WALTHAM, Mass. / May 03, 2023 / Business Wire / Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.
“We have had a very strong start to 2023, achieving significant milestones including the completion of enrollment for the MOTION pivotal Phase 3 study of vimseltinib in TCGT patients, presentation of the ctDNA data for QINLOCK in second-line GIST patients with mutations in KIT Exon 11 and 17/18, and receiving Breakthrough Therapy Designation from the FDA for QINLOCK in this patient population,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “These advancements in our late-stage pipeline position us for a catalyst-rich remainder of 2023, in which we expect top-line results from the MOTION study and plan to initiate INSIGHT, the pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18.”
Mr. Hoerter continued, “We continue to complement this impressive momentum with progress in our early-stage programs, including the recent presentations at AACR, which highlighted the productivity of our kinase switch-control research engine. We were excited to present the preclinical data for DCC-3084, a potential best-in-class pan-RAF inhibitor, and announce the nomination of our newest development candidate, DCC-3009, a potential best-in-class pan-KIT inhibitor. We also presented preclinical data supporting the study of DCC-3116 in combination with QINLOCK in GIST and with encorafenib and cetuximab in colorectal cancer. This encouraging progress demonstrates that, as we work toward becoming a company with multiple approved medicines, our proprietary drug discovery platform continues to fuel our pipeline with innovative, potential first- and best-in-class kinase inhibitors.”
First Quarter 2023 Highlights and Upcoming Milestones
QINLOCK® (ripretinib)
Vimseltinib
DCC-3116
DCC-3084
DCC-3009
Kinase Switch-Control Research Engine
Corporate Update
First Quarter 2023 Financial Results
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement today, May 3, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BI75fb53c225a648b486e50d922b166468. A live webcast of the conference call will be available in the “Events and Presentations” page in the “Investors & News” section of the Company’s website at https://investors.deciphera.com/events-presentations. A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.
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 switch-control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Israel, Macau, New Zealand, Switzerland, Taiwan, the United Kingdom, and the United States. 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 and timing regarding the potential for our preclinical and/or clinical stage pipeline assets to be first-in-class and/or best-in-class treatments; our planned Phase 3 INSIGHT study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18; plans to present posters at the 2023 ASCO Annual Meeting; plans to announce top-line results from the pivotal Phase 3 MOTION study of vimseltinib in TGCT patients in the fourth quarter of 2023; plans to present updated data from the phase 1/2 study of vimseltinib in TGCT patients in the second half of 2023; plans to initiate one or more expansion cohorts in the Phase 1/2 study of DCC-3116 in the second half of 2023 in combination with trametinib, binimetinib, or sotorasib; plans to initiate two new dose escalation studies evaluating DCC-3116 in combination with ripretinib in GIST patients and in combination with encorafenib and cetuximab in patients with CRC; the anticipated benefits of our collaboration and supply agreement with Pfizer; plans to submit an IND for DCC-3084 in the second half of 2023; plans to submit an IND for DCC-3009 in the first half of 2024; and cash guidance. 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, our ability to successfully demonstrate the efficacy and safety of our drug or drug candidates, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, 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, 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 and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Annual Report on Form 10-K for the year ended December 31, 2022, 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.
The Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks and Deciphera is a trademark of Deciphera Pharmaceuticals, LLC.
Deciphera Pharmaceuticals, Inc. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | |||||||
| March 31, 2023 |
| December 31, 2022 | ||||
Assets |
|
|
| ||||
Current assets: |
|
|
| ||||
Cash and cash equivalents | $ | 114,637 |
|
| $ | 64,741 |
|
Short-term marketable securities |
| 283,996 |
|
|
| 259,745 |
|
Accounts receivable, net |
| 22,439 |
|
|
| 22,429 |
|
Inventory |
| 25,528 |
|
|
| 20,561 |
|
Prepaid expenses and other current assets |
| 29,559 |
|
|
| 25,482 |
|
Total current assets |
| 476,159 |
|
|
| 392,958 |
|
Long-term marketable securities |
| 27,627 |
|
|
| 14,550 |
|
Long-term investments—restricted and other long-term assets |
| 3,277 |
|
|
| 3,277 |
|
Property and equipment, net |
| 6,511 |
|
|
| 6,707 |
|
Operating lease assets |
| 35,445 |
|
|
| 36,547 |
|
Total assets | $ | 549,019 |
|
| $ | 454,039 |
|
Liabilities and Stockholders' Equity |
|
|
| ||||
Current liabilities: |
|
|
| ||||
Accounts payable | $ | 19,670 |
|
| $ | 18,612 |
|
Accrued expenses and other current liabilities |
| 60,942 |
|
|
| 64,622 |
|
Operating lease liabilities |
| 3,301 |
|
|
| 3,235 |
|
Total current liabilities |
| 83,913 |
|
|
| 86,469 |
|
Operating lease liabilities, net of current portion |
| 25,022 |
|
|
| 25,879 |
|
Total liabilities |
| 108,935 |
|
|
| 112,348 |
|
Commitments and contingencies |
|
|
| ||||
Stockholders' equity: |
|
|
| ||||
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized; no shares issued or outstanding |
| — |
|
|
| — |
|
Common stock, $0.01 par value per share; 125,000,000 shares authorized; 78,507,752 shares and 67,637,351 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively |
| 785 |
|
|
| 676 |
|
Additional paid-in capital |
| 1,722,452 |
|
|
| 1,575,361 |
|
Accumulated other comprehensive income (loss) |
| (181 | ) |
|
| (983 | ) |
Accumulated deficit |
| (1,282,972 | ) |
|
| (1,233,363 | ) |
Total stockholders' equity |
| 440,084 |
|
|
| 341,691 |
|
Total liabilities and stockholders' equity | $ | 549,019 |
|
| $ | 454,039 |
|
Deciphera Pharmaceuticals, Inc. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share amounts) | |||||||
| Three Months Ended March 31, | ||||||
|
| 2023 |
|
|
| 2022 |
|
Revenues: |
|
|
| ||||
Product revenues, net | $ | 33,222 |
|
| $ | 28,809 |
|
Collaboration revenues |
| 223 |
|
|
| 414 |
|
Total revenues |
| 33,445 |
|
|
| 29,223 |
|
Cost and operating expenses: |
|
|
| ||||
Cost of sales |
| 488 |
|
|
| 382 |
|
Research and development |
| 54,765 |
|
|
| 47,412 |
|
Selling, general, and administrative |
| 31,449 |
|
|
| 28,321 |
|
Total cost and operating expenses |
| 86,702 |
|
|
| 76,115 |
|
Loss from operations |
| (53,257 | ) |
|
| (46,892 | ) |
Other income (expense): |
|
|
| ||||
Interest and other income, net |
| 3,648 |
|
|
| — |
|
Total other income (expense), net |
| 3,648 |
|
|
| — |
|
Net loss | $ | (49,609 | ) |
| $ | (46,892 | ) |
|
|
|
| ||||
Net loss per share—basic and diluted | $ | (0.60 | ) |
| $ | (0.80 | ) |
Weighted average common shares outstanding—basic and diluted |
| 82,676,624 |
|
|
| 58,616,458 |
|
Last Trade: | US$25.51 |
Daily Change: | 0.01 0.04 |
Daily Volume: | 549,775 |
Market Cap: | US$2.210B |
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