UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 16, 2019
KURA ONCOLOGY, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-37620 | 61-1547851 | ||
(State of incorporation) | (Commission File No.) | (IRS Employer Identification No.) |
3033 Science Park Road, Suite 220 San Diego, CA | 92121 | |
| (Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (858)500-8800
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-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 | ||
| Common Stock, par value $0.0001 per share | KURA | The Nasdaq Global Select Market |
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 Rule12b-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 8.01 | Other Events. |
On December 16, 2019, Kura Oncology, Inc. (the “Company”) issued a press release announcing (i) that the U.S. Food and Drug Administration has granted Fast Track designation to the Company’s lead drug candidate, tipifarnib, for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas after progression on platinum therapy and (ii) that based on a recent evaluation of current screening and enrollment rates, the Company currently projects that enrollment of the Company’s ongoing registration-directed trial,AIM-HN, which was initiated in November 2018, will be completed in the first quarter of 2021.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit | Description | |
| 99.1 | Press Release dated December 16, 2019. | |
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 hereunto duly authorized.
| Date: December 16, 2019 | KURA ONCOLOGY, INC. | |||||
| By: | /s/ Marc Grasso, M.D. | |||||
| Marc Grasso, M.D. | ||||||
| Chief Financial Officer and Chief Business Officer | ||||||