Welcome to our dedicated page for Delcath Sys SEC filings (Ticker: DCTH), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Delcath Systems Inc (DCTH) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Delcath, an interventional oncology company focused on primary and metastatic liver cancers, uses these filings to report financial results, corporate actions, and material clinical developments related to its hepatic delivery technologies HEPZATO KIT and the CHEMOSAT Hepatic Delivery System for Melphalan.
Investors can review Form 8-K current reports that cover topics such as quarterly and preliminary financial results, updated revenue guidance, and non-GAAP measures like adjusted EBITDA. These filings also document material events including the authorization of a share repurchase program, publication of CHOPIN trial results, and other significant clinical or corporate milestones. Additional 8-Ks describe amendments to the company’s bylaws, clarifying stockholder nomination procedures, officer roles, and indemnification provisions.
Through Stock Titan, Delcath’s filings are supplemented with AI-powered summaries that explain the key points of lengthy documents in plain language. Users can quickly understand what a particular 8-K, 10-Q, or 10-K means for revenue composition, product performance (HEPZATO KIT and CHEMOSAT), cash and investment levels, and operating expenses, without reading every line of the original text.
The filings page also serves as a starting point for tracking ongoing disclosure practices, including how Delcath presents forward-looking statements under the Private Securities Litigation Reform Act of 1995 and how it reconciles GAAP and non-GAAP metrics. For those analyzing DCTH, this resource helps answer questions about the company’s financial condition, governance changes, and material clinical trial updates, with real-time EDGAR-sourced documents and AI-generated highlights to streamline review.
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. (DCTH) filed a Form S-8 to register additional common stock for issuance under its 2020 Omnibus Equity Incentive Plan, 2021 Employee Stock Purchase Plan and 2023 Inducement Awards Plan, incorporating prior S-8 disclosures by reference. The filing lists related exhibits including amended charter documents, bylaws, the equity plan documents, legal opinion/consents, and a fee table.
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.
Delcath Systems, Inc. (DCTH) — Quarterly highlights (six months ended June 30, 2025)
Product revenue grew to $43.94 million for the six months (2024: $10.91 million) driven by HEPZATO KIT and CHEMOSAT; Q2 product revenue was $24.156 million (Q2 2024: $7.766 million). Gross profit was $37.78 million for six months and operating income was $3.232 million. Net income was $3.766 million for six months (Q2 net income $2.697 million). Cash and cash equivalents totaled $34.421 million and short-term investments $46.584 million (combined $81.005 million) at June 30, 2025.
Operations and development: FDA-approved HEPZATO (Aug 14, 2023); first commercial use Jan 2024. IND for Phase 2 mCRC cleared Dec 2024 (approx. 90 patients; enrollment H2 2025; hPFS readout end 2027). IND for Phase 2 mBC cleared Apr 28, 2025 (approx. 90 patients; enrollment Q4 2025; hPFS readout end 2028). CHEMOSAT received two-year reimbursement in Vastra Gotaland, Sweden (June 2025). On May 22, 2025 Delcath entered NDRA/PPA obligations including 340B pricing and Medicaid rebates effective July 1, 2025.