NEW
YORK, July 20, 2022 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology company
focused on the treatment of primary and metastatic cancers of the
liver, today announced the closing of the previously announced
private placement for the issuance and sale of 690,954 shares of
common stock (the "Common Stock") and 566,751 pre-funded warrants
to purchase Common Stock (the "Pre-Funded Warrants") to certain
investors. Each share of Common Stock was sold at a price per share
of $3.98 and the Pre-Funded Warrants
were sold at a price of $3.97 per
Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price
of $0.01 per share of Common Stock
and are immediately exercisable.
Delcath received gross proceeds from the Private Placement of
approximately $5.0 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 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 percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the
PHP system is being developed under the tradename HEPZATO™ KIT
(melphalan hydrochloride for injection/hepatic delivery system), or
HEPZATO, for the treatment of patients with unresectable
hepatic-dominant metastatic ocular melanoma (mOM), also known as
metastatic uveal melanoma (mUM) and is considered a combination
drug and device product regulated by the United States Food and
Drug Administration (FDA).
In Europe, the PHP system is
now regulated as a Class lll medical device and is approved for
sale under the trade name CHEMOSAT Hepatic Delivery System for
Melphalan, or CHEMOSAT, where it has been used 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 news 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 expected uses of the proceeds from
the Private Placement. Factors that may cause such differences
include, but are not limited to, uncertainties relating to: the
timing and results of the Company's clinical trials, including
without limitation the mOM and ICC clinical trial programs, as well
as the receipt of additional data and the performance of additional
analyses with respect to the mOM clinical trial, our determination
whether to continue the ICC clinical trial program or to focus on
other alternative indications, and timely monitoring and treatment
of patients in the global Phase 3 mOM clinical trial and the impact
of the COVID-19 pandemic on the completion of our clinical trials;
the impact of the presentations at major medical conferences and
future clinical results consistent with the data presented;
approval of Individual Funding Requests for reimbursement of the
CHEMOSAT procedure; the impact, if any, of ZE reimbursement on
potential CHEMOSAT product use and sales in Germany; clinical adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in Europe including the
key markets of Germany and the UK;
the Company's ability to successfully commercialize the HEPZATO
KIT/CHEMOSAT system and the potential of the HEPZATO KIT/CHEMOSAT
system as a treatment for patients with primary and metastatic
disease in the liver; our ability to obtain reimbursement for the
CHEMOSAT system in various markets; approval of the current or
future HEPZATO KIT/CHEMOSAT system for delivery and filtration of
melphalan or other chemotherapeutic agents for various indications
in the U.S. and/or in foreign markets; actions by the FDA or
foreign regulatory agencies; the Company's ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same;
uncertainties relating to the timing and results of research and
development projects; and uncertainties regarding the Company's
ability to obtain financial and other resources for any research,
development, clinical trials and commercialization activities.
These factors, and others, are discussed from time to time in our
filings with the Securities and Exchange Commission. 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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SOURCE Delcath Systems, Inc.