Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, today announced financial results for the fourth quarter and year ended December 31, 2009. Management also highlighted the progress made in clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin, including the Company's pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and recurrent chest wall breast cancer.
"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase I/II recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."
Financial Results
For the fourth quarter ended December 31, 2009, Celsion reported a net loss of $2.3 million, or $0.19 per diluted share, compared to a net loss of $0.9 million, or $0.09 per diluted share, for the fourth quarter of 2008. For the year ended December 31, 2009, Celsion reported a net loss of $15.2 million, or $1.43 per diluted share, compared to a net loss of $11.8 million, or $1.16 per diluted share, in 2008. The Company ended the year with a total of $14.1 million of cash, investments and other receivables and current assets.
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