DELCATH SYSTEMS, INC.

Delcath Systems, Inc. is an interventional oncology company that focuses on treating cancers that are either primary to or have spread to the liver. The company's main product is the HEPZATO TM KIT (melphalan for Injection/Hepatic Delivery System), a drug/device combination product. The HEPZATO KIT was approved by the US Food and Drug Administration (FDA) on August 14, 2023. It is indicated as a liver-directed treatment for adult patients with uveal melanoma that has spread to the liver (unresectable hepatic metastases) affecting less than 50% of the liver, with no disease outside the liver, or with disease outside the liver limited to the bone, lymph nodes, subcutaneous tissues, or lung that can be removed by surgery or treated with radiation. The first commercial use of HEPZATO for metastatic hepatic dominant uveal melanoma (mUM) occurred in January 2024. In the United States, HEPZATO is regulated as a drug by the FDA, with primary regulatory jurisdiction assigned to the FDA's Center for Drug Evaluation and Research. Delcath Systems has received six orphan drug designations from the FDA: five for melphalan for treating ocular (uveal) melanoma, cutaneous melanoma, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications, and one for doxorubicin for treating hepatocellular carcinoma. The company has enough raw materials and components for the HEPZATO KIT to meet expected demand and manages supply chain risk by stockpiling inventory and using multiple suppliers for critical components.