Celsion Reports Third Quarter 2011 Financial Results and Provides Business Updates
"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
Recent Business Developments
- In August,
Celsion announced that it had reached its target enrollment of 600 patients in the Company's pivotal, Phase III HEAT Study, a multinational, randomized, double-blind, placebo-controlled clinical study of ThermoDox® in combination with radio frequency ablation (RFA) for the treatment of primary liver cancer. The target enrollment figure is designed to ensure that the study's primary end point, progression-free survival, can be achieved with statistical significance, and is one of two triggers for an interim efficacy analysis by the study's independent Data Monitoring Committee, the second being a minimum of 190 progression-free survival events realized in the study population. The HEAT Study is being conducted under a FDA Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by theNational Institutes of Health ; - During the third quarter ended
September 30, 2011 , the Company strengthened its balance sheet through the completion of the following two equity financing transactions:- In July, a registered direct offering of
$6.6 million in common stock and warrants. - In July, 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 was from other investors in a private placement.
- In July, a registered direct offering of
Financial Results
For the third quarter ended
Research and development costs, as expected, were
For the third quarter ended
Other Business Highlights
- In August,
Celsion convened a clinical symposium inHong Kong to discuss the reach and market potential of ThermoDox® in theAsia Pacific region. In attendance at the symposium were 35 clinical investigators participating in the Phase III HEAT Study. TheAsia Pacific region has the world's highest incidence of HCC, due primarily to the endemic status of chronic hepatitis B and C viruses, which lead to liver cirrhosis and an increased risk of liver cancer. With a growing incidence, it is projected that HCC will surpass lung cancer as the largest global cancer indication within the next decade; - In August,
Celsion announced the publication of a clinical and scientific review of ThermoDox® in theAugust 2011 issue of Future Oncology (Volume 7, Number 8). The article, titled "Lyso-Thermosensitive Liposomal Doxorubicin: An Adjuvant to Increase the Cure Rate of Radiofrequency Ablation (RFA) in Liver Cancer," provides an overview of current standard and investigational approaches to the treatment of HCC, focusing on the curative and synergistic potential of combining lyso-thermosensitive liposomal doxorubicin (LTLD or "ThermoDox®") and RFA as front-line therapy; - In August,
Celsion appointedGary Renshaw , D.O., as Executive Medical Director. Dr. Renshaw possesses an extensive record of successful drug development in oncology, with industry experience in various clinical and regulatory positions at DelCath Systems, Celgene Corporation, Johnson & Johnson PRD, EISAI Co., andEli Lily and Company ; and - In late October, the Company moved into its new corporate headquarters at
997 Lenox Drive , Suite 100,Lawrenceville, New Jersey 08648, under attractive lease terms. The Company received a New Jersey Economic Development Authority Business Employment Incentive Program (BEIP) grant, approved in August, to support the move. The grant provides for up to$1.12 million in tax incentives for jobs created in, or relocated to the State. The Company's new telephone number is (609) 896-9100.
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss the third quarter 2011 results at
The call will be archived for replay on
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
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
For more information on
Celsion Corporation
Condensed Statements of Operations
(in thousands except for per share amounts)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
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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
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Current assets
Cash and cash equivalents $ 11,133 $ 1,139
Short term investments 10,277 396
Prepaid expenses and other current assets 804 492
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Total current assets 22,214 2,027
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Property and equipment 583 378
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Other assets
Deposits and other assets 350 77
Patent license fees, net 38 43
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Total other assets 388 120
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Total assets $ 23,185 $ 2,525
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued liabilities $ 4,549 $ 6,673
Note payable - current portion 89 123
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Total current liabilities 4,638 6,796
Common stock warrant liability 291 248
Other liabilities - noncurrent portion - 57
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Total liabilities 4,929 7,101
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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)
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Subtotal 21,166 (1,499)
Less: Treasury stock (2,910) (3,077)
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Total stockholders' equity (deficit) 18,256 (4,576)
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Total liabilities and stockholders'
equity (deficit) $ 23,185 $ 2,525
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Investor Contact:David Pitts Argot Partners 212-600-1902 Email Contact
Source:
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