NEW YORK, March 20, 2024 /PRNewswire/ -- Delcath Systems,
Inc. (Nasdaq: DCTH), an interventional oncology company focused on
the treatment of primary and metastatic cancers of the liver,
confirmed the closing of the previously announced private placement
with certain accredited investors comprised of existing investors,
Delcath Executives and members of its Board of Directors, for a
private placement transaction (the "Private Placement").
Delcath issued and sold 876,627 shares of its common stock (the
"Common Stock") at a price per share of $3.72, and, to certain investors, in lieu of
shares of Common Stock, 1,008,102 pre-funded warrants to purchase
up to 1,008,102 shares of Common Stock (the "Pre-Funded Warrants")
at a price per Pre-Funded Warrant of $3.71. The Pre-Funded Warrants have an exercise
price of $0.01 per share of Common
Stock, be immediately exercisable and remain exercisable until
exercised in full.
Delcath received gross proceeds from the Private Placement of
approximately $7 million before
deducting offering expenses payable by Delcath. Delcath intends to
use the net proceeds from the Private Placement for working capital
purposes and other general corporate purposes.
The securities to be sold in the Private Placement, including
the shares of common stock underlying the Pre-Funded Warrants, have
not been registered under the Securities Act of 1933, as amended,
or state securities laws as of the time of issuance and may not be
offered or sold in the United
States absent registration with the Securities and Exchange
Commission ("SEC") or an applicable exemption from such
registration requirements. Delcath has agreed to file one or more
registration statements with the SEC registering the resale of the
Common Stock and the shares issuable upon exercise of the
Pre-Funded Warrants purchased in the Private Placement.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy these securities nor shall there be
any sale of these securities in any state or jurisdiction in which
such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
state or jurisdiction.
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 (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 surgically isolate the liver 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, in particular, the statements regarding our Private
Placement and expected gross proceeds and the expected uses of the
proceeds from the Private Placement. 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.