Business
Delcath Systems Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update
NEW YORK, March 27, 2023 /PRNewswire/ -- 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, March 27, 2023 /PRNewswire/ -- 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 fourth quarter and full year ended December 31, 2022.\n\n \n \n \n \n \n \n\n \nRecent Business Highlights\nDuring and since the fourth quarter, Delcath Systems, Inc. (Delcath or the Company):\nReceived an acceptance of the NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit® (melphalan hydrochloride for injection/Hepatic Delivery System) with a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2023,Priced a financing that is expected to provide an initial upfront funding of $25 million, with up to an additional $60 million tied to satisfaction of milestones, in gross proceeds to Delcath through a private placement. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management, LLC, Serrado Capital LLC and existing investor, Rosalind Advisors,Completed in December a private placement with existing investors priced at market for a total of $11.2 million funds raised in 2022,Announced the rotation of its Board of Directors with John R. Sylvester appointed as Chairman, andReached terms of settlement to end its dispute with medac, its former distributor in Europe.In addition, during and since the fourth quarter, independent investigators published:\nUpdated results from the CHOPIN phase 1B trial in which seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab show a median PFS of 29.1 months at a median follow-up of 29.1 months, andResults of a Single Center Study in the treatment of Cholangiocarcinoma (CCA) in which the authors concluded that percutaneous hepatic perfusion (PHP) with CHEMOSAT is an effective and safe treatment option for patients with advanced CCA and has the potential to prolong life in patients with inoperable, treatment-refractory liver metastases. The authors highlighted the increasing importance of locoregional forms of therapy in the treatment of CCA and that the new edition of the German S3 cancer guideline \"Diagnostics and Therapy of Hepatocellular Carcinoma and Biliary Carcinomas\" now includes PHP with melp...