Delcath Systems Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events
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Item 7.01 Regulation FD Disclosure.
On May 22, 2025, Delcath Systems, Inc. (“Delcath”) issued a press release announcing 2025 full year guidance. A copy of the press release is furnished pursuant to Item 7.01 as Exhibit 99.1 hereto and is incorporated herein by reference.
The information furnished pursuant to this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
On May 22, 2025, Delcath announced that it plans to enter into a National Medicaid Drug Rebate Agreement (the “NDRA”) with the Centers for Medicare & Medicaid Services and that it expects the NDRA to take effect at the beginning of the third quarter of 2025.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Delcath or on its behalf. This Form 8-K contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to Delcath’s ability to successfully enter into the NDRA and its potential impact Delcath’s business and operations. For additional information and other factors that may impact Delcath, please see Delcath’s other filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, investors should not place undue reliance on these forward-looking statements, which speak only as of this Current Report on Form 8-K. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated May 22, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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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: May 22, 2025 | By: | /s/ Sandra Pennell | ||||
| Name: Sandra Pennell | ||||||
| Title: Chief Financial Officer | ||||||
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