Patient Enrollment in Phase III Metastatic Melanoma Trial Now at 79
Conference Call to Discuss Second Quarter Results Today at 4:30 PM
ET 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(TM)
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 http://www.delcath.com/. An archived webcast will also
be available at http://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 http://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.
(tables to follow) DELCATH SYSTEMS, INC. (A Development Stage
Company) Condensed Balance Sheets June 30, December 31, 2009 2008
---- ---- Assets Current assets Cash and cash equivalents
$7,435,673 $6,939,233 Investments - CDs 1,472,928 3,847,904
Investments - treasury bills - 200,710 Investments - marketable
equity security 36,000 22,000 Income Tax Receivable 298,535 -
Prepaid expenses 324,253 331,346 ------- ------- Total current
assets 9,567,389 11,341,193 Property and equipment, net 14,558
17,489 ------ ------ Total assets $9,581,947 $11,358,682 ==========
=========== Liabilities and Stockholders' Equity Current
liabilities Accounts payable and accrued expenses $344,083 $703,489
Derivative instrument liability 7,105,454 448,318 --------- -------
Total current liabilities 7,449,537 1,151,807 --------- ---------
Commitments and contingencies - - Stockholders' equity Common
stock, $.01 par value; 70,000,000 shares authorized 262,530 253,834
Additional paid-in capital 58,019,453 57,343,507 Deficit
accumulated during development stage (56,088,270) (47,315,163)
Treasury Stock (51,103) (51,103) Accumulated other comprehensive
loss (10,200) (24,200) ------- ------- Total stockholders' equity
2,132,410 10,206,875 --------- ---------- Total liabilities and
stockholders' equity $9,581,947 $11,358,682 ========== ===========
Delcath Systems, Inc. (A Development Stage Company) Condensed
Statements of Operations (Unaudited) Three Months Ended Six Months
Ended June 30, June 30, 2009 2008 2009 2008 ---- ---- ---- ----
Costs and expenses: General and administrative expenses $544,913
$699,136 $1,019,876 $1,140,140 Research and development costs
2,195,036 1,099,488 3,656,226 2,088,444 --------- ---------
--------- --------- Total costs and expenses 2,739,949 1,798,624
4,676,102 3,228,584 --------- --------- --------- ---------
Operating loss before taxes (2,739,949) (1,798,624) (4,676,102)
(3,228,584) Derivative instrument income (expense) (3,904,379)
(671,652) (4,466,157) (473,401) Interest income 18,167 50,002
68,928 223,965 Other income - - 1,689 - Interest expense - - - - -
- - - Net loss before tax benefit (6,626,161) (2,420,274)
(9,071,642) (3,478,020) Income tax benefit 298,535 - 298,535 -
------- - ------- - Net loss $(6,327,626) $(2,420,274) $(8,773,107)
$(3,478,020) =========== =========== =========== =========== Common
share data: Basic and diluted loss per share $(0.25) $(0.10)
$(0.34) $(0.14) ====== ====== ====== ====== Weighted average number
of shares of common stock outstanding 25,528,282 25,262,031
25,455,818 25,260,658 ========== ========== ========== ==========
DATASOURCE: Delcath Systems, Inc. CONTACT: Approved By Eamonn
Hobbs, President & CEO of Delcath Systems, Inc.,
+1-212-489-2100; or Investors, Doug Sherk, +1-415-652-9100, or
Media, Steve DiMattia, +1-646-201-5445, both for Delcath Systems,
Inc. Web Site: http://www.delcath.com/
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