On January 3, 2023 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, reported its strategic outlook for 2023 and planned 2023 corporate milestones, and reported preliminary unaudited fourth quarter and full year 2022 revenue (Press release, Deciphera Pharmaceuticals, JAN 3, 2023, View Source [SID1234625729]).
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In a separate press release issued today, Deciphera announced results from an exploratory analysis of circulating tumor DNA (ctDNA) from the INTRIGUE Phase 3 clinical study of QINLOCK in patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib, demonstrating substantial clinical benefit of QINLOCK in second-line GIST patients with mutations in KIT exon 11 and 17/18 only. The Company also announced plans to initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in this patient population in the second half of 2023.
"We are extremely proud of the significant progress made across our pipeline in 2022 and are in a strong position to build upon this momentum in 2023 with key commercial, clinical, and preclinical milestones on the horizon," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "We believe that Deciphera is on track to become a company with multiple approved products, and that QINLOCK and vimseltinib together have the potential to exceed one billion dollars in global revenue annually. At the same time, we continue to complement these commercial goals with research and development innovation powered by our proprietary switch-control discovery platform to drive new growth opportunities with potential first-in-class or best-in-class kinase inhibitors."
Business updates and planned 2023 corporate milestones include:
QINLOCK (ripretinib)
Present additional data from the INTRIGUE Phase 3 exploratory ctDNA analysis at a medical meeting in January 2023.
Initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18 only in the second half of 2023.
Continue European geographic expansion of QINLOCK in 2023, with planned commercial launches following conclusion of pricing and reimbursement negotiations in key European markets.
Vimseltinib
Complete enrollment for the pivotal Phase 3 MOTION study of vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R for the potential treatment of tenosynovial giant cell tumor (TGCT), in the first half of 2023 and announce top-line results from the study in the fourth quarter of 2023.
Present updated data from the Phase 1/2 study of vimseltinib in the second half of 2023.
DCC-3116
Present updated data from the single agent dose escalation phase and initial data from the combination dose escalation cohorts of the Phase 1/2 study of DCC-3116, an investigational switch-control kinase inhibitor of ULK1/2 designed to inhibit autophagy, in the second half of 2023.
Initiate one or more expansion cohorts in the ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in combination with the MEK inhibitors trametinib or binimetinib, or the KRASG12C inhibitor sotorasib.
Initiate a new dose escalation combination study evaluating DCC-3116 in combination with encorafenib and cetuximab in patients with colorectal cancer in the second half of 2023. Under the terms of the clinical trial collaboration and supply agreement with Pfizer, Inc., Deciphera will sponsor the trial and Pfizer will supply encorafenib at no cost.
Present preclinical data on new clinical combinations with DCC-3116 in the first half of 2023.
DCC-3084
Submit an investigational new drug (IND) application with the FDA for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the second half of 2023.
Present in vitro and in vivo data demonstrating a preclinical profile as a potent and selective inhibitor of BRAF/CRAF kinases, with optimized pharmaceutical properties for development in both single-agent and combination opportunities, in the first half of 2023.
Kinase Switch-Control Research Engine
Nominate a new development candidate from Deciphera’s proprietary discovery engine of novel switch-control inhibitors in the first half of 2023.
Present new preclinical data from research programs at medical meetings in 2023.
Preliminary 2022 Financial Results
Based on preliminary unaudited financial information, Deciphera expects total fourth quarter 2022 revenue to be approximately $36 million and total full year 2022 revenue to be approximately $134 million. QINLOCK net product revenue is estimated to be approximately $33 million, including approximately $26 million in U.S. net product revenue and approximately $7 million in international net product revenue, in addition to approximately $3 million in collaboration revenue. International and total net product revenue for the fourth quarter includes a one-time reserve for QINLOCK product sales in Germany due to a change in German law effective retroactively as of November 2022 shortening the free pricing period to six months from twelve months.
In addition, cash, cash equivalents, and marketable securities was approximately $339 million as of December 31, 2022. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Preliminary selected financial information presented in this release are unaudited, subject to adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results expected in February 2023.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss the ctDNA analysis results from the INTRIGUE Phase 3 clinical study, its planned 2023 corporate milestones and a general business update, today, January 3, 2023, at 5:00 PM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BI4841f7cb08a04e5ba80127e42e643432. 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 View Source 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.