NEW YORK, Sept. 29, 2016 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH) (the "Company"), an interventional oncology
company focused on treatments for primary and metastatic liver
cancers, today announced that it intends to offer shares of its
common stock and warrants to purchase shares of common stock in an
underwritten public offering. The completion of the offering
is subject to market and other conditions, and there can be no
assurance as to whether or when the offering may be completed, or
as to the actual size or terms of the offering.
Roth Capital Partners is acting as the sole manager for the
offering.
The Company intends to use the net proceeds from the offering
(including any resulting from the exercise of the warrants, if any)
for general corporate purposes, including, but not limited to,
funding of its clinical trials, commercialization of its products,
obtaining regulatory approvals, research, capital expenditures and
working capital.
The securities described above are being offered by the Company
pursuant to a registration statement previously filed with and
subsequently declared effective by the Securities and Exchange
Commission ("SEC"). An electronic preliminary
prospectus relating to the offering will be filed with the SEC and
when filed will be available on the SEC's website at
http://www.sec.gov.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any of the securities described
herein, 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. Copies of the
preliminary prospectus supplement and accompanying base prospectus
relating to this offering may be obtained from Roth Capital
Partners, 888 San Clemente, Newport
Beach, CA 92660, (800) 678-9147 or by accessing the SEC's
website, www.sec.gov.
About Delcath
Delcath Systems, Inc. is an interventional oncology Company
focused on the treatment of primary and metastatic liver cancers.
Our investigational product—Melphalan Hydrochloride for Injection
for use with the Delcath Hepatic Delivery System (Melphalan/HDS)
—is designed to administer high-dose chemotherapy to the liver
while controlling systemic exposure and associated side effects. We
have commenced a global Phase 3 FOCUS clinical trial for Patients
with Hepatic Dominant Ocular Melanoma (OM) and a global Phase 2
clinical trial in Europe and the U.S. to investigate the
Melphalan/HDS system for the treatment of primary liver cancer
(HCC) and intrahepatic cholangiocarcinoma (ICC). Melphalan/HDS has
not been approved by the U.S. Food & Drug Administration (FDA)
for sale in the U.S. In Europe, our system has been
commercially available since 2012 under the trade name Delcath
Hepatic CHEMOSAT® Delivery System for Melphalan
(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
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. 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 OM, HCC ,and ICC clinical trial programs, timely
enrollment and treatment of patients in the global Phase 3 FOCUS
Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma
and the global Phase 2 HCC and ICC clinical trials, IRB or ethics
committee clearance of the Phase 2 HCC/ICC and/or Phase 3
OM protocols from participating sites and the timing of
site activation and subject enrollment in each trial, the impact,
if any, of publication of the Phase 3 trial manuscript to support
the Company's efforts,the impact of the presentations at major
medical conferences and future clinical results consistent with the
data presented, 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, the Company's
ability to successfully commercialize the CHEMOSAT/Melphalan HDS
system and the potential of the CHEMOSAT/Melphalan HDS 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, the Company's ability to satisfy the remaining
requirements of the FDA's Complete Response Letter and provide the
same in a timely manner, approval of the current or future
Melphalan HDS/CHEMOSAT system for delivery and filtration of
melphalan for various indications in the U.S. and/or in foreign
markets, actions by the FDA or other 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, our
ability to maintain NASDAQ listing, 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.
Contact Information:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.