LAWRENCEVILLE, NJ--(Marketwire -06/28/12)- Celsion Corporation (CLSN), a leading oncology drug development company, today announced that it has entered into a $10 million tranched loan facility with Oxford Finance LLC and Horizon Technology Finance Corporation (HRZN). Under the terms of the loan agreement, Celsion received $5 million upon closing, with the remaining $5 million available for draw following positive data from the Company's pivotal, Phase III HEAT Study. This study is a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox®, in combination with radiofrequency ablation (RFA), for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. A total of 380 events of progression are required to reach the planned final analysis of the study, which are projected to occur in late 2012. Celsion expects that the funds will further ensure a strong balance sheet following the announcement of the HEAT Study results, and adds to its ability to conduct pre-commercialization activities and preparation activities related to a New Drug Application (NDA) for ThermoDox®.
"This facility provides added financial strength to our balance sheet, with each $5 million tranche extending our Company's operating horizon by an additional quarter at current spending levels," said Gregory Weaver, Celsion's Chief Financial Officer. "Our current cash position, $24.6 million as of March 31, 2012, is expected to provide sufficient cash to fund operations into the third quarter of 2013. This loan, in addition to our cash reserves and investments, should provide us with the financial flexibility to meet a number of key, value-driving objectives, in addition to providing leverage in evaluating global strategic partners for ThermoDox®. We appreciate the support of our lender group and their confidence in ThermoDox®, the HEAT Study and Celsion."
The loan facility was led by Oxford Finance LLC and partnered with Horizon Technology Finance Corporation. Christopher A. Herr, Managing Director at Oxford Finance, said: "We are pleased to have led this $10 million loan facility to support the execution of Celsion's HEAT Study. Through our diligence process, we have gained great confidence in the trial's rigorous design and execution."
The initial $5 million tranche is structured to have an interest-only period through March 31, 2013. The second $5 million tranche is structured to have an interest-only period for the three months following the date of funding. Both tranches will be followed by a 30-month amortization period. In conjunction with the loan, Celsion granted the lenders warrants to purchase an aggregate of 51,370 shares at an exercise price of $2.92, or 3% of the funded loan amount. Warrants of equivalent value will be due if the second tranche is drawn.
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. In the Company's Phase III HEAT Study and Phase II ABLATE Study, ThermoDox® is administered intravenously in combination with Radio Frequency Ablation (RFA). Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
The Company's Phase III HEAT Study, a randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer, is being conducted at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. The Company's Phase II ABLATE Study is being conducted at four clinical sites in the U.S. and is a randomized, blinded clinical trial of ThermoDox® in combination with RFA for the treatment of colorectal liver metastases with a PFS endpoint. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
About Celsion Corporation
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford.
For more information on Celsion, visit our website: http://www.celsion.com.
About Oxford Finance LLC
Oxford Finance is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. In recent years, Oxford has originated nearly $2 billion in loans, with lines of credit ranging from $500 thousand to $50 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in California, Illinois, Massachusetts and North Carolina. For more information on Oxford, visit www.oxfordfinance.com.
About Horizon Technology Finance
Horizon Technology Finance Corporation is a business development company that provides secured loans to development-stage companies backed by established venture capital and private equity firms within the technology, life science, healthcare information and services, and clean-tech industries. The investment objective of Horizon Technology Finance is to maximize total risk-adjusted returns by generating current income from a portfolio of directly originated secured loans as well as capital appreciation from warrants to purchase the equity of portfolio companies. Headquartered in Farmington, Connecticut, with a regional office in Walnut Creek, California, the Company is externally managed by its investment advisor, Horizon Technology Finance Management LLC. Horizon's common stock trades on the NASDAQ Global Select Market under the ticker symbol "HRZN." In addition, the Company's 7.375% Senior Notes due 2019 trade on the New York Stock Exchange under the ticker symbol "HTF." To learn more, please visit www.horizontechnologyfinancecorp.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of Celsion's research and development activities and clinical trials; the second $5m tranche of the loan facility is subject to closing conditions; Celsion's cash needs could increase; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. Celsion undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.