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Kura Oncology Reports Third Quarter 2025 Financial Results

Key Takeaway: Kura Oncology reported its third quarter 2025 financial results, highlighting the ongoing FDA Priority Review for ziftomenib's New Drug Application. The company is advancing its Phase 3 KOMET-017 trials for ziftomenib in acute myeloid leukemia (AML) and plans to present findings at the upcoming ASH Annual Meeting. Kura's financial health is robust, with significant cash reserves to support ongoing programs.

Market Sentiment Analysis

POSITIVE FACTORS

  • Ziftomenib's NDA is under FDA Priority Review.
  • Phase 3 trials for ziftomenib are accelerating.
  • Strong financial position with $609.7 million in pro forma cash.
  • Promising clinical data for darlifarnib and tipifarnib.

Full Press Release Details

– New Drug Application for ziftomenib in adults with R/RNPM1-m AML remains under FDA Priority Review, with a PDUFA target action date of November 30, 2025 –
– KOMET 017 Phase 3 trials to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy in frontline AML are accelerating; ziftomenib being investigated in settings representing more than 50% of AML patients –
– Two oral presentations at 2025 ASH Annual Meeting on ziftomenib in combination with venetoclax / azacitidine chemotherapy in frontline and R/RNPM1-m AML –
– Clinical data at ESMO 2025 Congress highlight promise of second strategic program – FTIs darlifarnib and tipifarnib show promising safety profile and clinical activity with targeted therapies in solid tumors –
– $609.7 million inpro formacash, together with anticipated collaboration payments, expected to support ziftomenib AML program through topline results in KOMET-017 –
– Management to host webcast and conference call today at 8:00 a.m. ET –
SAN DIEGO, Nov. 04, 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 third quarter 2025 financial results and provided a corporate update.
“Our momentum is accelerating across the ziftomenib program and our broader precision oncology pipeline,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer. “With the initiation of the pivotal KOMET-017 Phase 3 trials, we are executing a robust, focused development strategy to unlock ziftomenib’s best-in-class potential across the continuum of unmet need in AML. Bolstered by a strong balance sheet and our productive partnership with Kyowa Kirin, we are well positioned to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value across our pipeline for patients and other key stakeholders.”

Recent Highlights

Forecasted Milestones

Financial Results

Conference Call and Webcast- Third Quarter 2025 Financial Results

Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, November 4, 2025, to discuss the financial results for the third quarter of 2025 and to provide a corporate update. A live webcast and archived replay of the event will be availablehereor online from the investor relations section of the Company’s website atwww.kuraoncology.com.

Conference Call and Webcast –ASH 2025 Annual Meeting

Kura plans to host a virtual analyst and investor event at 12:30 p.m. ET / 9:30 a.m. PT on Monday, December 8, 2025, to discuss the Company’s presentations from ziftomenib in combination with ven/aza chemotherapy in patients with newly diagnosed and R/RNPM1-m orKMT2A-r AML at the 67thAnnual Meeting of the American Society of Hematology. A live webcast and archived replay of the event will be available online from the investor relations section of the Company’s website atwww.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 of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and it continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://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, ziftomenib’s best-in-class potential across the continuum of unmet need in AML; Kura’s ability to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value for patients and other stakeholders; 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; continued regulatory interactions with the FDA; the efficacy, safety and therapeutic potential of Kura’s product candidates, ziftomenib, darlifarnib and tipifarnib; the expected timing of clinical trials; the expected timing and presentation of results and data from clinical trials; the strength of Kura’s balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund Kura’s current operating expenses into 2027 and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, to support Kura’s ziftomenib AML program through topline results from KOMET-017. Factors that may cause actual results to differ materially include risks associated with the commercialization of ziftomenib, 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, 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.
FLT3,Fms-like tyrosine kinase 3; HNSCC, head and neck squamous cell carcinoma;KMT2A, lysine methyltransferase 2A;NPM1,nucleophosmin 1; R/R, relapsed / refractory; ven/aza, venetoclax / azacitidine.
KURA ONCOLOGY, INC.
Statements of Operations Data
(unaudited)
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2025 2024 2025 2024
Collaboration revenue $ 20,750 $ $ 50,146 $
Operating expenses
Research and development 67,908 41,705 186,666 117,700
General and administrative 32,839 18,179 80,843 53,040
Total operating expenses 100,747 59,884 267,509 170,740
Other income, net 5,881 5,480 19,922 15,974
Income tax expense (226 )
Net loss $ (74,116 ) $ (54,404 ) $ (197,667 ) $ (154,766 )
Net loss per share, basic and diluted $ (0.85 ) $ (0.63 ) $ (2.26 ) $ (1.80 )
Weighted average number of shares used in computing net loss per share, basic and diluted 87,645 86,950 87,550 85,834
KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
September 30, December 31,
2025 2024
Cash, cash equivalents and short-term investments $ 549,665 $ 727,395
Working capital 499,359 666,117
Total assets 649,381 760,159
Long-term liabilities 285,535 267,807
Accumulated deficit (1,093,089 ) (895,422 )
Stockholders’ equity 242,542 413,640

Contacts

Frequently Asked Questions

What is the status of ziftomenib's NDA?

Ziftomenib's New Drug Application is currently under FDA Priority Review.

What are the KOMET-017 trials?

The KOMET-017 trials are Phase 3 studies evaluating ziftomenib in AML patients.

When will Kura present at the ASH Annual Meeting?

Kura plans to present at the ASH Annual Meeting on December 8, 2025.

How much cash does Kura have?

Kura has $609.7 million in pro forma cash to support its programs.

What are the promising results from ESMO 2025?

Darlifarnib and tipifarnib showed a promising safety profile in solid tumors.

Last updated: Nov 4, 2025