Delcath Systems Announces Additional $16.3 Million in Funding From Series E and E1 Warrant Exercises
31 December 2024 - 12:00AM
Business Wire
Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the
“Company”), an interventional oncology company focused on the
treatment of primary and metastatic cancers of the liver, today
announced the exercise of 1.7 million Series E and E1 warrants
which resulted in $16.3 million of funding. Approximately 6.6% of
the warrants exercised were subject to cashless exercise
provisions. The warrants, issued in July and August 2019 as a
component of a private placement, had an exercise price of $10.00
per share and expired on December 24, 2024.
“With the exercise of these warrants, current cash on hand and
cash expected from operations as a result of our revenue growth, we
believe that we are in a strong position to execute on our ongoing
commercialization efforts and our robust clinical development
plan,” said Gerard Michel, Delcath’s Chief Executive Officer. Mr.
Michel continued, “As we continue to drive the commercial success
of HEPZATO to treat uveal melanoma patients we can confidently
invest in new clinical trials.”
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
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™ (HEPZATO
(melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT®
Hepatic Delivery System for Melphalan percutaneous hepatic
perfusion (PHP), are designed to administer high-dose chemotherapy
to the liver while controlling systemic exposure and associated
side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered a combination
drug and device product and is regulated and approved for sale as a
drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic
drug melphalan and Delcath's proprietary Hepatic Delivery System
(HDS). The HDS is used to isolate the hepatic venous blood from the
systemic circulation while simultaneously filtrating hepatic venous
blood during melphalan infusion and washout. The use of the HDS
results in loco-regional delivery of a relatively high melphalan
dose, which can potentially induce a clinically meaningful tumor
response with minimal hepatotoxicity and reduce systemic exposure.
HEPZATO KIT is approved in the United States as 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. Please see the full Prescribing
Information, including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only configuration of the HDS is regulated
as a Class III medical device and is approved for sale under the
trade name CHEMOSAT Hepatic Delivery System for Melphalan, or
CHEMOSAT, where it has been used in the conduct of percutaneous
hepatic perfusion procedures at major medical centers to treat a
wide range of cancers of the liver.
Safe Harbor / 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241230005270/en/
Investor Relations: ICR Healthcare
investorrelations@delcath.com
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