First patient dosed in Delcath’s phase 2 trial for colorectal cancer

NEW YORK - Delcath Systems, Inc. (NASDAQ:DCTH) announced Tuesday that the first patient has been dosed at City of Hope National Medical Center in its global Phase 2 clinical trial evaluating HEPZATO in combination with standard treatments for liver-dominant metastatic colorectal cancer. The company, currently valued at $372.2 million, has demonstrated strong financial health according to InvestingPro analysis, with analysts forecasting significant revenue growth of 153% for fiscal year 2025.

The randomized, controlled trial will assess HEPZATO combined with trifluridine-tipiracil and bevacizumab against the standard drugs alone in approximately 90 patients receiving third-line treatment. The study will be conducted at more than 20 sites across the United States and Europe.

Results for the primary endpoint of hepatic progression-free survival are expected by mid-2028, with overall survival data anticipated in late 2028, according to the company’s press release statement.

Delcath estimates the total addressable market for liver-dominant metastatic colorectal cancer patients receiving third-line treatment ranges between 6,000 and 10,000 patients annually in the United States.

"Dosing the first patient in this Phase 2 trial is an exciting step toward exploring HEPZATO’s potential to provide a new treatment option for patients with metastatic colorectal cancer," said Vojislav Vukovic, Chief Medical Officer of Delcath Systems.

HEPZATO KIT, a combination drug and device product regulated as a drug by the FDA, is currently approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma with specific disease characteristics. The system is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.

In other recent news, Delcath Systems Inc. reported a notable earnings beat for the second quarter of 2025. The company achieved earnings per share of $0.07, exceeding the forecasted $0.03. Revenue also outperformed expectations, coming in at $24.2 million compared to the anticipated $22.78 million. These results underscore the company’s strong performance in the recent quarter. Analysts and investors have shown confidence in Delcath Systems following this announcement. While no specific analyst upgrades or downgrades were mentioned, the earnings report has certainly drawn attention. These developments highlight Delcath’s ability to surpass market expectations.

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