Delcath Receives Funding Triggered by FDA Approval of Hepzato Kit

September 6, 2023—Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, recently announced that it raised approximately $35 million through the exercise of all the Tranche A warrants issued as part of the Private Investment in Public Equity (PIPE) financing that was announced on March 29, 2023.

According to the company, the warrants were exercisable until the earlier of March 31, 2026, or 21 days after the FDA approved the Hepzato Kit (melphalan) for injection/hepatic delivery system. FDA approval was announced on August 14, 2023.

Tranche B warrants, also issued as part of the PIPE financing, could generate approximately $25 million in additional proceeds and are exercisable until the earlier of March 31, 2026, or 21 days after the company’s public announcement of recording at least $10 million in quarterly revenue in the United States from the commercialization of Hepzato.

FDA approval and additional financing triggers an extension of the interest-only period from September 30, 2023, to December 31, 2023, for an existing loan agreement with Avenue Venture Opportunities Fund, L.P.

The company advised that it plans to have commercial product of Hepzato Kit available for uveal melanoma patients by the end of 2023. Until that time, patients will continue to be enrolled and treated at Expanded Access Program sites.

Hepzato Kit is a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation, stated Delcath’s press release.

Gerard Michel, Delcath’s Chief Executive Officer, commented in the press release, “With the exercise of these warrants we have, as planned, accessed adequate capital to fund the commercial launch of Hepzato Kit without adding to our fully diluted share count. We can now focus on providing access to Hepzato Kit to uveal melanoma patients as well as expanding our development efforts to treat other liver dominant cancers.”