NEW YORK, July 27 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq:
DCTH), a medical technology company developing a minimally invasive drug
delivery platform for the regional treatment of cancer metastatic to the liver, today
reported on the Company’s recent progress. In addition, the Company reported
its financial results for the second quarter ended June
30, 2009.
Recent Highlights
- Screened 40 Additional Patients for Enrollment in
Phase III Metastatic Melanoma Trial
- Since Late April, Enrolled an Additional
18 Patients in Trial
- Total Trial Patient Enrollment Now at
79
- 12 Total Participating Centers; FDA Grants Approval to Increase Maximum Number
of Centers Enrolling Patients to 28
- Received Orphan Drug Designation for
the Drug Melphalan for the Treatment of Patients with Neuroendocrine
Tumors.
- Accomplished Medical Device Executive Eamonn Hobbs Appointed President &
CEO
- Cash as of June 30, 2009 at $8.9 Million
- Company Invited to Present at 29th Annual
Canaccord Adams Global Growth Conference on August
13, the Rodman & Renshaw Annual Global Investment Conference on September 10-11 and Maxim Group Growth Conference on September 29.
- Delcath’s PHP System™ scheduled
to be included in presentations at The Liver Symposium on August 22 in Denver, the Western
Angiographic and Interventional Society Meeting on August
29-September 2 in La Jolla, and the National Carcinoid/Neuroendocrine Tumor
Patient Conference on September 24-26 in New Orleans.
“During the past
few months, we continued to achieve patient enrollment milestones in our Phase
III Metastatic Melanoma Trial. Based on recent trends, we continue to be
optimistic about completing enrollment of 92 patients in this trial before the end of
the fourth quarter,” commented Mr. Hobbs. “The patient enrollment
progress has made me even more excited about the potential for Delcath. Our drug
delivery platform is unique in the interventional oncology space. We have the
potential to address a large and growing unmet medical need with our technology and
I look forward to completing our Phase III trial and submitting for FDA approval
in a timely manner. Meanwhile, we’ve been focusing on expanding the
awareness of our technology within the medical and professional communities and expect
to add more presentations as we move into the fall,” Mr. Hobbs added.
Financial Results
During the second quarter of 2009, Delcath Systems recorded no revenue.
General and administrative expenses declined 22% as compared to the second
quarter of 2008 due to reduced consultant fees. R&D costs doubled to $2.2 million from $1.1 million
in the second quarter of 2008 due to costs associated with the Phase III
Metastatic Melanoma Trial. The Company recorded a derivative instrument expense in the
second quarter of $3.9 million related to
warrants issued in 2007 and 2009. The net loss for the quarter was $6.3 million, or $0.25 per share,
compared with $2.4 million or $0.10 for the second quarter of 2008, an increase of $3.9 million, of which $3.3 million was
related to non-cash derivative instrument expense.
For the six months ended June 30, 2009,
the net loss was $8.8 million, or $0.34 per share, versus a net loss for the first six months of 2008
of $3.5 million, or $0.14 per share, an increase of $5.3 million of
which $4.5 million is related to non-cash derivative
instrument expense. As of June 30, the Company
had cash and cash equivalents of $8.9 million.
Conference Call
Delcath Systems will host a conference call and webcast today, Monday, July 27, 2009 at 4:30
p.m. Eastern / 1:30 p.m. Pacific to
discuss the Company’s recent progress. The dial-in number for the conference call
is 877-941-0844 for domestic participants and 480-629-9645 for international
participants.
A taped replay of the conference call will also be available beginning
approximately one hour after the call’s conclusion and will be available for
seven days. This replay can be accessed by dialing 800-406-7325 for domestic
callers and 303-590-3030 for international callers, both using passcode 4117854#.
To access the live webcast of the call, go to Delcath’s website at www.delcath.com. An archived
webcast will also be available at www.delcath.com.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical device company specializing in cancer
treatment. The Company is testing a proprietary, patented drug delivery system
for the treatment of liver cancers. Delcath's novel drug delivery platform is
testing the delivery of ultra-high doses of anti-cancer drugs to the liver while
preventing these high doses of drug from entering the patient's bloodstream. The
Company is currently enrolling patients in Phase III and Phase II clinical
studies for the treatment of liver cancers using high doses of melphalan. The
Company's intellectual property portfolio consists of twenty-seven patents on a
worldwide basis including the U.S., Europe, Asia and Canada. For
more information, please visit the Company's website at www.delcath.com.
The 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 our ability to successfully complete Phase
III clinical trials and secure regulatory approval of our current or future
drug-delivery system 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.
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SOURCE Delcath Systems, Inc.