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SCHEDULE 14A
(RULE 14A-101)
INFORMATION REQUIRED IN PROXY STATEMENT
SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(A) OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
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Filed by the registrant /X/
Filed by a party other than the registrant / /
Check the appropriate box:
/ / Preliminary proxy statement
/ / Definitive proxy statement
/X/ Definitive additional materials
/ / Soliciting material pursuant to Rule 14a-11(c) or Rule
14a-12
CELSION CORPORATION
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(Name of Registrant as Specified in Its Charter)
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(Name of Person(s) Filing Proxy Statement)
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Payment of filing fee (Check the appropriate box):
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April , 2000 / D R A F T
DEAR FELLOW SHAREHOLDERS:
We are pleased to enclose Celsion's 10K Annual Report along with a notice and
proxy materials for an annual stockholders meeting scheduled for June 1, 2000.
With your support, Celsion is thriving. I'll explain how shortly, but let's take
a moment to review what the company does. As noted in the Annual Report, Celsion
has exclusive commercial application rights for seven patented,
focused-microwave heat technologies. A number of products are in varying stages
of testing or development including:
- BREAST CANCER TREATMENT SYSTEM to kill tumors with focused microwave
heat alone, without surgery.
- PROSTATE TREATMENT SYSTEM to relieve urinary obstruction (BPH) with
microwave focused heat.
- HEAT-ACTIVATED, SITE SPECIFIC CANCER DRUGS delivery where focused heat
releases a drug in the targeted tumor.
THE FOUNDATION OF THE COMPANY'S BUSINESS IS OUR ABILITY TO FOCUS HEAT.
Celsion's products are based upon MIT's Adaptive Phased Array (APA) Technology,
originally developed for the U.S. Strategic Defense Initiative Program as
illustrated below:
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[Illustrations and Captions Omitted - at this location,
there is a graphic comparing targeted radar with targeted
heat, with captions describing both]
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HERE IS HOW WE ARE THRIVING:
ALLIANCES WITH MAJOR UNIVERSITIES AND HOSPITALS HAVE BEEN FORMED.
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To develop technologies and obtain
licensing agreements, the Company
1) has forged alliances with a
number of universities, and 2) has
undertaken Phase I clinical trials
and has agreed to conduct Phase II [Illustration and Caption Omitted -
clinical trials with leading at this location, there is a picture
hospitals. at a university hospital and a list
of scientific and medical alliances]
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SIGNIFICANT FINANCING HAS BEEN ARRANGED
A total of $4.3 million was obtained in a recent private placement. In addition,
two classes of Celsion warrants have been called for redemption, adding an
additional $5.0 million to Celsion's
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capital. As a result, Celsion has the funding to finish all its clinical
research (Phase I &II) for both Breast Cancer and Benign Prostatic Hyperplasia
(BPH). It also has the funds to begin research on targeted drug delivery.
TESTING THE SAFETY AND FEASIBILITY OF OUR BREAST CANCER SYSTEM IN PHASE I
CLINICAL TRIALS (UTILIZING MIT'S APA TECHNOLOGY) IS WELL UNDERWAY
The results of Phase I clinical trials have led the principal investigators at
UCLA and the Breast Surgery Center at Columbia/HCA to plan two exciting
protocols for Phase II clinical testing.
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1. The total ablation (death) of small
cancerous breast tumors using focused
microwave heat alone in patients
prior to undergoing lumpectomy.
2. The downsizing of large cancerous
tumors to small tumors using microwave
focused heating. If successful, this
could result in women whose tumors [Illustration and Caption
were so large that mastectomy was Omitted - at this location, there
required, only having to undergo a is a graphic of the breast cancer
lumpectomy once the tumor was downsized. ablation system used in Phase I
Clinicals]
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Dr. Robert Gardner, Celsion's principal investigator at the Breast Cancer
Surgery Center explained, "WE ARE VERY PLEASED WITH THE PRELIMINARY RESULTS OF
THE APA TREATMENT, WHICH HAS SIGNIFICANTLY REDUCED THE SIZE OF LARGE CANCEROUS
BREAST TUMORS IN OUR PATIENTS, WITH A SINGLE APPLICATION OF FOCUSED HEAT".
BENIGN PROSTATIC HYPERPLASIA (BPH) TRIALS ARE TOTALLY ON TARGET.
Phase I BPH clinicals are being conducted by Dr. Arnold Melman,
Chairman-Department of Urology, Montefiore Medical Center, NY after showing
promising initial results on a first set of patients. Patients experienced
improved symptoms, which have been at least maintained or further improved over
time. Dr. Melman reports, "TO DATE EACH OF OUR PATIENTS HAS HAD A PAINLESS
OUTPATIENT TREATMENT IN OUR OFFICE WITH GOOD RESOLUTION OF SYMPTOMS AND
IMPROVEMENT IN URINARY FLOW. MOST OF THE MEN ARE AMAZED THAT THEY CAN DRIVE HOME
BY THEMSELVES AND DO NOT NEED A CATHETER AFTER THE THERAPY. WE ARE LOOKING
FORWARD TO COMPLETING THIS PHASE I STUDY." Both Johns Hopkins and Walter Reed
Hospitals have agreed to join us in our Phase II clinical trials.
RIGHTS LICENSED FROM DUKE UNIVERSITY FOR THE COMMERCIAL DEVELOPMENT OF
HEAT-TRIGGERED LIPOSOMES
Duke University scientists implanted human tumors in mice. When treated with a
cancer killing drug delivered through heat-triggered micro-carriers called
Liposomes, these tumors regressed completely in 11 out of 11 mice tested. The
finding raises the possibility of treating cancers by injecting such Liposomes
into cancer patients and, with Celsion's APA focused heat technology, applying
heat only at the region of a tumor to selectively release cancer killing drugs.
Celsion is currently working with scientists and physicians at Duke to organize
a Phase I clinical feasibility demonstration of the concepts of targeted drug
delivery in patients, scheduled to begin early next year.
GENE DELIVERY AND GENE THERAPY BIOTECHNOLOGY PRODUCTS IN DEVELOPMENT
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Celsion has been collaborating with scientists at Memorial Sloan Kettering on
the development of heat-sensitive gene therapy compounds. These biological
modifiers can be activated by Celsion's APA focused heat to significantly reduce
a tumor's ability to resist radiation, chemotherapy or heat. Memorial Sloan
Kettering has filed a patent application for this proprietary, heat-sensitive,
gene-based, biological modifier. Celsion has an exclusive option to negotiate a
worldwide license for the commercialization of this technology and is in active
negotiations to finalize the license terms. Celsion is also planning a
pre-clinical feasibility demonstration on the use of the biological modifier for
cancer treatment. This would provide the data to apply for approval from the FDA
to begin clinical trials in patients to demonstrate safety and efficacy of this
biotechnological cancer treatment approach.
BUSINESS ADVISORY BOARD
Celsion has formed a Business Advisory Board which includes the group of
professionals shown below, who have agreed to be available to Celsion for advice
on a wide array of business issues:
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MEMBER COMPANY AFFILIATION
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Brian Cunningham Former Chairman/CEO, Computer Entry Systems Corp
Anthony Buono General Manager, Hartz Mountain Group
Anthony Deasey CFO, World Kitchens (Corning)
Margaret Grayson CFO, The V1Corporation
William F. Leimkuhler Former VP/General Counsel, Allen and Company
Gordon Macklin First President of Nasdaq and Former CEO of
Hambrecht & Quist
Jonathan J. Prinz Former President, The Schechter Group
Alan Pottash Former Senior Vice President, PepsiCo
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IMPORTANT CHANGES AIMED AT MAXIMIZING LIQUIDITY AND SHARE VALUE PLANNED.
Celsion's Board of Directors believes that the Company has reached the point in
its history when a listing on the NASDAQ SmallCap Market is in the interest of
its shareholders. A listing should provide greater visibility, make it easer for
us to interest the Wall Street research community in our progress, and, equally
important, is intended to increase liquidity in the market for Celsion's shares.
We have recently filed the necessary application and hope it will be approved
shortly. While none of us can control fluctuations in the security markets, it's
our hope that this listing will enhance the long term value of your overall
holdings in the years ahead.
We also want to make two changes in Celsion's structure that require your
approval.
1. We will be asking you to authorize an increase in our authorized
shares from 100 million to 150 million, and to create a class of
authorized preferred stock. While we have no current plans to use
those shares, having them at our disposal will provide your management
with greater flexibility in building our Company, including allowing
for acquisitions, future financings and/or stock splits when, and if,
required.
2. The Board is also asking that you authorize moving the Company's
domicile to Delaware from Maryland. This change in the Company's state
of incorporation is especially important. As the Company plans for the
future, it is essential that Celsion operate under the
well-established principles of corporate governance and flexibility,
and take advantage of the widely-accepted body of precedents that are
hallmarks of Delaware corporate law. It
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is the reason that most large and many smaller public companies as
well as financial institutions use Delaware as their corporate
domicile.
The enclosed proxy statement fully describes the reasons and the mechanism for
authorizing more shares and for changing the corporate domicile, and also
contains information on the election of directors and the selection of auditors.
We encourage you to review the text carefully.
THANK YOU SHAREHOLDERS
Celsion has come a long way since its founding in 1982. Exciting technology
which we feel will have a measurable impact upon the health of countless human
beings is at the root of that success. But we never could have made this
progress, or looked to such a bright future, without your support. The Board of
Directors joins us in thanking you for your continuing confidence.
Sincerely,
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[Signature Omitted] [Signature Omitted]
Augustine Y. Cheung, PhD Spencer Volk
Chairman & Chief Scientific Officer President & Chief Executive Officer
Celsion Corporation Celsion Corporation
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