Every 8-K that Delcath Sys (DCTH) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow DCTH and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DCTH filings page.
Delcath Systems, Inc. updated its corporate governance documents by amending and restating its Bylaws, effective August 12, 2026. The Board of Directors, following a recommendation from the Nominating and Corporate Governance Committee, adopted provisions specifying where certain legal disputes must be brought.
The revised Bylaws provide that, unless Delcath consents in writing to an alternative forum, the Court of Chancery of the State of Delaware (or, if it lacks subject matter jurisdiction, the federal district court for the District of Delaware) is the exclusive forum for internal corporate claims. They also state that the federal district courts of the United States are the exclusive forum for claims arising under the Securities Act of 1933. The full Bylaws are filed as Exhibit 3.1.
Delcath Systems, Inc. reported second quarter 2026 results, with total revenue of $29.1 million, up from $24.2 million a year earlier, driven by HEPZATO KIT revenue of $27.1 million and CHEMOSAT revenue of $2.0 million. Gross margin rose to 90% from 86%, while net income was $2.7 million in both periods.
Non-GAAP adjusted EBITDA was $7.6 million, compared with $9.8 million in the prior-year quarter, and operating cash flow was $5.7 million. Cash and investments totaled $95.9 million as of June 30, 2026, with no debt, supporting expansion to 31 active treatment centers and ongoing clinical trials.
For full-year 2026, Delcath increased its revenue guidance for HEPZATO KIT and CHEMOSAT to $104–$108 million, targeting gross margins of 86–89% and positive adjusted EBITDA, and highlighted approximately 30% growth in HEPZATO volume and new data and trials across uveal melanoma and metastatic breast cancer.
Delcath Systems, Inc. reported the results of its 2026 annual meeting of stockholders, where investors approved increasing the 2020 Omnibus Equity Incentive Plan by 1,800,000 shares of common stock. The plan provides additional shares for future equity-based awards to employees, directors and other participants.
Stockholders also elected two Class II directors to serve until the 2029 annual meeting, ratified CBIZ CPAs P.C. as independent auditor for the year ending December 31, 2026, and approved a non-binding advisory vote on executive compensation. Of 34,618,159 eligible common and convertible preferred shares, 23,346,271 shares, or about 67.44%, were represented at the meeting, indicating a solid voting turnout.
Delcath Systems reported first quarter 2026 revenue of $25.0 million, up from $19.8 million a year earlier, driven by $23.3 million from HEPZATO KIT and $1.7 million from CHEMOSAT. Gross margin was 85%.
The company posted a net loss of $1.1 million versus net income of $1.1 million in the prior-year quarter, and non-GAAP adjusted EBITDA declined to $3.4 million from $7.6 million. Delcath ended March 31, 2026 with $89.3 million in cash and investments and no debt, and repurchased 316,023 shares for about $3.0 million.
For full-year 2026, Delcath expects total HEPZATO KIT and CHEMOSAT revenue of at least $100 million, gross margins between 84% and 87%, and positive adjusted EBITDA. The quarter also featured publication of Phase 2 CHOPIN trial results and new clinical guideline recognition for CHEMOSAT.
Delcath Systems filed an 8-K to share that full results from the investigator-initiated Phase 2 CHOPIN trial in metastatic uveal melanoma have been published in The Lancet Oncology. The study tested percutaneous hepatic perfusion (PHP) with Delcath’s CHEMOSAT Hepatic Delivery System alone or combined with ipilimumab and nivolumab in 76 patients.
The company highlights that combining PHP with dual immunotherapy more than tripled the 1-year progression-free survival rate and nearly doubled the 2-year overall survival compared with PHP alone, while also improving liver disease control and depth of response. Safety trade-offs were notable: grade 3 or higher treatment-related adverse events occurred in 82% of patients in the combination arm versus 41% in the PHP-alone arm, with one treatment-related death reported, though most events were described as manageable and without new safety signals.
Delcath frames these data as reinforcing the clinical value of its liver-directed PHP platform (HEPZATO KIT/CHEMOSAT) for metastatic uveal melanoma and as a rationale to explore this approach in other liver-dominant cancers, while also reiterating extensive forward-looking risk factors around commercialization, reimbursement, supply chain, and regulatory oversight.
Delcath Systems reported strong fourth quarter and full year 2025 results and provided 2026 guidance. Total revenue reached $20.7 million in the fourth quarter and $85.2 million for 2025, up from $37.2 million in the prior year, driven mainly by HEPZATO KIT sales.
Gross margins were 85% in the quarter and 86% for the year. The company posted a 2025 net income of $2.7 million versus a net loss of $26.4 million in 2024, with non-GAAP adjusted EBITDA of $25.1 million. Delcath repurchased 628,572 shares for $6.0 million and ended 2025 with $91.0 million in cash and investments and no debt.
Management sees 2026 as a year of continued expansion, guiding for at least $100 million in combined HEPZATO KIT and CHEMOSAT revenue and gross margins between 84% and 87%, supported by 28 active treatment centers and growing procedure volume.
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.
Delcath Systems, Inc. announced that its board of directors has authorized a share repurchase program. Under this program, the company may buy back up to $25 million of its outstanding common stock. Repurchases may occur from time to time and are subject to market conditions, giving the company flexibility in how and when it executes the program.
Delcath Systems (DCTH) filed an 8-K to furnish a press release announcing financial results and business highlights for the quarter ended September 30, 2025. The press release is provided as Exhibit 99.1 under Item 2.02. The company states the information, including the press release, is furnished, not filed under the Exchange Act and will not be incorporated by reference into other SEC filings. The 8-K was signed by CFO Sandra Pennell.
Delcath Systems, Inc. filed an 8-K announcing preliminary third-quarter results and an update to 2025 full-year revenue guidance, alongside results from its CHOPIN Trial. The company reported $88.9 million in cash, cash equivalents and short-term investments and no debt as of September 30, 2025.
Two press releases were furnished: one covering preliminary Q3 financial and operational results and updated 2025 revenue guidance (Exhibit 99.1), and another detailing CHOPIN Trial results (Exhibit 99.2). The trial compared PHP using Delcath’s CHEMOSAT HDS with melphalan versus the same PHP combined with immune checkpoint inhibitors ipilimumab and nivolumab.
The preliminary figures are unaudited, subject to quarter-end procedures, and may change. The furnished information under Items 2.02 and 7.01 is not deemed filed and is not subject to Section 18 liabilities of the Exchange Act.
Delcath Systems, Inc. reported a material corporate governance event filing on Form 8-K noting that its Amended and Restated By-Laws were adopted and are effective immediately. The document identifies an amended version dated August 12, 2025 and an interactive cover page data file dated August 15, 2025. The filing is signed by David Hoffman, listed as General Counsel, Chief Compliance Officer and Secretary. No other operational, financial or transaction details are provided in the disclosed text.