DELCATH SYSTEMS Business Summary

Delcath Systems Inc. (DCTH) is a commercial-stage interventional oncology company that generates revenue primarily through the sale of its proprietary percutaneous hepatic perfusion (PHP) systems: the HEPZATO KIT, FDA-approved for metastatic uveal melanoma (mUM), and its European counterpart, CHEMOSAT. The business model relies on high-margin, single-use product sales of these combination drug-device kits, which deliver concentrated melphalan directly to the liver while utilizing a proprietary filtration system to limit systemic exposure. For fiscal year 2025, the company reported preliminary total revenue of $85.2 million, representing a significant growth trajectory fueled by a 140% increase in procedure volume across 25 active U.S. treatment centers. Delcath operates within the specialized liver-directed therapy market, competing directly with TriSalus Life Sciences, Boston Scientific (TheraSphere), and Sirtex Medical (SIR-Spheres). It maintains a dominant market position as the only provider of an FDA-approved liver-directed therapy for mUM, occupying a high-moat niche between systemic chemotherapy and localized embolization. The executive team is led by CEO Gerard Michel, a biopharmaceutical veteran who previously served as CFO of Vericel, where he successfully transitioned the firm from R&D to commercial profitability. The C-suite includes Chief Financial Officer Sandra Pennell, Chief Medical Officer Vojislav “Vojo” Vukovic, MD, PhD, and Chief Operating Officer Martha S. Rook, PhD, who joined in 2024 with a background in technical operations from insitro and MilliporeSigma. Governance is overseen by Chairman John R. Sylvester and a board that includes Steven A. J. Salamon and Gil Aharon, both principals at Rosalind Advisors, which remains a dominant institutional shareholder. Other major investors include Vivo Capital, BlackRock, and Vanguard, supporting a capital structure that, as of February 2026, features a strong cash position of approximately $91 million and zero debt, positioning the firm for continued expansion into additional liver-dominant cancer indications.