Delcath Systems (DCTH) Registration Filing summary

Company overview and business model

• Focuses on interventional oncology, targeting primary and metastatic liver cancers.

• Lead product, HEPZATO KIT, is FDA-approved for liver-directed treatment of uveal melanoma with unresectable hepatic metastases.

• In Europe, markets CHEMOSAT Hepatic Delivery System as a stand-alone device for a range of liver cancers.

• Holds multiple orphan drug designations and manages supply chain risk through inventory and multiple suppliers.

• Plans to expand clinical studies for HEPZATO KIT to additional liver-related cancers in 2024.

Financial performance and metrics

• Audited consolidated financial statements as of December 31, 2023 and 2022 are incorporated by reference, with a going concern explanatory paragraph.

Use of proceeds and capital allocation

• Net proceeds will be used for general corporate purposes, including commercialization, manufacturing, R&D, and administrative expenses.

• May use proceeds to pay off debt or acquire complementary businesses, products, or technologies.

• Pending use, proceeds will be invested in short-term, investment-grade securities.