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. furnished an update with preliminary, unaudited financial and operating results for the fourth quarter and full year ended December 31, 2025. The company disclosed that as of December 31, 2025 it had 25 active sites utilizing its HEPZATO KIT treatment and approximately 34.7 million shares of common stock issued and outstanding. Delcath also reported that it achieved positive operating cash for the quarter ended December 31, 2025, signaling an important shift in quarterly cash generation. All figures are preliminary, subject to completion of the financial close process and potential audit adjustments. The details are provided in a press release and corporate presentation furnished as exhibits.
Delcath Systems, Inc. director reports open-market stock purchase. A company director bought 4,386 shares of Delcath Systems common stock on 11/21/2025 at a price of $8.89 per share in a transaction reported as a purchase. After this trade, the director beneficially owns 14,936 shares, held directly. The filing is a routine Form 4 disclosure showing insider ownership and the latest change in the director's personal investment in Delcath stock.
Delcath Systems, Inc. announced that its board of directors has authorized a share repurchase program. Under this program, the company may buy back up to $25 million of its outstanding common stock. Repurchases may occur from time to time and are subject to market conditions, giving the company flexibility in how and when it executes the program.
Delcath Systems (DCTH) reported an insider share purchase by its Chief Executive Officer and Director, Gerard Michel. On 11/11/2025, he purchased 11,500 shares of common stock at $8.526 per share, coded as “P,” indicating a purchase. Following this transaction, his beneficial ownership stands at 330,834 shares, held directly.
Delcath Systems (DCTH) reported strong Q3 2025 growth as product revenue reached $20.6 million, up from $11.2 million a year ago. HEPZATO KIT drove results with $19.3 million, while CHEMOSAT contributed $1.3 million. Gross profit was $17.9 million.
The quarter showed a small operating loss of $0.4 million but net income of $0.8 million, aided by $0.8 million of net interest income. For the first nine months, revenue rose to $64.5 million (from $22.1 million), with operating income of $2.8 million and net income of $4.6 million, marking a turnaround from last year’s loss.
Cash and cash equivalents were $41.8 million and short‑term investments were $47.1 million at September 30, 2025. Operating cash flow was $14.3 million year‑to‑date, supported by warrant and option exercises in financing activities. The company reiterated it believes existing cash, investments, and operating cash flow are sufficient for at least 12 months. As of October 27, 2025, 35,313,718 common shares were outstanding.
Clinical updates included positive Phase 2 CHOPIN data combining CHEMOSAT with checkpoint inhibitors, and ongoing Phase 2 programs in liver‑dominant colorectal and breast cancers.
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.