Delcath Systems Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Regulation FD Disclosure
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Item 2.02 Results of Operations and Financial Condition.
On January 9, 2026, Delcath Systems, Inc. (“Delcath”) issued a press release (the “Press Release”) and released a presentation (the “Corporate Presentation”) each announcing preliminary financial results for the quarter ended and full year ended December 31, 2025. Copies of the Press Release and the Corporate Presentation are furnished pursuant to Item 2.02 as Exhibit 99.1 and Exhibit 99.2, respectively, and each such exhibit is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibits 99.1, and 99.2 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 nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On January 9, 2026, Delcath made available the Corporate Presentation that may be used in connection with presentations at conferences and investor meetings, which can be found on the Company’s website. The Corporate Presentation is furnished as Exhibit 99.2 and incorporated by reference in this Item 7.01.
The information contained in this Item 7.01, including Exhibit 99.2, 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 nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On January 9, 2026, Delcath disclosed in the Corporate Presentation that as of December 31, 2025, (i) it had a total of 25 active sites utilizing HEPZATO KIT and (ii) there were approximately 34.7 million shares of its common stock issued and outstanding. In addition, Delcath disclosed in the Corporate Presentation that the Company achieved positive operating cash for the quarter ended December 31, 2025.
On January 9, 2026, Delcath also announced the following preliminary unaudited fourth quarter and full year 2025 financial and operational results:
| • | Total fourth quarter and full year revenue expected to be approximately $20.7 million and $85.2 million, respectively |
| • | HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $19.0 million and $78.8 million, respectively |
| • | CHEMOSAT® fourth quarter and full year revenue expected to be approximately $1.7 million and $6.4 million, respectively |
| • | 628,572 shares of common stock repurchased for $6.0 million through December 31, 2025 under the approved $25.0 million Share Buyback Program |
| • | As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt compared to cash and short-term investments of $88.9 million as of September 30, 2025 |
Delcath has not yet completed its financial close process for the fourth quarter and full year 2025 and, as a result, actual results may vary from the estimated preliminary results set forth in this Current Report on Form 8-K due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2025, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Delcath’s independent registered public accounting firm. These estimates should not be viewed as a substitute for Delcath’s full interim or annual audited financial statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated January 9, 2026. | |
| 99.2 | Corporate Presentation, dated January 9, 2026. | |
| 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: January 12, 2026 | By: | /s/ Sandra Pennell | ||||
| Name: Sandra Pennell | ||||||
| Title: Chief Financial Officer | ||||||