Celsion Corporation
Feb 17, 2010

Celsion Reports Fourth Quarter and Full Year 2009 Financial Results

62 Clinical Trial Sites Enrolling Patients in the Pivotal Phase III ThermoDox(R) Trial

COLUMBIA, Md., Feb 17, 2010 /PRNewswire via COMTEX News Network/ -- 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(R), 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

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(R)

ThermoDox(R) in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox(R) 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(R) 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(R) 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(R) 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)


                                        Three Months           Year Ended
                                      Ended December 31,      December 31,
                                      -----------------     -----------------
                                        2009     2008        2009      2008
                                      -----------------     -----------------

    Licensing Revenue:                 $     -  $ 2,500    $      -  $  2,500

    Operating expenses:
       Research and development        $ 3,006  $ 3,584    $ 13,681  $ 12,006
       General and administrative          812      457       3,327     2,043
                                           ---      ---       -----     -----
           Total operating expenses      3,818    4,041      17,008    14,049
                                         -----    -----      ------    ------

    Loss from operations                (3,818) (1,541)     (17,008)  (11,548)

          Other income (expense), net      744      607       1,009      (238)
                                           ---      ---       -----      ----

    Net loss before income taxes        (3,074)    (934)    (15,999)  (11,786)

          Income tax benefit               806        -         806         -
                                           ---      ---         ---       ---

    Net Loss                           $(2,268) $  (934)   $(15,193) $(11,786)
                                       =======    =====    ========  ========


    Basic and diluted net loss per
     common share                      $ (0.19) $ (0.09)   $  (1.43) $  (1.16)
                                        ======   ======      ======    ======

    Basic and diluted weighted
     average shares outstanding         12,043   10,154      10,655    10,149
                                        ======   ======      ======    ======



                             Celsion Corporation
                                Balance Sheets
                  (in thousands except for per share amounts)


                                                  December 31,
                                                     2009        December 31,
    ASSETS                                        (Unaudited)        2008
                                                  ------------   ------------
     Current assets
       Cash and cash equivalents                       $ 6,924        $ 3,456
       Short term investments available for sale         5,695          4,061
       Due from Boston Scientific Corporation                -         15,000
       Refundable income taxes                             806
       Prepaid expenses and other receivables              695            306
                                                           ---            ---
           Total current assets                         14,120         22,823
                                                        ------         ------

       Property and equipment                              537            223
                                                           ---            ---

     Other assets
       Note receivable                                       -            221
       Deposits                                             97            363
       Other assets                                         51             58
                                                           ---            ---
           Total other assets                              148            642
                                                           ---            ---

    Total assets                                       $14,805        $23,688
                                                       =======        =======

    LIABILITIES AND STOCKHOLDERS' EQUITY
     Current liabilities
       Accounts payable - trade                        $ 2,191        $ 1,187
       Indemnity reserve                                     -          1,053
       Other accrued liabilities                         1,452          1,459
       Note payable - current portion                      108            235
                                                           ---            ---
           Total current liabilities                     3,751          3,934

       Warrant liability                                   822              -
       Other liabilities - noncurrent                      197             28
                                                           ---            ---
           Total liabilities                             4,770          3,962
                                                         -----          -----

     Stockholders' equity
       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)                                      129            108
       Additional paid-in capital                       95,035         89,183
       Accumulated deficit                             (82,052)       (66,924)
                                                       -------        -------
             Subtotal                                   13,112         22,367
       Less: Treasury stock - at cost                   (3,077)        (2,641)
                                                        ------         ------
           Total stockholders' equity                   10,035         19,726
                                                        ------         ------

    Total liabilities and stockholders' equity         $14,805        $23,688
                                                       =======        =======


SOURCE Celsion Corporation

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