Delcath Systems, Inc. announced that the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) 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. mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year. 90% of mUM involves the liver, and liver failure is often the cause of death.

National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases. HEPZATO K IT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO Kit, is already included in the NCCN guidelines. The Company plans to have commercial product available in the fourth quarter, and patients will continue to be enrolled and treated at Expanded Access Program (EAP) sites.

The approval of HEPZATO K It was based primarily on the results of the FOCUS Study (NCT02678572), a Phase 3, single arm, multicenter, open label study, which administered HEPZATO (melphalan) via the hepatic delivery system (HDS) during a PHP procedure. Ninety-one (91) patients received treatment every 6 to 8 weeks, for up to 6 treatments. Because of this, National Comprehensive Cancer Network guidelines recommends liver-directed therapies for patients with metastases to the liver, including embolization (i.e., transarterialchemoembolization, radioembolization or immunoembolization), ablative procedures (i.e., thermal ablation, cryotherapy) as well as PHP which can only be performed with the HEPZATO KATO KIT.

It is noteworthy that PHP was already on guidelines prior to FDA approval. Metastatic uveal melanoma tumors in the liver tend to have a miliary pattern of spread where there are numerous radiographically evident and microscopically occult metastases in the liver. Delcath will hold a business update conference call August 15, 2023, at 8:00 AM Eastern Time to discuss the FDA approval.

HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZatO KIT REMS. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO TIT; the Company's successful management of the HEPZATOKIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATOkIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZatOKIT KIT's successful implementation and management of The HEPZATO. The approval effectively triggers the second tranche of financing tied to the previously announced March 29, 2023Private Investment in Public Equity (PIPE) financing. Participants in the PIPE have 21 days to exercise their Tranche A warrants, translating to up to approximately $34.9 million of additional funding to Delcath.

In addition, upon the Company's announcement of recording at least $10.0 million in quarterly U.S. revenue from the commercialization of HEPZATO KIT, participants in the PIPE will have 21 days to exercise their Tranche B warrants, resulting in up to an additional $24.9 million in funding to Delcath.