NASDAQ false 0000872912 0000872912 2022-06-06 2022-06-06

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): June 6, 2022

DELCATH SYSTEMS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware |  | 001-16133 |  | 06-1245881
(State or other jurisdiction of incorporation) |  | (Commission File Number) |  | (IRS Employer Identification No.)

1633 Broadway, Suite 22C, New York, New York 10019
(Address of principal executive offices) (Zip Code)

(212) 489-2100

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class |  | Trading symbol(s) |  | Name of each exchange on which registered
Common Stock, $.01 par value |  | DCTH |  | The NASDAQ Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On June 6, 2022, Delcath Systems, Inc. (the “Company”) updated its corporate presentation. A copy of the slides used in the presentation are attached hereto as Exhibit 99.1. The furnishing of the attached corporate presentation is not an admission as to the materiality of any information therein. The information contained in the slides is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures. For important information about forward looking statements, see the slide titled “Forward Looking Statements” in Exhibit 99.1 attached hereto.

The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the presentation attached as Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 8.01. | Other Events.

On June 6, 2022, the Company issued a press release announcing three American Society of Clinical Oncology presentations related to percutaneous hepatic perfusion, or PHP, namely: (i) positive initial results from the Phase 1b portion of the CHOPIN trial of PHP in combination with ipilimumab plus nivolumab in treatment of advanced uveal melanoma patients, (ii) updated efficacy and safety results from the single-arm phase 3 FOCUS trial in metastatic uveal melanoma and (iii) the publication of an abstract reporting on a retrospective analysis in the change of Quality of Life using the Functional Assessment of Cancer Therapy – General scores for 13 PHP treated patients at the University of Southampton. The full text of the press release is attached as Exhibit 99.2 and incorporated in this Item 8.01 by reference.

Item 9.01. | Financial Statements and Exhibits.

(d) Exhibits:

99.1 |  | Delcath Systems, Inc. corporate presentation dated June 2022
99.2 |  | Delcath Systems, Inc. press release dated June 6, 2022
104 |  | Cover Page Interactive File (the cover page tags embedded within the Inline XBRL document)

SIGNATURE

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 thereunto duly authorized.

|  |  |  | DELCATH SYSTEMS, INC.
Date: June 7, 2022 |  |  |  | By: |  | /s/ Gerard Michel
|  |  |  |  |  | Name: Gerard Michel
|  |  |  |  |  | Title: Chief Executive Officer