0001599298FALSE00015992982022-09-282022-09-28
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): September 28, 2022
| | | | | | | | |
| Summit Therapeutics Inc. |
| (Exact Name of Registrant as Specified in Its Charter) |
| | | |
| Delaware | 001-36866 | 37-1979717 |
(State or Other Jurisdiction
of Incorporation) | (Commission
File Number) | (IRS Employer
Identification No.) |
| |
2882 Sand Hill Road, Suite 106, Menlo Park, CA | 94025 |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: 617-514-7149
| | |
| Not applicable |
| (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 Instruction 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 |
| Common stock, $0.01 par value per share | SMMT | The Nasdaq Stock Market LLC |
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. ☐
On September 28, 2022, Summit Therapeutics Inc. (the “Company”) determined that it will seek partners or a divestiture of ridinilazole as the path forward for the clinical development of the asset. Ridinilazole is the Company’s Phase III product candidate for the treatment of patients with Clostridioides difficile infection (“C. diff. infection” or “CDI”). As a result of this determination, the Company will discontinue its only active study for ridinilazole, a pediatric clinical trial evaluating ridinilazole for treating adolescent patients with CDI.
As previously communicated, the Company held a Type C meeting with the US Food & Drug Administration (“FDA”) during which the FDA and Summit discussed a possible pathway in which to advance ridinilazole forward with the goal of achieving marketing authorization. This pathway would involve at least one additional registrational trial, for which we will seek a partner to perform.
Further, the Company plans to present the data associated with ridinilazole’s Phase III clinical trial, Ri-CoDIFy, at IDWeek 2022 later this month.
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| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| | | | | |
Exhibit Number | Description |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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.
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| | SUMMIT THERAPEUTICS INC. |
| | |
| | |
| Date: October 4, 2022 | By: | /s/ Ankur Dhingra |
| | | Chief Financial Officer |
| | | (Principal Financial Officer) |