Celsion (CLSN) Q2 2012 Earnings Call August 14, 2012 11:00 am ET Executives Jeffrey W. Church - Senior Vice President of Corporate Strategy and Investor Relations Michael H. Tardugno - Chief Executive Officer, President and Director Gregory L. Weaver - Chief Financial Officer and Senior Vice President Nicholas Borys - Chief Medical Officer and Vice President Analysts Joseph Pantginis - Roth Capital Partners, LLC, Research Division Michael G. King - Rodman & Renshaw, LLC, Research Division Keith Albert Markey - Griffin Securities, Inc., Research Division Mara Goldstein - Cantor Fitzgerald & Co., Research Division Presentation Operator
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Before we begin the call, we wish to inform participants that forward-looking statements 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 costs of our research and development activities and clinical trials by others; possible acquisition of other technologies, assets or businesses; and possible adverse 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.We are joined today by Michael Tardugno, President and CEO at Celsion, Dr. Nick Borys, our Chief Medical Officer; and Greg Weaver, our Chief Financial Officer. On today's call, Mike will provide a corporate update, including an outline of the important milestones ahead in our Phase III HEAT Study for ThermoDox in primary liver cancer. Greg will discuss our second quarter 2012 financial results. Following that, Dr. Borys will discuss in further details our overall ThermoDox clinical development program. We will now open the call for your -- After then, we'll open the call for questions which we ask that you keep to no more than 2. With that, I'd like to turn the call over to Mike. Michael H. Tardugno Thanks, Jeff. Good morning, and thank you for joining us. I know of no better way to open this call than with a comment that I made at the annual shareholder meeting this last June. And that is this, this is a great time for Celsion and I daresay to be a Celsion shareholder. I'm pleased to report that your company has never been so well positioned. For those on the call who are shareholders, I'd like to express our thanks for your support and continued confidence in your company's strategic clinical focus and innovative heat-sensitive liposome technology. The HEAT Study, our Phase III pivotal trial combining the first drug in our tumor-targeting platform, ThermoDox, with RFA to treat hepatocellular carcinoma or HCC is fully enrolled. We are now looking forward to data by our best estimate in the fourth quarter of this year from the largest pivotal trial ever conducted in the intermediate stage, the largest unmet need in oncology. And we have the financial resources sufficient to see us through data and well beyond, which means to be clear, we have no current plans for equity financing prior to data, and Greg will discuss this in more detail during his comments.
And if we are right about the outcome of the HEAT Study, we have every reason to believe that we will -- believe we will be bringing to market one of the most important new drugs in a generation, that's ThermoDox. You don't have to take our word for it. Look at the support we've had from multiple regulatory agencies around the world and, in particular, from the FDA. We've negotiated an SPA. We have Fast Track. We have Orphan Designation. We have an agreement to file using a 505(b)(2) approach, and we are candidate for priority review as a function of the strength of our data. The reason for this, well, it's clear. HCC is an enormous unmet medical need.Let's go through the facts because I think you'll agree with me, they are sobering. ThermoDox's principle indication is HCC, the world's fifth largest cancer and a disease of significant concern within the global oncology community and public health agency. Incidents is approximately 28,000 in the United States. It's tripled in incidents over the 30 year period from 1977 to 2007. There are 40,000 incidents in Europe, and is growing rapidly at 5% worldwide from a base of 750,000 new cases annually. Over 50% of these new cases will be in China, emphasizing the importance of this market for us and a rationale for a high concentration of investigator sites in that country. The World Health Organization predicts that HCC will become the #1 cancer worldwide by 2020, surpassing lung cancer. For countries in the West and Japan, during the 10-year period ending 2019, incidents is expected to increase by 20% and prevalence by 47%. It's also clear that the evidence for a successful HEAT trial is on our side. We know doxorubicin, the anticancer agent in ThermoDox is active in liver cancer. Our drug system technology is designed to improve its efficacy in the presence of heat. We know that combining ThermoDox with RFA has shown remarkable potential in early phase studies to delay disease progression. We know that delayed progression or PFS, progression-free survival, is both sensitive and specific as a surrogate for overall survival. In our target population, median time to progression is 12 months with median time to death 30 months. Outcome statistics in this population have remained constant since we began our research into HCC over 6 years ago. Read the rest of this transcript for free on seekingalpha.com