Celsion Reports Third Quarter 2010 Financial Results and Provides Business Update
"We are approaching 80% completion of patient enrollment into our Phase III primary liver cancer HEAT study of ThermoDox®. Together with our Special Protocol Assessment for the HEAT study,
Financial Results
For the third quarter ended
The Company ended the third quarter with
Recent Business Highlights
- Patient enrollment for the Phase III HEAT study to date is approaching 80% completion. Efforts to stimulate patient enrollment continue with full enrollment expected in the first quarter of 2011;
The Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) issued a positive opinion on the Company's application for Orphan Drug Designation for ThermoDox® for the treatment of HCC;- The Independent Data Monitoring Committee unanimously recommended continuation of the Phase III HEAT study to treat Primary Liver Cancer after review of 401 patients enrolled in the trial;
- Fast Track designation received for ThermoDox® development program to Treat Primary Liver Cancer from the
FDA ; - NCI Consensus published in
Journal of Clinical Oncology recommended the Phase III HEAT study as a Priority Clinical Trial for HCC; - Positive
FDA guidance relating to 505(b)(2) regulatory submission received for the Company's New Drug Application for ThermoDox® to Treat Primary Liver Cancer; - ThermoDox® clinical data presented at the 2010 Breast Cancer Symposium;
- SBIR grant received to expand technology platform; and
Celsion presented at two Healthcare Conferences inNew York City .
The Company is holding a conference call to provide a business update and discuss the third quarter 2010 results at
The call will be archived for replay on
About ThermoDox®
ThermoDox® in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. 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 including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) 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 and enrollment is anticipated to be completed in the first quarter of 2011. For recurrent chest wall breast cancer, ThermoDox® is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site.
About
Investor Contact | |
Marcy Nanus | |
The Trout Group | |
646-378-2927 or mnanus@troutgroup.com | |
For more information on
Celsion Corporation Condensed Statements of Operations (Unaudited) (in thousands except for per share amounts) | |||||||||
Three Months | Nine Months | ||||||||
2010 | 2009 | 2010 | 2009 | ||||||
Operating expenses: | |||||||||
Research and development | $ | 3,951 | $ | 3,503 | $ | 10,666 | $ | 10,676 | |
General and administrative | 1,220 | 1,224 | 3,544 | 2514 | |||||
Total operating expenses | 5,171 | 4,727 | 14,210 | 13,190 | |||||
Loss from operations | (5,171) | (4,727) | (14,210) | (13,190) | |||||
Other income (expense): | |||||||||
Change in fair value of common stock warrants | 453 | - | 712 | - | |||||
Other income (expense), net | 1 | 10 | 5 | 265 | |||||
Total other income (expense), net | 454 | 10 | 217 | 265 | |||||
Net Loss | $ | (4,717) | $ | (4,717) | $ | (13,493) | $ | (12,925) | |
Net loss per common share — basic and diluted | $ | (0.38) | $ | (0.47) | $ | (1.10) | $ | (1.27) | |
Weighted average common shares outstanding | |||||||||
— basic and diluted | 12,340 | 10,118 | 12,303 | 10,166 | |||||
Celsion Corporation Balance Sheets (in thousands except for per share amounts) | ||||||
ASSETS | September 30, 2010 (Unaudited) | December 31, 2009 | ||||
Current assets | ||||||
Cash and cash equivalents | $ | 1,824 | $ | 6,924 | ||
Short term investments | 1,380 | 5,695 | ||||
Refundable income taxes | - | 806 | ||||
Prepaid expenses and other receivables | 460 | 695 | ||||
Total current assets | 3,664 | 14,120 | ||||
Property and equipment | 417 | 537 | ||||
Other assets | ||||||
Deposits | 77 | 97 | ||||
Other assets | 45 | 51 | ||||
Total other assets | 122 | 148 | ||||
Total assets | $ | 4,203 | $ | 14,805 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current liabilities | ||||||
Accounts payable | $ | 2,742 | $ | 2,191 | ||
Other accrued liabilities | 1,986 | 1,452 | ||||
Note payable - current portion | 119 | 108 | ||||
Total current liabilities | 4,847 | 3,751 | ||||
Common stock warrant liability | 110 | 822 | ||||
Other liabilities — noncurrent | 89 | 197 | ||||
Total liabilities | 5,046 | 4,770 | ||||
Stockholders' equity | ||||||
Common stock, $0.01 par value (75,000 shares authorized; 13,508 and 12,895 shares issued and 12,748 and 12,135 shares outstanding at September 30, 2010 and December 31, 2009, respectively) | 135 | 129 | ||||
Additional paid-in capital | 97,755 | 95,035 | ||||
Accumulated other comprehensive (loss) income | (44) | 68 | ||||
Accumulated deficit | (95,612) | (82,120) | ||||
Subtotal | 2,234 | 13,112 | ||||
Less: Treasury stock - at cost | (3,077) | (3,077) | ||||
Total stockholders' equity | (843) | 10,035 | ||||
Total liabilities and stockholders' equity | $ | 4,203 | $ | 14,805 | ||
SOURCE
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