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Peregrine Pharmaceuticals (PPHM)
Q3 2011 Earnings Call
March 11, 2011 4:30 pm ET
Joseph Shan - Vice President of Clinical & Regulatory Affairs
Steven King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc
Previous Statements by PPHM
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Philip Thorpe - Member of Scientific Resource Board of Core Technologies
Amy Figueroa - IR, BioCom Partners
Joseph Pantginis - Roth Capital Partners, LLC
George Zavoico - McNicoll, Lewis & Vlak LLC
Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals Third Quarter Fiscal Year 2011 Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to your host, Ms. Amy Figueroa with Peregrine Pharmaceuticals. Please go ahead.
Thanks, Melina. Good afternoon, and thank you for joining us on today's call to discuss our financial results for the third quarter fiscal year 2011 ended January 31, 2011 and review our clinical development programs. Participating on today's call are Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; Joe Shan, Vice President of Clinical and Regulatory Affairs; and we have a special guest today, Dr. Phil Thorpe, President of Pharmacology at UT Southwestern Medical Center, Scientific Adviser to Peregrine and inventor of our PS-targeting technology.
Before we begin, we would like to advise that this conference call includes forward-looking statements. 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 factors 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 the fiscal year ended April 30, 2010, and quarterly report on Form 10-Q for the quarter ended January 31, 2011, which was filed 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 would now like to turn the call over to our CEO, Steve King.
Thank you, Amy. I'd like to start by thanking the investors and analysts that have joined us for the conference call this afternoon. Before we get started, I would like to ask for a moment of silence in respect of those that have lost their lives in the devastating earthquake in Japan. Thank you.
Peregrine has a unique combination of powerful science, Phase II clinical product candidates and an integrative biomanufacturing business that, together, hold the key to driving future value creation as we move closer to achieving our ultimate goal: To advance novel, monoclonal antibody based therapies with broad therapeutic potential in patients with life-threatening diseases to the marketplace.
I would like to start by reviewing recent clinical progress and upcoming milestones for 2011. Our company focus remains on advancing our clinical pipeline, our largest value driver. Since our last call in December, we have made significant progress, including starting two new randomized Phase II trials, bringing our total to four. Positive data from these randomized trials should go a long way in validating our technology in several oncology and viral disease indications. These trials have the potential to generate exactly the type of data that investors, as well as potential partners have been waiting for. Clearly, positive data from these trials should create tremendous value for Peregrine.
In addition, we have kicked off our first three investigator-sponsored trials or ISTs. These trials have the potential to generate data that could again be instrumental in validating the technology platform, as well as guiding future clinical development with new therapeutic combinations or clinical indications. We have not only started new studies, but we have also completed patient enrollment in two trials: A Phase I bavituximab HCV safety study and a Phase II trial for our novel GBM therapy Cotara. We expect data from these trials be presented over the coming months and in the case of Cotara, should result in the meeting with the FDA in the second half of the year to discuss and define a registrational pathway for the product.
Positive Phase II data for Cotara, combined with a clear registrational pathway, will add tremendous value to the program and increase the options for Peregrine from a clinical development as well as a partnering perspective. To support these advancing programs, we have expanded our management team, bringing onboard Doctor Kerstin Menander as our Head of Medical Oncology. Kerstin has extensive experience in clinical development and has a track record of helping achieve 15 product approvals in the U.S. and Europe. Throughout Peregrine Avid, we have brought onboard some key professionals in the areas of manufacturing, process science and clinical and regulatory and our team is excited about driving our future success.
Looking ahead this year, we believe our clinical progress will provide a potential robust flow of clinical data reports. Let me quickly review our expected future clinical milestones. For bavituximab, we expect to complete enrollment in our two randomized Phase II lung cancer trials around midyear, and report interim tumor response data from our front-line open-label study in the second half of the year, followed by top line overall data from both the front and second line double-blinded trials by the end of the year. We also plan to report interim data as available from our recently initiated open-label trials for bavituximab, including the randomized Phase II pancreatic cancer trial and the company-sponsored HCV study, and are hopeful that data may also be available from the three ISTs that are now underway.