Celsion Corporation
Nov 10, 2011

Celsion Reports Third Quarter 2011 Financial Results and Provides Business Updates

Company to Hold Conference Call Thursday, November 10th at 11:00 a.m. ET

LAWRENCEVILLE, NJ -- (MARKET WIRE) -- 11/10/11 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced financial results for the third quarter ended September 30, 2011, and provided a business update including development progress with ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin currently under evaluation in a pivotal Phase III study, the HEAT Study, in patients with non-resectable primary liver cancer (hepatocellular carcinoma or "HCC"). The Company recently announced that the HEAT Study, which is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health, has reached its enrollment target of 600 patients.

"The third quarter was a pivotal period in our evolution as a biopharmaceutical company, having reached the enrollment objective in our Phase III HEAT Study," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Celsion has taken great care over the past several years to conduct this study to the highest standards of clinical, statistical and regulatory rigor, in an effort to ensure a successful review process in a multitude of territories around the world, following a positive study outcome. These efforts are particularly significant as we approach the preplanned interim analysis, which is scheduled for the current quarter. The Company remains well funded to execute this study to final data readout, which we continue to anticipate in late 2012."

Recent Business Developments

Financial Results

For the third quarter ended September 30, 2011, Celsion reported a net loss of $6.4 million, or $0.25 per share, compared to a net loss of $4.7 million, or $0.38 per share, in the same period of 2010. For the first nine months of 2011, net cash used in operations was $18.3 million. Celsion reported a net loss of $17.1 million for the first nine months of 2011, compared to a net loss of $13.5 million for the same period of 2010. In the third quarter of 2011, Celsion recorded a $375,000 non-cash benefit related to the change in the common stock warrant liability compared to $453,000 in the same period of last year. In the first nine months of 2011, Celsion recorded a $42,000 non-cash charge related to the change in the common stock warrant liability compared to a non-cash benefit of $712,000 in the same period last year.

Research and development costs, as expected, were $1.5 million higher in the third quarter of 2011 compared to the prior year, primarily due to increased costs for investigator grants, monitoring costs and milestone payments associated with higher patient enrollment levels for the Company's Phase III HEAT Study. Also contributing to this increase were activities associated with development expenses related to commercial manufacturing for ThermoDox®. General and administrative expenses were $189,000 higher in the quarter ended September 30, 2011 compared to the prior year as a result of increased professional services and personnel costs to support the Company's growth.

For the third quarter ended September 30, 2011, net cash used in operations was $6.9 million. The Company ended the quarter with $21.4 million of cash and investments. This figure included gross proceeds of $19.6 million from two registered direct financings, $5.4 million from a private placement financing and $0.4 million from common stock warrant exercises completed during the third quarter of 2011.

Other Business Highlights

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss the third quarter 2011 results at 11:00 a.m. Eastern Time Thursday, November 10, 2011. To participate in the call, interested parties may dial 1-888-427-9380 (Toll-Free/North America) or 1-719-785-1749 (International/Toll) and use Conference ID: 3247371 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, 2011 at 2:00 p.m. Eastern Time and will remain available until November 17, 2011. The replay can be accessed at 1-877-870-5176 (Toll-Free/North America) or 1-858-384-5517 (International/Toll) using Conference ID: 3247371. An audio replay of the call will also be available on the Company's website, http://www.celsion.com, for 30 days after 2:00 p.m. Eastern Time Thursday, November 10, 2011.

About Primary Liver Cancer

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, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 700,000 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; however, 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® 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 76 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 study' independent Data Monitoring Committee by year end. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.

About Celsion Corporation

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, the University of Pisa, 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)

                                (Unaudited)



                                  Three Months Ended     Nine Months Ended

                                     September 30,         September 30,

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

                                    2011       2010       2011       2010

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



Licensing revenue                $       -  $       -  $   2,000  $       -

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



Operating expenses:

  Research and development           5,414      3,951     14,727     10,666

  General and administrative         1,409      1,220      3,906      3,544

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

    Total operating expenses         6,823      5,171     18,633     14,210

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



Loss from operations                (6,823)    (5,171)   (16,633)   (14,210)

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



Other income (expense):

  Gain (loss) from valuation of

   common stock warrant

   liability                           375        453        (42)       712

  Interest, dividends and other

   income (expense), net                55          1       (426)         6

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

  Total other income (expense),

   net                                 430        454       (468)       718

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



Net Loss                         $  (6,393) $  (4,717) $ (17,101) $ (13,492)

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



Net loss per common share -

  basic and diluted              $   (0.25) $   (0.38) $   (0.93) $   (1.10)

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



Weighted average common shares

 outstanding - basic and diluted    25,150     12,340     18,360     12,303

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







                            Celsion Corporation

                     Selected Balance Sheet Information

                               (in thousands)



                                                (Unaudited)

                                               September 30,   December 31,

ASSETS                                              2011           2010

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

Current assets

  Cash and cash equivalents                    $      11,133  $       1,139

  Short term investments                              10,277            396

  Prepaid expenses and other current assets              804            492

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

      Total current assets                            22,214          2,027

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



  Property and equipment                                 583            378

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



Other assets

  Deposits and other assets                              350             77

  Patent license fees, net                                38             43

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

      Total other assets                                 388            120

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



Total assets                                   $      23,185  $       2,525

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



LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities

  Accounts payable and accrued liabilities     $       4,549  $       6,673

  Note payable - current portion                          89            123

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

      Total current liabilities                        4,638          6,796



  Common stock warrant liability                         291            248

  Other liabilities - noncurrent portion                   -             57

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

      Total liabilities                                4,929          7,101

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



Stockholders' equity (deficit)

  Common stock                                           274            141

  Additional paid-in capital                         139,140         99,317

  Accumulated other comprehensive loss                  (157)           (18)

  Accumulated deficit                               (118,091)      (100,939)

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

      Subtotal                                        21,166         (1,499)

  Less: Treasury stock                                (2,910)        (3,077)

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

      Total stockholders' equity (deficit)            18,256         (4,576)

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



      Total liabilities and stockholders'

       equity (deficit)                        $      23,185  $       2,525

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



Investor Contact:

David Pitts

Argot Partners

212-600-1902

Email Contact



Source: Celsion Corporation

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