UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On November 30, 2020, Deciphera Pharmaceuticals, Inc. (the “Company”) announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK® compared to sunitinib in patients with second-line gastrointestinal stromal tumor (“GIST”). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for 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 it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Events. |
On November 30, 2020, the Company announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK compared to sunitinib in patients with second-line GIST. The Company expects to announce top-line results for INTRIGUE in the second half of 2021.
Cautionary Note Regarding Forward-Looking Statements
Statements in this Current Report on Form 8-K contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the Company’s expectations regarding timing for top-line data from the Company’s INTRIGUE study. Any forward-looking statements in this report are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this report, including, without limitation, risks and uncertainties related to the severity and duration of the impact of COVID-19 on the Company’s business and operations, the Company’s ability to successfully demonstrate the efficacy and safety of the Company’s drug candidates and in additional indications for the Company’s existing drug, the preclinical or clinical results for the Company’s product candidates, which may not support further development of such product candidates, the Company’s ability to manage its reliance on sole-source third parties such as its third party drug substance and drug product contract manufacturers, actions of regulatory agencies, any or all of which may affect the initiation, timing and progress of clinical studies and the timing of and the Company’s ability to obtain additional regulatory approvals, and other risks identified in the Company’s Securities and Exchange Commission (SEC) filings, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this report represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Press Release issued by Deciphera Pharmaceuticals, Inc. on November 30, 2020, furnished herewith | |
| 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 hereunto duly authorized.
| Date: November 30, 2020 | DECIPHERA PHARMACEUTICALS, INC. | |||||
| By: | /s/ Steven L. Hoerter | |||||
| Name: | Steven L. Hoerter | |||||
| Title: | President and Chief Executive Officer | |||||