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TheStreet Open House

Delcath Systems 's CEO Discusses Q2 2012 Results - Earnings Call Transcript

Factors that could cause actual results to differ are discussed from time to time in the company’s filings with the SEC, including our annual report on Form 10-K, and our reports on Form 10-Q and 8-K. These documents are available on the investor relations section of our website, and we encourage you to review the materials. The company has no obligation to publicly update or revise these forward-looking statements to reflect the events or circumstances after the date they are made.

Participating on today’s call are Eamonn Hobbs, President and Chief Executive Officer;

and Graham Miao, Executive Vice President and Chief Financial Officer. Following their opening remarks, we will open the call to questions from analysts and institutional investors. To maximize the time allowed for Q&A, please ask two questions and if you have additional questions please requeue to ask those additional questions. In advance, we thank you for your cooperation.

And now I would like to turn the call over to Mr. Hobbs.

Eamonn Hobbs

Thanks Doug, and good morning everyone. Since we last spoke with you in May, Delcath has made important progress on a number of fronts. During our second quarter and in recent weeks, we made substantial progress towards completion of our new drug application, and are on schedule for submission to the FDA this month, received FDA acceptance of the IND Amendments for use of our Generation 2 filter in our US Expanded Access Program, expanded the total number of leading European cancer centers participating in our CHEMOSAT launch program to 13, recognized our first-ever commercial revenues, raised approximately $21 million in net proceeds through a follow on offering, and strengthened our board of directors with the appointment of two pharma industry veterans.

On our call this morning, I will provide some detail on these operational highlights and then Graham will review our financial results. Then we will be happy to take questions. I will begin with an update on our NDA submission. I am pleased to report that as we reported at our annual meeting we resolved all outstanding safety queries and locked the database on May 25.

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