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 7, 2024, Kura Oncology, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the third quarter ended September 30, 2024 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 7, 2024 |
|
By: |
/s/ Teresa Bair |
|
|
|
Teresa Bair |
|
|
|
Chief Legal Officer |
Exhibit 99.1
Kura Oncology Reports Third Quarter 2024
Financial Results
– Topline results from registration-directed trial of ziftomenib in R/R NPM1-mutant AML expected in early 2025; Phase 1 results published in The Lancet Oncology –
– Data from 100 patients in Phase 1a dose-escalation study of ziftomenib combined with ven/aza in R/R AML and 7+3 in 1L adverse risk AML to be presented at ASH –
– Phase 1b expansion study of ziftomenib in combination with standards of care now enrolling at 600 mg in all cohorts –
– Preclinical data support opportunity for ziftomenib in GIST; proof-of-concept study expected to begin in 1H 2025 –
– First patient dosed in study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC –
– $455.3 million in cash, cash equivalents and investments provide runway into 2027 –
– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, Nov. 7, 2024 – 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 2024 financial results and provided a corporate update.
“We approach the end of 2024 in a strong position, with a series of important catalysts ahead,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “First, we look forward to sharing a robust dataset from more than 100 patients in our Phase 1a dose-escalation study of ziftomenib in combination with standards of care in acute myeloid leukemia (AML) at the upcoming American Society of Hematology (ASH) Annual Meeting, followed by topline results from our registration-directed trial of ziftomenib in relapsed/refractory (R/R) NPM1-mutant (NPM1-m) AML early next year. In the meantime, we continue to enroll rapidly across all our ziftomenib studies, further supporting the broad development of our menin inhibitor programs.”
Recent Highlights
Financial Results
Forecasted Milestones
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, November 7, 2024, to discuss the financial results for the third quarter 2024 and to provide a corporate update. The live call may be accessed by dialing (800) 225-9448 for domestic callers and (203) 518-9708 for international callers and entering the conference ID: KURAQ3. A live webcast and archive of the call will be available online from the investor relations section of the company 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 that target cancer signaling pathways. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received BTD for the treatment of R/R NPM1-m AML. Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML (KOMET-001). The Company is also 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-r AML. Kura is evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC (KURRENT-HN). 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, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the strength of Kura’s balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund its current operating plan into 2027. 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, applications 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, 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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
41,705 |
|
|
$ |
29,328 |
|
|
$ |
117,700 |
|
|
$ |
82,702 |
|
General and administrative |
|
|
18,179 |
|
|
|
13,145 |
|
|
|
53,040 |
|
|
|
36,340 |
|
Total operating expenses |
|
|
59,884 |
|
|
|
42,473 |
|
|
|
170,740 |
|
|
|
119,042 |
|
Other income, net |
|
|
5,480 |
|
|
|
3,871 |
|
|
|
15,974 |
|
|
|
9,197 |
|
Net loss |
|
$ |
(54,404 |
) |
|
$ |
(38,602 |
) |
|
$ |
(154,766 |
) |
|
$ |
(109,845 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.50 |
) |
|
$ |
(1.80 |
) |
|
$ |
(1.53 |
) |
Weighted average number of shares used in computing net loss per share, basic and diluted |
|
|
86,950 |
|
|
|
77,241 |
|
|
|
85,834 |
|
|
|
71,845 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
KURA ONCOLOGY, INC. |
|
|||||||
Balance Sheet Data |
|
|||||||
(unaudited) |
|
|||||||
(in thousands) |
|
|||||||
|
|
|
|
|
|
|
||
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Cash, cash equivalents and short-term investments |
|
$ |
455,297 |
|
|
$ |
423,957 |
|
Working capital |
|
|
422,817 |
|
|
|
397,218 |
|
Total assets |
|
|
478,837 |
|
|
|
448,935 |
|
Long-term liabilities |
|
|
14,694 |
|
|
|
16,399 |
|
Accumulated deficit |
|
|
(876,205 |
) |
|
|
(721,439 |
) |
Stockholders’ equity |
|
|
423,771 |
|
|
|
397,273 |
|
Contacts
Investors:
Pete De Spain
Executive Vice President, Investor Relations & Corporate Communications
(858) 500-8833
pete@kuraoncology.com
Media:
Cassidy McClain
Vice President
Inizio Evoke Comms
(619) 849-6009
cassidy.mcclain@inizioevoke.com