NEW YORK –
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160930005402/en/
LHA
Ann Marie Fields, 212-838-3777
afields@lhai.com