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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Delaware
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52-1256615
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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997 Lenox Drive, Suite 100
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Lawrenceville, NJ
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08648
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(Address of principal executive offices)
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(Zip Code)
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o
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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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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o
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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
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Results of Operations and Financial Condition.
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Item 9.01
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Financial Statements and Exhibits.
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Exhibit
Number
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Description
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99.1
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Press release titled “Celsion Reports Year End 2011 Financial Results and Provides Business Update” issued by Celsion Corporation on March 15, 2012.
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Number
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Description
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Press release titled “Celsion Reports Year End 2011 Financial Results and Provides Business Update” issued by Celsion Corporation on March 15, 2012.
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·
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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 the FDA. In March 2012, the Company reported that, based on feedback from the FDA, its special protocol assessment would remain unchanged, and that the HEAT Study would continue to its planned final analysis.
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·
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In December 2011, Celsion completed its consultative review process with the European 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:
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●
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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
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●
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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.
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·
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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.
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●
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In January 2011, a registered offering of $5.1 million of convertible preferred stock and common stock warrants;
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During the first quarter of 2011, three draws totaling $3.4 million under our committed equity financing facility with Small Cap Biotech Value Ltd.;
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●
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In June 2011, a private placement offering of $8.6 million in common stock and warrants;
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In July 2011, a registered direct offering of $6.6 million in common stock and warrants;
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●
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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;
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●
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In December 2011, a private placement of $15 million in common stock and warrants; and
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●
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Approximately $0.4 million from common stock warrant exercises during 2011.
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Investor Contact: |
David Pitts |
Argot Partners |
212-600-1902 |
David@argotpartners.com |
Year ended
December 31,
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||||||||
2011
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2010
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|||||||
Licensing revenue
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$ | 2,000 | $ | - | ||||
Operating expenses:
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||||||||
Research and development
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19,864 | 14,714 | ||||||
General and administrative
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5,155 | 4,923 | ||||||
Total operating expenses
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25,019 | 19,637 | ||||||
Loss from operations
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(23,019 | ) | (19,637 | ) | ||||
Other income (expense):
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||||||||
Gain from valuation of common stock warrant liability
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82 | 574 | ||||||
Interest, dividends and other income (expense), net
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(286 | ) | 245 | |||||
Total other income (expense), net
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(204 | ) | 819 | |||||
Net Loss
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$ | (23,223 | ) | $ | (18,818 | ) | ||
Net loss per common share – basic and diluted
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$ | (1.11 | ) | $ | (1.52 | ) | ||
Weighted average common shares outstanding – basic and diluted
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20,918 | 12,375 |
ASSETS
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December 31,
2011
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December 31,
2010
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||||||
Current assets
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||||||||
Cash and cash equivalents
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$ | 20,146 | $ | 1,139 | ||||
Short term investments
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10,401 | 396 | ||||||
Prepaid expenses and other current assets
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961 | 492 | ||||||
Total current assets
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31,508 | 2,027 | ||||||
Property and equipment
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783 | 378 | ||||||
Other assets
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||||||||
Deposits and other assets
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323 | 77 | ||||||
Patent license fees, net
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35 | 43 | ||||||
Total other assets
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358 | 120 | ||||||
Total assets
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$ | 32,649 | $ | 2,525 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
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||||||||
Current liabilities
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||||||||
Accounts payable and accrued liabilities
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$ | 6,042 | $ | 6,673 | ||||
Note payable - current portion
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110 | 123 | ||||||
Total current liabilities
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6,152 | 6,796 | ||||||
Common stock warrant liability
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166 | 248 | ||||||
Other liabilities – noncurrent portion
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137 | 57 | ||||||
Total liabilities
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6,455 | 7,101 | ||||||
Stockholders' equity (deficit)
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||||||||
Common stock
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339 | 141 | ||||||
Additional paid-in capital
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153,237 | 99,317 | ||||||
Accumulated other comprehensive loss
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(276 | ) | (18 | ) | ||||
Accumulated deficit
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(124,222 | ) | (100,939 | ) | ||||
Subtotal
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29,078 | (1,499 | ) | |||||
Less: Treasury stock
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(2,884 | ) | (3,077 | ) | ||||
Total stockholders' equity (deficit)
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26,194 | (4,576 | ) | |||||
Total liabilities and stockholders' equity
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$ | 32,649 | $ | 2,525 |