFA-Datum am 30. November 2025. Das Unternehmen meldete 15,3 Millionen US-Dollar Einnahmen aus Kooperationen und schloss das zweite Quartal mit 630,7 Millionen US-Dollar an liquiden Mitteln ab.
Wichtige klinische Erfolge umfassen positive Ergebnisse der wegweisenden KOMET-001-Studie mit einer kompletten Remissionsrate von 23% sowie vielversprechende Daten aus der Phase-1b-Erweiterungskohorte der KOMET-007-Studie. Das Unternehmen plant, in der zweiten Hälfte 2025 zwei Phase-3-Studien in der Erstlinientherapie der AML zu starten und wird drei klinische Abstracts seines FTI-Programms auf dem ESMO-Kongress 2025 präsentieren.
Im zweiten Quartal 2025 wurde ein Nettoverlust von 66,1 Millionen US-Dollar verzeichnet, mit Forschungs- und Entwicklungskosten von 62,8 Millionen US-Dollar und Verwaltungsaufwand von 25,2 Millionen US-Dollar. Die derzeitige Liquidität reicht bis ins Jahr 2027.
- FDA granted Priority Review for ziftomenib with PDUFA date set for November 30, 2025
- Strong cash position of $630.7 million with runway into 2027
- Collaboration revenue of $15.3 million in Q2 2025
- Positive KOMET-001 trial results with 23% complete remission rate
- High MRD-negativity rates in KOMET-007 trial (68% NPM1-m and 83% KMT2A-r patients)
- Commercial team hiring and onboarding completed ahead of potential launch
- Increased net loss of $66.1 million vs $50.8 million in Q2 2024
- Higher operating expenses with R&D costs up to $62.8 million from $39.7 million
- Cash position decreased from $727.4 million to $630.7 million since December 2024
Insights
Kura's ziftomenib advancing toward potential November approval with strong clinical data, positioning company for commercial launch and expanded indications.
Kura's regulatory progress with ziftomenib represents a significant near-term catalyst with the FDA's November 30, 2025 PDUFA date approaching rapidly. The Priority Review designation and previous Breakthrough Therapy Designation for relapsed/refractory NPM1-mutant AML highlight the drug's potential to address a significant unmet need in this difficult-to-treat population.
The clinical data package supporting approval is impressive, with the pivotal KOMET-001 trial achieving a CR+CRh rate of
Strategically, Kura is executing a comprehensive development plan for ziftomenib across the AML treatment continuum. The Phase 1b data from KOMET-007 presented at EHA demonstrates encouraging early efficacy when combined with standard chemotherapy in frontline settings, with
The diabetes program represents an intriguing expansion beyond oncology, leveraging menin inhibition's potential metabolic benefits, though details remain limited and this represents a longer-term opportunity.
Strong financial position with $630.7M cash runway into 2027, partnership revenue flowing, and near-term commercial opportunity ahead.
Kura's financial position remains robust with
Revenue generation has begun with
The completed hiring of the U.S. sales team ahead of the November PDUFA date indicates management's confidence in approval and demonstrates proper operational execution. This strategic investment is critical as commercial preparations typically require 6-9 months lead time for successful launches in oncology.
Beyond ziftomenib, Kura's diversified pipeline includes promising FTI candidates, with three clinical abstracts accepted at ESMO 2025. This expanding pipeline provides potential additional value drivers beyond the lead program, creating a more balanced risk profile for investors looking beyond the initial AML commercial opportunity.
� FDA Priority Review of New Drug Application (NDA) for ziftomenib in adults with R/R NPM1-m AML with Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2025 �
� Fully engaged in commercial readiness activities in alignment with regulatory review timeline �
� KOMET-017-IC (intensive chemotherapy) and NIC (non-intensive chemotherapy) phase 3 studies in newly diagnosed AML on track to start in 2H 2025 �
� Three clinical abstracts from Kura’s farnesyl transferase inhibitors (FTI) development program accepted for presentation at the 2025 ESMO Congress �
�
� Management to host webcast and conference call today at 4:30 p.m. ET �
SAN DIEGO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported second quarter 2025 financial results and provided a corporate update.
“FDA’s acceptance of our NDA for ziftomenib represents another important step toward addressing a high unmet need in patients with relapsed or refractory NPM1-mutant AML,� said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer ofKura Oncology. “As a menin inhibitor, ziftomenib targets a fundamental disease driver in certain genetically defined subsets of AML, and along with our partners at Kyowa Kirin, we are committed to advancing ziftomenib as a potential therapy for patients throughout the continuum of care. With preparations underway for commercialization, upcoming initiation of two registrational trials of ziftomenib in the frontline setting and a strong pipeline to support future growth, we believe Kura is well-positioned to deliver meaningful benefit to patients and long-term value to stakeholders.�
Recent Highlights
- FDA Priority Review of New Drug Application for ziftomenib with PDUFA target action date of November 30, 2025 � In June 2025, Kura and Kyowa Kirin Co., Ltd. (Kyowa Kirin) announced the U.S. Food and Drug Administration (FDA) accepted Kura’s NDA seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 mutation (NPM1-m). Ziftomenib is the only menin inhibitor to receive Breakthrough Therapy Designation (BTD) for this indication. The application has been granted Priority Review and assigned a PDUFA target action date of November 30, 2025.
- Commercial readiness activities advancing in line with the regulatory review timeline � Pre-launch efforts by medical affairs, market access, patient support, and sales continue. Hiring and onboarding of U.S. field sales team are now complete. Pre-approval information exchange with key stakeholders across the AML ecosystem is ongoing.
- Presentation of positive results from the KOMET-001 pivotal trial of ziftomenib in R/R NPM1-m AML at 2025 ASCO Annual Meeting � The study achieved a complete remission (CR) plus CR with partial hematologic recovery (CRh) rate of
23% , an improvement over historical controls in a heavily pretreated patient population with limited survival and few treatment options. Key safety and tolerability measures, including manageable differentiation syndrome, low rates of ziftomenib-related myelosuppression and treatment discontinuation, absence of clinically significant QTc prolongation and minimal drug-drug interactions highlighted a potentially favorable benefit-risk profile for ziftomenib. - Presentation of clinical data from the Phase 1b expansion cohort of KOMET-007 evaluating ziftomenib in combination with intensive chemotherapy (7+3) in newly diagnosedNPM1-m andKMT2A-rearranged AML at 2025 EHA Congress � High rates of CR and measurable residual disease (MRD) negativity with ziftomenib in combination with intensive chemotherapy in newly diagnosed NPM1-m and KMT2A-rearranged (KMT2A-r) AML were reported. Among patients achieving a composite CR,
68% of NPM1-m and83% of KMT2A-r patients reached MRD-negative status at a median of ~4�5 weeks. At a median follow-up of 25 and 16 weeks,96% and88% of patients in the respective cohorts remained alive and on study. Ziftomenib was well tolerated, enabling patients to remain on treatment through consolidation and maintenance, without interruption, dose reduction, or added myelosuppression. - Nomination of next-generation menin inhibitor designed for the treatment of Type 1 and Type 2 diabetes and menin-dependent cardiometabolic indications - In preclinical models of type 2 diabetes, ziftomenib has been shown to improve glucose control, enhance insulin production, reduce insulin resistance, and selectively induce beta-cell proliferation, supporting menin as a therapeutic target for beta-cell regeneration. Kura has nominated a next-generation menin inhibitor for evaluation in diabetes. Development plans and timelines will be announced in a future update.
- Three clinical abstracts from Kura’s farnesyl transferase inhibitor (FTI) program accepted for presentation at the 2025 ESMO Congress - The presentations will include the first clinical data on Kura’s lead investigational FTI therapy, KO-2806, in combination with cabozantinib in renal cell carcinoma (Poster #2604P), as well as KO-2806 monotherapy in advanced RAS-mutant solid tumors (Poster #981P). An additional abstract will highlight clinical data from the combination of the FTI tipifarnib and alpelisib in patients with PIK3CA-mutant head and neck squamous cell carcinoma (HNSCC) (Poster #1349P).
Financial Results
- Collaboration revenue from our Kyowa Kirin partnership for the second quarter of 2025 was
$15.3 million , compared to no revenue for the second quarter of 2024. - Research and development expenses for the second quarter of 2025 were
$62.8 million , compared to$39.7 million for the second quarter of 2024. - General and administrative expenses for the second quarter of 2025 were
$25.2 million , compared to$16.7 million for the second quarter of 2024. - Net loss for the second quarter of 2025 was
$66.1 million , compared to a net loss of$50.8 million for the second quarter of 2024. Net loss for the second quarter included non-cash share-based compensation expense of$6.9 million , compared to$8.4 million for the same period in 2024. - As of June 30, 2025, Kura had cash, cash equivalents and short-term investments of
$630.7 million , compared to$727.4 million as of December 31, 2024. - Based on our current plans, we believe that our cash, cash equivalents and short-term investments as of June 30, 2025 will be sufficient to enable us to fund our current operating expenses into 2027, and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, should support our ziftomenib AML program through commercialization in the frontline combination setting.
Forecasted Milestones
- Continued regulatory interactions with the FDA ahead of the November 30, 2025 PDUFA target action date for ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-m AML.
- Initiate KOMET-017, two independent Phase 3 registration-enabling trials in frontline intensive chemotherapy and non-intensive chemotherapy AML settings, in the second half of 2025.
- Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib in combination with venetoclax and azacitidine in the second half of 2025.
- Initiate one or more FIT-001 expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the second half of 2025.
- Present data from the FIT-001 Phase 1 trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma at the 2025 ESMO Congress in October 2025.
- Present data from the FIT-001 Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS-mutant solid tumors at the 2025 ESMO Congress in October 2025.
- Present data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent HNSCC at the 2025 ESMO Congress in October 2025.
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 7, 2025, to discuss the financial results for the second quarter of 2025 and to provide a corporate update. The live call may be accessed by dialing (800) 579-2543 for domestic callers and (785) 424-1789 for international callers and entering the conference ID: KURAQ2. A live webcast and archived replay of the event will be available or online from the investor relations section of the Company’s website at .
About Kura Oncology
Kura Oncologyis a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation (BTD) from theU.S. Food and Drug Administration(FDA) for the treatment of relapsed or refractory (R/R)NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). InNovember 2024,Kura Oncologyentered into a global strategic collaboration agreement with Kyowa Kirin to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in KOMET-001, a Phase 2 registration-directed trial of ziftomenib in R/RNPM1-m AML, has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/RNPM1-m AML and assignment of a Prescription Drug User Fee Act target action date ofNovember 30, 2025. Kura and Kyowa Kirin are conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/RNPM1-m andKMT2A-rearranged AML. Ziftomenib is also being evaluated in a Phase 1 dose-escalation trial (KOMET-015) in combination with imatinib for treatment of patients with advanced gastrointestinal stromal tumors (GIST). KO-2806, a next-generation farnesyl transferase inhibitor (FTI), is being evaluated in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients withPIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit the Kura website atand follow us onԻ.
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, the efficacy, safety and therapeutic potential of Kura’s product candidates, ziftomenib, KO-2806 and tipifarnib; the expected timing of clinical trials; the expected timing and presentation of results and data from clinical trials; the potential duration of FDA’s review of the NDA; the potential FDA approval of product candidates; the success and impact of interactions with the FDA; the strength of Kura’s balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund its current operating plan to 2027 and, combined with anticipated collaboration funding under the Kyowa Agreement, to support Kura’s ziftomenib AML program through commercialization in the 1L combination setting. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, 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.
KURA ONCOLOGY, INC. | ||||||||||||||||
Statements of Operations Data | ||||||||||||||||
(unaudited) | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Collaboration revenue | $ | 15,288 | $ | � | $ | 29,396 | $ | � | ||||||||
Operating expenses | ||||||||||||||||
Research and development | 62,785 | 39,727 | 118,758 | 75,995 | ||||||||||||
General and administrative | 25,169 | 16,677 | 48,004 | 34,861 | ||||||||||||
Total operating expenses | 87,954 | 56,404 | 166,762 | 110,856 | ||||||||||||
Other income, net | 6,544 | 5,567 | 14,041 | 10,494 | ||||||||||||
Income tax expense | � | � | (226 | ) | � | |||||||||||
Net loss | $ | (66,122 | ) | $ | (50,837 | ) | $ | (123,551 | ) | $ | (100,362 | ) | ||||
Net loss per share, basic and diluted | $ | (0.75 | ) | $ | (0.59 | ) | $ | (1.41 | ) | $ | (1.18 | ) | ||||
Weighted average number of shares used in computing net loss per share, basic and diluted | 87,586 | 86,635 | 87,501 | 85,270 | ||||||||||||
KURA ONCOLOGY, INC. | ||||||||
Balance Sheet Data | ||||||||
(unaudited) | ||||||||
(in thousands) | ||||||||
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Cash, cash equivalents and short-term investments | $ | 630,728 | $ | 727,395 | ||||
Working capital | 552,901 | 666,117 | ||||||
Total assets | 682,425 | 760,159 | ||||||
Long-term liabilities | 269,765 | 267,807 | ||||||
Accumulated deficit | (1,018,973 | ) | (895,422 | ) | ||||
Stockholders� equity | 305,486 | 413,640 | ||||||
Contacts
Investors and media:
Greg Mann
858-987-4046
