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): November 10, 2009
(Exact Name of Registrant as Specified in Charter)
|
Delaware |
001-15911 |
52-1256615 | |
|
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
|
10220-L
Old Columbia Road, Columbia, Maryland |
21046-2364 |
|
(Address
of principal executive office) |
(Zip Code) |
Registrant’s telephone number, including area code: (410) 290-5390
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 obligations of the registrant under any of the following provisions (see General Instruction A.2. below):
|
[ ] |
Written communication 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 240.135-4(c)) |
On November 10, 2009, Celsion Corporation issued a press release reporting its financial results for the quarter and nine months ended September 30, 2009 (the “Earnings Release”). The Earnings Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this report shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statement and Exhibits
(d) Exhibits.
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Exhibit Number |
Description |
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99.1 |
Earnings Release, dated November 10, 2009, furnished pursuant to Item 2.02 of Form 8-K.
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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.
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CELSION CORPORATION
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Date: November 10, 2009 |
By: |
/s/ Sean F. Moran | |
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Sean F. Moran
Sr. Vice President and Chief Financial Officer | |||
Exhibit Index
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Exhibit No. |
Description | |
|
99.1 |
Earnings Release, dated November 10, 2009, furnished pursuant to Item 2.02 of Form 8-K.
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Exhibit
99.1
Celsion
Reports Third Quarter 2009 Financial Results and Business Update
Enrollment
Continues to Accelerate in ThermoDox® Phase III Trial for Primary Liver Cancer
with the Addition of New Clinical Sites in the Far East
COLUMBIA,
MD (BUSINESS WIRE) November 10, 2009 – Celsion Corporation (NASDAQ: CLSN), a
leading oncology drug development company, announced financial results for the
third quarter ended September 30, 2009 and highlighted the progress made in the
commercialization of ThermoDox®, Celsion’s heat activated liposomal
encapsulation of doxorubicin for the treatment of hepatocellular carcinoma
(HCC), the most common form of primary liver cancer, and recurrent chest wall
breast cancer.
“We
achieved key milestones during the quarter against our corporate objectives to
advance the development and commercialization of ThermoDox to create inherent
value for our shareholders,” stated Michael H. Tardugno, Celsion’s Chief
Executive Officer. “We have expanded the HEAT trial (ThermoDox global Phase III
HCC study) to the Asia Pacific region where the incidence of primary liver
cancer is endemic. We recently received regulatory approval to treat
liver cancer patients in China, Malaysia and the Philippines and the first
patient has already been treated in Japan. To date, we have enrolled 196
patients (one third of the trial) and are on target to complete enrollment in
the spring of 2010 and have sixty clinical sites activated by the end
2009. Radio frequency ablation (RFA) is emerging globally as a
first-line treatment for early stage non-resectable HCC. Our HEAT
trial has been designed to evaluate the efficacy of ThermoDox in combination
with RFA to improve patient outcomes for this cost effective, minimally invasive
procedure.”
Financial
Results
For the
third quarter ended September 30, 2009, Celsion reported a net loss of $4.7
million, or $0.47 per diluted share, compared to a net loss of $4.3 million, or
$0.43 per diluted share for the third quarter of 2008. For the nine months ended
September 30, 2009, Celsion reported a net loss of $12.9 million, or $1.27 per
diluted share, compared to a net loss of $10.9 million, or $1.07 per diluted
share in 2008. The Company ended the quarter with a total of $16.3 million in
cash and short-term investments. In
September 2009, the Company completed a registered direct offering with a select
group of institutional investors that raised $7.1 million of gross
proceeds.
Recent Company
Highlights
|
·
|
Enrolled
196 patients (one third of target) in the ThermoDox primary liver cancer
trial
|
|
·
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Received
regulatory approvals in China, Malaysia and the Philippines to expand the
ThermoDox primary liver cancer trial to these
countries
|
|
·
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Treated
the first patient in Japan with ThermoDox in the primary liver cancer
trial
|
|
·
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Data
Safety Monitoring Board recommended the continuation of the ThermoDox
trial for primary liver cancer
|
|
·
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Partnered
with the American Liver Foundation to Promote Awareness of primary liver
cancer and the ThermoDox primary liver cancer
trial
|
|
·
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Raised
$7.1 million from a registered direct
offering
|
|
·
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Received
positive FDA guidance to CMC submission which cleared way for the
validation and scale-up of the ThermoDox manufacturing
process
|
|
·
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Patient
enrollment in Phase II DIGNITY trial for the treatment of recurrent chest
wall breast cancer continues to progress; Company launched an innovative,
integrated media outreach campaign.
|
|
·
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Completed
feasibility testing with Phillips Medical for the combination of ThermoDox
with Phillips MR-guided high intensity focused ultrasound device; IND
submissions targeted for 2010 for the treatment of pancreatic cancer and
cancer metastasis in bone.
|
The
Company is holding a conference call to provide a business update and discuss
the third quarter 2009 results at 11:00 a.m. Eastern Time on Tuesday
, November 10, 2009. To participate in the call,
interested parties may dial 1.877.852.6580 (Toll-free) or 1.719.325.4751
(Toll/International) and use Conference ID: 2474093 to register ten minutes
before the call is scheduled to begin. The call will also be broadcast live on
the Internet at http://www.celsion.com
The call
will be archived for replay on November 10, 2009 at 2:00 P.M. ET and will remain
available until November 17, 2009. The replay can be accessed at
1.888.203.1112 (Toll-free) or 1.719.457.0820 (Toll/International) using
Conference ID: 2474093. The call will also be available on the
Company's website, www.celsion.com , for 30 days after 2:00 P.M. on Tuesday,
November 10, 2009.
About
the Phase III HEAT Clinical Trial
Celsion’s
global Phase III HEAT trial is evaluating the safety and efficacy of ThermoDox
in combination with radiofrequency ablation (RFA) when compared to RFA alone.
The trial is being conducted under a Special Protocol Assessment and the FDA has
agreed to progression free survival as the primary and accelerated endpoint with
overall survival being a secondary endpoint. The trial will enroll up to six
hundred patients at clinical sites in Japan, China, Malaysia, Thailand,
Philippines, Hong Kong, Korea, Taiwan, Italy, the United States and
Canada
Additional
information can be found at: http://www.clinicaltrials.gov/
About
Primary Liver Cancer
Primary
liver cancer is a type of cancer that begins in the cells of the liver and is
not typically detected early, often resulting in a poor patient
prognosis. Globally, primary liver cancer is one of the most deadly
forms of cancer and ranks as the fifth most common solid tumor cancer. The
incidence of primary liver cancer is approximately 20,000 cases per year in the
United States and is rapidly growing worldwide at approximately 660,000 cases
per year, due to the high prevalence of Hepatitis B and C in developing
countries. The standard first line treatment for liver cancer is surgical
resection of the tumor, but 80% to 90% of patients are ineligible for surgery.
Radio frequency ablation (RFA) has increasingly become the standard of care for
non-resectable liver tumors, but the treatment becomes less effective for larger
tumors. There are few non-surgical therapeutic treatment options available as
radiation therapy and chemotherapy are largely ineffective in the treatment of
primary liver cancer.
About
ThermoDox
ThermoDox
in combination with hyperthermia has the potential to provide local tumor
control and improve quality of life. ThermoDox is a proprietary heat-activated
liposomal encapsulation of doxorubicin, an approved and frequently used oncology
drug for the treatment of a wide range of cancers including breast cancer.
Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped
doxorubicin from the liposome. This delivery technology enables high
concentrations of doxorubicin to be deposited preferentially in a targeted
tumor.
ThermoDox
has demonstrated evidence of efficacy in a Phase I study for primary liver
cancer and the FDA has granted Orphan Drug designation for this indication. For
recurrent chest wall breast cancer, ThermoDox is being evaluated in a pivotal
Phase I/II open-label, dose-escalating trial that is designed to measure durable
local complete response at the tumor site.
ThermoDox®
is a registered trademark of Celsion Corporation
About
Celsion
Celsion
is dedicated to the development and commercialization of innovative oncology
drugs including tumor-targeting treatments using focused heat energy in
combination with heat-activated drug delivery systems. Celsion has licensed
ThermoDox® to Yakult-Honsha for the Japanese market and has a partnership
agreement with Phillips Medical to jointly develop its heat activated liposomal
technology in combination with high intensity focused ultrasound to treat
difficult cancers. Celsion has research, license, or commercialization
agreements with leading institutions such as the National Institutes of Health,
Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and
the North Shore Long Island Jewish Health System.
For more
information on Celsion, visit our website: http://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.
Contacts:
Celsion
Corporation
Sean
Moran, 410-290-5390
Senior
Vice President and Chief Financial Officer
smoran@celsion.com
or
The Trout
Group
Marcy
Nanus, 646-378-2927
mnanus@troutgroup.com
Celsion
Corporation
Condensed
Statements of Operations
(Unaudited)
(in
thousands except for per share amounts)
|
Three
Months
Ended
September 30,
|
Nine
Months
Ended
September 30,
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|||||||
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2009
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2008
|
2009
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2008
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|||||
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Operating
expenses:
|
||||||||
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Research
and development
|
$
|
3,503
|
$
|
3,840
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$
|
10,676
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$
|
8,422
|
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General
and administrative
|
1,224
|
510
|
2,514
|
1,586
|
||||
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Total
operating expenses
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4,727
|
4,350
|
13,190
|
10,008
|
||||
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Loss from
operations
|
(4,727)
|
(4,350)
|
(13,190)
|
(10,008)
|
||||
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Other
income (expense), net
|
10
|
10
|
265
|
(844)
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||||
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Net
loss before income taxes
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(4,717)
|
(4,340)
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(12,925)
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(10,852)
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||||
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Income
taxes
|
-
|
-
|
-
|
-
|
||||
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Net Loss
|
$
|
(4,717)
|
$
|
(4,340)
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$
|
(12,925)
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$
|
(10,852)
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Basic
and diluted net loss per common share
|
$
|
(0.47)
|
$
|
(0.43)
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$
|
(1.27)
|
$
|
(1.07)
|
|
Basic
and diluted weighted average shares outstanding
|
10,118
|
10,149
|
10,166
|
10,146
|
||||
Celsion
Corporation
Balance
Sheets
(in
thousands except for per share amounts)
|
ASSETS
|
September
30, 2009 (Unaudited)
|
December
31, 2008
|
|||
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Current
assets
|
|||||
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Cash
and cash equivalents
|
$
|
12,098
|
$
|
3,456
|
|
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Short
term investments available for sale
|
4,204
|
4,061
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|||
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Due
from Boston Scientific Corporation
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-
|
15,000
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|||
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Prepaid
expenses and other receivables
|
440
|
306
|
|||
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Total
current assets
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16,742
|
22,823
|
|||
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Property
and equipment
|
205
|
223
|
|||
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Other
assets
|
|||||
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Note
receivable
|
-
|
221
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|||
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Deposits
|
744
|
363
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|||
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Other
assets
|
52
|
58
|
|||
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Total
other assets
|
796
|
642
|
|||
|
Total
assets
|
$
|
17,743
|
$
|
23,688
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||
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Current
liabilities
|
|||||
|
Accounts
payable - trade
|
$
|
2,840
|
$
|
1,187
|
|
|
Indemnity
reserve
|
-
|
1,053
|
|||
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Other
accrued liabilities
|
1,293
|
1,459
|
|||
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Note
payable - current portion
|
-
|
235
|
|||
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Total
current liabilities
|
4,132
|
3,934
|
|||
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Warrant
liability
|
1,554
|
-
|
|||
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Other
liabilities – noncurrent
|
19
|
28
|
|||
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Total
liabilities
|
5,705
|
3,962
|
|||
|
Stockholders'
equity
|
|||||
|
Common
stock - $0.01 par value (75,000,000 and 250,000,000 shares authorized;
12,874,241 and 10,816,088 shares issued: 12,113,967 and 10,156,350 shares
outstanding at September 30, 2009 and December 31, 2008,
respectively)
|
129
|
108
|
|||
|
Additional
paid-in capital
|
94,776
|
89,183
|
|||
|
Accumulated
deficit
|
(79,790)
|
(66,924)
|
|||
|
Subtotal
|
15,115
|
22,367
|
|||
|
Less:
Treasury stock - at cost
|
(3,077)
|
(2,641)
|
|||
|
Total
stockholders' equity
|
12,038
|
19,726
|
|||
|
Total
liabilities and stockholders' equity
|
$
|
17,743
|
$
|
23,688
|