UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): June 27, 2006
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-16133 06-1245881
(State or other jurisdiction of (Commission File Number) (IRS Employer
incorporation) Identification No.)
1100 Summer Street, Stamford, Connecticut 06905
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (203) 323-8668
N/A
(Former name or former address, if changed since last report)
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 (see General Instruction A.2 below):
[ ] 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))
Section 8 - Other Events
Item 8.01 Other Events.
On June 27, 2006, Delcath Systems, Inc. (the "Company") issued a press
release announcing that it had issued a letter to its shareholders. The
Company's press release dated June 27, 2006 is incorporated herein by reference
and filed as an exhibit hereto.
Section 9 - Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(a) Not applicable
(b) Not applicable.
(c) Not applicable.
(d) Exhibits:
Exhibit Description
99 Press Release dated June 27, 2006 of Delcath Systems, Inc.
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.
DELCATH SYSTEMS, INC.
By: /s/ M. S. KOLY
-----------------------------------
M. S. Koly
President and Chief Executive
Officer
Date: June 27, 2006
EXHIBIT INDEX
Exhibit Description
99 Press Release dated June 27, 2006 of Delcath Systems, Inc.
[GRAPHIC OMITTED]
FOR IMMEDIATE RELEASE
Company Contact: Investor Contacts:
Delcath Systems, Inc. Todd Fromer / Michael Cimini
M. S. Koly, Chief Executive Officer KCSA Worldwide
203-323-8668 (212) 896-1215 / (212) 896-1233
www.delcath.com tfromer@kcsa.com / mcimini@kcsa.com
- --------------- ---------------- ----------------
Media Contacts:
Lewis Goldberg
KCSA Worldwide
(212) 896-1216
lgoldberg@kcsa.com
- ------------------
Delcath Systems Issues Letter to Shareholders
STAMFORD, Conn., June 27, 2006 -- Delcath Systems, Inc. (NASDAQ: DCTH), today
issued the following letter to its shareholders.
Dear Fellow Delcath Shareholders:
I would like to thank all who participated in this year's annual meeting of
shareholders. Both management and your Board enjoy speaking with and value the
opinions of all Delcath shareholders, both large and small. In response to
comments provided by shareholders at the annual meeting, your Board of Directors
has decided to undertake several initiatives and has been working diligently on
an implementation plan.
EXPANSION OF THE BOARD
First, the Board of Directors has determined that it is in the best interests of
the Company and its shareholders to add two new independent directors over the
coming months. The Board believes that the addition of two new highly-qualified
independent Board members who can provide access to additional opportunities in
the clinical field, and/or have significant expertise in research and clinical
trials, will provide Delcath with additional perspective and greater
opportunities to complete its trials and further position the Company to execute
its long term strategy for maximizing value for shareholders. The Board intends
to commence its search promptly, with the aim of having a new director in place
by the end of the third quarter of this year and a second new director in place
by the end of the year. Of course, the Board will consider all highly qualified
candidates with significant expertise meeting the stringent NASDAQ independence
standards, including those identified by our shareholders.
INVESTOR RELATIONS
Second, the Board has taken action to expand Delcath's investor and public
relations campaigns to introduce the Delcath story to new institutional
investors and to the major broadcast and print media. The expanded program
includes an intensive schedule of investor meetings and interviews with major
business and health care trade reporters. In the Board's estimation, this
program will help raise the Company's profile among investors, significantly
enhance the Company's ability to attract interest from major hospitals, and
support our efforts to add new sites for our current clinical trials.
SHAREHOLDER COMMUNICATIONS
Third, the Board of Delcath has instituted a more robust shareholder
communications plan to ensure that our existing shareholders are better, and
more frequently, apprised of our progress. In addition to more frequent and
timely communications, Delcath intends to provide shareholders with regular
quarterly update releases distributed through one of the major newswires after
the close of each reporting period. These quarterly communications will provide
a summary of our important developments.
SHAREHOLDER PROPOSAL
Also, at this year's annual meeting, a majority of the shares that were voted
(but still less than a majority of the total outstanding shares) approved a
non-binding measure proposed by a shareholder to retain the services of a
nationally known investment bank and/or merger advisory firm with experience in
the medical device industry to assist the Company in exploring a potential sale
to or business combination with a third party. Your Board of Directors
unanimously agrees that a sale of the Company prior to the completion of our
pivotal Phase III trial is premature and would significantly limit the long-term
value shareholders could realize if, as we expect, FDA approval of the Delcath
system is granted. However, since the annual meeting we have had preliminary
discussions with several investment banking firms regarding their possible
engagement by Delcath to assist the Board with its continuing evaluation of all
available options.
In closing, when considering the underlying value of the Company, the Board
would like to impress upon shareholders that the Delcath system is a platform
technology with twelve patents issued and/or pending. Delcath is well positioned
to leverage its intellectual property and expand the application of the Delcath
system through partnerships and potentially lucrative licensing arrangements.
While the Company currently is focused on cancer of the liver, these twelve
patents represent an as-yet unrealized potential for future product applications
for the treatment of long-bone, abdominal, uterine and kidney cancers. The Board
believes that these additional applications, as well as the use of the Delcath
technology in the treatment of Hepatitis as part of its "platform strategy",
will greatly increase the overall value of the Delcath technology and generate
significant long-term value for Delcath shareholders during the years to come.
On behalf of the entire Board of Directors, I thank you for your support of
Delcath. We greatly appreciate the role that each shareholder plays in the
success of our Company and the ongoing fight against cancer.
For further information, shareholders may contact Delcath's investor relations
representative, Todd Fromer of KCSA Worldwide, at (212) 896-1215.
Sincerely,
M.S. Koly
President and Chief Executive Officer
About Delcath Systems, Inc.
Delcath Systems is a developer of isolated perfusion technology for organ or
region-specific delivery of therapeutic agents. The company's intellectual
property portfolio currently consists of 12 patents on a worldwide basis,
including the United States, Europe, Asia and Canada. For more information,
please visit the company's website, www.delcath.com.
This release contains "forward-looking statements" based on current expectations
but involving known and unknown risks and uncertainties. Actual results or
achievements may be materially different from those expressed or implied.
Delcath's plans and objectives are based on assumptions involving judgments with
respect to future economic, competitive and market conditions, its ability to
consummate, and the timing of, acquisitions and future business decisions, all
of which are difficult or impossible to predict accurately and many of which are
beyond its control. Therefore, there can be no assurance than any
forward-looking statement will prove to be accurate.
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