Delcath Highlights First Quarter 2012 And Recent Accomplishments

       Delcath Highlights First Quarter 2012 And Recent Accomplishments

--Conference Call and Webcast Today at 4:30 p.m. ET--

PR Newswire

NEW YORK, May 8, 2012

NEW YORK, May 8, 2012 /PRNewswire/ -- Delcath Systems (NASDAQ: DCTH) today
announced financial results and highlights for its first quarter 2012 ended
March 31, 2012 and recent weeks.

Highlights for the first quarter 2012 and recent weeks include:

  oReceipt of CE Mark approval for the second generation hemofiltration
    cartridge ("Generation 2") for Hepatic CHEMOSAT^® delivery system
  oTreatment of the first patient with Generation 2
  oAdditional patients treated with liver dominant metastases from multiple
    tumor types
  oPresentation of the first evidence of the dramatically improved
    side-effect profile for chemosaturation therapy with Generation 2
  oAddition of eight EU cancer centers to the CHEMOSAT initial launch and
    training program; the Company now has a presence in five of its seven
    target markets
  oReceipt of the first commercial orders for CHEMOSAT
  oFinal preparations for filing the new drug application (NDA) for CHEMOSAT
    with the FDA
  oRegulatory approval in Australia for CHEMOSAT
  oSecure a $20 million working capital credit facility with Silicon Valley
    Bank
  oAddition of pharmaceutical industry veterans Chris Houchins and Jennifer
    Simpson, Ph.D. to the management team

"During the first quarter, we delivered several significant accomplishments
which build on the solid foundation we established in 2011 to help realize the
commercial potential of our chemosaturation system," said Eamonn P. Hobbs,
President and CEO of Delcath. "The Generation 2 CHEMOSAT system received CE
Marking in early April, and we believe that initial validation of the new
system's potential to dramatically improve the side-effect profile for
chemosaturation therapy was immediately seen in the first case treated with
Generation 2. Prior treatments in Europe also included patients suffering
from a wide variety of tumor types, which we believe is a sign of the broad
potential physicians at our early launch centers see for chemosaturation
therapy. These successes culminated in receipt of our first commercial order
for CHEMOSAT, which we are confident will be followed by others as the
benefits of the Generation 2 CHEMOSAT system become more widely known."

Mr. Hobbs stated, "At the same time, we are in the final stages of completing
our New Drug Application (NDA) submission for filing with the FDA. Safety data
collection and database migration is complete, the clinical sites have been
notified that we will lock the databases on May 25^th, and we are confident of
submitting our NDA in mid-August. We have submitted an amendment to our
Investigational New Drug application to include Generation 2 in our Expanded
Access Program and all future clinical trials, compassionate use cases, and
have initiated a dialogue with the FDA to discuss the optimal approval path
for Gen 2 in the U.S."

For the three months ended March 31, 2012, Delcath's operating loss was $14.6
million, which included approximately $0.9 in non-cash stock-based
compensation expense. Operating loss for the three months ended March 31,
2011 was $7.8 million, which included approximately $1.3 million in non-cash
stock-based compensation expense. General and administrative (G&A) expenses
were $7.4 million for the first quarter of 2012, compared to $4.2 million for
the same period in 2011. The increase was primarily due to an expansion in
staff particularly for the Company's EU headquarters in Galway, Ireland and
for sales and marketing support staff in the EU. Research and development
(R&D) expenses were $7.1 million for the first quarter of 2012, compared to
$3.6 million for the same period in 2011. The increase was primarily due to
global regulatory efforts including continued preparation of the NDA
submission to the FDA, securing CE Mark for Generation 2, and expansion of
addressable markets through the pursuit of additional regional regulatory
approvals.

At March 31, 2012, cash, cash equivalents and certificates of deposit were
$20.8 million, compared to $30.8 million at December 31, 2011. Gross cash
spend in the first quarter 2012 was $14.7 million, as compared to $7.8 million
in the same period in the prior year. The increase was primarily driven by NDA
submission related costs, staff increases in various functions to support
commercialization, and operational costs related to the new EU headquarters.
Average monthly operating gross spend was $4.9 million, which was in line
with our expectation of between $4 million to $5 million. After proceeds
generated from the Company's At-the-Market facility, the net cash spend was
approximately $10 million, or a monthly average of $3.3 million.

Following the anticipated NDA submission in mid-August, Delcath expects
monthly cash expenses to decrease to $3 million to $4 million for the
remainder of 2012. The Company expects revenue from CHEMOSAT sales in the
second half of the year will partially offset cash expenditures.

Conference Call and Webcast

The Company will host a conference call today, May 8, 2012 at 4:30 p.m. ET.
To participate in the live call by telephone, please dial 866-202-1971 for
domestic participants and 617- 213-8842 for international participants, both
using passcode 12208526. To access the live webcast, go to the Events &
Presentations page on Delcath's website at
http://www.delcath.com/investors/events/.

A taped replay of the conference call will also be available beginning
approximately two hours after the call's conclusion and will be available for
seven days. This replay can be accessed by dialing 888-286-8010 for domestic
callers and 617-801-6888 for international callers, both using passcode
69501976. An archived webcast will also be available at
http://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 III 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 II trial to treat other liver cancers. The Company obtained
authorization to affix a CE Mark for the Delcath Hepatic CHEMOSAT® delivery
system in April 2011. The right to affix the CE mark allows the Company to
market and sell the CHEMOSAT system in Europe. The Company has not yet
received FDA approval for commercial sale of its system in the United States.
The Company continues with the preparation of its NDA submission and intends
to seek FDA approval for commercial sale of its chemosaturation system with
melphalan. 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 benefits of the Generation 2
CHEMOSAT system and market acceptance of the same, patient outcomes using the
Generation 2 system, the timing of the supply and distribution of the CHEMOSAT
system to early launch centers Europe, the time required to build inventory
and establish commercial operations in Europe, adoption, use and resulting
sales, if any, for the Hepatic CHEMOSAT delivery 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
terminal metastatic disease in the liver, acceptability of the Phase III
clinical trial data by the FDA, our ability to address the issues raised in
the Refusal to File letter received from the FDA and the timing of our
re-submission of our NDA, re-submission and acceptance of the Company's NDA by
the FDA, approval of the Company's NDA for the treatment of metastatic
melanoma to the liver, adoption, use and resulting sales, if any, in the
United States, approval of the current or future chemosaturation system for
other indications, actions by the FDA or other foreign regulatory agencies,
our ability to obtain reimbursement for the CHEMOSAT system, our ability to
successfully enter into distribution and strategic partnership agreements in
foreign markets and the corresponding revenue associated with such foreign
markets, uncertainties relating to the results of research and development
projects and future clinical trials, acceptance of our IND amendment, the
timing and use, if any, of the line of credit from SVB, and our ability to
access this facility, 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



DELCATH SYSTEMS, INC.
(A Development Stage Company)
Condensed Consolidated Statements of Operations and Comprehensive Loss
for the Three Months Ended March 31, 2012 and 2011 and
Cumulative from Inception (August 5, 1988) to March 31, 2012
(in thousands, except share and per share data)
                                                              Cumulative from
                                                              inception
                                ThreemonthsendedMarch31,  (August 5, 1988)
                                                              to
                                2012            2011          March 31, 201
Costs and expenses
   General and administrative   $   7,423       $   4,166     $    68,571
   expenses(1)
   Research and development         7,131           3,648          88,894
   costs(1)
Total costs and expenses            14,554          7,814          157,465
Operating loss                      (14,554)        (7,814)        (157,465)
Derivative instrument income        (338)           5,966          (5,471)
(expense)
Interest income                     3               -              2,880
Other expense and interest          -               -              (274)
expense
Net loss                        $   (14,889)    $   (1,848)   $    (160,330)
Common share data:
Basic and diluted loss per      $   (0.31)      $   (0.04)
share
Weighted average number of
basic and diluted common        48,341,670      42,953,553
shares outstanding
Comprehensive Loss              $   (14,889)    $   (1,856)   $    (160,376)
   Note 1:
   Includes non-cash stock-based compensation
   as follows:
                                ThreemonthsendedMarch31,
                                2012            2011
   General and administrative   $   563         $   887
   expenses
   Research and development         370             406
   costs
   Total stock-based            $   933         $   1,293
   compensation expense



DELCATH SYSTEMS, INC.
(A Development Stage Company)
Condensed Consolidated Balance Sheets as of March 31, 2012 and December 31,
2011
(in thousands, except share data)
                                                 March31,    December31,
                                                 2012           2011
Assets:
Current assets
    Cash and cash equivalents                  $ 17,050       $ 25,777
    Investments – Certificates of deposit        3,735          4,980
    Prepaid expenses and other current assets    1,345          1,231
                     Total current assets        22,130         31,988
    Property, plant and equipment
           Land                                  154            154
           Furniture and fixtures                904            880
           Machinery and equipment               1,424          1,371
           Computer software and equipment       1,469          1,212
           Leasehold improvements                1,386          1,148
                                                 5,337          4,765
           Less: accumulated depreciation        (1,834)        (1,512)
           Property, plant and equipment, net    3,503          3,253
                     Total assets              $ 25,633       $ 35,241
Liabilities and Stockholders' Equity:
Current liabilities
    Accounts payable                           $ 1,802        $ 925
    Accrued expenses                             3,824          5,473
    Warrant liability                            2,930          2,439
                     Total current               8,556          8,837
                     liabilities
Deferred revenue                                 300            300
Commitments and contingencies                    -              -
Stockholders' equity
    Preferred stock, $.01 par value;
    10,000,000 shares authorized; no shares      -              -
    issued and outstanding at March 31, 2012
    and December 31, 2011
    Common stock, $.01 par value; 70,000,000
    shares authorized; 49,788,761 and
    48,237,630 shares issued and 49,760,661      498            482
    and 48,209,534 shares outstanding at
    March 31, 2012 and December 31, 2011,
    respectively
    Additional paid-in capital                   178,159        172,613
    Deficit accumulated during the               (161,829)      (146,940)
    development stage
    Treasury stock, at cost; 28,100 shares at    (51)           (51)
    March 31, 2012 and December 31, 2011
                     Total stockholders'         16,777         26,104
                     equity
                     Total liabilities and     $ 25,633       $ 35,241
                     stockholders' equity



SOURCE Delcath Systems, Inc.
 
Press spacebar to pause and continue. Press esc to stop.