Celsion Corporation
Mar 25, 2011

Celsion Corporation Reports Year End 2010 Financial Results and Provides Business Update

Company to Hold Conference Call Today at 11:00 a.m. ET

COLUMBIA, MD -- (MARKET WIRE) -- 03/25/11 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced financial results for the year ended December 31, 2010 and addressed the progress of its clinical trials of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. ThermoDox® is currently being evaluated under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA) in a 600 patient pivotal Phase III trial (the HEAT study) in patients with non-resectable primary liver cancer and in a Phase I/II trial for patients with recurrent chest wall breast cancer. The HEAT study has been designated as a Priority Trial for liver cancer by the National Institutes of Health, has received Fast Track Designation from the FDA and has received Orphan Drug Designation in both the U.S. and Europe.

"Celsion is nearing enrollment completion for the HEAT study and, within a similar timeframe, the pre-planned interim efficacy analysis of this pivotal study by its independent Data Monitoring Committee. We expect that these key events will serve to reinforce our confidence in ThermoDox® as a potential first line treatment for HCC as we work toward top-line results from the study in 2012 and the expansion of our ThermoDox® program into multiple indications, including secondary liver cancers, bone cancer and recurrent chest wall breast cancer, in 2011," said Michael Tardugno, Celsion's President and Chief Executive Officer. "As always, our focus is on reaching our clinical, regulatory and financial objectives while maintaining fiscal discipline, with the goal of building value for our shareholders. The recent financing in January 2011 and the acceleration of $4 million in future milestone payments from our Japanese development partner are further evidence of this commitment and continued support for ThermoDox® and the HEAT study."

Financial Results

For the year ended December 31, 2010, Celsion reported a net loss of $18.8 million ($1.52 per share), compared to a net loss of $15.2 million ($1.43 per share) for the same period of 2009. Excluding non-recurring items in 2009 (a non-cash indemnity reserve benefit of $1.1 million and an income tax benefit totaling $806,000), operating costs were $1.7 million higher in 2010 primarily due to increased costs for investigator grants, monitoring costs and milestone payments associated with higher patient enrollment levels for the Company's HEAT study. Also contributing to this increase were activities associated with late stage/commercial manufacturing for ThermoDox®. In 2010, Celsion recorded as other income a $574,000 non-cash benefit related to a mark-to-market change in the common stock warrant liability related to a stock offering completed in September 2009, compared to a $732,000 non-cash benefit in 2009.

For the year ended December 31, 2010, net cash used in operations was $13.4 million. The Company's 2010 net loss included $1.7 million in non-cash stock-based compensation expense and approximately $2.5 million in accrued expenses associated with unbilled clinical trial costs and ThermoDox® manufacturing-related activities. The Company's 2010 cash flow was also favorably impacted by the receipt of an $806,000 tax refund in the first quarter of 2010. The Company ended the year with $1.5 million of cash and investments. Since January 1, 2010, the Company completed the following transactions to address its future capital requirements:

Recent Business Highlights

The Company is holding a conference call to provide a business update and discuss fiscal year 2010 results at 11:00 a.m. Eastern Time on March 25, 2011. To participate in the call, interested parties may dial 1-800-289-0479 (Toll-Free/North America) or 1-913-312-0658 (Toll/International) and use Conference ID: 3852577 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 Friday, March 25, 2011 at 2:00 p.m. Eastern Time and will remain available until Friday, April 1, 2011. The replay can be accessed at 1-877-870-5176 (Toll-Free/North America) or 1-858-384-5517 (Toll/International) using Replay PIN: 3852577. An audio replay of the call will also be available on the Company's website for 30 days after 2:00 p.m. Eastern Time on March 25, 2011.

About ThermoDox® and the Phase III HEAT Study

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. In the HEAT Study, ThermoDox® is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA 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 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with Radio Frequency Ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population. Additional information on the Company's 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 its proprietary heat-activated drug delivery systems. Celsion has licensed ThermoDox® to Yakult-Honsha for the Japanese market and has a partnership agreement with Royal Phillips Electronics 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.

                            Celsion Corporation

                     Condensed Statements of Operations

                (in thousands except for per share amounts)

                                                             Year Ended

                                                            December 31,


                                                           2010      2009

                                                        ---------  --------

Operating expenses:

  Research and development                              $  14,714   $13,681

  General and administrative                                4,923     3,327

                                                        ---------  --------

     Total operating expenses                              19,637    17,008

                                                        ---------  --------

Loss from operations                                      (19,637)  (17,008)

                                                        ---------  --------

Other income:

  Gain from valuation of common stock warrants                574       732

  Other income, net                                           245       274

                                                        ---------  --------

  Total other income, net                                     819     1,006

                                                        ---------  --------

Loss before income taxes                                  (18,818)  (16,002)

Income tax benefit                                              -       806

                                                        ---------  --------

Net Loss                                                $ (18,818) $(15,196)

                                                        =========  ========

Net loss per common share - basic and diluted           $   (1.52)   $(1.43)

                                                        =========  ========

Weighted average common shares outstanding - basic and

 diluted                                                   12,375    10,655

                                                        =========  ========

                            Celsion Corporation

                              Balance Sheets

                (in thousands except for per share amounts)

                                             December 31,    December 31,

ASSETS                                           2010            2009

                                            --------------  --------------

Current assets

  Cash and cash equivalents                 $        1,139  $        6,924

  Short term investments                               396           5,695

  Refundable income taxes                                -             806

  Prepaid expenses and other current assets            492             695

                                            --------------  --------------

     Total current assets                            2,027          14,120

                                            --------------  --------------

  Property and equipment                               378             537

                                            --------------  --------------

Other assets

  Deposits and other assets                             77              97

  Patent license fees, net                              43              51

                                            --------------  --------------

     Total other assets                                120             148

                                            --------------  --------------

Total assets                                $        2,525  $       14,805

                                            ==============  ==============


Current liabilities

  Accounts payable and accrued liabilities  $        6,673  $        3,643

  Note payable - current portion                       123             108

                                            --------------  --------------

     Total current liabilities                       6,796           3,751

  Common stock warrant liability                       248             822

  Other liabilities - noncurrent portion                57             197

                                            --------------  --------------

     Total liabilities                               7,101           4,770

                                            --------------  --------------

Stockholders' equity

  Common stock, $0.01 par value (75,000

   shares authorized; 14,091 and 12,895

   shares issued and 13,331 and 12,135

   shares outstanding at December 31, 2010

   and 2009, respectively)                             141             129

  Additional paid-in capital                        99,317          95,035

  Accumulated other comprehensive (loss)

   income                                              (18)             68

  Accumulated deficit                             (100,939)        (82,120)

                                            --------------  --------------

     Subtotal                                       (1,499)         13,112

  Less: Treasury stock - at cost                    (3,077)         (3,077)

                                            --------------  --------------

     Total stockholders' (deficit) equity           (4,576)         10,035

                                            --------------  --------------

     Total liabilities and stockholders'

      (deficit) equity                               2,525          14,805

                                            ==============  ==============

Investor Contact

David Pitts

Argot Partners


Email Contact

Source: Celsion Corporation

News Provided by Acquire Media