On September 1, 2023 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it raised approximately $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 (Press release, Delcath Systems, SEP 1, 2023, View Source [SID1234634835]). The warrants were exercisable until the earlier of 3/31/2026 or 21 days after the U.S. 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 $25 million in additional proceeds and are exercisable until the earlier of 3/31/2026 or 21 days following the Company’s public announcement of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO.
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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, L.P.
"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. Mr. 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.
About HEPZATO KIT
HEPZATO KIT is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) 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.
HEPZATO KIT is a combination product that administers HEPZATO (melphalan), a well-known and long-approved chemotherapeutic agent, directly to the liver through Delcath’s novel Hepatic Delivery System (HDS), which permits higher drug exposure in target tissues while limiting systemic toxicity. The use of the HDS allows a healthcare provider team to surgically isolate the liver while the hepatic venous blood is filtered during melphalan infusion and subsequent washout during a Percutaneous Hepatic Perfusion (PHP) procedure. PHP, which can only be performed with Delcath’s HDS, resulting in loco-regional delivery of a relatively high melphalan dose.
Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.
Important Safety Information
Patients eligible for HEPZATO should NOT have any of the following medical conditions:
Active intracranial metastases or brain lesions with a propensity to bleed
Liver failure, portal hypertension, or known varices at risk for bleeding
Surgery or medical treatment of the liver in the previous 4 weeks
Active cardiac conditions including unstable or severe angina or myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease
History of allergies or known hypersensitivity to melphalan or a component or material utilized within the HEPZATO KIT including natural rubber latex, heparin, and severe hypersensitivity to iodinated contrast not controlled by antihistamines and steroids
Most common adverse reactions or laboratory abnormalities occurring with HEPZATO treatment are thrombocytopenia, fatigue, anemia, nausea, musculoskeletal pain, leukopenia, abdominal pain, neutropenia, vomiting, increased alanine aminotransferase, prolonged activated partial thromboplastin time, increased alkaline phosphatase, increased aspartate aminotransferase and dyspnea.
Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of HEPZATO. HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS. Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Additional cycles of HEPZATO therapy will be delayed until blood counts have improved.
Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.