UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 11, 2004 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 001-16133 06-1245881 (State or other (Commission File Number) (IRS Employer jurisdiction of Identification No.) incorporation) 1100 Summer Street, Stamford, Connecticut 06905 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (203) 323-8668 N/A (Former name or former address, if changes since last report) 2 Item 5. Other Events and Regulation FD Disclosure On March 11, 2004, Delcath Systems, Inc. (the "Company") issued a press release relating to the enrollment of the first patient in its Phase III clinical trial for inoperable cancer in the liver Company's press release dated March 11, 2004 is incorporated herein by reference and filed as an exhibit hereto. Item 7. Financial Statements and Exhibits. (a) Not applicable (b) Not applicable. (c) Exhibits: Exhibit Description ------- ----------- 99 Press Release dated March 11, 2004 of Delcath Systems, Inc. 3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. DELCATH SYSTEMS, INC. By: /s/ M. S. KOLY ---------------------- M. S. Koly President and Chief Executive Officer Date: March 11, 2004 EXHIBIT INDEX Exhibit Description ------- ----------- 99 Press Release dated March 11, 2004 of Delcath Systems, Inc.