[8-K] DELCATH SYSTEMS, INC. Reports Material Event

Rhea-AI Filing Summary

Delcath Systems, Inc. furnished an update with preliminary, unaudited financial and operating results for the fourth quarter and full year ended December 31, 2025. The company disclosed that as of December 31, 2025 it had 25 active sites utilizing its HEPZATO KIT treatment and approximately 34.7 million shares of common stock issued and outstanding. Delcath also reported that it achieved positive operating cash for the quarter ended December 31, 2025, signaling an important shift in quarterly cash generation. All figures are preliminary, subject to completion of the financial close process and potential audit adjustments. The details are provided in a press release and corporate presentation furnished as exhibits.

Insights

Biopharma & earnings disclosure analyst

Delcath reports preliminary 2025 results with Q4 operating cash turning positive.

Delcath Systems, Inc. provided preliminary, unaudited fourth quarter and full year 2025 results, emphasizing operational metrics rather than detailed income statement figures. As of December 31, 2025 it reported 25 active sites using HEPZATO KIT, which highlights early commercial deployment of its therapy across multiple centers. The update also states there were approximately 34.7 million common shares issued and outstanding at year-end, giving investors a current equity base reference.

A notable point is that Delcath achieved positive operating cash for the quarter ended December 31, 2025. Moving to a quarter of positive operating cash indicates that, for this period, cash generated from operations exceeded operating cash uses, which is a meaningful operational milestone for a company in a commercialization phase. However, the company stresses that these results are preliminary, unaudited, and may change as the financial close and audit processes are completed.

The information is furnished via a press release and a corporate presentation, not filed for liability purposes under certain Exchange Act provisions. Subsequent formal quarterly or annual statements will provide the full audited financials and clarify how sustainable positive operating cash might be over future periods, but that detail is not included in this update.

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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): January 9, 2026

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.)

566 Queensbury Avenue

Queensbury, NY 12804

(Address of principal executive offices) (Zip Code)

(518) 743-8892

(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 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