On January 8, 2024 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 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue (Press release, Deciphera Pharmaceuticals, JAN 8, 2024, View Source [SID1234639071]).

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"2023 was a year of important progress across our organization, in which we demonstrated our ability to drive commercial growth while advancing our clinical pipeline and strategically investing in key earlier-stage programs," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "Thanks to our late-stage clinical execution and global commercial excellence, we have the potential to reach $1 billion in peak revenue with QINLOCK and vimseltinib, and we look forward to continuing this exciting evolution as we work to become a self-sustaining, multi-product company."

Planned 2024 corporate milestones and business updates include:

QINLOCK (ripretinib)

Continue enrolling the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in second-line gastrointestinal stromal tumor (GIST) patients with mutations in KIT exon 11 and 17/18 only.
Publication in Nature Medicine in January 2024 of the results of a ctDNA analysis from the INTRIGUE Phase 3 study demonstrating substantial clinical benefit of QINLOCK in second-line GIST patients with mutations in KIT exon 11 and 17/18 only.
Continue the geographic expansion of QINLOCK in fourth-line GIST, with planned commercial launches following conclusion of pricing and reimbursement negotiations in European and international markets.
The Company has entered into a supply and distribution agreement with GENESIS Pharma, a leading regional biopharma company, in Central and Eastern Europe under which GENESIS Pharma will be the exclusive distributor of QINLOCK in 14 countries in the European Union with a combined population of 118 million including Czech Republic, Greece, Hungary, Romania and Poland.
Vimseltinib

Submit an NDA to the U.S. Food and Drug Administration (FDA) in the second quarter of 2024 and a MAA to the European Medicines Agency in the third quarter of 2024 for vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R, for the potential treatment of TGCT.
Present additional results from Part 1 of the pivotal Phase 3 MOTION study of vimseltinib at a medical meeting in the second quarter of 2024.
Present updated data from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
Initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of cGVHD in the fourth quarter of 2024.
Early-Stage Pipeline

DCC-3116

The Company expects to select a recommended Phase 2 dose for expansion cohort(s) for DCC-3116, an investigational switch-control kinase inhibitor of ULK1/2 designed to inhibit autophagy, in 2024.
The Company has prioritized the development of DCC-3116 in combination with sotorasib and with QINLOCK and discontinued development of the encorafenib and cetuximab combination cohort prior to enrollment in any clinical studies as well as the two MEK combination cohorts.
DCC-3084

Initiate a Phase 1 study for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the first half of 2024.
DCC-3009

Submit an investigational new drug (IND) application with the FDA for DCC-3009, a potential best-in-class pan-KIT inhibitor, in the first half of 2024 and initiate a Phase 1 study in the second half of 2024.
Preliminary 2023 Financial Results

Based on preliminary unaudited financial information, Deciphera expects total fourth quarter 2023 revenue to be approximately $47 million and total full year 2023 revenue to be approximately $162 million. QINLOCK net product revenue is estimated to be approximately $46 million in the fourth quarter 2023, including approximately $35 million in U.S. net product revenue and approximately $11 million in international net product revenue, in addition to approximately $1 million in collaboration revenue.

In addition, preliminary unaudited cash, cash equivalents, and marketable securities was approximately $352 million as of December 31, 2023. 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 the second half of 2026.

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 2024.