Delcath Systems Secures $35M Following FDA Approval of HEPZATO KIT

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Delcath Systems, Inc., an interventional oncology company, has secured approximately $35 million through the exercise of Tranche A warrants. This move follows the recent FDA approval of the HEPZATO KIT for the treatment of primary and metastatic liver cancers.

Key Highlights

  • Delcath Systems raised the funds through the exercise of all Tranche A warrants, which were part of a Private Investment in Public Equity (PIPE) financing announced on March 29, 2023.
  • The FDA granted approval for the HEPZATO KIT on August 14, 2023.
  • Tranche B warrants, also part of the PIPE financing, have the potential to generate an additional $25 million.
  • The FDA’s approval and the subsequent financing have extended the interest-only period for an existing loan agreement with Avenue Venture Opportunities Fund, L.P. to December 31, 2023.
  • Delcath Systems aims to make the HEPZATO KIT commercially available for uveal melanoma patients by the end of 2023.

Source: PR Newswire

Notable Quotes

  • “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,” – Gerard Michel, CEO at Delcath Systems
  • “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.” – Gerard Michel

SoH's Take

The successful exercise of Tranche A warrants and the subsequent capital raise by Delcath Systems is a significant milestone, especially following the FDA’s approval of the HEPZATO KIT. This move not only provides the company with the necessary capital to launch the product but also underscores the potential of the HEPZATO KIT in addressing unmet needs in the treatment of liver cancers. The company’s focus on expanding its treatment offerings and its commitment to making the product available by the end of 2023 is commendable and is likely to position Delcath Systems as a leader in interventional oncology.

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