EXHIBIT 99.1
[CELSION LETTERHEAD]
November 30, 2001
Dear Shareholder:
In the three months since our last letter, we have made excellent progress
against our milestones and in implementing our business plan.
1. PATIENT ENROLLMENT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) PIVOTAL PHASE
II CLINICAL TRIALS COMPLETE
In our August letter, we indicated that we would complete patient
enrollment for our Pivotal Phase II Clinical Trials by the end of
October 2001. We actually enrolled the final patient on November 14 and,
as of today, all the patients have been treated. We have also submitted
to the FDA the first two modules of our PMA and expect to file the final
module in March 2002, after we have completed the three-month patient
follow-ups. If our results are acceptable to the FDA, our BPH treatment
system could receive FDA approval during the summer of 2002.
2. BREAST CANCER PIVOTAL PHASE II TRIALS GAIN MOMENTUM
Although we continue to focus our resources on the BPH business, our
Breast Cancer Phase II Clinical Trials are underway and gaining
momentum. Since our last letter we have treated five additional patients
at Columbia Breast Surgery Medical Center in Florida and Halle Martin
Luther Breast Center in Halle in Germany. We have also treated our first
patients at Harbor UCLA Medical Center in Torrance, California and at
Oklahoma University. We have now treated a total of nine patients (out
of a total of 173 during the course of the Trials). We expect to sign up
two more sites in the United States before the end of the year and,
potentially, two additional sites in Europe early in 2002.
Once we have completed the BPH Phase II Clinical Trials we expect to
focus on approval and subsequent commercialization of our Breast Cancer
treatment system. As a result, we anticipate that patient enrollment
should accelerate, enabling us to complete the Phase II Clinical Trials
by the end of 2002.
EXHIBIT 99.1
3. CELSION/DUKE UNIVERSITY HEAT ACTIVATED LIPOSOMES
We have also completed the large animal toxicity studies for our heat
activated liposome compound at Roswell Park Cancer Institute in Buffalo,
New York. We expect to file an Investigational New Drug (IND)
application for this compound around the end of this year. Assuming the
FDA approval process runs its normal course, we could commence human
Phase I Clinical Trials on this new drug early in 2002.
4. CELSION/SLOAN-KETTERING GENE THERAPY
Dr. Gloria Li, at Memorial Sloan-Kettering, continues to make good
progress developing our temperature activated, gene based, antisense,
"biological modifier". She is currently performing an efficacy study
using human tumors in mice and is preparing to conduct large animal
toxicity studies. Celsion is in active discussions with clinicians at
Memorial Sloan-Kettering regarding the design of clinical trials with an
eye toward filing an IND application for the biological modifier and
beginning patient studies. While this development is still a long way
from commercialization, we believe that the initial results of Dr. Li's
research show great promise.
5. CASH POSITION
Over the last six weeks we have undertaken a private placement of
equity. As of November 30, we have firm commitments for the $3 million
minimum necessary for a first closing, which should take place early in
the week of December 3, 2001. Beyond this minimum, we expect to raise
additional funds, to a maximum of $5 million of gross offering proceeds,
and to close the offering before the end of the year. We expect that
this cash will provide Celsion with sufficient funds for its development
activities and other operations over the next 12 months. We are actively
engaged in negotiations with potential strategic partners in Asia for
the development of our BPH and liposome businesses in Asian markets. We
had hoped to conclude these negotiations during 2001, but a number of
events, not the least of which was the tragic occurrence on September
11th, have delayed completion. We remain confident that we will
consummate one or more agreements, resulting in further cash infusions,
as well as accelerated commercialization of our products, in the New
Year.
EXHIBIT 99.1
6. PERSONNEL
On October 4, 2001, Spencer Volk indicated that he had decided to retire
as President and CEO and to relinquish his position on the Board of
Directors. During the last four years, Spencer has changed the profile
of Celsion, launching the commercialization plan that we are executing.
He also put in place the foundation for an excellent management team,
which we are confident will guide Celsion to future success. We would
like to thank Spence for all his contributions personally and on behalf
of all our shareholders. We wish him all the best for the future.
With Spencer's departure Dr. Augustine Cheung, our Founder and Chief
Scientific Officer has again assumed the position of Chief Executive
Officer and Dr. Max Link, a long-time director of Celsion, has assumed
the position of Chairman of the Board. Max will be a major help to
Celsion in identifying and negotiating with strategic partners as
Celsion's products and businesses mature.
*****
We would also like to take this opportunity to cover some administrative
items.
First, we have moved the date of our Annual Meeting forward, from May to
February, in order to be better in keeping with our September 30 fiscal
year end. Please mark you calendar and plan to join us in February.
Second, it has been difficult to co-ordinate the delivery of shareholder
letters in time for the quarterly shareholder conference calls. We have,
therefore, scheduled the calls for 2002 as follows:
February 15 (Annual Shareholders' Meeting)
June 7
September 12
December 6
We expect to post the specific details of each call, including access
numbers, on our website (www.celsion.com) 14 days before the date of the
call.
* * * * * *
EXHIBIT 99.1
In conclusion, we are confident that the current management team will
take Celsion's businesses to commercialization. We have laid out a
series of milestones to reach the goal of commercialization and are
committed to meeting those milestones. Over the last three months, we
have made very real progress and we expect to continue to do so in the
future. Assuming we successfully sustain and build upon our current
momentum, the market promptly should recognize the value Celsion has
within its reach.
Thank you for your continued support.
Max E. Link Augustine Y. Cheung
Chairman President & Chief Executive Officer