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Kura Oncology Reports First Quarter 2025 Financial Results

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Kura Oncology (KURA) reported significant progress in Q1 2025, highlighted by the submission of its first NDA for ziftomenib to treat adult patients with relapsed/refractory NPM1-mutant AML. The company earned a $45 million milestone payment from Kyowa Kirin for the NDA submission. Q1 financial results showed collaboration revenue of $14.1M, with a net loss of $57.4M. The company maintains a strong financial position with $703.2 million in pro forma cash. Key upcoming milestones include data presentations at ASCO and EHA, initiation of two Phase 3 trials in frontline AML settings, and expansion of clinical programs. First patients were dosed in the KOMET-015 Phase 1 trial for GIST treatment. The company's cash runway extends into 2027 and is expected to support ziftomenib commercialization through frontline AML combination setting.
Kura Oncology (KURA) ha riportato progressi significativi nel primo trimestre del 2025, evidenziati dalla presentazione della sua prima NDA per ziftomenib destinato al trattamento di pazienti adulti con AML mutante NPM1 recidivante/refrattaria. L'azienda ha ricevuto un pagamento milestone di 45 milioni di dollari da Kyowa Kirin per la presentazione della NDA. I risultati finanziari del primo trimestre hanno mostrato ricavi da collaborazione pari a 14,1 milioni di dollari, con una perdita netta di 57,4 milioni di dollari. L'azienda mantiene una solida posizione finanziaria con 703,2 milioni di dollari in cassa pro forma. Tra i principali traguardi imminenti vi sono presentazioni di dati all'ASCO e all'EHA, l'avvio di due studi di Fase 3 in contesti di AML di prima linea e l'espansione dei programmi clinici. I primi pazienti sono stati trattati nello studio di Fase 1 KOMET-015 per il trattamento del GIST. La disponibilità finanziaria dell'azienda si estende fino al 2027 e si prevede che supporterà la commercializzazione di ziftomenib nel contesto della combinazione per AML di prima linea.
Kura Oncology (KURA) reportó avances significativos en el primer trimestre de 2025, destacando la presentación de su primera NDA para ziftomenib para tratar a pacientes adultos con AML mutante NPM1 recidivante/refractaria. La compañía recibió un pago por hito de 45 millones de dólares de Kyowa Kirin por la presentación de la NDA. Los resultados financieros del primer trimestre mostraron ingresos por colaboración de 14,1 millones de dólares, con una pérdida neta de 57,4 millones de dólares. La empresa mantiene una sólida posición financiera con 703,2 millones de dólares en efectivo pro forma. Entre los hitos clave próximos se incluyen presentaciones de datos en ASCO y EHA, el inicio de dos ensayos de Fase 3 en entornos de AML de primera línea y la expansión de los programas clínicos. Los primeros pacientes fueron dosificados en el ensayo de Fase 1 KOMET-015 para el tratamiento del GIST. La liquidez de la compañía se extiende hasta 2027 y se espera que apoye la comercialización de ziftomenib en combinación para AML de primera línea.
Kura Oncology(KURA)는 2025년 1분기에 중요한 진전을 보고했으며, 이는 재발/불응성 NPM1 변이 AML 성인 환자를 치료하기 위한 지프트오메닙(ziftomenib)의 첫 NDA 제출로 강조되었습니다. 회사는 NDA 제출에 대해 Kyowa Kirin으로부터 4,500만 달러의 마일스톤 지급금을 받았습니다. 1분기 재무 결과는 협력 수익 1,410만 달러와 순손실 5,740만 달러를 기록했습니다. 회사는 7억 3,320만 달러의 프로포마 현금으로 강력한 재무 상태를 유지하고 있습니다. 주요 예정 마일스톤으로는 ASCO 및 EHA에서의 데이터 발표, 전선 AML 환경에서 두 건의 3상 시험 시작, 임상 프로그램 확장이 포함됩니다. 첫 환자들이 GIST 치료를 위한 KOMET-015 1상 시험에 투여되었습니다. 회사의 현금 유동성은 2027년까지 연장되며, 전선 AML 병용 요법에서 지프트오메닙의 상업화를 지원할 것으로 예상됩니다.
Kura Oncology (KURA) a annoncé des progrès significatifs au premier trimestre 2025, notamment la soumission de sa première NDA pour ziftomenib destiné au traitement des patients adultes atteints de LMA mutante NPM1 en rechute/réfractaire. La société a reçu un paiement de jalon de 45 millions de dollars de Kyowa Kirin pour la soumission de la NDA. Les résultats financiers du premier trimestre ont montré des revenus de collaboration de 14,1 millions de dollars, avec une perte nette de 57,4 millions de dollars. La société maintient une solide position financière avec 703,2 millions de dollars de trésorerie pro forma. Les jalons clés à venir incluent des présentations de données à l'ASCO et à l'EHA, le lancement de deux essais de phase 3 en première ligne de LMA, et l'expansion des programmes cliniques. Les premiers patients ont été traités dans l'essai de phase 1 KOMET-015 pour le traitement du GIST. La trésorerie de la société est assurée jusqu'en 2027 et devrait soutenir la commercialisation de ziftomenib en combinaison dans le cadre de la LMA de première ligne.
Kura Oncology (KURA) meldete im ersten Quartal 2025 bedeutende Fortschritte, insbesondere die Einreichung seines ersten NDA für ziftomenib zur Behandlung erwachsener Patienten mit rezidivierter/refraktärer NPM1-mutierter AML. Das Unternehmen erhielt von Kyowa Kirin eine Meilensteinzahlung in Höhe von 45 Millionen US-Dollar für die NDA-Einreichung. Die Finanzergebnisse des ersten Quartals zeigten Kollaborationsumsätze von 14,1 Mio. USD bei einem Nettoverlust von 57,4 Mio. USD. Das Unternehmen verfügt über eine starke finanzielle Position mit 703,2 Millionen US-Dollar an Pro-forma-Barmitteln. Wichtige bevorstehende Meilensteine sind Datenpräsentationen bei ASCO und EHA, der Start von zwei Phase-3-Studien im Frontline-AML-Bereich sowie die Erweiterung der klinischen Programme. Die ersten Patienten wurden in der KOMET-015 Phase-1-Studie zur Behandlung von GIST dosiert. Die Liquidität des Unternehmens reicht bis 2027 und soll die Kommerzialisierung von ziftomenib in der Frontline-AML-Kombination unterstützen.
Positive
  • NDA submission completed for ziftomenib in R/R NPM1-mutant AML
  • $45 million milestone payment earned from Kyowa Kirin partnership
  • Strong cash position of $703.2M in pro forma cash
  • Cash runway extends into 2027
  • Multiple clinical trial milestones and data readouts expected in 2025
  • First patients dosed in new GIST indication trial
Negative
  • Increased net loss to $57.4M compared to $49.5M in Q1 2024
  • Higher R&D expenses at $56.0M vs $36.3M year-over-year
  • Increased G&A expenses to $22.8M from $18.2M year-over-year

Insights

Kura's NDA submission for ziftomenib in NPM1-mutant AML represents meaningful regulatory progress backed by substantial financial resources for commercialization.

Kura Oncology has achieved a critical regulatory milestone with its first NDA submission for ziftomenib targeting NPM1-mutated relapsed/refractory AML. This submission triggers a standard 60-day FDA filing review, with potential for Priority Review that would compress the target review period to six months. The acceptance of their KOMET-001 trial data for an oral presentation at ASCO suggests clinically meaningful results, though specific efficacy metrics aren't disclosed in this release.

The company is executing a comprehensive development strategy beyond the initial indication, with combination studies in both intensive (7+3 chemotherapy) and non-intensive (venetoclax/azacitidine) frontline AML regimens. Data from these combinations will be presented at upcoming medical meetings, with two Phase 3 registration-enabling trials in frontline AML expected to initiate in H2 2025.

Kura has expanded ziftomenib's development into solid tumors, with patients now dosed in a Phase 1 GIST trial combining ziftomenib with imatinib. This follows preclinical evidence showing activity in both imatinib-sensitive and resistant GIST models. The company is also advancing KO-2806, a next-generation farnesyl transferase inhibitor being studied with cabozantinib in renal cell carcinoma, while diversifying into metabolic disease with a novel menin inhibitor program for diabetes.

Kura's $703M cash position and Kyowa Kirin partnership provide substantial runway through commercialization while Q1 results show strategic R&D investment.

Kura's Q1 2025 financial results demonstrate a significantly strengthened balance sheet through their Kyowa Kirin collaboration. The company reported $14.1 million in collaboration revenue, a material improvement from zero revenue in Q1 2024. The recent NDA submission for ziftomenib triggered a $45 million milestone payment, bringing their pro forma cash position to $703.2 million.

R&D expenses increased to $56.0 million from $36.3 million year-over-year, while G&A expenses rose to $22.8 million from $18.2 million, reflecting expanded clinical programs and pre-commercial infrastructure development. The net loss was $57.4 million, compared to $49.5 million in Q1 2024.

The Kyowa Kirin partnership continues to transform Kura's financial outlook. Following the $330 million upfront payment received in December 2024 and the current $45 million milestone, management anticipates up to $375 million in additional near-term milestone payments. This non-dilutive capital significantly de-risks their development strategy.

Management projects their current financial resources will fund operations into 2027 and support the ziftomenib AML program through commercialization in the frontline combination setting. This strong cash position enables Kura to execute their ambitious clinical development strategy while building commercial capabilities without near-term financing pressure.

– NDA submitted in 1Q 2025 for ziftomenib for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation –

– Data from Phase 1b/2 registration-directed trial of ziftomenib selected for oral presentation at ASCO Annual Meeting –

$45.0 million milestone payment earned for NDA submission under collaboration agreement with Kyowa Kirin –

– First patients dosed in Phase 1 trial of ziftomenib plus imatinib in GIST –

$703.2 million in pro forma cash, together with anticipated collaboration agreement payments, expected to support ziftomenib commercialization through the frontline AML combination setting –

– Management to host webcast and conference call today at 4:30 p.m. ET –

SAN DIEGO, May 01, 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 first quarter 2025 financial results and provided a corporate update.

“In the first quarter of 2025, we achieved a significant milestone with the submission of our first NDA for ziftomenib,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We are committed to working with FDA to support its review and are strategically advancing our pre-commercial activities to prepare for potential approval for the treatment of adult patients with relapsed or refractory NPM1-mutant AML. Beyond the monotherapy setting, we look forward to sharing data on the combination of ziftomenib with intensive and non-intensive standards of care, while gearing up for two Phase 3 studies in the frontline setting. With a strong pipeline, multiple clinical data readouts expected this year, and a solid financial foundation, we are well-positioned to drive progress across our programs.”

Recent Highlights

  • Submission of New Drug Application for ziftomenib to FDA – Kura and Kyowa Kirin Co., Ltd. (Kyowa Kirin) announced submission of the New Drug Application (NDA) for ziftomenib for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025. From the time of submission, the FDA has a 60-day filing review period, and the Company expects to receive notification from the FDA on this preliminary evaluation in the second quarter of 2025. If Priority Review is granted, it would provide a target FDA review period of six months after NDA acceptance.

  • Abstracts accepted for presentation at ASCO and EHA – In February 2025, Kura and Kyowa Kirin announced positive topline results from the KOMET-001, the Phase 2 registration-directed trial of ziftomenib in patients with R/R NPM1-mutant (NPM1-m) AML. These data have been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and accepted for an encore presentation at the European Hematology Association (EHA) Congress in Milan, Italy. In addition, preliminary clinical data from the Phase 1b expansion cohort evaluating ziftomenib in combination with intensive (7+3) in the frontline setting has been accepted for an oral presentation at EHA. Abstract titles and presentation details can be found on the ASCO and EHA meeting sites at the lift of the respective embargos.

  • Submission of the NDA for ziftomenib has triggered a $45 million milestone payment obligation from Kyowa Kirin – As a result of the NDA submission for ziftomenib, Kura has earned a $45 million milestone payment under the global strategic collaboration agreement between Kura and Kyowa Kirin to develop and commercialize ziftomenib in acute leukemias (Kyowa Agreement). Under the terms of the Kyowa Agreement, Kura received an upfront payment of $330 million in December 2024 and accounting for this $45 million milestone payment, Kura expects to receive up to $375 million in additional, near-term milestone payments.

  • First patients dosed in KOMET-015 trial in GIST – Earlier this week, Kura announced the first patients have been dosed in its KOMET-015 Phase 1 clinical trial of ziftomenib in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure. In October 2024, Kura presented preclinical data at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, supporting the potential for ziftomenib in combination with KIT inhibitors for the treatment of GIST. The combination of ziftomenib and imatinib demonstrated robust and durable antitumor activity in imatinib-sensitive (1L) and imatinib-resistant (2L/3L) GIST patient-derived xenograft models.

  • Preclinical data for KO-2806 presented in oral minisymposium session at AACR Annual Meeting – Last month, Kura presented preclinical data for KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib for the treatment of clear cell renal cell carcinoma at the American Association for Cancer Research (AACR) Annual Meeting in Chicago. These data add to a growing body of preclinical evidence demonstrating the potential of FTIs as companion therapeutic agents to augment the antitumor activities of and to overcome resistance to various targeted therapies.

Financial Results

  • Collaboration revenue from our Kyowa Kirin partnership for the first quarter of 2025 was $14.1 million, compared to no revenue for the first quarter of 2024.

  • Research and development expenses for the first quarter of 2025 were $56.0 million, compared to $36.3 million for the first quarter of 2024.

  • General and administrative expenses for the first quarter of 2025 were $22.8 million, compared to $18.2 million for the first quarter of 2024.

  • Net loss for the first quarter of 2025 was $57.4 million, compared to a net loss of $49.5 million for the first quarter of 2024.

  • Net loss for the first quarter of 2025 included non-cash, share-based compensation expense of $7.8 million. This compares to $8.5 million for the same period in 2024.

  • As of March 31, 2025, Kura had cash, cash equivalents and short-term investments of $658.2 million, compared to $727.4 million as of December 31, 2024.

  • As adjusted for the $45 million NDA submission milestone payment earned under our collaboration agreement with Kyowa Kirin, Kura had, on a pro forma basis, $703.2 million in cash, cash equivalents and short-term investments as of March 31, 2025.

  • Based on our current plans, we believe our cash, cash equivalents and short-term investments as of March 31, 2025 will be sufficient to enable us to fund our current operating expenses into 2027 and, combined with anticipated collaboration funding under the Kyowa Agreement, should support our ziftomenib AML program through commercialization in the frontline combination setting.

Forecasted Milestones

  • Present data from the KOMET-001 Phase 1b/2 registration-directed trial in R/R NPM1-m AML at ASCO and EHA in the second quarter of 2025.

  • Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with intensive chemotherapy (7+3) in the frontline setting at EHA in the second quarter of 2025.

  • Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with venetoclax and azacitidine in the frontline setting at a medical meeting in the second half of 2025.

  • Initiate two independent Phase 3 registration-enabling trials in 1L intensive (KOMET-017-IC) and non-intensive (KOMET-017-NIC) AML in the second half of 2025.

  • Nominate a development candidate for next-generation menin inhibitor program in diabetes in mid-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 in the second half of 2025.

  • Present data from the FIT-001 Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS mutations in the second half of 2025.

  • Present data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) in the second half of 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, May 1, 2025, to discuss the financial results for the first quarter of 2025 and to provide a corporate update. The live call may be accessed by dialing (800) 245-3047 for domestic callers and (203) 518-9765 for international callers and entering the conference ID: KURAQ1. A live webcast and archived replay of the event will be available here or online from the investor relations section of the Company’s website at www.kuraoncology.com.

About Kura Oncology

Kura Oncology is 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 from the FDA for the treatment of R/R NPM1-m AML. In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML has been completed, and in the second quarter of 2025, the companies announced submission of an NDA for ziftomenib for the treatment of adult patients with R/R NPM1-m AML. 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/R NPM1-m and KMT2A-rearranged AML. KO-2806, a next-generation 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 with PIK3CA-dependent HNSCC. For additional information, please visit Kura’s website at www.kuraoncology.com 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, 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 anticipated timing of FDA’s notification on its preliminary evaluation of the NDA for ziftomenib; 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 
  March 31, 
  2025  2024 
Collaboration revenue $14,108  $ 
Operating expenses      
Research and development  55,973   36,268 
General and administrative  22,835   18,184 
Total operating expenses  78,808   54,452 
Other income, net  7,497   4,927 
Income tax expense  (226)   
Net loss $(57,429) $(49,525)
Net loss per share, basic and diluted $(0.66) $(0.59)
Weighted average number of shares used in computing net loss per share, basic and diluted  87,415   83,905 
       


KURA ONCOLOGY, INC. 
Balance Sheet Data 
(unaudited) 
(in thousands) 
       
  March 31,  December 31, 
  2025  2024 
Cash, cash equivalents and short-term investments $658,191  $727,395 
Working capital  634,432   666,117 
Total assets  743,764   760,159 
Long-term liabilities  289,592   267,807 
Accumulated deficit  (952,851)  (895,422)
Stockholders’ equity  364,406   413,640 


Contacts

Investors:
Patti Bank
Managing Director
(415) 513-1284
patti.bank@icrhealthcare.com 

Media:
Alexandra Weingarten
Associate Director, Corporate Communications
(858) 500-8822
alexandra@kuraoncology.com 


FAQ

What is the status of KURA's ziftomenib NDA submission for AML treatment?

Kura Oncology submitted the NDA for ziftomenib on March 31, 2025, for treating adult patients with relapsed/refractory NPM1-mutant AML. FDA notification is expected in Q2 2025, with potential Priority Review providing a 6-month review period.

How much cash does Kura Oncology (KURA) have as of Q1 2025?

Kura has $703.2 million in pro forma cash, cash equivalents and short-term investments as of March 31, 2025, which includes the $45 million milestone payment from Kyowa Kirin.

What were KURA's Q1 2025 financial results?

In Q1 2025, Kura reported collaboration revenue of $14.1M, R&D expenses of $56.0M, G&A expenses of $22.8M, and a net loss of $57.4M.

What are the key upcoming milestones for Kura Oncology (KURA) in 2025?

Key milestones include data presentations at ASCO/EHA in Q2, initiation of two Phase 3 trials in frontline AML, nomination of a diabetes candidate mid-year, and multiple clinical data readouts in H2 2025.

What is the partnership between Kura Oncology and Kyowa Kirin worth?

The partnership included a $330M upfront payment in December 2024, a recent $45M milestone payment for NDA submission, and potential for up to $375M in additional near-term milestone payments.
Kura Oncology Inc

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