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): August 14, 2023
DELCATH SYSTEMS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 001-16133 | 06-1245881 | ||
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (IRS Employer Identification No.) |
1633 Broadway, Suite 22C, New York, New York 10019 |
(Address of principal executive offices) |
(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, $0.01 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 August 14, 2023, Delcath Systems, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) approved the Company’s HEPZATO Kit™ (“HEPZATO”) for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On August 14, 2023, the Company released an updated corporate presentation on the “Events & Presentations” section of the Company’s website at https://delcath.com/investors/events-presentations/. The Company has scheduled a conference call to take place on August 15, 2023, relating to the FDA approval of HEPZATO. A copy of the corporate presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be deemed incorporated by reference in any registration statement or other filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.
Item 8.01. | Other Events. |
On August 14, 2023, the FDA approved HEPZATO for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release, dated August 14, 2023. | |
99.2 | Corporate Presentation. | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
DELCATH SYSTEMS, INC. | ||||||
Date: August 15, 2023 | By: | /s/ Gerard Michel | ||||
Name: | Gerard Michel | |||||
Title: | Chief Executive Officer |