PPHM - Peregrine Pharmaceuticals - Q4 2013 Earnings Call Transcript

    Company Name:Peregrine Pharmaceuticals
    Event Title:Q4 2013 Earnings Call Transcript
    Event Date:11-Jul-2013
    Event Time:04:30 PM ET



    Good day, ladies and gentlemen and welcome to the Peregrine Pharmaceuticals Inc. Fourth Quarter Fiscal Year 2013 Results Conference Call.

    At this time, all participants are in a listen-only mode. Later, we will have a question-and-answer session and instructions will follow at that time. [Operator Instructions]. And as a reminder, today's conference is being recorded for replay purposes.

    I would now like to turn the conference over to your host for today Mr. Jay Carlson. Sir you may begin.

    Jay Carlson

    Manager, Investor Relations
    Thanks, Merry. Good afternoon and thank you for joining us. On today's call we have Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; Joe Shan, Vice President of Clinical and Regulatory Affairs and Rob Garnick, Head of Regulatory Affairs.

    Steve will begin by providing a brief overview of the company's progress over the last quarter including the company sponsored trials as well as the investigator-sponsored trials or ISTs and how these events set the stage for numerous near-term clinical data milestones.

    Joe will then review the clinical developments of the quarter with Rob then discussing our regulatory plans as we advance our Bavituximab and Cotara programs. Paul will then finish with a summary of our financial results for the fourth quarter and fiscal year 2013. After our prepared remarks, we welcome your questions.

    Before we begin, we would like to remind you that during this call we will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ. These forward-looking statements reflect our current views about future events and financial performance and are identified by the use of terms and phrases such as believe, expect, plan, anticipate, on target and similar expressions identifying forward-looking statements.

    These risks include but are not limited to the risk factors detailed from time to time in our filings with the Securities and Exchange Commission including but not limited to the Annual Report on Form 10-K for our fiscal year 2013 ended April 30, 2013, which was just filed earlier today. Investors should not rely on forward-looking statements because they are subjects to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. And we expressly do not undertake any duty to update forward-looking statements whether as a result of new information, future events or otherwise.

    I will now turn the call over to Steve.

    Steven W. King

    President and Chief Executive Officer, Director
    Thanks, Jay and thank you to everyone who are participating in today's quarterly call.

    We've had a number of important events take place since our last quarterly call in March. These events started with an important revolution further defining bavituximab 's immunotherapy mechanism of action. They extended to compelling final data from our Phase II second line non-small cell lung cancer study. That was the cornerstone for our successful end of Phase II discussions with the FDA.

    That resulted in approval of our Phase III clinical trial design. The better understanding of the mechanism of action has given us a completely new insight into recent clinical results and even further strengthened our excitement about the Phase III trial design combining Bavituximab with docetaxel based on its immune attachment characteristics.

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