2012-10-26 12:30:45 -
NEW YORK, October 26, 2012 -- Delcath Systems, Inc. (Nasdaq: DCTH) announced
today that it will host a conference call and webcast on Wednesday, November
7, 2012 at 4:30 p.m. ET to discuss its financial results for the third quarter
ended September 30, 2012, and provide an update on recent corporate progress.
The dial-in numbers for the conference call are 800-299-0148 (U.S. participants)
and 617-801-9711 (International participants); both numbers require passcode
42632846. To access the live webcast, go to the Events & Presentations page on
the Investor Relations section of the company's
website at
www.delcath.com/investors/events/.
A taped replay of the call will be available beginning approximately two hours
after the call's conclusion and will be available for seven days. Dial-in
numbers for the replay are 888-286-8010 and 617-801-6888 for U.S. and
International callers, respectively. The replay passcode for both U.S. and
international callers is 87111973. An archived webcast will also be available at
www.delcath.com/investors/events/.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company
focused on oncology. Delcath's proprietary system for chemosaturation is
designed to administer high dose chemotherapy and other therapeutic agents to
diseased organs or regions of the body while controlling the systemic exposure
of those agents. The Company's initial focus is on the treatment of primary and
metastatic liver cancers. In 2010, Delcath announced that its randomized Phase
3 clinical trial for patients with metastatic melanoma in the liver had
successfully achieved the study's primary endpoint of extended hepatic
progression-free survival. The Company also completed a multi-arm Phase 2 trial
to treat other liver cancers. The Company obtained authorization to affix a CE
Mark for the for the Generation Two CHEMOSAT(® )Delivery System for melphalan
hydrochloride in April 2012. The right to affix the CE mark allows the Company
to market and sell CHEMOSAT system for melphalan hydrochloride in Europe. In
October 2012, the Company satisfied all of the requirements to affix the CE Mark
to its CHEMOSAT Delivery System for use with doxorubicin hydrochloride
injection, providing a regulatory pathway for CHEMOSAT with doxorubicin
hydrochloride injection for countries in Asia that accept CE Marking as part of
their national regulatory requirements. The Company has not yet received FDA
approval for commercial sale of its system in the United States. The Company's
NDA has been accepted for filing and substantive review by the FDA. The Company
is seeking approval for its proprietary chemosaturation system with melphalan
hydrochloride as a treatment for patients with unresectable metastatic melanoma
in the liver.
For more information, please visit the Company's website at www.delcath.com.
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 contents of the 74 Day FDA letter and our
ability to address the same, timing of the PDUFA date, timing of completion of
the FDA's review of our NDA, the extent to which the FDA may request additional
information or data and our ability to provide the same in a timely manner, FDA
approval of the Company's NDA for the treatment of metastatic melanoma to the
liver, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA,
adoption, use and resulting sales, if any, in the United States, patient
outcomes using the Generation 2 system, adoption, use and resulting sales, if
any, for the CHEMOSAT system in the EEA, our ability to successfully
commercialize the chemosaturation system and the potential of the
chemosaturation system as a treatment for patients with primary and metastatic
disease in the liver, approval of the current or future chemosaturation system
for other indications, actions by the FDA or other foreign regulatory agencies,
our ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets including key Asian markets and timing of the
same, the initiation of clinical trials in key Asian markets with the CHEMOSAT
system with doxorubicin and timing and results of the same, approval of the
CHEMOSAT system with doxorubicin in key Asian markets, patient outcomes using
the CHEMOSAT system with doxorubicin, our ability to obtain reimbursement for
the CHEMOSAT system, uncertainties relating to the results of research and
development projects and future clinical trials, and uncertainties regarding our
ability to obtain financial and other resources for any research, development
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: Media Contact:
Doug Sherk/Gregory Gin Janine McCargo
EVC Group EVC Group
415-568-4887/646-445-4801 646-688-0425
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Delcath Systems, Inc via Thomson Reuters ONE
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