Peregrine Pharmaceuticals, Inc. (PPHM)
F1Q2011 Earnings Call Transcript
September 9, 2010 4:30 pm ET
Amy Figueroa – Senior Director, IR and Corporate Communications
Steve King – President and CEO
Chris Eso – VP, Business Operations, Avid
Paul Lytle – CFO
Joe Pantginis – Roth Capital Partners
George Zavoico – MLV
Bill Dawson – LifeTech Capital
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Good day, ladies and gentlemen. Welcome to Peregrine Pharmaceuticals first-quarter fiscal year 2011 financial results conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions)
As a reminder, today's call is being recorded. At this time, I would now like to turn the conference over to Amy Figueroa. You may begin.
Thanks, Joe. Good afternoon and thank you for joining us on today's call to discuss our financial results for the first quarter of fiscal year 2011 ended July 31, 2010 and review our clinical development program. Participating on today's call are Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer, Rob Garnick, Head of Regulatory Affairs; and Chris Eso, Vice President of Business Operations.
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 year ended April 30, 2010 and Quarterly Report on Form 10-Q for the quarter ended July 31, 2010 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. Steve?
Thank you, Amy. Let me start by thanking our investors and analysts for joining us for our quarterly conference call this afternoon. Let me start by saying that we believe the most important future value drivers for Peregrine lie in our multiple Phase 2 clinical programs and I'm pleased to report that over the past quarter, we have advanced these programs across the board. At the beginning of this quarter, we reported positive data at ASCO, showing encouraging objective response in medium progression-free survival data for our lead PS-targeting antibody, Bavituximab, in both lung and advanced breast cancer indications.
Building on this positive data, we initiated two randomized Phase 2B clinical trials for Bavi in non-small-cell lung cancer, representing two independent pathways toward commercialization. Our third oncology Phase 2 development opportunity is for our novel brain cancer therapy, Cotara, for which we also presented data at ASCO demonstrating its excellent targeting capability.
We are currently wrapping up enrollments in an ongoing Phase 2 trial in recurrent GBM which we expect to complete prior to year end. In addition, we have begun seeing increased activity in our Phase 1 clinical trial evaluating Bavi in HCV infected patients and are currently on track to also complete this study by year end, renewing interest in another important potential value driver for the company.
Taken together, we ended the quarter with several advancing clinical trial programs, many with interim data reads possible over the coming year and planning underway for several new trials to further explore the broad potential of our PS-targeting platform helping us to lay the foundation for what we believe can be an exciting year of clinical progress as we pursue multiple development opportunities toward what we hope will be successful commercialization of these exciting compounds in the future.
What I find most exciting about the coming year is that we are running clinical trials that have the potential of creating huge value for each of our clinical programs. Drug development is a long process that typically requires 10 to 15 years or more of investment in research, preclinical studies and multiple levels of clinical trials.
During this entire time, value is built into the program at each phase of development. And our Phase 2 oncology programs are at the point of generating what we believe can be perhaps the most significant value in this process.
Phase 2 proof-of-principle studies, generally the penultimate step in the drug development process.
Starting from our technology platforms built on powerful science to having three Phase 2 oncology clinical trials targeting independent indications, we have made important progress over the past several years. Today, we are clearly focused on executing our programs for future success by advancing the developments of our target therapeutics that have demonstrated broad therapeutic potential in multiple cancer and viral disease indications. And very importantly, our ongoing programs provide several opportunities for initial and potentially even subsequent indication should our efforts be successful.
Joe Shan, our Vice President of Clinical and Regulatory Affairs is currently in Europe to present at a Biological Therapy of Cancer Symposium cosponsored by the European Society for Medical Oncology. In Joe's absence, I will provide you with an update on our clinical programs which are advancing across the board.