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. 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.
Delcath Systems, Inc. reported that Chief Executive Officer Michel Gerard J acquired equity awards consisting of stock options and restricted stock units. He received stock options for 195,000 shares at an exercise price of $0.0000 per share, classified as a grant or award acquisition.
The option vests at a rate of one‑thirty‑sixth per month starting on February 17, 2026, continuing monthly while he remains an employee under the company’s 2020 Omnibus Equity Incentive Plan. He was also granted 97,500 restricted stock units, each representing a contingent right to one share of common stock.
One‑third of the RSUs 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.
Delcath Systems, Inc. received an amended Schedule 13D/A from the Rosalind group detailing their equity stake and governance role. Rosalind Advisors, Inc. reports beneficial ownership of 6,719,993 shares of common stock equivalents, representing 9.9% of the class after applying ownership blockers. These securities are primarily preferred stock and warrants that cannot be converted or exercised if ownership would exceed 9.99% for preferred shares or 4.99% for warrants. The percentages are based on 35,313,718 common shares outstanding as of October 27, 2025. Rosalind Master Fund L.P. reports 2,871,335 shares (4.4%), and Rosalind Opportunities Fund I L.P. reports 3,530,215 shares (4.9%). Steven Salamon and Gil Aharon, Canadian citizens and portfolio managers at Rosalind Advisors, also report 9.9% beneficial ownership each and serve as independent directors of Delcath, with board terms scheduled to run through the 2024 and 2025 annual meetings, respectively.