Business
Delcath Systems Provides Business Update and Reports Preliminary First Quarter 2023 Financial Results
NEW YORK, May 12, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (Delcath or the "Company"), an interventional oncology company focused on the
About this update from Delcath Systems, Inc.
[{"type":"text","content":"NEW YORK, May 12, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (Delcath or the \"Company\"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and certain preliminary financial results for the first quarter ended March 31, 2023.\n\n \n \n \n \n \n \n\n \nRecent Business Highlights\nDuring and since the first quarter, Delcath:\nReceived an acknowledgement of Class 2 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) goal date of August 14, 2023,Completed a private placement of up to $85 million in gross proceeds, including the closing of initial upfront funding of $25 million. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management LLC, and Serrado Capital LLC as well as existing investors including Rosalind Advisors,Amended an existing loan agreement with Avenue Venture Opportunities Fund, L.P. to provide an interest only period spanning March 31, 2023, to September 30, 2023 thereby deferring $4.3 million in principal payments,Appointed John R. Sylvester as Chairman of the Board, andAnnounced that updated results from the CHOPIN phase 1B trial were published in the Journal Cardiovascular and Interventional Radiology. The article reported seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab showed a median PFS of 29.1 months at a median follow-up of 29.1 months.\"With a critical financing behind us, the Company is focused on preparing to commercialize Hepzato if approved,\" said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, \"Importantly, as we approach the August 14 PDUFA date, we continue to expand the list of institutions that have indicated their interest in becoming a treating center upon approval.\"\nPreliminary First Quarter 2023 Financial Results\nDelcath is in the process of completing its customary quarter-end close and review procedures, including certain valuation work associated with the issuance of warrants and preferred stock in Delcath's previously announced private placement that closed on March 29, 2023, as of and for the quarter ended Ma...