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, INC.$9.04 per share. Following this transaction, she directly owned a total of 77,018 common shares, which includes 10,433 shares acquired under the company’s 2021 Employee Stock Purchase Plan.
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, INC. chief executive officer Michel Gerard purchased 11,200 shares of common stock in an open-market transaction. The shares were bought at an average price of $8.9562 per share and are held directly. After this purchase, he owns 342,034 common shares.
Delcath Systems is an interventional oncology company focused on treating cancers in or spreading to the liver. Its lead product, HEPZATO KIT, a melphalan-based drug/device combination, was approved by the FDA in August 2023 for adult uveal melanoma with unresectable liver‑dominant metastases, with first commercial use in January 2024.
In Europe, the company markets the device-only configuration as CHEMOSAT, which is MDR-certified and used at major centers to treat a range of liver cancers. Delcath cites large addressable markets across uveal melanoma, colorectal, breast, neuroendocrine, pancreatic, cholangiocarcinoma, hepatocellular and non‑small cell lung cancers with liver involvement.
The company is running Phase 2 trials of HEPZATO in liver‑dominant metastatic colorectal and breast cancer, aiming to improve hepatic progression‑free survival when added to standard regimens. It highlights FOCUS and CHOPIN trial data supporting efficacy in metastatic uveal melanoma and combination use with checkpoint inhibitors.
Delcath has secured key U.S. market access milestones for HEPZATO, including a permanent J-code, transitional pass‑through payment, NTAP status, and participation in Medicaid, 340B and VA pricing programs, while pursuing reimbursement expansion for CHEMOSAT in Europe. The filing also details extensive regulatory, reimbursement, supply, manufacturing, IP, and competitive risks.
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.
Hoffman David L. reported acquisition or exercise transactions in this Form 4 filing.
Delcath Systems, Inc. reported that its General Counsel, Chief Compliance Officer and Secretary, David L. Hoffman, received equity awards under the company’s 2020 Omnibus Equity Incentive Plan. He was granted stock options for 56,500 shares at no cost and 28,250 restricted stock units, each representing one share of common stock.
The option award vests in equal monthly installments over 36 months, beginning on February 17, 2026, as long as he remains an employee. The RSU award vests over three years, with one-third vesting on February 17, 2027 and the remaining two-thirds vesting in equal annual installments over the next two years, contingent on continued service.
Delcath Systems, Inc. granted equity awards to Kevin Muir, its GM Interventional Oncology. On February 17, 2026, he acquired a stock option covering 56,500 shares at an exercise price of $0.00 per share, vesting in equal monthly installments over 36 months, starting February 17, 2026, while he remains an employee and subject to the company’s 2020 Omnibus Equity Incentive Plan.
On the same date, he also received 28,250 restricted stock units (RSUs), each representing a contingent right to one share of common stock. One-third of this RSU award will vest on February 17, 2027, with the remaining two-thirds vesting in equal annual installments over the following two years, subject to his continuous service through each vesting date.
Pennell Sandra reported acquisition or exercise transactions in this Form 4 filing.
Delcath Systems Chief Financial Officer Sandra Pennell reported equity awards that increase her potential ownership stake over time. She was granted stock options for 56,500 shares at no cost, which vest monthly in equal installments over 36 months starting on February 17, 2026, as long as she remains an employee.
She also received 28,250 restricted stock units, each representing a right to one share of common stock. One-third of these RSUs will vest on February 17, 2027, with the remaining two-thirds vesting in equal annual installments over the following two years, subject to her continued service.
Delcath Systems chief medical officer Vojo Vukovic received new equity awards. On February 17, 2026, he was granted stock options for 56,500 shares at an exercise price of $0.00 per share and 28,250 restricted stock units (RSUs).
The options vest at a rate of one‑thirty‑sixth per month starting on February 17, 2026, as long as he remains an employee under the company’s 2020 Omnibus Equity Incentive Plan. Each RSU represents a contingent right to one share of common stock, with one‑third vesting on February 17, 2027 and the remaining two‑thirds in equal annual installments over the following two years, subject to continued service.
Rook Martha S. reported acquisition or exercise transactions in this Form 4 filing.
Delcath Systems chief operating officer Martha S. Rook reported new equity compensation grants. She received stock options for 56,500 shares at no cost, vesting at a rate of one‑thirty‑sixth per month starting on February 17, 2026, as long as she remains an employee.
Rook also received 28,250 restricted stock units, each representing one share of common stock. One‑third of these RSUs will vest on February 17, 2027, with the remaining two‑thirds vesting in equal annual installments over the following two years, subject to her continuous service.