Celsion announces $20 million strategic loan facility: Celsion (NASDAQ: CLSN) announced that it has entered into a loan agreement with Hercules Technology Growth Capital (NASDAQ:HTGC) that would permit up to $20 million in new capital distributable in multiple tranches with agreement from Hercules. Celsion drew the first tranche of $5 million upon closing of the loan agreement on November 25, 2013. Approximately $4 million of the proceeds were used to repay the outstanding obligations under the Company's loan agreement with Oxford Finance LLC and Horizon Technology Finance Corporation. The Company anticipates that it would use any additional funding provided under the agreement for working capital or in support of its previously announced strategic acquisition initiative, which is designed to identify new technologies and clinical stage products for its development pipeline.
- Overall survival results from the HEAT Study continue to show a positive trend.
- Meetings are planned with regulatory agencies in anticipation of a pivotal ThermoDox trial. Management plans to meet with the FDA and China's regulators to discuss the results from a subpopulation of the HEAT Study and a new clinical trial design.
- We believe Celsion is about to expand its R&D pipeline. The recent financing gives the company the flexibility to complete an acquisition that will probably draw upon the Company's expertise in oncology. This might be a single drug or a technology that supports development of anticancer drugs.
THERMODOX BENEFIT NEARS SIGNIFICANCE :
Celsion has continued to monitor the status of patients who participated in the HEAT Study. The key metric is overall survival, since it is the endpoint favored by the FDA for clinical trials involving oncology therapeutics. While all patients are being followed, a subpopulation that had single tumors in the 3 cm - 7 cm range and was treated with RFA for at least 45 minutes is the focus of the corporate attention. The HEAT Study yielded the first evidence that prolonged heating is more effective than shorter treatment regimens in delivering ThermoDox to the fringes of a tumor. The overall survival data, which is being compiled at the end of each quarter, has been moving closer to showing a significant difference between patients who received the ThermoDox-RFA combination and those treated only with RFA.
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