e60641756frm8k.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): April 22, 2009
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DELCATH
SYSTEMS, INC.
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(Exact
Name of Registrant as Specified in
Charter)
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DELAWARE
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001-16133
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06-1245881
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(State
of Incorporation)
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(Commission
File
Number)
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(IRS
Employer Identification No.)
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600
FIFTH AVENUE, 23rd
FLOOR
NEW
YORK, NEW YORK
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10020
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant's
telephone number, including area code: (212) 489-2100
Check the
appropriate box below if the Form 8−K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[ ]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ]
Soliciting material pursuant to Rule 14a−12 under the Exchange Act (17 CFR
240.14a−12)
[ ]
Pre−commencement communications pursuant to Rule 14d−2(b) under the Exchange Act
(17 CFR 240.14d−2(b))
[ ]
Pre−commencement communications pursuant to Rule 13e−4(c) under the Exchange Act
(17 CFR 240.13e−4(c))
Item
7.01 Regulation FD Disclosure.
On April
22, 2009, Delcath Systems, Inc. (the “Company”) held a previously noticed
quarterly update conference call and access thereto. The call will be archived
and made available shortly on the Company’s website, www.delcath.com. On
the call, among other things, the Company announced that it was granted FDA
approval to increase the maximum number of centers that can participate in the
Company’s trials from the current 15 to a maximum of 28 centers. It was also
announced that patient enrollment passed the halfway point in December and
accrual is set to exceed 75% by this summer. It was further announced
that the Company remains on its stated target to complete enrollment in its
trials by year-end 2009, with current enrollment currently at 61 patients, of
which 31 have been randomized to receive the Delcath treatment and 30 have been
randomized to receive best alternative care.
The
information contained in Item 7.01 of this Report shall not be deemed “filed”
for the purposes of Section 18 of the Securities Exchange Act of 1934 (the
“Exchange Act”), or otherwise subject to the liabilities of that section, and
shall not be incorporated by reference into any registration statement or other
document filed under the Securities Act of 1933 or the Exchange
Act.
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
report 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 the timing of and our ability to successfully enroll
patients or otherwise 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.
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the Registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly
authorized.
Date: April
23, 2009
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DELCATH
SYSTEMS, INC.
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By:
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/s/
Richard L. Taney
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Name:
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Richard
L. Taney
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Title:
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Chief
Executive Officer
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