Delcath Systems announces additional funding for Hepzato Kit FDA approval


Delcath Systems, an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, has announced that it raised approximately US$35 million through the exercise of all the Tranche A warrants issued as part the previously announced March 29, 2023 private investment in public equity (PIPE) financing.

The warrants were exercisable until the earlier of March 3, 2026 or 21 days after the US Food and Drug Administration (FDA) approval of the Hepzato Kit (melphalan) for injection/hepatic delivery system, which occurred on August 14, 2023. Tranche B warrants, also issued as part of the PIPE financing, could generate approximately US$25 million in additional proceeds and are also exercisable until the earlier of March 3, 2026 or 21 days following the Company’s public announcement of recording at least US$10 million in quarterly US revenue from the commercialisation of Hepzato.

The 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.

“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,” said Gerard Michel, Delcath’s chief executive officer. Michel continued: “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.”

The company plans to have commercial product 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 (EAP) sites.


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