Delcath Sys SEC Filings

Delcath Systems, Inc. reported first-quarter 2026 revenue of $24.99 million, up from $19.78 million a year earlier, driven by continued uptake of the HEPZATO KIT in the United States. CHEMOSAT contributed $1.75 million, roughly flat year over year.

Gross profit rose to $21.26 million, but higher research and development spending of $9.82 million and selling, general and administrative expenses of $13.07 million led to a net loss of $1.07 million, compared with net income of $1.07 million in the prior-year quarter.

The company ended March 31, 2026 with $41.3 million in cash and cash equivalents and $48.0 million in short-term investments, and believes this liquidity will fund operations for at least 12 months. Delcath is advancing Phase 2 trials of HEPZATO in liver-dominant metastatic colorectal and breast cancer and continues a share repurchase program, having bought back approximately $9.0 million of stock under a $25.0 million authorization.

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 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.

BlackRock, Inc. reports 1,733,824 shares of DELCATH SYS INC common stock, representing 4.98% of the class as of 03/31/2026. The filing shows sole voting power for 1,703,693 shares and sole dispositive power for 1,733,824 shares. The filing is a Schedule 13G/A amendment reporting ownership by BlackRock Reporting Business Units.

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.