Delcath’s shares rose 35.8% after a record $35.1 million in third-quarter revenue, up 71% year over year, alongside positive operating cash flow. HEPZATO volume growth and improving profitability were the clearest positives, while slower-than-expected breast cancer trial enrollment remains a development risk.
- Total revenue was $35.1 million versus $20.6 million a year earlier; HEPZATO revenue was $32.7 million, with volume up 72% year over year and 19% sequentially.
- Gross margin expanded to 89% from 87%. Net income was $7.0 million versus $0.8 million, and adjusted EBITDA rose to $11.5 million from $5.3 million.
- The company reported positive operating cash flow and 33 active U.S. treatment centers; it expects at least 36 by year-end.
- Breast cancer trial enrollment is slower than initially anticipated, and the company cannot yet provide a timing estimate for interim analysis. The colorectal trial remains on pace for an interim analysis in mid-2027.
- Delcath plans an IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, aims to begin preclinical development of an oxaliplatin-based PHP program by mid-2027.
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