NEW YORK, Feb. 11, 2015 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH) today announced that it has priced an
underwritten public offering of 2,460,000 shares of its common
stock and warrants to purchase up to 1,107,000 shares of common
stock at a combined price to the public of $1.15 per share and related warrant for gross
proceeds of $2.8 million. The
warrants are exercisable beginning on the date six months after the
date of issuance at an exercise price of $1.38 per share and will expire, unless
exercised, on the fifth anniversary of the date of issuance. The
net proceeds from the sale of the shares and the related warrants,
after deducting the underwriters' discounts and other estimated
offering expenses payable by Delcath, will be approximately
$2.4 million, which does not include
any potential proceeds from the cash exercise of any warrants.
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. The offering is expected to close on or about February 17, 2015, subject to the satisfaction of
customary closing conditions.
Roth Capital Partners is acting as the sole manager for the
offering. Lake Street Capital Markets provided certain financial
consulting services in connection with the offering.
A shelf registration statement (File No. 333-183675) relating to
these securities was filed with the Securities and Exchange
Commission on August 31, 2012, which
was declared effective on October 9,
2012. A preliminary prospectus supplement related to the
offering was filed with the Securities and Exchange Commission on
February 10, 2015. The securities may
be offered only by means of a prospectus, including a prospectus
supplement, forming 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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.