Current Report · Items 2.02, 7.01, 8.01, 9.01 · 8-K
Delcath Systems, Inc.
DCTHNASDAQEQUITYCurrent
Results of Operations and Financial Condition · Regulation FD Disclosure · Other Events
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.…
Filed Jan 12, 2026Accepted Jan 12, 2026, 4:41 PM ESTCIK 872912Accession 0001193125-26-010498
Company context
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.
Current securities
Disclosure sections
Items 2.02, 7.01, 8.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 2.02Item 2.02 - Results of Operations
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 7.01Item 7.01 - Regulation FD Disclosure
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 8.01Item 8.01 - Other Events
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.
Filed exhibits (2)
EX-99.1 (by filename) d52022dex991.htmEX-99.1
2
d52022dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2025 Financial Results
QUEENSBURY, NY - January 9, 2026, Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional
oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025.
Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited)
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 common shares 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 com…
Open exhibit ↗EX-99.2 (by filename) d52022dex992.htmEX-99.2
3
d52022dex992.htm
EX-99.2
EX-99.2
Exhibit 99.2 Corporate Presentation NASDAQ: DCTH January 9,
2026
Forward-Looking Statement alternative indications; the impact of the
COVID-19 pandemic or other pandemics on the The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward- completion of our clinical trials; the impact of the presentations at major medical looking statements made by the
Company or on its behalf. This presentation contains conferences and future clinical results consistent with the data presented; uncertainties forward-looking statements, which are subject to certain risks and uncertainties that can relating to the
timing and results of research and development projects; and uncertainties cause actual results to differ materially from those described. The words “anticipate,” regarding the Company’s ability to obtain financial and other
resources for any research, “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” development, clinical
trials and commercialization activities. These factors, and others, are “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions…
Open exhibit ↗