KURA 8-K
Kura Oncology, Inc. (KURA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices)
|
(Zip Code) |
|
Registrant’s Telephone Number, Including Area Code: (
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 4, 2025, Kura Oncology, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the third quarter ended September 30, 2025 and providing a corporate update. A copy of this press release is furnished herewith as Exhibit 99.1.
The information contained in this Current Report on Form 8-K under Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
|
Description |
99.1 |
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
KURA ONCOLOGY, INC. |
|
|
|
|
|
Date: November 4, 2025 |
|
By: |
/s/ Teresa Bair |
|
|
|
Teresa Bair |
|
|
|
Chief Legal Officer |
Exhibit 99.1
Kura Oncology Reports Third Quarter 2025 Financial Results
– 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/R NPM1-m AML –
– $609.7 million in pro forma cash, 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, November 4, 2025 – 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
2
Forecasted Milestones
Financial Results
3
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 available here or online from the investor relations section of the Company’s website at www.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/R NPM1-m or KMT2A-r AML at the 67th Annual 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 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 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
4
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; 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.
5
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
Investors and media:
Greg Mann
858-987-4046
[email protected]
6