Delcath (DCTH)

Executive Summary

Delcath Systems is a commercial-stage interventional oncology company focused on targeted liver-directed therapies. Its lead product, HEPZATO KIT (melphalan), is FDA-approved for the treatment of metastatic uveal melanoma (mUM) in the liver. The company's proprietary Hepatic Delivery System (HDS) isolates hepatic circulation, enabling high-dose chemotherapy delivery while filtering excess drug to reduce systemic toxicity. With a growing commercial presence, Delcath is positioned to address a significant unmet need in liver cancers. The company continues to explore label expansion opportunities and pipeline advancements to broaden its therapeutic reach, while building on its established revenue base from HEPZATO sales.

Upcoming Catalysts (preview)

• 2027FDA label expansion of HEPZATO KIT into additional liver cancer indications (e.g., colorectal liver metastases)60% success
• 2026Pivotal trial data readout for HEPZATO in primary hepatocellular carcinoma (HCC)50% success
• 2026Completion of enrollment or interim analysis for HEPZATO in metastatic colorectal cancer (mCRC) liver metastases55% success