Celsion Reports Year End 2011 Financial Results and Provides Business Update
"The interim efficacy analysis of the HEAT Study by the Company's independent Data Monitoring Committee in the fourth quarter of 2011 reinforces our confidence in ThermoDox® as a potential first line treatment for HCC," said
Recent Business Developments
- In
November 2011 ,Celsion announced that the independent Data Monitoring Committee (DMC) for the HEAT Study completed a pre-planned interim analysis for safety, efficacy and futility and unanimously recommended that the study continue to its final analysis as planned. The DMC evaluated data from 613 patients in its review, which was conducted following realization of 219 progression-free survival (PFS) events within the study population. A total of 380 progression events are required to reach the planned final analysis of the study which the Company reconfirmed was projected to occur in late 2012. Concurrent with its review, the DMC weighed the potential of an additional interim efficacy analysis to accelerate data readout, a potential which the Company discussed with theFDA . InMarch 2012 , the Company reported that, based on feedback from theFDA , its special protocol assessment would remain unchanged, and that the HEAT Study would continue to its planned final analysis. - In
December 2011 ,Celsion completed its consultative review process with theEuropean Medicines Agency (EMA) for the HEAT Study and received written scientific advice from the EMA confirming that the Company's HEAT Study is acceptable as a basis for submission of a marketing authorization application. Other important feedback received from this review process were:- Future results demonstrating a convincing magnitude of improvement in PFS along with a favorable benefit-risk ratio would be sufficient as a primary basis for registration of ThermoDox® in
Europe , and - The EMA also supported the Company's manufacturing strategy and technology transfer protocols which will allow the Company to establish multiple manufacturing sites to support commercialization of ThermoDox® outside
the United States .
- Future results demonstrating a convincing magnitude of improvement in PFS along with a favorable benefit-risk ratio would be sufficient as a primary basis for registration of ThermoDox® in
- In
January 2012 , the Company announced the enrollment of the first patient in its randomized Phase II study of ThermoDox® in combination with radiofrequency ablation for the treatment of colorectal liver metastases.
Financial Results
For the year ended
Research and development costs were
The Company ended the year with
- In
January 2011 , a registered offering of$5.1 million of convertible preferred stock and common stock warrants; - During the first quarter of 2011, three draws totaling
$3.4 million under our committed equity financing facility withSmall Cap Biotech Value Ltd. ; - In
June 2011 , a private placement offering of$8.6 million in common stock and warrants; - In
July 2011 , a registered direct offering of$6.6 million in common stock and warrants; - In
July 2011 , sales of an aggregate$18.4 million of the Company's securities, of which$13.0 million was from institutional investors in a registered direct offering and an additional$5.4 million from other investors in a private placement; - In
December 2011 , a private placement of$15 million in common stock and warrants; and - Approximately
$0.4 million from common stock warrant exercises during 2011.
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss the year end 2011 results at
The call will be archived for replay on
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 Radio Frequency Ablation (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 global, multi-center, randomized, pivotal Phase III HEAT Study at 79 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 with a secondary confirmatory endpoint of overall survival. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
About
For more information on
Celsion Corporation
Condensed Statements of Operations
(in thousands except per share amounts)
Year ended
December 31,
--------------------
2011 2010
--------- ---------
Licensing revenue $ 2,000 $ -
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Operating expenses:
Research and development 19,864 14,714
General and administrative 5,155 4,923
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Total operating expenses 25,019 19,637
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Loss from operations (23,019) (19,637)
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Other income (expense):
Gain from valuation of common stock warrant
liability 82 574
Interest, dividends and other income (expense), net (286) 245
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Total other income (expense), net (204) 819
--------- ---------
Net Loss $ (23,223) $ (18,818)
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Net loss per common share - basic and diluted $ (1.11) $ (1.52)
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Weighted average common shares outstanding - basic and
diluted 20,918 12,375
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Celsion Corporation
Selected Balance Sheet Information
(in thousands)
ASSETS December 31, December 31,
2011 2010
------------ ------------
Current assets
Cash and cash equivalents $ 20,146 $ 1,139
Short term investments 10,401 396
Prepaid expenses and other current assets 961 492
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Total current assets 31,508 2,027
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Property and equipment 783 378
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Other assets
Deposits and other assets 323 77
Patent license fees, net 35 43
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Total other assets 358 120
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Total assets $ 32,649 $ 2,525
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued liabilities $ 6,042 $ 6,673
Note payable - current portion 110 123
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Total current liabilities 6,152 6,796
Common stock warrant liability 166 248
Other liabilities - noncurrent portion 137 57
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Total liabilities 6,455 7,101
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Stockholders' equity (deficit)
Common stock 339 141
Additional paid-in capital 153,237 99,317
Accumulated other comprehensive loss (276) (18)
Accumulated deficit (124,222) (100,939)
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Subtotal 29,078 (1,499)
Less: Treasury stock (2,884) (3,077)
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Total stockholders' equity (deficit) 26,194 (4,576)
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Total liabilities and stockholders' equity $ 32,649 $ 2,525
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Investor Contact:David Pitts Argot Partners 212-600-1902 Email Contact
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