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WALTHAM, Mass.--(BUSINESS WIRE)--Nov 3, 2022--
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 third quarter ended September 30, 2022 and provided a corporate update.
“Our strong third quarter results continue the exceptional progress we have made across our business in 2022: QINLOCK® delivered another quarter of record revenue, we reported exciting data at ESMO for our two clinical programs and we nominated the next clinical development candidate from our proprietary research platform,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “We have already begun building upon this momentum in the fourth quarter with key milestones including our announcement today of the opening of enrollment in our combination escalation cohorts in the Phase 1 study of DCC-3116 and the treatment of the first patient.”
Mr. Hoerter continued, “We remain inspired by QINLOCK’s impact on the treatment of patients with GIST, in the U.S., Europe, and other countries around the world, as we focus on expanding the geographic reach of this breakthrough medicine. We achieved important milestones in the third quarter in our two clinical programs, vimseltinib and DCC-3116, with exciting data updates at the ESMO Congress in September. The best-in-class potential of vimseltinib in TGCT was underscored by the high response rates and the preliminary patient-reported outcome results, which found clinically meaningful improvements in both pain and stiffness. We also presented first-in-human data for DCC-3116 demonstrating a favorable safety and pharmacokinetic profile and strong target inhibition across all dose levels studied. Building upon this quarter’s clinical success and leveraging the full potential of our switch control kinase inhibitor discovery platform, we are excited to announce our new clinical development candidate, DCC-3084, that has best-in-class potential as a pan-RAF inhibitor.”
Third Quarter 2022 Highlights and Upcoming Milestones
QINLOCK (ripretinib)
Vimseltinib
DCC-3116
DCC-3084
Corporate Update
Third Quarter 2022 Financial Results
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement today, November 3, 2022, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BIddf165cd801a473885dd3605fd55f7da. A live webcast of the conference call will be available in the “Events and Presentations” page in the “Investors” 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, 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 our plans to expand the geographic reach of QINLOCK, the potential for our pre-clinical and/or clinical stage pipeline assets to be first-in-class and/or best-in-class treatments, enrollment of three combination dose escalation cohorts in the Phase 1 study of DCC-3116, enrollment in the pivotal Phase 3 MOTION study of vimseltinib in TGCT patients, the potential for DCC-3084 to be a key differentiator from other pan-RAF programs in development, 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, 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of Deciphera Pharmaceuticals, LLC.
Deciphera Pharmaceuticals, Inc. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | ||||||||
| September 30, 2022 |
| December 31, 2021 | |||||
Assets |
|
|
| |||||
Current assets: |
|
|
| |||||
Cash and cash equivalents | $ | 82,538 |
|
| $ | 87,063 |
| |
Short-term marketable securities |
| 282,039 |
|
|
| 198,571 |
| |
Accounts receivable, net |
| 23,278 |
|
|
| 20,595 |
| |
Inventory |
| 19,129 |
|
|
| 14,125 |
| |
Prepaid expenses and other current assets |
| 13,895 |
|
|
| 18,660 |
| |
Total current assets |
| 420,879 |
|
|
| 339,014 |
| |
Long-term marketable securities |
| 7,006 |
|
|
| 41,950 |
| |
Long-term investments—restricted and other long-term assets |
| 3,276 |
|
|
| 3,110 |
| |
Property and equipment, net |
| 7,152 |
|
|
| 8,610 |
| |
Operating lease assets |
| 37,639 |
|
|
| 36,800 |
| |
Total assets | $ | 475,952 |
|
| $ | 429,484 |
| |
Liabilities and Stockholders' Equity |
|
|
| |||||
Current liabilities: |
|
|
| |||||
Accounts payable | $ | 12,800 |
|
| $ | 13,130 |
| |
Accrued expenses and other current liabilities |
| 59,498 |
|
|
| 80,773 |
| |
Operating lease liabilities |
| 3,170 |
|
|
| 2,870 |
| |
Total current liabilities |
| 75,468 |
|
|
| 96,773 |
| |
Operating lease liabilities, net of current portion |
| 26,708 |
|
|
| 27,991 |
| |
Total liabilities |
| 102,176 |
|
|
| 124,764 |
| |
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; 67,429,720 shares and 58,549,644 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively |
| 674 |
|
|
| 585 |
| |
Additional paid-in capital |
| 1,562,572 |
|
|
| 1,358,516 |
| |
Accumulated other comprehensive income (loss) |
| (2,042 | ) |
|
| 51 |
| |
Accumulated deficit |
| (1,187,428 | ) |
|
| (1,054,432 | ) | |
Total stockholders' equity |
| 373,776 |
|
|
| 304,720 |
| |
Total liabilities and stockholders' equity | $ | 475,952 |
|
| $ | 429,484 |
|
Deciphera Pharmaceuticals, Inc. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended September 30, |
| Nine Months Ended September 30, | |||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||||||
Revenues: |
|
|
|
|
|
|
| |||||||||
Product revenues, net | $ | 32,318 |
|
| $ | 21,682 |
|
| $ | 92,624 |
|
| $ | 63,692 |
| |
Collaboration revenues |
| 3,656 |
|
|
| 1,538 |
|
|
| 5,067 |
|
|
| 8,257 |
| |
Total revenues |
| 35,974 |
|
|
| 23,220 |
|
|
| 97,691 |
|
|
| 71,949 |
| |
Cost and operating expenses: |
|
|
|
|
|
|
| |||||||||
Cost of sales |
| 3,344 |
|
|
| 917 |
|
|
| 5,525 |
|
|
| 2,414 |
| |
Research and development |
| 47,485 |
|
|
| 66,444 |
|
|
| 139,755 |
|
|
| 182,109 |
| |
Selling, general, and administrative |
| 30,026 |
|
|
| 35,527 |
|
|
| 87,972 |
|
|
| 99,102 |
| |
Total cost and operating expenses |
| 80,855 |
|
|
| 102,888 |
|
|
| 233,252 |
|
|
| 283,625 |
| |
Loss from operations |
| (44,881 | ) |
|
| (79,668 | ) |
|
| (135,561 | ) |
|
| (211,676 | ) | |
Other income (expense): |
|
|
|
|
|
|
| |||||||||
Interest and other income, net |
| 1,838 |
|
|
| (170 | ) |
|
| 2,565 |
|
|
| 107 |
| |
Total other income (expense), net |
| 1,838 |
|
|
| (170 | ) |
|
| 2,565 |
|
|
| 107 |
| |
Net loss | $ | (43,043 | ) |
| $ | (79,838 | ) |
| $ | (132,996 | ) |
| $ | (211,569 | ) | |
|
|
|
|
|
|
|
| |||||||||
Net loss per share—basic and diluted | $ | (0.55 | ) |
| $ | (1.37 | ) |
| $ | (1.82 | ) |
| $ | (3.65 | ) | |
Weighted average common shares outstanding—basic and diluted |
| 78,206,647 |
|
|
| 58,107,611 |
|
|
| 73,129,804 |
|
|
| 57,948,612 |
|
View source version on businesswire.com:https://www.businesswire.com/news/home/20221103005478/en/
CONTACT: Investor Relations:
Maghan Meyers
Argot Partners
Deciphera@argotpartners.com
212-600-1902Media:
David Rosen
Argot Partners
david.rosen@argotpartners.com
212-600-1902
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY
SOURCE: Deciphera Pharmaceuticals, Inc.
Copyright Business Wire 2022.
PUB: 11/03/2022 07:00 AM/DISC: 11/03/2022 07:02 AM
http://www.businesswire.com/news/home/20221103005478/en