Business
Delcath Systems Reports Third Quarter 2022 Results and Provides Business Update
NEW YORK, Nov. 8, 2022 /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, Nov. 8, 2022 /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 third quarter ended September 30, 2022.\n\n \n \n \n \n \n \n\n \nRecent Business Highlights\nDuring and since the third quarter, Delcath:\nConfirmed the pending resubmission of the NDA for the Hepzato Kit® (melphalan hydrochloride for injection/Hepatic Delivery System) to the FDA by the end of the year,Attracted a growing number of sites to our Expanded Access Program (EAP),Strengthened its balance sheet by raising $5 million in a private placement priced at market,Reached terms of settlement to end its dispute with medac, its former distributor in Europe, andAnnounced that independent investigators published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology\"We are excited by the level of clinician interest in Hepzato and have enrolled three EAP sites with an additional four sites in process\" said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, \"We continue to make progress toward the resubmission of the Hepzato Kit NDA by the end of this year, and assuming a six-month review, we consequently would expect a PDUFA date by the end of June 2023.\"\nThird Quarter 2022 Results\nIncome Statement Highlights.\nTotal revenue for the three months ended September 30, 2022, was approximately $0.9 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to direct product sales for the third quarter of 2022 compared to the revenue share arrangement with our distribution partner in Europe during the third quarter of 2021. \nResearch and development expenses for the quarter were $4.0 million, compared to $3.0 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the expenses incurred in preparation for our NDA filing by the end of the year. Selling, general and administrative expenses for the quarter were approximately $4.5 million, compared to ...