Business
Delcath Systems Reports First Quarter 2022 Results and Provides Business Update
NEW YORK , May 10, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and
About this update from Delcath Systems, Inc.
[{"type":"text","content":"NEW YORK , May 10, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the first quarter ended March 31, 2022. Recent Business Highlights During and since the first quarter, Delcath: Held a pre-NDA meeting with FDA and announced plans to file an NDA in the third quarter of 2022,Announced the acceptance of a poster presentation updating results from the FOCUS Phase 3 Trial at the upcoming American Society of Clinical Oncology (ASCO) 2022 Annual Meeting,Resumed direct responsibility for sales, marketing, and distribution activities for the CHEMOSAT® Hepatic Delivery System in all of Europe,Achieved medical device regulation (MDR) certification for CHEMOSAT in Europe, which is now regulated as a Class lll device,Announced that investigators from the University Hospital Southampton published in Melanoma Research results of a single center study on Delcath's CHEMOSAT Hepatic Delivery System in 81 metastatic uveal melanoma patients with liver dominant disease receiving 250 treatments showing hepatic disease control rate of 88.9%, hepatic response rate of 66.7% and overall response rate of 60.5%, andAppointed David Hoffman as General Counsel and Chief Compliance Officer and Anthony Dias as Vice President of Finance. “During and since the first quarter, we held a pre-NDA meeting with FDA and, while we wait for the final meeting minutes from FDA, we do not believe any additional pre-clinical or clinical studies will be required in order to file the NDA. We expect to file the NDA in the third quarter of 2022,” said Gerard Michel, CEO of Delcath. “Additionally, the body of published research on the efficacy of our CHEMOSAT system in the European commercial setting continued to grow, we resumed direct sales of CHEMOSAT in Europe, and we strengthened our leadership team. These accomplishments move us much closer to achieving our strategic priorities — filing of the HEPZATO NDA, preparing for the subsequent US launch when approved, and expanding the clinical development of HEPZATO and CHEMOSAT into additional indications of high unmet medical need.” First Quarter 2022 Results Income Statement Highlights. Total revenue for the three months ended March 31, 2022 and 20...