UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-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): February 16, 2021 (February 12, 2021)
G1 THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-38096 | 26-3648180 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
700 Park Offices Drive Suite 200 Research Triangle Park, NC | 27709 | |||
(Address of principal executive offices) | (zip code) |
Registrant’s telephone number, including area code: (919) 213-9835
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:
☐ | 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 | Name of each exchange on which registered | ||
Common stock, $0.0001 par value | GTHX | The Nasdaq Stock Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 7.01 | Regulation FD Disclosure |
On February 12, 2021, G1 Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration approved the Company’s new drug application for COSELATM (trilaciclib) for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Also attached hereto as Exhibit 99.2 is a presentation (the “Presentation”), which is incorporated herein by reference. The Company will use the Presentation in various meetings with securities analysts, investors, and others beginning February 16, 2021.
Pursuant to General Instruction B.2 of Current Report on Form 8-K, the information contained in, or incorporated into, Item 7.01, including the press release and Presentation, attached hereto as Exhibit 99.1 and Exhibit 99.2, are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit | Description | |
99.1 | Press Release dated February 12, 2021 | |
99.2 | Presentation dated February 16, 2021 | |
104 | Cover Page Interactive Data File (embedded with 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.
G1 THERAPEUTICS, INC. | ||
By: | /s/ James Stillman Hanson | |
James Stillman Hanson | ||
General Counsel |
Date: February 16, 2021