NEW
YORK, Dec. 13, 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 with certain accredited investors (the "Private
Placement").
Delcath issued and sold 1,448,889 shares of its common stock
(the "Common Stock") at a price per share of $2.90, or, in lieu of shares of Common Stock,
692,042 pre-funded warrants to purchase Common Stock (the
"Pre-Funded Warrants") at a price per Pre-Funded Warrant of
$2.89. The Pre-Funded Warrants will
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 $6.2 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
HEPZATOTM 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 statements regarding our Private
Placement and expected gross proceeds and 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.
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.