Fourth-quarter and full-year 2009 results announced by Celsion

Feb 17 2010

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.

Recent Company Highlights

• Received regulatory approvals to expand the Phase III HEAT trial for ThermoDox in primary liver cancer into China, Malaysia and the Philippines
• Held educational meetings in China and Japan with principal investigators and institutional staff, a critical regulatory step to rapidly enrolling patients in the HEAT trial
• Treated the first patients in Japan, China and the Philippines in the HEAT trial
• Launched a CME accredited educational webcast for physicians that features recent advances made in the treatment of HCC and Celsion's ThermoDox Phase III HEAT clinical study; done in partnership with the American Liver Foundation
• Submitted abstract "A Phase I Trial of ThermoDox in Patients Undergoing Radiofrequency Ablation (RFA) of Liver Tumors" which was accepted for oral presentation at the 9th World Congress of the International Hepato-Pancreato-Biliary Association to be held April 18-22, 2010, in Buenos Aires, Argentina
• Will Host a Research and Development Day for Investors on Wednesday, February 24, 2010 from 7:30 AM - 10:30 AM ET in New York City with Investigators in Medical Oncology, Surgery, and Interventional Radiology. For an invitation please contact Marcy Nanus at [email protected].