Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, announced today financial results for the first quarter ended March 31, 2010 and addressed the progression of the clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin. ThermoDox® is currently being evaluated in the Phase III HEAT trial for the treatment of hepatocellular carcinoma (HCC) and in a Phase I/II trial for patients with recurrent chest wall breast cancer.
"We continue to make substantial progress recruiting patients into our Phase III HEAT trial for ThermoDox® and are on track to complete enrollment in the second half of this year with 331 patients enrolled to date," said Michael Tardugno, President and CEO of Celsion. "We have exceeded our goal of opening enrollment at 73 clinical trial sites world-wide. The Phase I/II DIGNITY trial of ThermoDox® in patients with recurrent chest wall breast cancer (RCW) also continues to advance. We are currently enrolling patients in the 50mg/m^2 dosing cohort, which will be used to determine our therapeutic dose."
Financial Results
For the first quarter ended March 31, 2010, Celsion reported a net loss from operations of $4.6 million, compared to a net loss from operations of $3.6 million for the same period of 2009. In the first quarter of 2010, the Company recorded a $1.6 million non-cash warrant liability charge. After effect of this non-cash charge, Celsion reported a net loss of $6.1 million, or $0.50 per diluted share, for the first quarter ended March 31, 2010 compared to a net loss of $3.6 million (after the effect of a $0.5 million noncash indemnity reserve benefit), or $0.35 per diluted share, in the same period of 2009. After the non-cash effect of the warrant liability charge of $1.6 million and other non-cash charges of $0.6 million related to stock based compensation and other expenses, and net balance sheet changes of $0.9 million, net cash used in operations totaled $3.0 million for the first quarter of 2010. The Company ended the quarter with a total of $10.4 million of cash, investments and other receivables and current assets.
Recent Company Highlights
- The Drug Safety Monitoring Board recommended continuation and dose escalation in the Phase I/II ThermoDox® study for RCW breast cancer
- The Data Monitoring Committee recommended continuation of the Phase III HEAT study
- Announced plans to launch a randomized Phase II Program to study ThermoDox® in combination with RFA for Colorectal Liver Metastases (CRLM) following completion of the enrollment of the current Phase III HEAT Trial. CRLM is the number one metastatic form of liver cancer in the US, representing approximately 50% of all liver metastases. ThermoDox® has shown potential to effectively treat this disease.
- Hosted a Research and Development Day in New York City
- Presented long-term follow-up data from the Phase I ThermoDox® trial at a press conference at the University of Hong Kong
- Presented data supporting the use of ThermoDox® in the treatment of colorectal liver metastases at the 9th World Congress of the International Hepato-Pancreato-Biliary Association in Buenos Aires, Argentina
- Announced an Abstract was accepted for presentation at the American Society of Clinical Oncology 2010 Annual Meeting on the Phase I/II trial of ThermoDox® in Recurrent Chest Wall Cancer
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