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Celsion Corporation (CLSM)
Q3 2012 Earnings Call
November 12, 2012 11:00 am ET
Jeffrey W. Church – Senior Vice President Corporate Strategy & Investor Relations
Michael H. Tardugno – President, Chief Executive Officer & Director
Nicholas Borys, M.D. – Vice President & Chief Medical Officer
Gregory L. Weaver – Chief Financial Officer & Senior Vice President
Keith Markey – Griffin Securities, Inc.
Joe Pantginis – Roth Capital Partners, LLC
[Ren Benjamin – Burrows & Company]
Mara Goldstein – Cantor Fitzgerald & Co.
[Tron Gilhald – Heart Stone Capital Management]
Michael G. King, Jr. – Dawson James Securities
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Jeffrey W. Church
Our third quarter 2012 financial results were released this morning before the market opened. We filed our third quarter Form 10Q on Friday after the market closed. The Form 10Q is available on the SEC’s Edgar system and the company’s earnings release and Form 10Q are both available on the company’s website at www.Celsion.com.
Today’s call will be archived, the replay beginning today at 2 PM Eastern and will remain available by phone until Monday, November 26, 2012 and on the company’s website for 30 days. Before we begin the call we wish to inform participants that forward-looking statement are made pursuant to the Safe Harbor Provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, the risk of clinical failures, delays, or increased costs, unforeseen changes in the cost of our research and development activities, and clinical trials by others, possible acquisition of other technologies, assets, or businesses, and possible adverse action by customers, suppliers, competitors, regulatory authorities and other risks detailed from time-to-time in the company’s periodic reports filed with the Securities & Exchange Commission.
Today, in addition to discussing our third quarter financial results, we will provide you with a corporate update including an outline of the events ahead in our Phase III HEAT study as well as our overall ThermoDox clinical development program. We will then open the call for questions which we ask that you keep to no more than two. With that, I’d like to turn the call over to Michael Tardugno, President and CEO of Celsion.
Michael H. Tardugno
Thank you for your interest in and support of Celsion, a company I trust you’ll agree is one of the most exciting and compelling in this world of biotech drug development. I am joined today by Nick Borys, our Chief Medical Officer; Greg Weaver, our Chief Financial Officer; and of course, Jeff Church from whom you’ve just heard, our Senior Vice President of Investor Relations and Corporate Strategy.
Before I get started this morning, on this Veterans’ Day I’d like to give a special welcome to those of you who are veterans of the US Military and on behalf of all of us, thank you for your service to our country. This is a great time for Celsion and by extension for our shareholders. Your confidence in our clinical focus and support for innovative technology has brought us very near to the transformative event for our company which is the announcement of the results from the HEAT study because if we are right, and we have no reason to believe we will not be, we will bring to market more than the promise of just hope, we will bring to the market ThermoDox. A drug that will extend life and perhaps provide a cure with those diagnosed with HCC or hepatocellular carcinoma, as you know the largest unmet medical need remaining in oncology.
Completion of development and transitioning to the commercialization of ThermoDox is an exciting milestone for our management team and I can tell you this is what we signed on for. This is why we’re here. In a sophisticated industry of clinical science and medicine full of regulatory complexity it’s good to know that many of you have been with us and are here with us this morning.
As I have been saying and continues to be, we have never been so well positioned. In mid September, the HEAT study, our fully enrolled 700 patient Phase-III pivotal trial of ThermoDox in combination with radiofrequency ablation [inaudible] for the treatment of non-resectable patients in HCC completed its last intermediate DMC review prior to final data. Last week, Friday to be exact, we announced that 380 progression free survival events, that’s PFS events have been projected in the HEAT study.
According to the study’s protocol 380 events followed the trial and 80% showed a 33% improvement to the time to progression in the therapeutic arm over the control arm. The final data collection process is followed by query resolution, tabulation of summary, unblinding and final analysis results by the study’s independent data monitoring committee. Following DMC review the company will disclose top line results which we expect will be in January.
I will remind you that PFS in the HEAT study is the HEAT study’s primary end point which has been granted a special protocol assessment, that’s an SPA by the FDA. 33% improvement in the hurdle of clinical benefit that supports approval. This is an exciting time for the company, maybe even more so by the fact that we have the financial resources sufficient to see us through data and well beyond.