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.
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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. (DCTH) 鈥� 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.
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