- Top-line Data from INVICTUS Pivotal Phase 3 Clinical Study of Ripretinib in Fourth-line and Fourth-line Plus GIST Patients Expected in Mid-2019 -
- Recommended Phase 2 Dose Selected for Part 2 of Phase 1b/2 Study of Rebastinib plus Paclitaxel; Enrollment in Part 2 with Expansion Cohorts Expected to Commence Second Quarter 2019 -
- Ended First Quarter 2019 with Cash, Cash Equivalents and Marketable Securities of $262 Million -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced financial results for the first quarter ended March 31, 2019 and provided an update on clinical and corporate developments.
“Our team made significant progress during the first quarter of 2019 advancing our portfolio of novel drug candidates from our proprietary kinase switch control inhibitor platform,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “We expect top-line data from our INVICTUS pivotal Phase 3 study of ripretinib for the treatment of fourth-line and fourth-line plus GIST patients in mid-2019 and pending favorable results from this study, we look forward to our first NDA submission and laying the groundwork for our first potential launch in the United States. In addition, we continue to advance key clinical trials of DCC-3014 and rebastinib and we expect to announce the initiation of IND-enabling preclinical studies for a new clinical candidate later this year.”
Recent Clinical Updates
Corporate Update
First Quarter 2019 Financial Results
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.
Availability of Other Information About Deciphera Pharmaceuticals
Investors and others should note that Deciphera Pharmaceuticals communicates with its investors and the public using its company website (www.deciphera.com), including but not limited to investor presentations and scientific presentations, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Deciphera Pharmaceuticals posts on these channels and websites could be deemed to be material information. As a result, Deciphera Pharmaceuticals encourages investors, the media and others interested in Deciphera Pharmaceuticals to review the information that it posts on these channels, including Deciphera Pharmaceuticals’ investor relations website, on a regular basis. This list of channels may be updated from time to time on Deciphera Pharmaceuticals' investor relations website and may include other social media channels than the ones described above. The contents of Deciphera Pharmaceuticals' website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
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, statements regarding our expectations regarding timing of reporting top-line data from our INVICTUS pivotal Phase 3 study, the potential for ripretinib (DCC-2618) and our other drug candidates based on our kinase switch control inhibitor platform to provide clinical benefit and treat cancers such as GIST and other possible indications, initiation of and enrollment for our INTRIGUE pivotal Phase 3 study, expectations for, progress with respect to and the timing of enrollment and data from our clinical trials with our investigational agent rebastinib, including, without limitation, our study of rebastinib in combination with carboplatin and in combination with paclitaxel, and the potential for rebastinib, alone or in combination with other agents or chemotherapy to treat cancers, expectations for presenting data from our studies of DCC-3014, enrollment of TGCT patients in our ongoing Phase 1 trial for DCC-3014, expectations regarding cash guidance, preparations for a possible NDA, pending positive study results, and commercial launch of ripretinib in fourth-line and fourth-line plus GIST, if approved, and expectations regarding designating a new clinical candidate and IND-enabling studies to support such candidate. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “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 delay of any current or planned clinical studies or the development of our drug candidates, including ripretinib, rebastinib, and DCC-3014, our advancement of multiple early-stage and later-stage efforts, our ability to successfully demonstrate the efficacy and safety of our drug candidates including in later-stage studies, the preclinical and clinical results for our drug candidates, which may not support further development of such drug candidates, our efforts to scale up and manage drug product manufacturing, our ability to implement commercial readiness, actions of regulatory agencies, any or all of which may affect the initiation, timing and progress of clinical studies and other risks identified in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2018, 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 its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| March 31, 2019 | December 31, 2018 | |||||||
| Assets | ||||||||
| Cash and cash equivalents and marketable securities | $ | 262,342 | $ | 293,764 | ||||
| Prepaid expenses and other current assets | 4,103 | 7,273 | ||||||
| Long-term investment restricted | 1,069 | 1,069 | ||||||
| Property and equipment, net | 1,504 | 13,453 | ||||||
| Operating lease, right-of-use assets | 670 | — | ||||||
| Total assets | $ | 269,688 | $ | 315,559 | ||||
| Liabilities and Stockholders' Equity | ||||||||
|
Accounts payable, accrued expenses and other
liabilities |
$ | 27,751 | $ | 22,398 | ||||
| Debt obligations | 1,263 | 1,294 | ||||||
| Operating lease liabilities | 678 | 11,886 | ||||||
| Total liabilities | 29,692 | 35,578 | ||||||
| Total stockholders' equity | 239,996 | 279,981 | ||||||
| Total liabilities and stockholders' equity | $ | 269,688 | $ | 315,559 | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||
| (In thousands, except share and per share data) | ||||||||||
| (Unaudited) | ||||||||||
| Three Months Ended | ||||||||||
| March 31, | ||||||||||
| 2019 | 2018 | |||||||||
| Revenue | $ | — | $ | — | ||||||
| Operating expenses: | ||||||||||
| Research and development | 35,789 | 16,925 | ||||||||
| General and administrative | 13,236 | 5,026 | ||||||||
| Total operating expenses | 49,025 | 21,951 | ||||||||
| Loss from operations | (49,025 | ) | (21,951 | ) | ||||||
| Other income (expense): | ||||||||||
| Interest expense | (13 | ) | (22 | ) | ||||||
| Interest and other income, net | 1,654 | 543 | ||||||||
| Total other income (expense), net | 1,641 | 521 | ||||||||
| Net loss | $ | (47,384 | ) | $ | (21,430 | ) | ||||
| Net loss per share—basic and diluted | $ | (1.25 | ) | $ | (0.66 | ) | ||||
| Weighted average common shares outstanding—basic and diluted | 38,057,018 | 32,594,074 | ||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190509005065/en/
Investor Relations:
Jen Robinson
Deciphera Pharmaceuticals,
Inc.
jrobinson@deciphera.com
781-906-1112
Media:
Gina Nugent, The Yates Network
gina@theyatesnetwork.com
617-460-3579