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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(Former name, former address and former fiscal year, if changed since last report)
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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 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 First Quarter 2012 Financial Results” issued by Celsion Corporation on May 15, 2012.
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CELSION CORPORATION
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Date: May 15, 2012
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By:
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/s/ Gregory Weaver | |
Gregory Weaver
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Senior Vice President and Chief Financial Officer |
Number
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Description
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Press Release titled “Celsion Reports First Quarter 2012 Financial Results” issued by Celsion Corporation on May 15, 2012.
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·
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In May, we announced the signing of a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. for the China territory. The agreement provides for Hisun funding of costs necessary to complete the technology transfer of the Company’s proprietary manufacturing process and the production of registration batches for the Chinese territory.
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·
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In May, following extensive evaluation of high intensity focused ultrasound (HIFU) in bone cancer patients, we announced the joint resubmission with Philips Healthcare of our combined IND/IDE proposal for a Phase II Study in prostate metastases to the bone, and the Company’s long term intent to pursue this important combination therapy through multiple programs.
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·
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In May, the Company and the Focused Ultrasound Foundation announced their support for preclinical studies designed to explore the use of ThermoDox® in combination with MR-guided HIFU for the treatment of pancreatic cancer. The studies are being conducted at the University of Washington School of Medicine by Joo Ha Hwang, M.D., Ph.D., Director, Endoscopic Research, Associate Professor of Medicine and Adjunct Professor of Bioengineering and Radiology.
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·
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In April, we announced that the HEAT Study achieved its 200 patient enrollment target in the People’s Republic of China (PRC), a key milestone for the Company’s global regulatory strategy as it allows for regulatory filing in China – a market which accounts for over 50% of the 750,000 annual incidences of liver cancer. Concurrently, Celsion announced that the HEAT Study’s independent Data Monitoring Committee (DMC) completed a safety review of 652 patients and unanimously recommended that the study continue according to protocol.
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·
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In February, we announced that the first patient was enrolled in a randomized Phase II study of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of colorectal liver metastases (CRLM).
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Three Months Ended
March 31,
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||||||||
2012
|
2011
|
|||||||
Licensing revenue
|
$ | – | $ | 2,000 | ||||
Operating expenses:
|
||||||||
Research and development
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4,693 | 4,349 | ||||||
General and administrative
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1,570 | 1,215 | ||||||
Total operating expenses
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6,263 | 5,564 | ||||||
Loss from operations
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(6,263 | ) | (3,564 | ) | ||||
Other income (expense):
|
||||||||
Gain from valuation of common stock warrant liability
|
78 | 168 | ||||||
Interest, dividends and other income (expense), net
|
(1 | ) | (368 | ) | ||||
Total other income (expense), net
|
77 | (200 | ) | |||||
Net Loss
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$ | (6,186 | ) | $ | (3,764 | ) | ||
Net loss per common share – basic and diluted
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$ | (0.19 | ) | $ | (0.28 | ) | ||
Weighted average common shares outstanding – basic and diluted
|
33,197 | 13,453 |
ASSETS
|
March 31,
2012
(unaudited)
|
December 31,
2011
|
||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$ | 9,122 | $ | 20,146 | ||||
Short term investments
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15,472 | 10,401 | ||||||
Other current assets
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1,179 | 961 | ||||||
Total current assets
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25,773 | 31,508 | ||||||
Property and equipment
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908 | 783 | ||||||
Other assets
|
||||||||
Deposits and other assets
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323 | 323 | ||||||
Patent license fees, net
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33 | 35 | ||||||
Total other assets
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356 | 358 | ||||||
Total assets
|
$ | 27,037 | $ | 32,649 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable and accrued liabilities
|
$ | 6,320 | $ | 6,042 | ||||
Note payable - current portion
|
78 | 110 | ||||||
Total current liabilities
|
6,398 | 6,152 | ||||||
Common stock warrant liability
|
89 | 166 | ||||||
Other liabilities – noncurrent portion
|
188 | 137 | ||||||
Total liabilities
|
6,675 | 6,455 | ||||||
Stockholders' equity
|
||||||||
Common stock
|
339 | 339 | ||||||
Additional paid-in capital
|
153,532 | 153,237 | ||||||
Accumulated other comprehensive loss
|
(278 | ) | (276 | ) | ||||
Accumulated deficit
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(130,473 | ) | (124,222 | ) | ||||
Subtotal
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23,120 | 29,078 | ||||||
Less: Treasury stock
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(2,758 | ) | (2,884 | ) | ||||
Total stockholders' equity
|
20,362 | 26,194 | ||||||
Total liabilities and stockholders' equity
|
$ | 27,037 | $ | 32,649 |