DELCATH SYSTEMS, INC.

Unless the context otherwise requires, all references in this Annual Report on Form 10-K to the Company , Delcath , Delcath Systems , we , our , and us refers to Delcath Systems, Inc., a Delaware corporation, incorporated in August 1988, and all entities included in our consolidated financial statements. Our corporate offices are located at 566 Queensbury Avenue, Queensbury, New York 12804. Our telephone number is (518) 743-8892 and our internet address is www.delcath.com. The information found on, or otherwise accessible through, our website is not incorporated by reference into, and does not form a part of, this Annual Report on Form 10-K. Company Overview We are an interventional oncology company focused on the treatment of cancers primary or metastatic to the liver. Our lead product, the HEPZATO TM KIT (melphalan for Injection/Hepatic Delivery System), a drug/device combination product ( HEPZATO or HEPZATO KIT ), was approved by the US Food and Drug Administration (the FDA ) on August 14, 2023, indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection, or radiation. The first commercial use of the HEPZATO for the treatment of metastatic hepatic dominant uveal melanoma ( mUM ) took place in January 2024. In the United States, HEPZATO is considered a combination drug and device product and is regulated as a drug by the FDA.