Delcath Systems, Inc. Announces Positive Results from Independent Study on Liver-Directed Therapy for Uveal Melanoma Patients

Delcath Systems, Inc. Announces Positive Results from Independent Study on Liver-Directed Therapy for Uveal Melanoma Patients

NEW YORK - August 28, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the Company or Delcath ), an interventional oncology company focused on

the treatment of primary and metastatic cancers of the liver, today announced the publication of a clinical study in the journal Therapeutic Advances in Medical Oncology. The publication, entitled Melanoma-specific survival of patients with

uveal melanoma and liver metastases diagnosed between 2005 and 2021 , was based on an independent retrospective clinical study conducted by investigators from the University of T bingen, Germany. The study demonstrates that first-line

liver-directed therapies, including Delcath s CHEMOSAT Hepatic Delivery System, significantly improve melanoma-specific survival (MSS) in patients with liver metastases from uveal

melanoma, compared to first-line systemic therapies.

Key Findings from the Study:

During the 2005-2015 period, 33 patients received

liver-directed therapy, with 8 of those receiving CHEMOSAT. In the 2016-2021 period, 56 patients received liver-directed therapy, with 30 of those receiving CHEMOSAT.

Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, We are encouraged by the findings from this independent study, which

reinforce the critical role of liver-directed therapies in the first-line setting, including our CHEMOSAT system, in treating patients with liver metastases from uveal melanoma.

The publication is available here.

Systems, Inc., HEPZATO KIT and CHEMOSAT

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic

liver cancers. The company s proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan

percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT

is comprised of the chemotherapeutic drug melphalan and Delcath s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating

hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically

meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) 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. Please see the full Prescribing

Information, including BOXED WARNING for the HEPZATO KIT.

In Europe, the device-only configuration of the HDS is regulated as a Class III

medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide

range of cancers of the liver.

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