NEW YORK, July 16, 2015 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and
medical device company focused on oncology with an emphasis on the
treatment of primary and metastatic liver cancers, announced today
that it priced an offering of 9,350,000 units, each unit consisting
of one share of its common stock, 0.75 of one Series A Warrant to
purchase one share of its common stock, and one Series B Warrant to
purchase one share of its common stock and 0.75 of one Series A
Warrant at a price of $0.75 per unit
in a registered underwritten public offering for gross proceeds of
$7.0 million. The Series A
Warrants are exercisable at an exercise price of $0.87 and will expire, unless exercised, on the
fifth anniversary of the date of issuance. The Series B Warrants
are exercisable at an exercise price of $0.75 and will expire, unless exercised, 90
trading days after the date of issuance. All of the securities
described above in the offering are to be sold by Delcath.
Net proceeds to Delcath from this offering are expected to be
approximately $6.2 million, after
deducting underwriting discounts and commissions, and other
estimated offering expenses payable by Delcath. The offering is
expected to close on or about July 21,
2015, subject to the satisfaction of customary closing
conditions.
Roth Capital Partners is acting as sole manager of the
offering.
A registration statement on Form S-1 relating to the public
offering of the shares of common stock described above was filed
with the Securities and Exchange Commission ("SEC") and has been
declared effective. The public offering will be made only by
means of a prospectus, copies of which may be obtained, when
available, from Roth Capital Partners, LLC, 888 San Clemente,
Newport Beach, CA 92660, (800)
678-9147 or by accessing the SEC's website, www.sec.gov.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy, nor shall there be any sale of
these securities in any state or jurisdiction in which such an
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 an emphasis 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
(HCC), and expect to initiate a global Phase 3 trial in ocular
melanoma (OM) that has metastasized to the liver and plan to
evaluate intrahepatic cholangiocarcinoma (ICC) 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 impact of the poster
presentation at ASCO 2015 and future clinical results consistent
with the data presented, timely patient enrollment the ability to
complete an interim evaluation of the Company's Global Phase 2 HCC
program, 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 for certain 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, 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:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.