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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): February 17, 2010
Celsion
Corporation
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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001-15911
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52-1256615
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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10220-L
Old Columbia Road, Columbia, Maryland
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21046-2364
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(Address
of principal executive office)
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(Zip
Code)
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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):
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[ ]
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Written
communication pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.135-4(c))
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Item
2.02 Results
of Operations and Financial Condition.
On
February 17, 2010, Celsion Corporation issued a press release reporting its
financial results for the quarter and year ended December 31, 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
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Description
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99.1
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Earnings
Release, dated February 17, 2010, 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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|||
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Date:
February 17, 2010
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By:
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/s/ Timothy J. Tumminello
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Timothy
J. Tumminello
Controller
and Interim Chief Accounting
Officer
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|||
Exhibit
Index
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Exhibit No.
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Description
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99.1
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Earnings
Release, dated February 17, 2010, furnished pursuant to Item 2.02 of
Form 8-K.
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Exhibit
99.1
Celsion
Reports Fourth Quarter and Full Year 2009 Financial Results
62
Clinical Trial Sites Enrolling Patients in the Pivotal Phase III ThermoDox®
Trial
COLUMBIA,
MD (PR Newswire) February 17, 2010 – Celsion Corporation (NASDAQ: CLSN), a
leading oncology drug development company, today announced financial results for
the fourth quarter and year ended December 31, 2009. Management also highlighted
the progress made in clinical trials of ThermoDox®, Celsion’s heat activated
liposomal encapsulation of doxorubicin, including the Company’s pivotal Phase
III trial for the treatment of hepatocellular carcinoma (HCC), the most common
form of primary liver cancer, and recurrent chest wall breast
cancer.
“We
continue to make substantive progress in our Phase III HEAT trial for ThermoDox
with over 45% of the 600 patients now enrolled in the study,” said Michael
Tardugno, President and CEO of Celsion. “With the recent addition of
China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and
Italy, we expect enrollment completion within the next 2 quarters. We
have achieved our goal of opening enrollment at 60 clinical trial sites
world-wide, and we anticipate initiating the trial at an additional 10 sites by
the end of this month. Additionally, our pivotal Phase I/II
recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a
sufficient number of patients in the Phase I portion to warrant a dose
escalation review by the DSMB. Assuming there will be no adverse events
suggesting dose limiting toxicity, the Dignity Study may be allowed to increase
dosage to the therapeutic dose as early as March of this year.”
Financial
Results
For the
fourth quarter ended December 31, 2009, Celsion reported a net loss of $2.3
million, or $0.19 per diluted share, compared to a net loss of $0.9 million, or
$0.09 per diluted share, for the fourth quarter of 2008. For the year
ended December 31, 2009, Celsion reported a net loss of $15.2 million, or $1.43
per diluted share, compared to a net loss of $11.8 million, or $1.16 per diluted
share, in 2008. The Company ended the year with a total of $14.1
million of cash, investments and other receivables and current
assets.
Recent
Company Highlights
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·
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Received
regulatory approvals to expand the Phase III HEAT trial for ThermoDox in
primary liver cancer into China, Malaysia and the
Philippines
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·
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Held
educational meetings in China and Japan with principal investigators and
institutional staff, a critical regulatory step to rapidly enrolling
patients in the HEAT trial
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·
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Treated
the first patients in Japan, China and the Philippines in the HEAT
trial
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·
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Launched
a CME accredited educational webcast for physicians that features recent
advances made in the treatment of HCC and Celsion's ThermoDox Phase III
HEAT clinical study; done in partnership with the American
Liver Foundation
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·
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Submitted
abstract "A Phase I Trial of ThermoDox in Patients Undergoing
Radiofrequency Ablation (RFA) of Liver Tumors" which was accepted for oral
presentation at the 9th World Congress of the International
Hepato-Pancreato-Biliary Association to be held April 18-22, 2010, in
Buenos Aires, Argentina
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·
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Will
Host a Research and Development Day for Investors on Wednesday, February
24, 2010 from 7:30 AM - 10:30 AM ET in New York City with Investigators in
Medical Oncology, Surgery, and Interventional Radiology. For an invitation
please contact Marcy Nanus at
mnanus@troutgroup.com.
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The
Company is holding a conference call to provide a business update and discuss
the fiscal 2009 results at 11:00 a.m. Eastern Time on Wednesday, February 17,
2010. To participate in the call, interested parties may dial 1-888-516-2377
(U.S./Canada) or 1-719-457-2716 (International) and use Conference ID: 9564955
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 Wednesday, February 17, 2010 at 3:00 P.M. ET and
will remain available until Wednesday, February 24, 2010. The replay can be
accessed at 1-888-203-1112 (Toll free U.S./Canada) or 1-719-457-0820
(Toll/International) using Replay Pin: #9564955. The call will also be available
on the Company's website, http://www.celsion.com, for 30 days after 3:00 P.M. on
Wednesday, February 17, 2010.
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.
For primary liver cancer, ThermoDox® is
being evaluated in a 600 patient global Phase III study at 60 clinical sites
under an FDA Special Protocol Assessment. The study is designed to evaluate the
efficacy of ThermoDox in combination with RFA when compared to patients who
receive RFA alone as the control. The primary endpoint for the study is
progression-free survival and enrollment is expected to be completed mid
2010. 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. Celsion expects to fully enroll the phase I portion of the
study in the first half of 2010. Additional information on these ThermoDox®
clinical studies may be found at http://www.clinicaltrials.gov
About
Celsion
Celsion
is a leading oncology company dedicated to the development and commercialization
of innovative cancer drugs including tumor-targeting treatments using focused
heat energy in combination with heat-activated drug delivery systems. 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.
Investor
Contact
Marcy
Nanus
The Trout
Group
646-378-2927
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.
Celsion
Corporation
Condensed
Statements of Operations
(Unaudited)
(in
thousands except for per share amounts)
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Three
Months
Ended
December 31,
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Year
Ended
December
31,
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|||||||
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2009
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2008
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2009
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2008
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|||||
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Licensing
Revenue:
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$
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---
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$
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2,500
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$
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---
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$
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2,500
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Operating
expenses:
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||||||||
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Research
and development
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$
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3,006
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$
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3,584
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$
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13,681
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$
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12,006
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General
and administrative
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812
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457
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3,327
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2,043
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Total
operating expenses
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3,818
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4,041
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17,008
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14,049
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Loss from
operations
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(3,818)
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(1,541)
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(17,008)
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(11,548)
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||||
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Other
income (expense), net
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744
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607
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1,009
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(238)
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||||
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Net
loss before income taxes
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(3,074)
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(934)
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(15,999)
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(11,786)
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||||
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Income
tax benefit
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806
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-
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806
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-
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||||
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Net Loss
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$
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(2,268)
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$
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(934)
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$
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(15,193)
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$
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(11,786)
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Basic
and diluted net loss per common share
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$
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(0.19)
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$
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(0.09)
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$
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(1.43)
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$
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(1.16)
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Basic
and diluted weighted average shares outstanding
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12,043
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10,154
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10,655
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10,149
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||||
Celsion
Corporation
Balance
Sheets
(in
thousands except for per share amounts)
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ASSETS
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December
31, 2009 (Unaudited)
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December
31, 2008
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|||
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Current
assets
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|||||
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Cash
and cash equivalents
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$
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6,924
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$
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3,456
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Short
term investments available for sale
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5,695
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4,061
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Due
from Boston Scientific Corporation
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-
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15,000
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Refundable
income taxes
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806
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Prepaid
expenses and other receivables
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695
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306
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Total
current assets
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14,120
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22,823
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Property
and equipment
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537
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223
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Other
assets
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|||||
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Note
receivable
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-
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221
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Deposits
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97
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363
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|||
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Other
assets
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51
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58
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|||
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Total
other assets
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148
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642
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|||
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Total
assets
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$
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14,805
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$
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23,688
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LIABILITIES
AND STOCKHOLDERS' EQUITY
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|||||
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Current
liabilities
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|||||
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Accounts
payable - trade
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$
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2,191
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$
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1,187
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Indemnity
reserve
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-
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1,053
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Other
accrued liabilities
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1,452
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1,459
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|||
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Note
payable - current portion
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108
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235
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|||
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Total
current liabilities
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3,751
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3,934
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|||
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Warrant
liability
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822
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-
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Other
liabilities – noncurrent
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197
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28
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|||
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Total
liabilities
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4,770
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3,962
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|||
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Stockholders'
equity
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|||||
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Common
stock - $0.01 par value (75,000,000 and 250,000,000 shares authorized;
12,895,174 and 10,816,088 shares issued: 12,134,900 and 10,156,350 shares
outstanding December 31, 2009 and 2008, respectively)
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129
|
108
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|||
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Additional
paid-in capital
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95,035
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89,183
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|||
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Accumulated
deficit
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(82,052)
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(66,924)
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|||
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Subtotal
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13,112
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22,367
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|||
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Less:
Treasury stock - at cost
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(3,077)
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(2,641)
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|||
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Total
stockholders' equity
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10,035
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19,726
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|||
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Total
liabilities and stockholders' equity
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$
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14,805
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$
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23,688
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