Delcath Prices Underwritten Public Offering of Common Stock and Warrants
September 30 2016 - 9:22AM
Business Wire
Delcath Systems, Inc. (DCTH) (the "Company"), an interventional
oncology company focused on treatments for primary and metastatic
liver cancers, today announced the pricing of an underwritten
public offering of 425,000 shares of its common stock at a price of
$3.00 per share, for gross proceeds of $1,275,000. Investors will
also receive 0.35 warrants to purchase an additional share of
common stock at an initial exercise price of $3.00 per share, with
a term of five years. The offering is expected to close on October
5, 2016, subject to customary closing conditions.
Roth Capital Partners is acting as 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 shares and warrants described above are being offered by
Delcath pursuant to a registration statement previously filed with
and subsequently declared effective by the Securities and Exchange
Commission. A prospectus supplement relating to the offering will
be filed with the SEC and 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 Drive, Suite 400, 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.
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LHAAnn Marie Fields, 212-838-3777afields@lhai.com