Business
Delcath Systems Reports Second Quarter 2023 Results and Provides Business Update
NEW YORK, Aug. 9, 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, Aug. 9, 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 financial results for the second quarter ended June 30, 2023.\n\n \n \n \n \n \n \n\n \nRecent Business Highlights\nDuring and since the second quarter, Delcath:\nHas continued to communicate with the United States Food and Drug Administration (FDA) as the agency continues its review of the HEPZATO KIT™ New Drug Application (NDA) resubmission with an anticipated PDUFA date of August 14, 2023;Received stockholders approval for the potential issuance in excess of 19.99% of Delcath's outstanding common stock upon the conversion of the preferred stock issued pursuant to a private placement that closed on March 29, 2023 and generated $25 million on closing with up to an additional $35 million expected upon the exercise of warrants into additional series of preferred stock upon the approval of the HEPZATO KIT NDA and up to an additional $25 million upon the achievement of $10 million in quarterly revenue;Hired Vojislav Vukovic, MD, PhD as Chief Medical Officer; Sandra Pennell as Senior Vice President of Finance; and Zac MacLean as Director of Sales and Strategy; andContinued to treat patients at 3 Expanded Access Program sites.\"As we approach the August 14 PDUFA date, the Company has been preparing for the commercialization of HEPZATO KIT, if approved,\" said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, \"As part of this preparation, we continue to add experienced personnel across the key functional areas involved in commercialization.\"\nDelcath will schedule an update call shortly after the FDA's action on the HEPZATO KIT NDA resubmission, which the Company expects to occur on or around the anticipated PDUFA date of August 14, 2023.\nSecond Quarter 2023 Results\nFinancial Highlights.\nTotal revenue for the three months ended June 30, 2023, was approximately $0.5 million, compared to $0.8 million for the prior year period, from our sales of CHEMOSAT in Europe. This decrease in product revenue is primarily due to potential commercial patients in the Netherlands being treated in the CHOPIN trial and reduced demand in Germany, possibly due to tebentefusp usage...