NEW YORK, Feb. 10, 2015 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH) today announced its intention to
offer, subject to market and other conditions, shares of its common
stock and warrants to purchase shares of common stock in an
underwritten public offering. The proceeds from the offering
(including any resulting from the exercise of the warrants, if any)
will primarily be used for general corporate purposes, including,
but not limited to, funding of clinical trials, commercialization
of products, obtaining regulatory approvals, research, capital
expenditures and working capital.
Roth Capital Partners is acting as the sole manager for the
offering.
Delcath intends to offer and sell these securities pursuant to
its existing shelf registration statement (File No. 333-183675)
filed with the Securities and Exchange Commission on August 31, 2012, which was declared effective on
October 9, 2012. A prospectus
supplement describing the terms of the offering will be filed with
the Securities and Exchange Commission and will form a part of the
effective registration statement. Copies of the prospectus
supplement and accompanying prospectus relating to the offering may
be obtained, when available, from Roth Capital Partners, 888 San
Clemente Drive, Newport Beach, CA
92660, (800) 678-9147. An electronic copy of the prospectus
supplement and accompanying prospectus relating to the offering is
available on the website of the Securities and Exchange Commission
at www.sec.gov
This press release does not constitute an offer to sell or
the solicitation of offers to buy any securities of Delcath, and
shall not constitute an offer, solicitation or sale of any security
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
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology with a principal focus on the
treatment of primary and metastatic liver cancers. Our proprietary
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. In April 2012 we obtained
authorization to affix a CE Mark to our second-generation system,
which is currently marketed in Europe as a device under the trade name
Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT).
In the U.S. the Melphalan/HDS system is considered a combination
drug and device product, and is regulated as a drug by the U.S.
Food and Drug Administration (FDA). The Melphalan/HDS system
has not been approved for sale in the U.S. We have commenced 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, and
in 2015 we expect to initiate a global Phase 3 trial in ocular
melanoma that has metastasized to the liver and plan to evaluate
intrahepatic cholangiocarcinoma in a Phase 2 clinical study.
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 HCC, ICC and OM clinical trial programs
timely enrollment and treatment of patients in the global Phase 2
HCC and ICC clinical trial, FDA approval of the global Phase 3 OM
clinical trial protocol, 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 of the presentations at ESSO
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 Value 4 status 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 Melphalan
HDS/CHEMOSAT system and the potential of the Melphalan HDS/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, the Company's ability to
satisfy the 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 or other chemotherapeutic agents 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.