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Peregrine Pharmaceuticals (PPHM)
Q1 2013 Earnings Call
September 10, 2012 11:00 am ET
Steven W. King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc
Joseph S. Shan - Vice President of Clinical & Regulatory Affairs
Robert Garnick - Head of Regulatory Affairs
Previous Statements by PPHM
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Joseph Pantginis - Roth Capital Partners, LLC, Research Division
Charles C. Duncan - JMP Securities LLC, Research Division
George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division
Gregory R. Wade - Wedbush Securities Inc., Research Division
Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals First Quarter Fiscal Year 2013 Financial Results Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded.
I'd now like to turn the conference over to your host, Mr. Jay Carlson, Investor Relations Department. Please go ahead.
Thanks, Allie. Good morning, 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 an overview for the company's progress over the last quarter and how these events paved the way for several important near-term clinical data and regulatory milestones. Joe and Rob will discuss our clinical and regulatory plans as we advance our 3 Phase II clinical programs for bavituximab and Cotara. Paul will finish with a summary of our financial results for the first quarter of fiscal year 2013 and to date, including discussion of our recently announced $30 million debt financing. After our prepared remarks, we'll 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 2012 ended April 30, 2012 and quarterly report on form 10-Q for the first quarter, ended July 13, 2012, which will be filed later today.
Investors should not rely on forward-looking statements because they are subject 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'll now turn the call over to Steve.
Steven W. King
Thanks, Jay. Since the beginning of last quarter, it has been an exceptional time for Peregrine as we have seen 2 of the most important milestones in the company history achieved, transitioning the company toward late-stage drug development. The exclamation point for these milestones came just last Friday with the report that patients receiving bavituximab plus chemotherapy in our proof-of-concept study in second-line non-small cell lung cancer had double the median overall survival compared to patients receiving chemotherapy plus placebo. These are truly remarkable results that are not only great for the program, providing a clear signal to proceed toward a Phase III clinical trial, providing proof-of-concept that bavituximab is an active drug when given with docetaxel, but also great news for the non-small cell lung cancer patients in the trial. While moving toward this important data, we also strengthened our balance sheet with a $30 million debt financing at favorable terms and continued to see good performance at our manufacturing subsidiary, Avid Bioservices, successfully navigating regulatory inspections and posting another solid quarter of revenues.
We are continuing to deliver on the milestones laid out earlier in the year and have more important events coming throughout the rest of this year, including our continuing bavituximab partnering discussions and due diligence which remains a highly active area, preparing for an end of Phase II meeting for the bavituximab program and awaiting additional clinical results from 8 ongoing clinical trials that will help further shape the program.
With that, I will now turn the call over to Joe for a recap of the exciting clinical data that was presented last week. Joe?
Joseph S. Shan
Thanks, Steve. I'd like to start by reviewing important details of the clinical data from our Phase II second-line bavituximab non-small cell lung cancer trial that was just presented last Friday in the Plenary session of the 2012 Chicago Multidisciplinary Symposium In Thoracic Oncology. I also encourage everyone to listen to the prerecorded webcast that can be found on our website for a more detailed discussion of the data presentation.
So this trial for our lead indication is a randomized, double-blinded placebo-controlled Phase II trial evaluating docetaxel with or without bavituximab as second-line treatment in patients with Stage IIIb or IV non-squamous non-small cell lung cancer. On study, all patients received standard second-line chemotherapy of up to 6 21-day cycles of docetaxel at 75 milligrams per meter squared. In addition, patients were randomly assigned to receive a blinded weekly infusion of placebo which we refer to as the control group, or 1 of 2 bavituximab doses studied either 1 or 3-milligram per kilogram until progression or toxicity. The primary endpoint of this trial is overall response rate and secondary endpoints include progression-free survival, overall survival and safety.