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): July 17, 2006
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-16133 06-1245881
(State or other jurisdiction (Commission File (IRS Employer
of incorporation) Number) 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))
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Section 8 - Other Events
Item 8.01 Other Events.
On July 17, 2006, Delcath Systems, Inc. (the "Company") issued a press
release announcing that it issued a second quarter update to shareholders. The
Company's press release dated July 17, 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 July 17, 2006 of Delcath Systems,
Inc.
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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: July 17, 2006
[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
- --------------- ---------------- ----------------
Delcath Systems Issues Second Quarter Update
STAMFORD, Conn., July 17, 2006 -- Delcath Systems, Inc. (NASDAQ: DCTH), today
issued the following second quarter update to shareholders.
To Our Shareholders:
As part of the expanded shareholder communications plan discussed in our June
27th letter to shareholders, Delcath is furnishing shareholders with this
quarterly update of our recent developments. Delcath intends to provide
shareholders with these regular quarterly update releases distributed through
one of the major newswires within approximately three weeks after the close of
each quarterly reporting period and within approximately 45 days after the close
of each fiscal year.
Clinical Trials
Management is currently reaching out to several medical centers worldwide to
participate in Delcath's Doxorubicin Phase III clinical trial. Concurrently,
given the FDA's award of fast-track status, management is also actively pursuing
the Melphalan Phase III trial.
As the lead site, the National Cancer Institute (NCI) continues to successfully
recruit and enroll patients in the Melphalan Phase III trial. Delcath has also
made a great deal of progress in recruiting the University of Maryland as a site
for the Melphalan Phase III trial. Recently, the Company met with the
University's principal investigator and several administrative and clinical
staff members to discuss the mechanics of the trial and contract and budgeting
issues. While the Company hopes to add this as the second site in the trial,
several steps remain before it can be added. For example, the Company needs to
receive approval from the University's Institutional Review Board and the NCI.
Management is also speaking with several other hospitals that have expressed
interest in participating either as a clinical site or by referring patients.
Due to the complex regulatory procedures, we are unable to provide a timeframe
for completion of this process.
The Phase II Melphalan Multi-Histology trial continues to successfully recruit
new patients, particularly in the Neuroendocrine arm of the study, which has
enrolled 9 of the 15 patients needed to evaluate whether or not to pursue the
full Phase II study. If the principal investigator moves forward with the full
Phase II Neuroendocrine arm of the study, an additional 10 patients will need to
be enrolled in the study for a total of 25 patients. Recently, because of our
encouraging results to date, the study's principal investigator issued a letter
to physicians, which emphasized that the positive results of the Phase I
Melphalan study have continued into the Phase II study. Delcath is pleased by
these results and plans to issue a formal update with quantifiable data as soon
as it becomes available for release.
Board Expansion
The Board has initiated a search for highly qualified new independent candidates
for the Board who can provide access to additional opportunities in the clinical
field and/or have significant expertise in research and clinical trials. The
Board remains on track to have one new director in place by the end of the third
quarter of 2006 and a second new director in place by the end of 2006. The Board
currently is in the process of interviewing potential candidates. Currently,
Delcath's Board of Director's consists of five directors, three of whom are
independent.
Investor Relations
Delcath's management is committed to broadening its shareholder base to provide
a stable platform for its common stock as Delcath seeks to maximize long-term
shareholder value. Throughout the second quarter and since the annual meeting,
management has held multiple meetings and conference calls with various
institutional shareholders in New York City, Maryland, Philadelphia and
Montreal. Meetings have also been scheduled with research analysts that have
expressed interest in initiating coverage of Delcath in order to increase the
Company's exposure to the broader capital markets.
Intellectual Property
Recently, management was informed by its patent counsel that one of its
international applications, EU Patent Application No. 0 936 933, has been
approved, pending no objections from outside parties. The application relates to
the Company's balloon catheter used to bypass blood from the inferior vena cava
to a special filter outside the patient's body, restricting blood flow from the
liver to the heart. Management anticipates this application will move to the
nationalization phase during the fourth quarter of 2006, at which point the
Company will be able to announce the addition of another international patent.
Special Meeting of Shareholders
On July 11, Delcath announced that Laddcap Value Partners LP, a 10 percent
holder of the Company's outstanding common stock, agreed to withdraw its
requests for a special meeting of Delcath's shareholders. In addition, both
Delcath and Laddcap have agreed to dismiss without prejudice the litigation
against Delcath commenced on June 6, 2006 in the Chancery Court of the State of
Delaware relating to Laddcap's demand to inspect certain books and records of
the Company pursuant to Section 220 of the General Corporation Law of the State
of Delaware. Both Delcath and Laddcap retain their rights to pursue any future
action without restriction or prejudice. Delcath looks forward to moving on and
focusing on maximizing shareholder value over the long term.
Shareholder Proposal
Since the annual meeting, in response to the approval by shareholders of a
non-binding shareholder proposal 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 additional strategic
alternatives, Delcath continues to have preliminary discussions with several
investment banking firms regarding their possible engagement by Delcath to
assist the Board with its ongoing evaluation of all available options. Your
Board of Directors unanimously continues to believe 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.
Shareholder Vote
At the request of several shareholders, we have provided the following table
ahead of our upcoming Form 10-QSB that discloses the vote totals from our 2006
Annual Meeting of Stockholders. The proposals included the election of directors
(Proposal 1) and the shareholder proposal (Proposal 2) recommending that the
Board of Directors retain a nationally recognized investment banking and/or
merger advisory firm.
SHARE INFORMATION
TOTAL SHARES PRESENT 17,886,476
PROPOSAL 1 (Directors)
DIRECTOR # VOTES FOR VOTES WITHHELD
1 - MARK A. CORIGLIANO 10,738,747 7,147,729
2 - VICTOR NEVINS 10,709,997 7,176,479
PROPOSAL 2 (Retain Investment Banking Firm)
VOTES FOR VOTES AGAINST VOTES ABSTAIN BROKER NON-VOTE
7,416,373 4,993,779 281,465 5,194,859
We look forward to the exciting opportunities ahead and appreciate your support.
We will continue to execute on the Company's successful business strategy in
order to maximize long-term value for all Delcath shareholders.
Sincerely,
M.S. Koly
President & 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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