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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): May 28, 2004
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Celsion Corporation
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-14242 52-1256615
- ---------------------------- ----------------- -------------------
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
10220-L Old Columbia Road, Columbia, Maryland 21046-2364
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(Address of principal executive office) (Zip Code)
Registrant's telephone number, including area code: (410) 290-5390
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(Former Name or Former Address, if Changed Since Last Report)
ITEM 5. OTHER EVENTS
(A) On May 28, 2004, Celsion Corporation (the "Registrant") announced, by
way of a press release, that it had become aware that its common stock
was listed for trading on the Berlin-Breman Stock Exchange and that it
had requested delisting from that Exchange. A copy of the press release
is attached as Exhibit 99.1 to this Report on Form 8-K.
(B) On June 1, 2004, the Registrant announced, by way of a press release,
that it had filed with the Food and Drug Administration (the "FDA") its
response to a warning letter issued to it by the FDA on May 7, 2004. A
copy of the press release is attached as Exhibit 99.2 to this Report on
Form 8-K.
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.
CELSION CORPORATION
Date: June 2, 2004 By: /s/ Augustine Y. Cheung
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President and Chief Executive Officer
Exhibit Index
Exhibit No. Description
99.1 Registrant's press release dated May 28, 2004,
regarding listing of its common stock on the
Berlin-Breman Stock Exchange and request for
delisting of the common stock.
99.2 Registrant's press release dated June 1, 2004,
regarding filing, by Registrant, of its response to a
warning letter received by it from the Food and Drug
Administration on May 7, 2004.
EXHIBIT 99.1
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NEWS RELEASE CELSION(TM)
- --------------------------------------------------------------------------------
For Further Information Contact:
Tony Deasey Steve Chizzik/ Richard Cooper/Jennifer Zimmons
Celsion Corporation Ira Weingarten Strategic Growth International, Inc.
410.290.5390 Equity Communications 212.838.1444
tony@celsion.com 973.912.0980 info@sgi-ir.com
chizz1@comcast.net ---------------
CELSION DEMANDS IMMEDIATE END TO UNAUTHORIZED TRADING ON BERLIN-BREMEN
STOCK EXCHANGE
COLUMBIA, MD - MAY 28, 2004: CELSION CORPORATION (AMEX: CLN) announced today
that it has learned that its common stock has been listed on the Berlin-Bremen
Stock Exchange without the Company's prior knowledge, consent or authorization.
The Company, through its counsel, has contacted the Berlin-Bremen Stock Exchange
and has demanded an immediate halt to trading in Celsion's stock, as well as an
immediate delisting of the stock.
Tony Deasey, Celsion's Executive Vice President and Chief Financial Officer,
said, "We did not apply for this listing. We were not consulted or contacted by
anyone at the Exchange, either before or after we were listed, and we certainly
did not request or consent to the listing. We have no interest in trading on the
Berlin-Bremen Exchange and are disturbed by media reports that brokers have been
using such listing as a mechanism for manipulating the price of U.S. stocks.
Therefore, our attorneys have demanded an immediate end to trading and immediate
delisting from the Exchange."
ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland, is a
biotechnology company dedicated to the development and commercialization of
treatment systems for cancer and other diseases using focused-heat energy,
either administered alone, or in combination with other therapeutic devices,
heat activated genes and heat activated drugs.
In January 2003, Celsion entered into a strategic alliance with Boston
Scientific Corporation (NYSE:BSX) in which Boston Scientific will initially
distribute Celsion's BPH product worldwide. Boston Scientific currently owns
approximately 7% of Celsion's outstanding stock.
Celsion has research, license or commercialization agreements with leading
institutions such as the National Institute of Health, Duke University Medical
Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center,
Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York
City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University.
For more information on Celsion, visit our website: www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release
are made pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without limitation,
unforeseen changes in the course of research and development activities and in
clinical trials by others; possible acquisitions of other technologies, assets
or businesses; possible actions by customers, suppliers, competitors, regulatory
authorities; and other risks detailed from time to time in the Company's
periodic reports filed with the Securities and Exchange Commission.
EXHIBIT 99.2
- ------------
NEWS RELEASE CELSION(TM)
- -------------------------------------------------------------------------------
For Further Information Contact:
Tony Deasey Steve Chizzik/ Richard Cooper/Jennifer Zimmons
Celsion Corporation Ira Weingarten Strategic Growth International, Inc.
410.290.5390 Equity Communications 212.838.1444
tony@celsion.com 973.912.0980 info@sgi-ir.com
chizz1@comcast.net ---------------
CELSION SUBMITS RESPONSE TO FDA WARNING LETTER
COLUMBIA, MD - JUNE 1, 2004: CELSION CORPORATION (AMEX: CLN) announced today
that its response to the warning letter issued to it by the Food and Drug
Administration (FDA) on May 7, 2004 was submitted to the FDA on Friday, May 28,
2004. As previously announced, the warning letter reflected certain matters that
arose in connection with the Phase I and Phase II clinical trials of Celsion's
Prolieve(TM) Thermodilatation system for the treatment of benign prostatic
hyperplasia. The FDA granted Premarketing Approval (PMA) to Celsion for the
Prolieve system earlier this year, and the system currently is being marketed
under a distribution agreement between Celsion and Boston Scientific
Corporation.
Tony Deasey, Celsion's Executive Vice President and Chief Operating Officer,
said, "We took, and continue to take, the FDA's letter extremely seriously and
have devoted significant attention and resources to our response. We believe
that we have responded to the FDA's immediate concerns and have initiated
actions necessary to address their longer-term comments on a schedule which,
based on discussions with the Agency, we believe will be acceptable. We are
putting processes in place to be fully compliant with FDA GCP regulations going
forward. Our actions in response to the FDA's findings should help us to meet
that goal and improve our clinical operations for the near and long term."
Carolyn Finkle, Celsion's Vice President, Regulatory Affairs, added, "We have
responded promptly to the findings raised by the FDA in its May 7, 2004 letter
and believe that we have addressed, or will address, all of the Agency's
concerns. So long as we do so and continue to work with the Agency, we do not
anticipate any further action by the FDA, including any actions that would
affect the Prolieve PMA." Ms. Finkle also indicated that the Company intends to
submit a redacted version of its response to the FDA shortly, with the request
that Celsion's response be posted for public review on the Agency's website at
www.fda.gov.
ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland, is a
biotechnology company dedicated to the development and commercialization of
treatment systems for cancer and other diseases using focused-heat energy,
either administered alone, or in combination with other therapeutic devices,
heat activated genes and heat activated drugs.
In January 2003, Celsion entered into a strategic alliance with Boston
Scientific Corporation (NYSE:BSX) in which Boston Scientific will initially
distribute Celsion's BPH product worldwide. Boston Scientific currently owns
approximately 7% of Celsion's outstanding stock.
Celsion has research, license or commercialization agreements with leading
institutions such as the National Institute of Health, Duke University Medical
Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center,
Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York
City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University.
For more information on Celsion, visit our website: www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release
are made pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without limitation,
unforeseen changes in the course of research and development activities and in
clinical trials by others; possible acquisitions of other technologies, assets
or businesses; possible actions by customers, suppliers, competitors, regulatory
authorities; and other risks detailed from time to time in the Company's
periodic reports filed with the Securities and Exchange Commission.