NEW
YORK, Sept. 1, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, announced today 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. 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.
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.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The Company's proprietary products, HEPZATO KIT (melphalan for
Injection/Hepatic Delivery System), approved for use in
the United States by FDA, and
CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic
perfusion (PHP), designated under the medical device regulation for
use in Europe and the United Kingdom, are designed to administer
high-dose chemotherapy to the liver while controlling systemic
exposure and associated side effects during a PHP procedure. For
more information regarding HEPZATO KIT and its use, including
Important Safety Information and Boxed Warning, please visit
HEPZATOKIT.com. For more information regarding CHEMOSAT and its
use, please visit Chemosat.com.
Forward Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a
safe harbor for forward-looking statements made by the Company or
on its behalf. This press release contains forward-looking
statements, which are subject to certain risks and uncertainties,
that can cause actual results to differ materially from those
described. The words "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "plan," "potential,"
"predict," "project," "should," "target," "will," "would" and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Factors that may cause such differences
include, but are not limited to, uncertainties relating to: the
Company's commercialization plans and its ability to successfully
commercialize the HEPZATO KIT; the Company's successful management
of the HEPZATO KIT supply chain, including securing adequate supply
of critical components necessary to manufacture and assemble the
HEPZATO KIT; successful FDA inspections of the facilities of the
Company and those of its third-party suppliers/manufacturers; the
Company's successful implementation and management of the HEPZATO
KIT Risk Evaluation and Mitigation Strategy; the potential benefits
of the HEPZATO KIT as a treatment for patients with primary
and metastatic disease in the liver; the Company's ability to
obtain reimbursement for the HEPZATO KIT; and the Company's ability
to successfully enter into any necessary purchase and sale
agreements with users of the HEPZATO KIT. For additional
information about these factors, and others that may impact the
Company, please see the Company's filings with the Securities and
Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K.
However, new risk factors and uncertainties may emerge from time to
time, and it is not possible to predict all risk factors and
uncertainties. Accordingly, you should not place undue reliance on
these forward-looking statements, which speak only as of the date
they are made. We undertake no obligation to publicly update or
revise these forward-looking statements to reflect events or
circumstances after the date they are made.
Contact:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.