On May 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 financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 3, 2023, View Source [SID1234630910]).

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"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 (Free AACR Whitepaper), 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)

Recorded $33.2 million in QINLOCK net product revenue in the first quarter of 2023, including $24.6 million in U.S. net product revenue and $8.6 million in international net product revenue, an increase of 15% compared to net product revenue of $28.8 million in the first quarter of 2022.
Granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) who received prior treatment with imatinib, and who harbor a KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18 mutations. The Company expects to initiate the INSIGHT study in the second half of 2023.
Included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for second-line GIST patients intolerant to sunitinib.
Will present posters at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting featuring updated overall survival (OS) and outcome data on patients without circulating tumor DNA (ctDNA) at baseline from the INTRIGUE Phase 3 study of QINLOCK in patients with advanced GIST previously treated with imatinib, along with information on the upcoming INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations.
Concluded successful price negotiations in Germany. In 2022, QINLOCK received a "major additional benefit" rating from Germany’s Federal Joint Committee (G-BA). QINLOCK is the first orphan oncology treatment in Germany to receive this rating for its lead indication and the only GIST treatment awarded with this recognition.
Vimseltinib

Completed enrollment for the MOTION pivotal Phase 3 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) and expects to announce top-line results from the study in the fourth quarter of 2023.
Expects to present updated data from the Phase 1/2 study of vimseltinib in the second half of 2023.
DCC-3116

Presented preclinical data on combinations with DCC-3116, an investigational, orally administered, selective, and potent switch-control kinase inhibitor of ULK1/2-mediated autophagy, at the American Association for Cancer (AACR) (Free AACR Whitepaper) Annual Meeting 2023, including preclinical models in combination with ripretinib in GIST models and with encorafenib and cetuximab in colorectal cancer (CRC) models.
Expects to initiate new combination escalation studies evaluating DCC-3116 in combination with ripretinib in patients with GIST and in combination with encorafenib and cetuximab in patients with CRC in the second half of 2023. Under the terms of the clinical trial collaboration and supply agreement with Pfizer, Inc., Deciphera will sponsor the study and Pfizer will supply encorafenib at no cost.
Expects to 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 KRAS G12C inhibitor sotorasib.
DCC-3084

Presented preclinical data for DCC-3084, a pan-RAF inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated a potential best-in-class profile based on its inhibition of Class I, II, and III BRAF mutations, BRAF fusions, and BRAF/CRAF heterodimers, and optimized pharmaceutical properties.
Expects to submit an investigational new drug (IND) application to the FDA for DCC-3084 in the second half of 2023.
DCC-3009

Presented preclinical data for DCC-3009, a potential best-in-class pan-KIT inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated its ability to potently and selectively inhibit the broad spectrum of known primary and secondary drug-resistant mutations in GIST models, spanning KIT exons 9, 11, 13, 14, 17, and 18.
Expects to submit an IND to the FDA for DCC-3009 in the first half of 2024.
Kinase Switch-Control Research Engine

Presented new preclinical data from research programs focused on GCN2 and PERK, novel targets in the integrated stress response pathway, at the AACR (Free AACR Whitepaper) Annual Meeting 2023.
Corporate Update

Announced the closing in January 2023 of its underwritten public offering of 7,986,111 shares of its common stock at a public offering price of $18.00. The aggregate gross proceeds to Deciphera from this offering were approximately $143.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
First Quarter 2023 Financial Results

Revenue: Total revenue for the first quarter of 2023 was $33.4 million, which includes $33.2 million of net product revenue of QINLOCK and $0.2 million of collaboration revenue compared to $29.2 million of total revenue, including $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue, for the same period in 2022.
Cost of Sales: Cost of sales were $0.5 million in the first quarter of 2023, which includes $0.4 million in cost of product sales, compared to cost of sales of $0.4 million for the first quarter of 2022. In the third quarter of 2022, Deciphera completed the sale of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
R&D Expenses: Research and development expenses for the first quarter of 2023 were $54.8 million, compared to $47.4 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs related to the MOTION Phase 3 study of vimseltinib, the Phase 1/2 study of DCC-3116, and clinical study costs for QINLOCK, including the Phase 3 INTRIGUE study. Non-cash, stock-based compensation was $5.4 million and $6.3 million for the first quarters of 2023 and 2022, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2023 were $31.4 million, compared to $28.3 million for the same period in 2022. The increase was primarily due to an increase in professional, consulting, and other expenses, partially offset by a decrease in personnel-related costs. Non-cash, stock-based compensation was $7.0 million and $8.0 million for the first quarters of 2023 and 2022, respectively.
Net Loss: For the first quarter of 2023, Deciphera reported a net loss of $49.6 million, or $0.60 per share, compared with a net loss of $46.9 million, or $0.80 per share, for the same period in 2022.
Cash Position: As of March 31, 2023, cash, cash equivalents, and marketable securities were $426.3 million, compared to $339.0 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 2026.
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 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.