Delcath Systems, Inc. filings document an interventional oncology company with Nasdaq-listed common stock and a liver-directed drug-device platform. Form 8-K reports furnish quarterly and annual financial results, preliminary results, Regulation FD presentations, product revenue for HEPZATO KIT and CHEMOSAT, clinical publication updates for CHOPIN, and board-authorized share repurchase activity.
The company’s proxy materials cover annual meeting governance, executive compensation, equity awards, and related shareholder voting disclosures. Delcath filings also identify its common stock, par value, trading symbol DCTH, and Nasdaq Capital Market listing, while formal exhibits provide press releases and corporate presentations used for operating, clinical, and capital-structure disclosures.
Delcath Systems, Inc. is asking stockholders to vote at a virtual annual meeting on May 13, 2026. Proposals include electing two Class II directors, Elizabeth Czerepak and John R. Sylvester, and approving an amendment to the 2020 Omnibus Equity Incentive Plan.
The equity plan amendment would add 1,800,000 shares of common stock to the plan, for a total reserve of 11,125,000 shares, which the Board describes as less than 5% of common share equivalents and sufficient for about one year of grants. Stockholders will also be asked to ratify CBIZ CPAs P.C. as independent auditor for 2026 and to approve, on an advisory basis, named executive officer compensation.
Delcath Systems, Inc. ownership filing shows Daniel Kaufman reports beneficial ownership of 1,766,432 shares of Common Stock, representing 5.08% of the class as reported on 03/18/2026. The filing is a Schedule 13G disclosure of an equity stake by an individual investor.
DELCATH SYSTEMS, INC. Chief Financial Officer Sandra Pennell reported an open-market purchase of common stock. She bought 5,533 shares of Delcath Systems common stock at a price of $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.