UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On January 11, 2021, Deciphera Pharmaceuticals, Inc., or the Company, issued the press release attached hereto as Exhibit 99.1.
The furnishing of the attached press release is not an admission as to the materiality of any information therein. The information contained in the press release is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the U.S. Securities and Exchange Commission, or the SEC, and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures. For important information about forward looking statements, see the “Cautionary Note Regarding Forward-Looking Statements” section of the press release in Exhibit 99.1 attached hereto.
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, or 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 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Press Release issued by Deciphera Pharmaceuticals, Inc. on January 11, 2021, 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: January 11, 2021 | DECIPHERA PHARMACEUTICALS, INC. | |||
| By: | /s/ Steven L. Hoerter | |||
| Name: | Steven L. Hoerter | |||
| Title: | President and Chief Executive Officer | |||
Exhibit 99.1
Deciphera Pharmaceuticals Provides Corporate Update and Highlights Key 2021 Corporate Milestones
- Top-line Data for INTRIGUE Pivotal Phase 3 Study of QINLOCK® in Patients with Second-line GIST
Expected in the Second Half of 2021 -
- Potential European Medicines Agency Approval of QINLOCK for Patients with Fourth-line GIST in the
Second Half of 2021 -
- Company Planning to Finalize Pivotal Development Plans for Both Vimseltinib (DCC-3014) and
Rebastinib in Second Half of 2021 -
Waltham, MA – January 11, 2021 – Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today provided a corporate update and highlighted key 2021 milestones in conjunction with its presentation at the 39th Annual J.P. Morgan Virtual Healthcare Conference. The Company will webcast its presentation today at 9:10 AM ET at https://investors.deciphera.com/news-events/events-presentations.
“Building on the successful U.S. launch of QINLOCK last year, we are focused in 2021 on expanding both the geographic reach for QINLOCK and the potential for this medicine to benefit patients with GIST even earlier in the course of their disease,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “We also look forward to sharing updated data from the vimseltinib (DCC-3014) and rebastinib programs, as well as finalizing our development plans to support potential registration for these two product candidates. With continued execution and investment in our pipeline, we believe we are well positioned to realize our 2021 goals and deliver important new medicines to patients.”
In 2021, the Company seeks to achieve the following milestones:
QINLOCK (ripretinib)
| • | Report top-line data from the INTRIGUE Phase 3 clinical study of QINLOCK in patients with secondline gastrointestinal stromal tumor (GIST) in the second half of 2021. |
| • | Receive approval from the European Medicines Agency (EMA) for QINLOCK for the treatment of patients with fourth-line GIST in the second half of 2021. |
Vimseltinib (DCC- 3014)
| • | Present updated data from the Phase 1/2 study of vimseltinib (DCC-3014), an inhibitor of CSF1R, in patients with tenosynovial giant cell tumor (TGCT) in the second half of 2021. |
| • | Finalize the pivotal development plan for vimseltinib in TGCT in the second half of 2021. |
Rebastinib
| • | Present updated data from its Phase 1b/2 study of rebastinib, an inhibitor of TIE2, in combination with paclitaxel for patients with endometrial cancer in the second quarter of 2021. |
| • | Present updated data from its Phase 1b/2 study of rebastinib in combination with paclitaxel for patients with platinum-resistant ovarian cancer in the second half of 2021. |
| • | Finalize the pivotal development plan for the rebastinib/paclitaxel combination in the second half of 2021. |
DCC-3116
| • | Initiate the Phase 1 study of DCC-3116, an inhibitor of ULK kinase for the potential treatment of patients with cancers driven by mutations in RAS genes, in the second quarter of 2021, subject to FDA authorization to proceed under the investigational new drug (IND) application submitted in the fourth quarter of 2020. |
Presentation at 39th Annual J.P. Morgan Healthcare Conference
Deciphera will webcast its corporate presentation from the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 9:10 AM ET. A live webcast of the presentation can be accessed under “Events & Presentations” in the Investors section of the Company’s website at deciphera.com. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation. In conjunction with the conference, the Company has also updated its corporate presentation, which can be found here: https://investors.deciphera.com/news-events/eventspresentations.
About Deciphera Pharmaceuticals
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourthline gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Canada and Australia. For more information, visit www.deciphera.com and follow us on LinkedIn and Twitter (@Deciphera).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations regarding 2021 corporate milestones and timing for these goals, including, without limitation, top-line data from our Phase 3 INTRIGUE study in second-line GIST, potential EMA approval of QINLOCK for the treatment of fourth-line GIST, finalizing pivotal study plans for vimseltinib (DCC-3014) in TGCT patients and for the rebastinib/paclitaxel combination, presenting updated data from the Phase 1/2 study of vimseltinib (DCC3014) in TGCT patients, presenting updated data from the Phase 1b/2 study of rebastinib in combination with paclitaxel for patients with endometrial cancer and also from patients with platinum-resistant ovarian cancer, and initiating a phase 1 study of DCC-3116; expanding the geographic reach of QINLOCK; and the potential for QINLOCK to benefit patients with earlier-stage GIST. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release 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 press release, including, without limitation, risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations, our ability to successfully demonstrate the efficacy and safety of our drug candidates and in additional indications for our existing drug, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, our ability to manage our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, our ability to build and scale our operations to support growth in additional geographies, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized, our ability to comply with healthcare regulations and laws, our ability to obtain, maintain and enforce our intellectual property rights, any or all of which may affect the initiation, timing and progress of clinical studies and the timing of and our ability to obtain additional regulatory approvals, and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim 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 press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.
Contacts
Investor Relations:
Jen Robinson
Deciphera Pharmaceuticals, Inc
jrobinson@deciphera.com
781-906-1112
Media:
David Rosen
Argot Partners
David.Rosen@argotpartners.com
212-600-1902