Item 8.01. Other Events.

Delcath Systems, Inc. (the "Company") previously stated in the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2022, the Company's plan to submit a New Drug Application for its Hepzato™ Kit (the "NDA") to the U.S. Food and Drug Administration ("FDA") by the end of 2022. The foregoing has been updated to reflect the Company's intention to submit the NDA to the FDA during the first quarter of 2023.

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